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

Product Name Aud Open Heart Pack, Medline Kit Number recalled

Medline Industries is recalling Product Name Aud Open Heart Pack, Medline Kit 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 DYNJ911589A, UDI/DI 10198459646102 (each) 40198459646103 (case), Lot Number 26CBD487; Medline product number/SKU DYNJ911710, UDI/DI 10198459515705 (each) 40198459515706 (case), Lot Number 26BLA622; Medline product number/SKU DYNJ35312K, UDI/DI 10198459311574 (each) 40198459311575 (case), Lot Number 26ADA368; Medline product number/SKU DYNJT7607, UDI/DI 10198459639470 (each) 40198459639471 (case), Lot Number 26ABP608; Medline product number/SKU DYNJ911710, UDI/DI 10198459515705 (each) 40198459515706 (case), Lot Number 25KLA755; Medline product number/SKU DYNJ35312K, UDI/DI 10198459311574 (each) 40198459311575 (case), Lot Number 25KDA055; Medline product number/SKU DYNJ911710, UDI/DI 10198459515705 (each) 40198459515706 (case), Lot Number 25JLA081; Medline product number/SKU DYNJ80549D, UDI/DI 10198459389610 (each) 40198459389611 (case), Lot Number 25JBQ932; Medline product number/SKU DYNJ35312K, UDI/DI 10198459311574 (each) 40198459311575 (case), Lot Number 25IDA242; Medline product number/SKU DYNJ80549D, UDI/DI 10198459389610 (each) 40198459389611 (case), Lot Number 25HBV035; Medline product number/SKU DYNJ24528P, UDI/DI 10198459129537 (each) 40198459129538 (case), Lot Number 25ELA868; Medline product number/SKU DYNJ35312K, UDI/DI 10198459311574 (each) 40198459311575 (case), Lot Number 25EDA603; Medline product number/SKU DYNJ24528P, UDI/DI 10198459129537 (each) 40198459129538 (case), Lot Number 25BLA807; Medline product number/SKU DYNJ24528P, UDI/DI 10198459129537 (each) 40198459129538 (case), Lot Number 25BLA545; Medline product number/SKU DYNJ24528P, UDI/DI 10198459129537 (each) 40198459129538 (case), Lot Number 25ALA107; Medline product number/SKU DYNJ35312J, UDI/DI 10195327209810 (each) 40195327209811 (case), Lot Number 24LDA717; Medline product number/SKU DYNJ35312J, UDI/DI 10195327209810 (each) 40195327209811 (case), Lot Number 24LDA627; Medline product number/SKU DYNJ24528P, UDI/DI 10198459129537 (each) 40198459129538 (case), Lot Number 24KLA675; Medline product number/SKU DYNJ908879C, UDI/DI 10195327690885 (each) 40195327690886 (case), Lot Number 24KBD462; Medline product number/SKU DYNJ24528P, UDI/DI 10198459129537 (each) 40198459129538 (case), Lot Number 24JLA497; Medline product number/SKU DYNJ908879C, UDI/DI 10195327690885 (each) 40195327690886 (case), Lot Number 24IBQ955; Medline product number/SKU DYNJ24528O, UDI/DI 10195327164836 (each) 40195327164837 (case), Lot Number 24HLA074; Medline product number/SKU DYNJ35312J, UDI/DI 10195327209810 (each) 40195327209811 (case), Lot Number 24HDA135; Medline product number/SKU DYNJ24528O, UDI/DI 10195327164836 (each) 40195327164837 (case), Lot Number 24GLA306; Medline product number/SKU DYNJ908879C, UDI/DI 10195327690885 (each) 40195327690886 (case), Lot Number 24GBA028; Medline product number/SKU DYNJ24528O, UDI/DI 10195327164836 (each) 40195327164837 (case), Lot Number 24FLA524; Medline product number/SKU DYNJ908879C, UDI/DI 10195327690885 (each) 40195327690886 (case), Lot Number 24FBI615; Medline product number/SKU DYNJ35312J, UDI/DI 10195327209810 (each) 40195327209811 (case), Lot Number 24EDA934; Medline product number/SKU DYNJ24528O, UDI/DI 10195327164836 (each) 40195327164837 (case), Lot Number 24BLA262; Medline product number/SKU DYNJ24528O, UDI/DI 10195327164836 (each) 40195327164837 (case), Lot Number 23LLA290; Medline product number/SKU DYNJ35312J, UDI/DI 10195327209810 (each) 40195327209811 (case), Lot Number 23LDA007; Medline product number/SKU DYNJ35312J, UDI/DI 10195327209810 (each) 40195327209811 (case), Lot Number 23KDB898; Medline