CLASS II ONGOING Device recall · Reported 21 Oct 2026 · FDA Enforcement Report

Medline surgical convenience kits labeled as: Spinal CDS recalled

Medline Industries is recalling Medline surgical convenience kits labeled as: Spinal CDS, Medline Product Number, distributed nationwide in the US. The recall was initiated on 2 Sep 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesMedline Product Number/SKU CDS940087AM, UDI/DI 10198459311499 (each) 40198459311490 (case), Lot Number 26DMG028; Medline Product Number/SKU CDS940087AM, UDI/DI 10198459311499 (each) 40198459311490 (case), Lot Number 26DMF181; Medline Product Number/SKU CDS940087AM, UDI/DI 10198459311499 (each) 40198459311490 (case), Lot Number 26DMD186; Medline Product Number/SKU CDS940087AM, UDI/DI 10198459311499 (each) 40198459311490 (case), Lot Number 26CMA323; Medline Product Number/SKU CDS940087AM, UDI/DI 10198459311499 (each) 40198459311490 (case), Lot Number 26BMJ234; Medline Product Number/SKU DYNJ907697C, UDI/DI 10195327697617 (each) 40195327697618 (case), Lot Number 26ALA854; Medline Product Number/SKU DYNJ0159820F, UDI/DI 10193489207057 (each) 40193489207058 (case), Lot Number 26ADB485; Medline Product Number/SKU DYNJ0159820F, UDI/DI 10193489207057 (each) 40193489207058 (case), Lot Number 26ADA395; Medline Product Number/SKU DYNJ67139D, UDI/DI 10195327668273 (each) 40195327668274 (case), Lot Number 26ABM111; Medline Product Number/SKU CDS780025AD, UDI/DI 10198459311598 (each) 40198459311599 (case), Lot Number 25LBH825; Medline Product Number/SKU CDS940087AM, UDI/DI 10198459311499 (each) 40198459311490 (case), Lot Number 25KMC475; Medline Product Number/SKU CDS940087AM, UDI/DI 10198459311499 (each) 40198459311490 (case), Lot Number 25KMB629; Medline Product Number/SKU DYNJ907697C, UDI/DI 10195327697617 (each) 40195327697618 (case), Lot Number 25KLA526; Medline Product Number/SKU CDS780025AD, UDI/DI 10198459311598 (each) 40198459311599 (case), Lot Number 25KBP981; Medline Product Number/SKU DYNJ0159820F, UDI/DI 10193489207057 (each) 40193489207058 (case), Lot Number 25JDB519; Medline Product Number/SKU CDS780025AD, UDI/DI 10198459311598 (each) 40198459311599 (case), Lot Number 25JBI857; Medline Product Number/SKU CDS940087AM, UDI/DI 10198459311499 (each) 40198459311490 (case), Lot Number 25IMC513; Medline Product Number/SKU DYNJ907697C, UDI/DI 10195327697617 (each) 40195327697618 (case), Lot Number 25ILA706; Medline Product Number/SKU DYNJ17333K, UDI/DI 10193489948998 (each) 40193489948999 (case), Lot Number 25IDB222; Medline Product Number/SKU DYNJ67139D, UDI/DI 10195327668273 (each) 40195327668274 (case), Lot Number 25IBP736; Medline Product Number/SKU DYNJ907697C, UDI/DI 10195327697617 (each) 40195327697618 (case), Lot Number 25HLA065; Medline Product Number/SKU CDS780025AD, UDI/DI 10198459311598 (each) 40198459311599 (case), Lot Number 25HBO604; Medline Product Number/SKU DYNJ0159820F, UDI/DI 10193489207057 (each) 40193489207058 (case), Lot Number 25GDB198; Medline Product Number/SKU DYNJ905276F, UDI/DI 10198459247965 (each) 40198459247966 (case), Lot Number 25GBS381; Medline Product Number/SKU CDS940087AM, UDI/DI 10198459311499 (each) 40198459311490 (case), Lot Number 25GBQ923; Medline Product Number/SKU DYNJ67139D, UDI/DI 10195327668273 (each) 40195327668274 (case), Lot Number 25GBJ981; Medline Product Number/SKU DYNJ907697C, UDI/DI 10195327697617 (each) 40195327697618 (case), Lot Number 25FLA160; Medline Product Number/SKU DYNJ17333K, UDI/DI 10193489948998 (each) 40193489948999 (case), Lot Number 25FDA332; Medline Product Number/SKU CDS940087AM, UDI/DI 10198459311499 (each) 40198459311490 (case), Lot Number 25FBN175; Medline Product Number/SKU DYNJ67139D, UDI/DI 10195327668273 (each) 40195327668274 (case), Lot Number 25EBV301; Medline Product Number/SKU CDS940087AM, UDI/DI 10198459311499 (each) 40198459311490 (case), Lot Number 25EBH152; Medline Product Number/SKU DYNJ907697C, UDI/DI 10195327697617 (each) 40195327697618 (case), Lot Number 25DLA962; Medline Product Number/SKU DYNJ17333K, UDI/DI 10193489948998 (each) 40193489948999 (case), Lot Number 25DDB837; Medline Product Number/SKU DYNJ0159820F, UDI/DI 10193489207057 (each) 40193489207058 (case), Lot Number 25DDA286; Medline Product Number/SKU CDS780025AC, UDI/DI 10195327212278 (each) 40195327212279 (case), Lot Number 25DBC339; Medline Product Number/SKU DYNJ907697C, UDI/DI 10195327697617 (each) 40195327697618 (case), Lot Number 25CLA883; Medline Product Number/SKU DYNJ67139D, UDI/DI 10195327668273 (each) 40195327668274 (case), Lot Number 25CBS904; Medline Product Number/SKU CDS940087AL, UDI/DI 10195327297824 (each) 40195327297825 (case), Lot Number 25CBP237; Medline Product Number/SKU CDS780025AC, UDI/DI 10195327212278 (each) 40195327212279 (case), Lot Number 25CBG304; Medline Product Number/SKU CDS780025AC, UDI/DI 10195327212278 (each) 40195327212279 (case), Lot Number 25CBE419; Medline Product Number/SKU DYNJ907697C, UDI/DI 10195327697617 (each) 40195327697618 (case), Lot Number 25ALA976; Medline Product Number/SKU DYNJ907697C, UDI/DI 10195327697617 (each) 40195327697618 (case), Lot Number 25ALA345; Medline Product Number/SKU DYNJ907697C, UDI/DI 10195327697617 (each) 40195327697618 (case), Lot Number 25ALA067; Medline Product Number/SKU CDS940087AL, UDI/DI 