CLASS II ONGOING Device recall · Reported 2 Sep 2026 · FDA Enforcement Report

Medline medical convenience kits, labeled as recalled

Medline Industries is recalling Medline medical convenience kits, labeled as: Laminectomy Pack, Medline Kit, distributed nationwide in the US. The recall was initiated on 8 Jul 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesMedline Kit SKU DYNJT6548, UDI/DI 10198459558764 (each) 40198459558765 (case), Lot Number 25JMF561; Medline Kit SKU DYNJ44504G, UDI/DI 10198459241956 (each) 40198459241957 (case), Lot Number 25EDA305; Medline Kit SKU DYNJ44504G, UDI/DI 10198459241956 (each) 40198459241957 (case), Lot Number 25EDB254; Medline Kit SKU DYNJ45419F, UDI/DI 10195327625689 (each) 40195327625680 (case), Lot Number 24JMF418; Medline Kit SKU DYNJ45419F, UDI/DI 10195327625689 (each) 40195327625680 (case), Lot Number 24JMJ129; Medline Kit SKU DYNJ46024F, UDI/DI 10195327237011 (each) 40195327237012 (case), Lot Number 23HBJ773; Medline Kit SKU DYNJ54479C, UDI/DI 10193489460254 (each) 40193489460255 (case), Lot Number 23HBA720; Medline Kit SKU DYNJ58006B, UDI/DI 10193489867381 (each) 40193489867382 (case), Lot Number 23BMC930; Medline Kit SKU DYNJ58006B, UDI/DI 10193489867381 (each) 40193489867382 (case), Lot Number 23FMD505; Medline Kit SKU DYNJ58006B, UDI/DI 10193489867381 (each) 40193489867382 (case), Lot Number 23JMH313; Medline Kit SKU DYNJ58006B, UDI/DI 10193489867381 (each) 40193489867382 (case), Lot Number 23LME066; Medline Kit SKU DYNJ58006B, UDI/DI 10193489867381 (each) 40193489867382 (case), Lot Number 22CMG565; Medline Kit SKU DYNJ58014A, UDI/DI 10193489864007 (each) 40193489864008 (case), Lot Number 24BME326; Medline Kit SKU DYNJ58014A, UDI/DI 10193489864007 (each) 40193489864008 (case), Lot Number 24EMF925; Medline Kit SKU DYNJ58014A, UDI/DI 10193489864007 (each) 40193489864008 (case), Lot Number 23AMJ184; Medline Kit SKU DYNJ58014A, UDI/DI 10193489864007 (each) 40193489864008 (case), Lot Number 23EMD739; Medline Kit SKU DYNJ58014A, UDI/DI 10193489864007 (each) 40193489864008 (case), Lot Number 23IME138; Medline Kit SKU DYNJ58014A, UDI/DI 10193489864007 (each) 40193489864008 (case), Lot Number 23KMB648; Medline Kit SKU DYNJ58014A, UDI/DI 10193489864007 (each) 40193489864008 (case), Lot Number 23LMB107; Medline Kit SKU DYNJ58014A, UDI/DI 10193489864007 (each) 40193489864008 (case), Lot Number 23LMH426; Medline Kit SKU DYNJ58014A, UDI/DI 10193489864007 (each) 40193489864008 (case), Lot Number 22FMF374; Medline Kit SKU DYNJ58014A, UDI/DI 10193489864007 (each) 40193489864008 (case), Lot Number 22KMH219; Medline Kit SKU DYNJ83585, UDI/DI 10195327283179 (each) 40195327283170 (case), Lot Number 23HMC695; Medline Kit SKU DYNJ88056, UDI/DI 10198459092725 (each) 40198459092726 (case), Lot Number 25CMD816; Medline Kit SKU DYNJ88056, UDI/DI 10198459092725 (each) 40198459092726 (case), Lot Number 24IMD021; Medline Kit SKU DYNJ88056, UDI/DI 10198459092725 (each) 40198459092726 (case), Lot Number 24IME838; Medline Kit SKU DYNJ900467I, UDI/DI 10195327181338 (each) 40195327181339 (case), Lot Number 23IBJ627; Medline Kit SKU DYNJ900467I, UDI/DI 10195327181338 (each) 40195327181339 (case), Lot Number 23IBL564; Medline Kit SKU PHS396933009C, UDI/DI 10193489753301 (each) 40193489753302 (case), Lot Number 22EDB595