10195327297824 (each) 40195327297825 (case), Lot Number 25ABU061; Medline Product Number/SKU CDS940087AL, UDI/DI 10195327297824 (each) 40195327297825 (case), Lot Number 24LBE127; Medline Product Number/SKU DYNJ907697C, UDI/DI 10195327697617 (each) 40195327697618 (case), Lot Number 24KLA163; Medline Product Number/SKU DYNJ67139D, UDI/DI 10195327668273 (each) 40195327668274 (case), Lot Number 24KBR641; Medline Product Number/SKU CDS780025AC, UDI/DI 10195327212278 (each) 40195327212279 (case), Lot Number 24KBD715; Medline Product Number/SKU DYNJ907697C, UDI/DI 10195327697617 (each) 40195327697618 (case), Lot Number 24JLA181; Medline Product Number/SKU DYNJ17333K, UDI/DI 10193489948998 (each) 40193489948999 (case), Lot Number 24JDA289; Medline Product Number/SKU CDS780025AC, UDI/DI 10195327212278 (each) 40195327212279 (case), Lot Number 24JBQ903; Medline Product Number/SKU CDS940087AL, UDI/DI 10195327297824 (each) 40195327297825 (case), Lot Number 24JBQ698; Medline Product Number/SKU CDS940087AL, UDI/DI 10195327297824 (each) 40195327297825 (case), Lot Number 24JBG248; Medline Product Number/SKU CDS780025AC, UDI/DI 10195327212278 (each) 40195327212279 (case), Lot Number 24IBK612; Medline Product Number/SKU DYNJ67139D, UDI/DI 10195327668273 (each) 40195327668274 (case), Lot Number 24HBT188; Medline Product Number/SKU DYNJ17333K, UDI/DI 10193489948998 (each) 40193489948999 (case), Lot Number 24GDA765; Medline Product Number/SKU CDS780025AC, UDI/DI 10195327212278 (each) 40195327212279 (case), Lot Number 24GBE280; Medline Product Number/SKU DYNJ907697C, UDI/DI 10195327697617 (each) 40195327697618 (case), Lot Number 24FLA764; Medline Product Number/SKU DYNJ0159820F, UDI/DI 10193489207057 (each) 40193489207058 (case), Lot Number 24FDA385; Medline Product Number/SKU CDS940087AL, UDI/DI 10195327297824 (each) 40195327297825 (case), Lot Number 24FBN519; Medline Product Number/SKU DYNJ67139D, UDI/DI 10195327668273 (each) 40195327668274 (case), Lot Number 24FBM920; Medline Product Number/SKU CDS780025AC, UDI/DI 10195327212278 (each) 40195327212279 (case), Lot Number 24FBE685; Medline Product Number/SKU DYNJ17333K, UDI/DI 10193489948998 (each) 40193489948999 (case), Lot Number 24DDB513; Medline Product Number/SKU DYNJ17333K, UDI/DI 10193489948998 (each) 40193489948999 (case), Lot Number 24DDA174; Medline Product Number/SKU CDS940087AL, UDI/DI 10195327297824 (each) 40195327297825 (case), Lot Number 24DBH403; Medline Product Number/SKU CDS780025AC, UDI/DI 10195327212278 (each) 40195327212279 (case), Lot Number 24CBP710; Medline Product Number/SKU DYNJ907697A, UDI/DI 10195327536459 (each) 40195327536450 (case), Lot Number 24BLA540; Medline Product Number/SKU CDS780025AC, UDI/DI 10195327212278 (each) 40195327212279 (case), Lot Number 24BBS351; Medline Product Number/SKU CDS940087AL, UDI/DI 10195327297824 (each) 40195327297825 (case), Lot Number 24BBR356; Medline Product Number/SKU CDS940087AL, UDI/DI 10195327297824 (each) 40195327297825 (case), Lot Number 24BBI372; Medline Product Number/SKU DYNJ80055, UDI/DI 10195327008741 (each) 40195327008742 (case), Lot Number 24BBD195; Medline Product Number/SKU CDS780025AC, UDI/DI 10195327212278 (each) 40195327212279 (case), Lot Number 24BBB443; Medline Product Number/SKU DYNJ17333K, UDI/DI 10193489948998 (each) 40193489948999 (case), Lot Number 24ADC061; Medline Product Number/SKU DYNJ0159820F, UDI/DI 10193489207057 (each) 40193489207058 (case), Lot Number 24ADA704; Medline Product Number/SKU DYNJ907697A, UDI/DI 10195327536459 (each) 40195327536450 (case), Lot Number 23LLA416; Medline Product Number/SKU DYNJ17333K, UDI/DI 10193489948998 (each) 40193489948999 (case), Lot Number 23LDA917; Medline Product Number/SKU CDS980929U, UDI/DI 10193489976427 (each) 40193489976428 (case), Lot Number 23LBC788; Medline Product Number/SKU DYNJ907697A, UDI/DI 10195327536459 (each) 40195327536450 (case), Lot Number 23KLB157; Medline Product Number/SKU DYNJ0159820F, UDI/DI 10193489207057 (each) 40193489207058 (case), Lot Number 23KDA615; Medline Product Number/SKU CDS980929U, UDI/DI 10193489976427 (each) 40193489976428 (case), Lot Number 23KBT094; Medline Product Number/SKU CDS940087AL, UDI/DI 10195327297824 (each) 40195327297825 (case), Lot Number 23KBP002; Medline Product Number/SKU CDS940087AL, UDI/DI 10195327297824 (each) 40195327297825 (case), Lot Number 23KBN905; Medline Product Number/SKU CDS780025AC, UDI/DI 10195327212278 (each) 40195327212279 (case), Lot Number 23KBC083; Medline Product Number/SKU DYNJ17333K, UDI/DI 10193489948998 (each) 40193489948999 (case), Lot Number 23JDB177; Medline Product Number/SKU DYNJ17333K, UDI/DI 10193489948998 (each) 40193489948999 (case), Lot Number 23IDB906; Medline Product Number/SKU DYNJ0159820F, UDI/DI 10193489207057 (each) 40193489207058 (case), Lot Number 23IDB810; Medline Product Number/SKU CDS940087AL, UDI/DI 10195327297824 (each) 40195327297825 (case), Lot Number 23IBW076; Medline Product Number/SKU CDS780025AC, UDI/DI 10195327212278 (each) 40195327212279 (case), Lot Number 23IBI612; Medline Product Number/SKU CDS940087AL, UDI/DI 10195327297824 (each) 40195327297825 (case), Lot Number 23IBD027; Medline Product Number/SKU CDS940087AL, UDI/DI 10195327297824 (each) 40195327297825 (case), Lot Number 23HBP378; Medline Product Number/SKU DYNJ0159820F, UDI/DI 10193489207057 (each) 40193489207058 (case), Lot Number 23GDC095; Medline Product Number/SKU DYNJ17333K, UDI/DI 10193489948998 (each) 40193489948999 (case), Lot Number 23FDB307; Medline Product Number/SKU CDS940087AL, UDI/DI 10195327297824 (each) 40195327297825 (case), Lot Number 23FBI843; Medline Product Number/SKU CDS780025AC, UDI/DI 10195327212278 (each) 40195327212279 (case), Lot Number 23FBH173; Medline Product Number/SKU CDS940087AL, UDI/DI 10195327297824 (each) 40195327297825 (case), Lot Number 23EBL944; Medline Product Number/SKU CDS780025AC, UDI/DI 10195327212278 (each) 40195327212279 (case), Lot Number 23EBJ659; Medline Product Number/SKU DYNJ17333K, UDI/DI 10193489948998 (each) 40193489948999 (case), Lot Number 23DDB819; Medline Product Number/SKU CDS940087AL, UDI/DI 10195327297824 (each) 40195327297825 (case), Lot Number 23DBN024; Medline Product Number/SKU DYNJ17333K, UDI/DI 10193489948998 (each) 40193489948999 (case), Lot Number 23CDA324; Medline Product Number/SKU CDS780025AC, UDI/DI 10195327212278 (each) 40195327212279 (case), Lot Number 23CBX130; Medline Product Number/SKU DYNJ17333K, UDI/DI 10193489948998 (each) 40193489948999 (case), Lot Number 23BDB285; Medline Product Number/SKU DYNJ0159820F, UDI/DI 10193489207057 (each) 40193489207058 (case), Lot Number 23ADB644; Medline Product Number/SKU CDS940087AL, UDI/DI 10195327297824 (each) 40195327297825 (case), Lot Number 23ABB068; Medline Product Number/SKU DYNJ49516, UDI/DI 10888277854369 (each) 40888277854360 (case), Lot Number 22LBM685; Medline Product Number/SKU CDS940087AK, UDI/DI 10195327257514 (each) 40195327257515 (case), Lot Number 22LBG216; Medline Product Number/SKU CDS780025AC, UDI/DI 10195327212278 (each) 40195327212279 (case), Lot Number 22LBF788; Medline Product Number/SKU DYNJ49516, UDI/DI 10888277854369 (each) 40888277854360 (case), Lot Number 22LBC322; Medline Product Number/SKU DYNJ17333K, UDI/DI 10193489948998 (each) 40193489948999 (case), Lot Number 22KDB263; Medline Product Number/SKU DYNJ0159820F, UDI/DI 10193489207057 (each) 40193489207058 (case), Lot Number 22KDA291; Medline Product Number/SKU DYNJ17333K, UDI/DI 10193489948998 (each) 40193489948999 (case), Lot Number 22JDA178; Medline Product Number/SKU DYNJ0159820F, UDI/DI 10193489207057 (each) 40193489207058 (case), Lot Number 22IDA027; Medline Product Number/SKU CDS940087AJ, UDI/DI 10195327210427 (each) 40195327210428 (case), Lot Number 22HBO525; Medline Product Number/SKU CDS780025AB, UDI/DI 10193489846966 (each) 40193489846967 (case), Lot Number 22HBB637; Medline Product Number/SKU DYNJ17333K, UDI/DI 10193489948998 (each) 40193489948999 (case), Lot Number 22GDA892; Medline Product Number/SKU CDS780025AB, UDI/DI 10193489846966 (each) 40193489846967 (case), Lot Number 22GBH493; Medline Product Number/SKU CDS940087AI, UDI/DI 10193489933758 (each) 40193489933759 (case), Lot Number 22GBE442; Medline Product Number/SKU CDS780025AB, UDI/DI 10193489846966 (each) 40193489846967 (case), Lot Number 22EBN090; Medline Product Number/SKU CDS940087AI, UDI/DI 10193489933758 (each) 40193489933759 (case), Lot Number 22EBG548; Medline Product Number/SKU CDS940087AI, UDI/DI 10193489933758 (each) 40193489933759 (case), Lot Number 22EBF695; Medline Product Number/SKU CDS940087AI, UDI/DI 10193489933758 (each) 40193489933759 (case), Lot Number 22EBA274; Medline Product Number/SKU CDS780025AB, UDI/DI 10193489846966 (each) 40193489846967 (case), Lot Number 22CBP174; Medline Product Number/SKU DYNJ17333K, UDI/DI 10193489948998 (each) 40193489948999 (case), Lot Number 22BDC466; Medline Product Number/SKU CDS940087AI, UDI/DI 10193489933758 (each) 40193489933759 (case), Lot Number 22BBY060; Medline Product Number/SKU DYNJ49516, UDI/DI 10888277854369 (each) 40888277854360 (case), Lot Number 22BBP492; Medline Product Number/SKU CDS780025AB, UDI/DI 10193489846966 (each) 40193489846967 (case), Lot Number 21LBU758; Medline Product Number/SKU CDS940087AI, UDI/DI 10193489933758 (each) 40193489933759 (case), Lot Number 21KBH163; Medline Product Number/SKU CDS940087AI, UDI/DI 10193489933758 (each) 40193489933759 (case), Lot Number 21JBF936; Medline Product Number/SKU CDS780025AB, UDI/DI 10193489846966 (each) 40193489846967 (case), Lot Number 21IBL720; Medline Product Number/SKU CDS940087AI, UDI/DI 10193489933758 (each) 40193489933759 (case), Lot Number 21IBJ260; Medline Product Number/SKU CDS780025AB, UDI/DI 10193489846966 (each) 40193489846967 (case), Lot Number 21HBL624; Medline Product Number/SKU DYNJ17333K, UDI/DI 10193489948998 (each) 40193489948999 (case), Lot Number 21GDD271; Medline Product Number/SKU CDS940087AI, UDI/DI 10193489933758 (each) 40193489933759 (case), Lot Number 21GBI183; Medline Product Number/SKU DYNJ49516, UDI/DI 10888277854369 (each) 40888277854360 (case), Lot Number 21FBB329; Medline Product Number/SKU DYNJ17333J, UDI/DI 10193489791525 (each) 40193489791526 (case), Lot Number 21EDB082; Medline Product Number/SKU CDS940087AG, UDI/DI 10193489847260 (each) 40193489847261 (case), Lot Number 21EBC900; Medline Product Number/SKU DYNJ17333J, UDI/DI 10193489791525 (each) 40193489791526 (case), Lot Number 21CDA517; Medline Product Number/SKU CDS780025AA, UDI/DI 10193489483932 (each) 40193489483933 (case), Lot Number 21CBD927.