Quantity recalled974 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-2997-2026
FDA event ID: 99489
Recalling firm: Medline Industries, Northfield, IL
Classification: Class II
Status: Ongoing
Recall initiated: 8 Jul 2026
FDA classified: 21 Aug 2026
Reported: 2 Sep 2026
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Other Reasons
Device type: Spinal Implants

Timeline

8 Jul 2026	Recall initiated by company
21 Aug 2026	Classified by FDA	+44 days
2 Sep 2026	Published in enforcement report	+12 days

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

Reason for recall

Specific item(s) and lot(s) of Medline convenience kits containing Pilling Wecksorb Neurosponges and Neurosponge Strips are being recalled due to potential out-of-specification levels of endotoxin of the neurosponges.

Product as listed by the FDA

Medline medical convenience kits, labeled as: 1) LAMINECTOMY PACK, Medline Kit SKU DYNJT6548; 2) ORTHO SPINE PACK, Medline Kit SKU DYNJ44504G; 3) NEURO SPINE PACK, Medline Kit SKU DYNJ45419F; 4) CRANIOTOMY PACK, Medline Kit SKU DYNJ46024F; 5) SPINE PACK, Medline Kit SKU DYNJ54479C; 6) CRANIOTOMY PACK, Medline Kit SKU DYNJ58006B; 7) ORTHO-LAMINECTOMY PACK, Medline Kit SKU DYNJ58014A; 8) SPINE PACK, Medline Kit SKU DYNJ83585; 9) ORTHO SPINE PACK, Medline Kit SKU DYNJ88056; 10) CRANI MT CARMEL, Medline Kit SKU DYNJ900467I; 11) GP-NEURO SPINE PACK-LF, Medline Kit SKU PHS396933009C.

Where it was distributed

US Nationwide distribution in the states of AZ, CA, IA, ID, IL, IN, MA, MD, MI, MN, MO, MT, NY, OH, TX, WI, WY.

Nationwide Arizona California Iowa Idaho Illinois Indiana Massachusetts Maryland Michigan Minnesota Missouri Montana New York Ohio Texas Wisconsin Wyoming

Questions about this recall

Why was it recalled?

Which lots are affected?