Quantity recalled6069 kits

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0179-2027
FDA event ID: 99886
Recalling firm: Medline Industries, Northfield, IL
Classification: Class II
Status: Ongoing
Recall initiated: 2 Sep 2026
FDA classified: 15 Oct 2026
Reported: 21 Oct 2026
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Packaging Defects
Device type: Spinal Implants

Timeline

2 Sep 2026	Recall initiated by company
15 Oct 2026	Classified by FDA	+43 days
21 Oct 2026	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or breaking during use.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

Medline surgical convenience kits labeled as: 1) SPINAL CDS, Medline Product Number/SKU CDS940087AM; 2) CUSTOM CRANI, Medline Product Number/SKU DYNJ907697C; 3) FEM POP PACK-LF, Medline Product Number/SKU DYNJ0159820F; 4) AV FISTULA PACK, Medline Product Number/SKU DYNJ67139D; 5) CRANIOTOMY CDS, Medline Product Number/SKU CDS780025AD; 6) LAMINECTOMY PACK, Medline Product Number/SKU DYNJ17333K; 7) EXTREMITY-LF, Medline Product Number/SKU DYNJ905276F; 8) CRANIOTOMY CDS, Medline Product Number/SKU CDS780025AC; 9) SPINAL CDS, Medline Product Number/SKU CDS940087AL; 10) CUSTOM CRANI, Medline Product Number/SKU DYNJ907697A; 11) NEURO-SPINE BASIN PACK, Medline Product Number/SKU DYNJ80055; 12) CRANIOTOMY-RICHMOND, Medline Product Number/SKU CDS980929U; 13) ACB EXTRAS PACK-6211, Medline Product Number/SKU DYNJ49516; 14) SPINAL CDS, Medline Product Number/SKU CDS940087AK; 15) SPINAL CDS, Medline Product Number/SKU CDS940087AJ; 16) CRANIOTOMY CDS, Medline Product Number/SKU CDS780025AB; 17) SPINAL CDS, Medline Product Number/SKU CDS940087AI; 18) LAMINECTOMY PACK, Medline Product Number/SKU DYNJ17333J; 19) SPINAL CDS, Medline Product Number/SKU CDS940087AG; 20) CRANIOTOMY CDS, Medline Product Number/SKU CDS780025AA.

Where it was distributed

US Nationwide distribution.

Nationwide

Questions about this recall

Why was it recalled?

Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or breaking during use.

Which lots are affected?

Medline Product Number/SKU CDS940087AM, UDI/DI 10198459311499 (each) 40198459311490 (case), Lot Number 26DMG028; Medline Product Number/SKU CDS940087AM, UDI/DI 10198459311499 (each) 40198459311490 (case), Lot Number 26DMF181; Medline Product Number/SKU CDS940087AM, UDI/DI 10198459311499 (each) 40198459311490 (case), Lot Number 26DMD186; Medline Product Number/SKU CDS940087AM, UDI/DI 10198459311499 (each) 40198459311490 (case), Lot Number 26CMA323; Medline Product Number/SKU CDS940087AM, UDI/DI 10198459311499 (each) 40198459311490 (case), Lot Number 26BMJ234; Medline Product Number/SKU DYNJ907697C, UDI/DI 10195327697617 (each) 40195327697618 (case), Lot Number 26ALA854; Medline Product Number/SKU DYNJ0159820F, UDI/DI 10193489207057 (each) 40193489207058 (case), Lot Number 26ADB485; Medline Product Number/SKU DYNJ0159820F, UDI/DI 10193489207057 (each) 40193489207058 (case), Lot Number 26ADA395; Medline Product Number/SKU DYNJ67139D, UDI/DI 10195327668273 (each) 40195327668274 (case), Lot Number 26ABM111; Medline Product Number/SKU CDS780025AD, UDI/DI 10198459311598 (each) 40198459311599 (case), Lot Number 25LBH825; Medline Product Number/SKU CDS940087AM, UDI/DI 10198459311499 (each) 40198459311490 (case), Lot Number 25KMC475; Medline Product Number/SKU CDS940087AM, UDI/DI 10198459311499 (each) 40198459311490 (case), Lot Number 25KMB629; Medline Product Number/SKU DYNJ907697C, UDI/DI 10195327697617 (each) 40195327697618 (case), Lot Number 25KLA526; Medline Product Number/SKU CDS780025AD, UDI/DI 10198459311598 (each) 40198459311599 (case), Lot Number 25KBP981; Medline Product Number/SKU DYNJ0159820F, UDI/DI 10193489207057 (each) 40193489207058 (case), Lot Number 25JDB519; Medline Product Number/SKU CDS780025AD, UDI/DI 10198459311598 (each) 40198459311599 (case), Lot Number 25JBI857; Medline Product Number/SKU CDS940087AM, UDI/DI 10198459311499 (each) 40198459311490 (case), Lot Number 25IMC513; Medline Product Number/SKU DYNJ907697C, UDI/DI 10195327697617 (each) 40195327697618 (case), Lot Number 25ILA706; Medline Product Number/SKU DYNJ17333K, UDI/DI 10193489948998 (each) 40193489948999 (case), Lot Number 25IDB222; Medline Product Number/SKU DYNJ67139D, UDI/DI 10195327668273 (each) 40195327668274 (case), Lot Number 25IBP736; Medline Product Number/SKU DYNJ907697C, UDI/DI 10195327697617 (each) 40195327697618 (case), Lot Number 25HLA065; Medline Product Number/SKU CDS780025AD, UDI/DI 10198459311598 (each) 40198459311599 (case), Lot Number 25HBO604; Medline Product Number/SKU DYNJ0159820F, UDI/DI 10193489207057 (each) 40193489207058 (case), Lot Number 25GDB198; Medline Product Number/SKU DYNJ905276F, UDI/DI 10198459247965 (each) 40198459247966 (case), Lot Number 25GBS381; Medline Product Number/SKU CDS940087AM, UDI/DI 10198459311499 (each) 40198459311490 (case), Lot Number 25GBQ923; Medline Product Number/SKU DYNJ67139D, UDI/DI 10195327668273 (each) 40195327668274 (case), Lot Number 25GBJ981; Medline Product Number/SKU DYNJ907697C, UDI/DI 10195327697617 (each) 40195327697618 (case), Lot Number 25FLA160; Medline Product Number/SKU DYNJ17333K, UDI/DI 10193489948998 (each) 40193489948999 (case), Lot Number 25FDA332; Medline Product Number/SKU CDS940087AM, UDI/DI 10198459311499 (each) 40198459311490 (case), Lot Number 25FBN175; Medline Product Number/SKU DYNJ67139D, UDI/DI 10195327668273 (each) 40195327668274 (case), Lot Number 25EBV301; Medline Product Number/SKU CDS940087AM, UDI/DI 10198459311499 (each) 40198459311490 (case), Lot Number 25EBH152; Medline Product Number/SKU DYNJ907697C, UDI/DI 10195327697617 (each) 40195327697618 (case), Lot Number 25DLA962; Medline Product Number/SKU DYNJ17333K, UDI/DI 10193489948998 (each) 40193489948999 (case), Lot Number 25DDB837; Medline Product Number/SKU DYNJ0159820F, UDI/DI 10193489207057 (each) 40193489207058 (case), Lot Number 25DDA286; Medline Product Number/SKU CDS780025AC, UDI/DI 10195327212278 (each) 40195327212279 (case), Lot Number 25DBC339; Medline Product Number/SKU DYNJ907697C, UDI/DI 10195327697617 (each) 40195327697618 (case), Lot Number 25CLA883; Medline Product Number/SKU DYNJ67139D, UDI/DI 10195327668273 (each) 40195327668274 (case), Lot Number 25CBS904; Medline Product Number/SKU CDS940087AL, UDI/DI 10195327297824 (each) 40195327297825 (case), Lot Number 25CBP237; Medline Product Number/SKU CDS780025AC, UDI/DI 10195327212278 (each) 40195327212279 (case), Lot Number 25CBG304; Medline Product Number/SKU CDS780025AC, UDI/DI 10195327212278 (each) 40195327212279 (case), Lot Number 25CBE419; Medline Product Number/SKU DYNJ907697C, UDI/DI 10195327697617 (each) 40195327697618 (case), Lot Number 25ALA976; Medline Product Number/SKU DYNJ907697C, UDI/DI 10195327697617 (each) 40195327697618 (case), Lot Number 25ALA345; Medline Product Number/SKU DYNJ907697C, UDI/DI 10195327697617 (each) 40195327697618 (case), Lot Number 25ALA067; Medline Product Number/SKU CDS940087AL, UDI/DI 10195327297824 (each) 40195327297825 (case), Lot Number 25ABU061; Medline Product Number/SKU CDS940087AL, UDI/DI 10195327297824 (each) 40195327297825 (case), Lot Number 24LBE127; Medline Product Number/SKU DYNJ907697C, UDI/DI 10195327697617 (each) 