Medline Kit SKU DYNJT6548, UDI/DI 10198459558764 (each) 40198459558765 (case), Lot Number 25JMF561; Medline Kit SKU DYNJ44504G, UDI/DI 10198459241956 (each) 40198459241957 (case), Lot Number 25EDA305; Medline Kit SKU DYNJ44504G, UDI/DI 10198459241956 (each) 40198459241957 (case), Lot Number 25EDB254; Medline Kit SKU DYNJ45419F, UDI/DI 10195327625689 (each) 40195327625680 (case), Lot Number 24JMF418; Medline Kit SKU DYNJ45419F, UDI/DI 10195327625689 (each) 40195327625680 (case), Lot Number 24JMJ129; Medline Kit SKU DYNJ46024F, UDI/DI 10195327237011 (each) 40195327237012 (case), Lot Number 23HBJ773; Medline Kit SKU DYNJ54479C, UDI/DI 10193489460254 (each) 40193489460255 (case), Lot Number 23HBA720; Medline Kit SKU DYNJ58006B, UDI/DI 10193489867381 (each) 40193489867382 (case), Lot Number 23BMC930; Medline Kit SKU DYNJ58006B, UDI/DI 10193489867381 (each) 40193489867382 (case), Lot Number 23FMD505; Medline Kit SKU DYNJ58006B, UDI/DI 10193489867381 (each) 40193489867382 (case), Lot Number 23JMH313; Medline Kit SKU DYNJ58006B, UDI/DI 10193489867381 (each) 40193489867382 (case), Lot Number 23LME066; Medline Kit SKU DYNJ58006B, UDI/DI 10193489867381 (each) 40193489867382 (case), Lot Number 22CMG565; Medline Kit SKU DYNJ58014A, UDI/DI 10193489864007 (each) 40193489864008 (case), Lot Number 24BME326; Medline Kit SKU DYNJ58014A, UDI/DI 10193489864007 (each) 40193489864008 (case), Lot Number 24EMF925; Medline Kit SKU DYNJ58014A, UDI/DI 10193489864007 (each) 40193489864008 (case), Lot Number 23AMJ184; Medline Kit SKU DYNJ58014A, UDI/DI 10193489864007 (each) 40193489864008 (case), Lot Number 23EMD739; Medline Kit SKU DYNJ58014A, UDI/DI 10193489864007 (each) 40193489864008 (case), Lot Number 23IME138; Medline Kit SKU DYNJ58014A, UDI/DI 10193489864007 (each) 40193489864008 (case), Lot Number 23KMB648; Medline Kit SKU DYNJ58014A, UDI/DI 10193489864007 (each) 40193489864008 (case), Lot Number 23LMB107; Medline Kit SKU DYNJ58014A, UDI/DI 10193489864007 (each) 40193489864008 (case), Lot Number 23LMH426; Medline Kit SKU DYNJ58014A, UDI/DI 10193489864007 (each) 40193489864008 (case), Lot Number 22FMF374; Medline Kit SKU DYNJ58014A, UDI/DI 10193489864007 (each) 40193489864008 (case), Lot Number 22KMH219; Medline Kit SKU DYNJ83585, UDI/DI 10195327283179 (each) 40195327283170 (case), Lot Number 23HMC695; Medline Kit SKU DYNJ88056, UDI/DI 10198459092725 (each) 40198459092726 (case), Lot Number 25CMD816; Medline Kit SKU DYNJ88056, UDI/DI 10198459092725 (each) 40198459092726 (case), Lot Number 24IMD021; Medline Kit SKU DYNJ88056, UDI/DI 10198459092725 (each) 40198459092726 (case), Lot Number 24IME838; Medline Kit SKU DYNJ900467I, UDI/DI 10195327181338 (each) 40195327181339 (case), Lot Number 23IBJ627; Medline Kit SKU DYNJ900467I, UDI/DI 10195327181338 (each) 40195327181339 (case), Lot Number 23IBL564; Medline Kit SKU PHS396933009C, UDI/DI 10193489753301 (each) 40193489753302 (case), Lot Number 22EDB595

Where was it sold?

US Nationwide distribution in the states of AZ, CA, IA, ID, IL, IN, MA, MD, MI, MN, MO, MT, NY, OH, TX, WI, WY.

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 26 Sep 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

3 other products · FDA event 99489

This product is part of a recall event; the main page for the event is Medline medical convenience kits, labeled as: Sinus Pack-lf recalled.

Reported	Class	Recall	Company	Reason	Where
2 Sep 2026	CLASS II	Medline medical convenience kits, labeled as: Sinus Pack-lf recalled	Medline Industries	Other	Nationwide
2 Sep 2026	CLASS II	Medline medical convenience kits, labeled as: Neuro CDS, Medline Kit recalled	Medline Industries	Other	Nationwide
2 Sep 2026	CLASS II	Medline medical convenience kits, labeled as recalled	Medline Industries	Other	Nationwide

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30 Sep 2026Device	CLASS II	Medline Convenience Kits: Major Pack recalled by Medline Industries	Medline Industries	Other	Nationwide
30 Sep 2026Device	CLASS II	Medline Convenience Kits: Peds Sinus Pack recalled by Medline Industries	Medline Industries	Other	Nationwide
30 Sep 2026Device	CLASS II	Medline Convenience Kits: Mfc Craniotomy Pack recalled	Medline Industries	Other	Nationwide

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