40195327697618 (case), Lot Number 24KLA163; Medline Product Number/SKU DYNJ67139D, UDI/DI 10195327668273 (each) 40195327668274 (case), Lot Number 24KBR641; Medline Product Number/SKU CDS780025AC, UDI/DI 10195327212278 (each) 40195327212279 (case), Lot Number 24KBD715; Medline Product Number/SKU DYNJ907697C, UDI/DI 10195327697617 (each) 40195327697618 (case), Lot Number 24JLA181; Medline Product Number/SKU DYNJ17333K, UDI/DI 10193489948998 (each) 40193489948999 (case), Lot Number 24JDA289; Medline Product Number/SKU CDS780025AC, UDI/DI 10195327212278 (each) 40195327212279 (case), Lot Number 24JBQ903; Medline Product Number/SKU CDS940087AL, UDI/DI 10195327297824 (each) 40195327297825 (case), Lot Number 24JBQ698; Medline Product Number/SKU CDS940087AL, UDI/DI 10195327297824 (each) 40195327297825 (case), Lot Number 24JBG248; Medline Product Number/SKU CDS780025AC, UDI/DI 10195327212278 (each) 40195327212279 (case), Lot Number 24IBK612; Medline Product Number/SKU DYNJ67139D, UDI/DI 10195327668273 (each) 40195327668274 (case), Lot Number 24HBT188; Medline Product Number/SKU DYNJ17333K, UDI/DI 10193489948998 (each) 40193489948999 (case), Lot Number 24GDA765; Medline Product Number/SKU CDS780025AC, UDI/DI 10195327212278 (each) 40195327212279 (case), Lot Number 24GBE280; Medline Product Number/SKU DYNJ907697C, UDI/DI 10195327697617 (each) 40195327697618 (case), Lot Number 24FLA764; Medline Product Number/SKU DYNJ0159820F, UDI/DI 10193489207057 (each) 40193489207058 (case), Lot Number 24FDA385; Medline Product Number/SKU CDS940087AL, UDI/DI 10195327297824 (each) 40195327297825 (case), Lot Number 24FBN519; Medline Product Number/SKU DYNJ67139D, UDI/DI 10195327668273 (each) 40195327668274 (case), Lot Number 24FBM920; Medline Product Number/SKU CDS780025AC, UDI/DI 10195327212278 (each) 40195327212279 (case), Lot Number 24FBE685; Medline Product Number/SKU DYNJ17333K, UDI/DI 10193489948998 (each) 40193489948999 (case), Lot Number 24DDB513; Medline Product Number/SKU DYNJ17333K, UDI/DI 10193489948998 (each) 40193489948999 (case), Lot Number 24DDA174; Medline Product Number/SKU CDS940087AL, UDI/DI 10195327297824 (each) 40195327297825 (case), Lot Number 24DBH403; Medline Product Number/SKU CDS780025AC, UDI/DI 10195327212278 (each) 40195327212279 (case), Lot Number 24CBP710; Medline Product Number/SKU DYNJ907697A, UDI/DI 10195327536459 (each) 40195327536450 (case), Lot Number 24BLA540; Medline Product Number/SKU CDS780025AC, UDI/DI 10195327212278 (each) 40195327212279 (case), Lot Number 24BBS351; Medline Product Number/SKU CDS940087AL, UDI/DI 10195327297824 (each) 40195327297825 (case), Lot Number 24BBR356; Medline Product Number/SKU CDS940087AL, UDI/DI 10195327297824 (each) 40195327297825 (case), Lot Number 24BBI372; Medline Product Number/SKU DYNJ80055, UDI/DI 10195327008741 (each) 40195327008742 (case), Lot Number 24BBD195; Medline Product Number/SKU CDS780025AC, UDI/DI 10195327212278 (each) 40195327212279 (case), Lot Number 24BBB443; Medline Product Number/SKU DYNJ17333K, UDI/DI 10193489948998 (each) 40193489948999 (case), Lot Number 24ADC061; Medline Product Number/SKU DYNJ0159820F, UDI/DI 10193489207057 (each) 40193489207058 (case), Lot Number 24ADA704; Medline Product Number/SKU DYNJ907697A, UDI/DI 10195327536459 (each) 40195327536450 (case), Lot Number 23LLA416; Medline Product Number/SKU DYNJ17333K, UDI/DI 10193489948998 (each) 40193489948999 (case), Lot Number 23LDA917; Medline Product Number/SKU CDS980929U, UDI/DI 10193489976427 (each) 40193489976428 (case), Lot Number 23LBC788; Medline Product Number/SKU DYNJ907697A, UDI/DI 10195327536459 (each) 40195327536450 (case), Lot Number 23KLB157; Medline Product Number/SKU DYNJ0159820F, UDI/DI 10193489207057 (each) 40193489207058 (case), Lot Number 23KDA615; Medline Product Number/SKU CDS980929U, UDI/DI 10193489976427 (each) 40193489976428 (case), Lot Number 23KBT094; Medline Product Number/SKU CDS940087AL, UDI/DI 10195327297824 (each) 40195327297825 (case), Lot Number 23KBP002; Medline Product Number/SKU CDS940087AL, UDI/DI 10195327297824 (each) 40195327297825 (case), Lot Number 23KBN905; Medline Product Number/SKU CDS780025AC, UDI/DI 10195327212278 (each) 40195327212279 (case), Lot Number 23KBC083; Medline Product Number/SKU DYNJ17333K, UDI/DI 10193489948998 (each) 40193489948999 (case), Lot Number 23JDB177; Medline Product Number/SKU DYNJ17333K, UDI/DI 10193489948998 (each) 40193489948999 (case), Lot Number 23IDB906; Medline Product Number/SKU DYNJ0159820F, UDI/DI 10193489207057 (each) 40193489207058 (case), Lot Number 23IDB810; Medline Product Number/SKU CDS940087AL, UDI/DI 10195327297824 (each) 40195327297825 (case), Lot Number 23IBW076; Medline Product Number/SKU CDS780025AC, UDI/DI 10195327212278 (each) 40195327212279 (case), Lot Number 23IBI612; Medline Product Number/SKU CDS940087AL, UDI/DI 10195327297824 (each) 40195327297825 (case), Lot Number 23IBD027; Medline Product Number/SKU CDS940087AL, UDI/DI 10195327297824 (each) 40195327297825 (case), Lot Number 23HBP378; Medline Product Number/SKU DYNJ0159820F, UDI/DI 10193489207057 (each) 40193489207058 (case), Lot Number 23GDC095; Medline Product Number/SKU DYNJ17333K, UDI/DI 10193489948998 (each) 40193489948999 (case), Lot Number 23FDB307; Medline Product Number/SKU CDS940087AL, UDI/DI 10195327297824 (each) 40195327297825 (case), Lot Number 23FBI843; Medline Product Number/SKU CDS780025AC, UDI/DI 10195327212278 (each) 40195327212279 (case), Lot Number 23FBH173; Medline Product Number/SKU CDS940087AL, UDI/DI 10195327297824 (each) 40195327297825 (case), Lot Number 23EBL944; Medline Product Number/SKU CDS780025AC, UDI/DI 10195327212278 (each) 40195327212279 (case), Lot Number 23EBJ659; Medline Product Number/SKU DYNJ17333K, UDI/DI 10193489948998 (each) 40193489948999 (case), Lot Number 23DDB819; Medline Product Number/SKU CDS940087AL, UDI/DI 10195327297824 (each) 40195327297825 (case), Lot Number 23DBN024; Medline Product Number/SKU DYNJ17333K, UDI/DI 10193489948998 (each) 40193489948999 (case), Lot Number 23CDA324; Medline Product Number/SKU CDS780025AC, UDI/DI 10195327212278 (each) 40195327212279 (case), Lot Number 23CBX130; Medline Product Number/SKU DYNJ17333K, UDI/DI 10193489948998 (each) 40193489948999 (case), Lot Number 23BDB285; Medline Product Number/SKU DYNJ0159820F, UDI/DI 10193489207057 (each) 40193489207058 (case), Lot Number 23ADB644; Medline Product Number/SKU CDS940087AL, UDI/DI 10195327297824 (each) 40195327297825 (case), Lot Number 23ABB068; Medline Product Number/SKU DYNJ49516, UDI/DI 10888277854369 (each) 40888277854360 (case), Lot Number 22LBM685; Medline Product Number/SKU CDS940087AK, UDI/DI 10195327257514 (each) 40195327257515 (case), Lot Number 22LBG216; Medline Product Number/SKU CDS780025AC, UDI/DI 10195327212278 (each) 40195327212279 (case), Lot Number 22LBF788; Medline Product Number/SKU DYNJ49516, UDI/DI 10888277854369 (each) 40888277854360 (case), Lot Number 22LBC322; Medline Product Number/SKU DYNJ17333K, UDI/DI 10193489948998 (each) 40193489948999 (case), Lot Number 22KDB263; Medline Product Number/SKU DYNJ0159820F, UDI/DI 10193489207057 (each) 40193489207058 (case), Lot Number 22KDA291; Medline Product Number/SKU DYNJ17333K, UDI/DI 10193489948998 (each) 40193489948999 (case), Lot Number 22JDA178; Medline Product Number/SKU DYNJ0159820F, UDI/DI 10193489207057 (each) 40193489207058 (case), Lot Number 22IDA027; Medline Product Number/SKU CDS940087AJ, UDI/DI 10195327210427 (each) 40195327210428 (case), Lot Number 22HBO525; Medline Product Number/SKU CDS780025AB, UDI/DI 10193489846966 (each) 40193489846967 (case), Lot Number 22HBB637; Medline Product Number/SKU DYNJ17333K, UDI/DI 10193489948998 (each) 40193489948999 (case), Lot Number 22GDA892; Medline Product Number/SKU CDS780025AB, UDI/DI 10193489846966 (each) 40193489846967 (case), Lot Number 22GBH493; Medline Product Number/SKU CDS940087AI, UDI/DI 10193489933758 (each) 40193489933759 (case), Lot Number 22GBE442; Medline Product Number/SKU CDS780025AB, UDI/DI 10193489846966 (each) 40193489846967 (case), Lot Number 22EBN090; Medline Product Number/SKU CDS940087AI, UDI/DI 10193489933758 (each) 40193489933759 (case), Lot Number 22EBG548; Medline Product Number/SKU CDS940087AI, UDI/DI 10193489933758 (each) 40193489933759 (case), Lot Number 22EBF695; Medline Product Number/SKU CDS940087AI, UDI/DI 10193489933758 (each) 40193489933759 (case), Lot Number 22EBA274; Medline Product Number/SKU CDS780025AB, UDI/DI 10193489846966 (each) 40193489846967 (case), Lot Number 22CBP174; Medline Product Number/SKU DYNJ17333K, UDI/DI 10193489948998 (each) 40193489948999 (case), Lot Number 22BDC466; Medline Product Number/SKU CDS940087AI, UDI/DI 10193489933758 (each) 40193489933759 (case), Lot Number 22BBY060; Medline Product Number/SKU DYNJ49516, UDI/DI 10888277854369 (each) 40888277854360 (case), Lot Number 22BBP492; Medline Product Number/SKU CDS780025AB, UDI/DI 10193489846966 (each) 40193489846967 (case), Lot Number 21LBU758; Medline Product Number/SKU CDS940087AI, UDI/DI 10193489933758 (each) 40193489933759 (case), Lot Number 21KBH163; Medline Product Number/SKU CDS940087AI, UDI/DI 10193489933758 (each) 40193489933759 (case), Lot Number 21JBF936; Medline Product Number/SKU CDS780025AB, UDI/DI 10193489846966 (each) 40193489846967 (case), Lot Number 21IBL720; Medline Product Number/SKU CDS940087AI, UDI/DI 10193489933758 (each) 40193489933759 (case), Lot Number 21IBJ260; Medline Product Number/SKU CDS780025AB, UDI/DI 10193489846966 (each) 40193489846967 (case), Lot Number 21HBL624; Medline Product Number/SKU DYNJ17333K, UDI/DI 10193489948998 (each) 40193489948999 (case), Lot Number 21GDD271; Medline Product Number/SKU CDS940087AI, UDI/DI 10193489933758 (each) 40193489933759 (case), Lot Number 21GBI183; Medline Product Number/SKU DYNJ49516, UDI/DI 10888277854369 (each) 40888277854360 (case), Lot Number 21FBB329; Medline Product Number/SKU DYNJ17333J, UDI/DI 10193489791525 (each) 40193489791526 (case), Lot Number 21EDB082; Medline Product Number/SKU CDS940087AG, UDI/DI 10193489847260 (each) 40193489847261 (case), Lot Number 21EBC900; Medline Product Number/SKU DYNJ17333J, UDI/DI 10193489791525 (each) 40193489791526 (case), Lot Number 21CDA517; Medline Product Number/SKU CDS780025AA, UDI/DI 10193489483932 (each) 40193489483933 (case), Lot Number 21CBD927.

Where was it sold?

US Nationwide distribution.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 27 Oct 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

9 other products · FDA event 99886

This product is part of a recall event; the main page for the event is Medline surgical convenience kits labeled as: Open Heart recalled.

Reported	Class	Recall	Company	Reason	Where
21 Oct 2026	CLASS II	Medline surgical convenience kits labeled as: Open Heart recalled	Medline Industries	Packaging Defects	Nationwide
21 Oct 2026	CLASS II	Medline surgical convenience kits labeled as recalled	Medline Industries	Packaging Defects	Nationwide
21 Oct 2026	CLASS II	Medline surgical convenience kits labeled as recalled	Medline Industries	Packaging Defects	Nationwide
21 Oct 2026	CLASS II	Medline surgical convenience kits labeled as recalled	Medline Industries	Packaging Defects	Nationwide
21 Oct 2026	CLASS II	Medline surgical convenience kits labeled as recalled	Medline Industries	Packaging Defects	Nationwide
21 Oct 2026	CLASS II	Medline surgical convenience kits labeled as recalled	Medline Industries	Packaging Defects	Nationwide
21 Oct 2026	CLASS II	Product Name Aud Open Heart Pack, Medline Kit Number recalled	Medline Industries	Packaging Defects	Nationwide
21 Oct 2026	CLASS II	Medline surgical convenience kits labeled as recalled	Medline Industries	Packaging Defects	Nationwide
21 Oct 2026	CLASS II	Medline surgical convenience kits labeled as: EAR recalled	Medline Industries	Packaging Defects	Nationwide

More recalls from Medline Industries

All 726

Reported	Class	Recall	Company	Reason	Where
21 Oct 2026Device	CLASS II	Medline surgical convenience kits labeled as: EAR recalled	Medline Industries	Packaging Defects	Nationwide
21 Oct 2026Device	CLASS II	Convenience Kits containing Conmed AirSeal Access Ports recalled	Medline Industries	Packaging Defects	Nationwide
21 Oct 2026Device	CLASS II	Medline surgical convenience kits labeled as recalled	Medline Industries	Packaging Defects	Nationwide
21 Oct 2026Device	CLASS II	Convenience Kits containing Conmed AirSeal Access Ports recalled	Medline Industries	Packaging Defects	Nationwide
21 Oct 2026Device	CLASS II	Convenience Kits containing Conmed AirSeal Access Ports recalled	Medline Industries	Packaging Defects	Nationwide

Other Spinal Implants recalls

All 1,161

Reported	Class	Recall	Company	Reason	Where
21 Oct 2026Device	CLASS II	Medline surgical convenience kits labeled as recalled	Medline Industries	Packaging Defects	Nationwide
30 Sep 2026Device	CLASS II	Extended Polyaxial Head, Attached Gimbal recalled	Seaspine Orthopedics	Other	Nationwide
30 Sep 2026Device	CLASS II	Medline Convenience Kits: Anterior Spine Pack recalled	Medline Industries	Other	Nationwide
9 Sep 2026Device	CLASS II	Neuro; Neuro; Crani; Ortho Spine Pack; Bmhm Neuro Pack recalled	Avid Medical	Sterility	Nationwide
9 Sep 2026Device	CLASS II	Halyard medical convenience kits labeled as: ENT recalled	Avid Medical	Sterility	Nationwide