product number/SKU DYNJ35312J, UDI/DI 10195327209810 (each) 40195327209811 (case), Lot Number 23KDB325; Medline product number/SKU DYNJ24528O, UDI/DI 10195327164836 (each) 40195327164837 (case), Lot Number 23ILA783; Medline product number/SKU DYNJ35312J, UDI/DI 10195327209810 (each) 40195327209811 (case), Lot Number 23IDB477; Medline product number/SKU DYNJ24528O, UDI/DI 10195327164836 (each) 40195327164837 (case), Lot Number 23HLA825; Medline product number/SKU DYNJ24528O, UDI/DI 10195327164836 (each) 40195327164837 (case), Lot Number 23HLA102; Medline product number/SKU DYNJ22052I, UDI/DI 10195327355012 (each) 40195327355013 (case), Lot Number 23EMA351; Medline product number/SKU DYNJ35312J, UDI/DI 10195327209810 (each) 40195327209811 (case), Lot Number 23EDC422; Medline product number/SKU DYNJ24528O, UDI/DI 10195327164836 (each) 40195327164837 (case), Lot Number 23DLA106; Medline product number/SKU DYNJ22052I, UDI/DI 10195327355012 (each) 40195327355013 (case), Lot Number 23CME779; Medline product number/SKU DYNJ24528O, UDI/DI 10195327164836 (each) 40195327164837 (case), Lot Number 23CLA041; Medline product number/SKU DYNJ35312J, UDI/DI 10195327209810 (each) 40195327209811 (case), Lot Number 23CDB348; Medline product number/SKU DYNJ35312J, UDI/DI 10195327209810 (each) 40195327209811 (case), Lot Number 23BDB876; Medline product number/SKU DYNJ35312J, UDI/DI 10195327209810 (each) 40195327209811 (case), Lot Number 23BDA883; Medline product number/SKU DYNJ24528O, UDI/DI 10195327164836 (each) 40195327164837 (case), Lot Number 23ALA790; Medline product number/SKU DYNJ24528O, UDI/DI 10195327164836 (each) 40195327164837 (case), Lot Number 22KLB130; Medline product number/SKU DYNJ24528O, UDI/DI 10195327164836 (each) 40195327164837 (case), Lot Number 22JLA337; Medline product number/SKU DYNJ24528O, UDI/DI 10195327164836 (each) 40195327164837 (case), Lot Number 22ILA503; Medline product number/SKU DYNJ24528O, UDI/DI 10195327164836 (each) 40195327164837 (case), Lot Number 22HLB081; Medline product number/SKU DYNJ908879, UDI/DI 10195327203429 (each) 40195327203420 (case), Lot Number 22HBX489; Medline product number/SKU DYNJ43937, UDI/DI 10888277077966 (each) 40888277077967 (case), Lot Number 22HBR302; Medline product number/SKU DYNJ24528O, UDI/DI 10195327164836 (each) 40195327164837 (case), Lot Number 22GLA012; Medline product number/SKU DYNJ43937, UDI/DI 10888277077966 (each) 40888277077967 (case), Lot Number 22FBR986; Medline product number/SKU DYNJ24528N, UDI/DI 10195327125257 (each) 40195327125258 (case), Lot Number 22DLA370; Medline product number/SKU DYNJ24528N, UDI/DI 10195327125257 (each) 40195327125258 (case), Lot Number 22CLA935; Medline product number/SKU DYNJ43937, UDI/DI 10888277077966 (each) 40888277077967 (case), Lot Number 22CBY756; Medline product number/SKU DYNJ43937, UDI/DI 10888277077966 (each) 40888277077967 (case), Lot Number 21VBC303; Medline product number/SKU DYNJ43937, UDI/DI 10888277077966 (each) 40888277077967 (case), Lot Number 21LBE903; Medline product number/SKU DYNJ43937, UDI/DI 10888277077966 (each) 40888277077967 (case), Lot Number 21LBD590; Medline product number/SKU DYNJ43937, UDI/DI 10888277077966 (each) 40888277077967 (case), Lot Number 21BBO692; Medline product number/SKU DYNJ43937, UDI/DI 10888277077966 (each) 40888277077967 (case), Lot Number 21BBK081; Medline product number/SKU DYNJ43937, UDI/DI 10888277077966 (each) 40888277077967 (case), Lot Number 21ABW871; Medline product number/SKU DYNJ43937, UDI/DI 10888277077966 (each) 40888277077967 (case), Lot Number 21ABB682.

Quantity recalled1834 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-0169-2027
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: Other Medical Devices

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

1) Product Name AUD OPEN HEART PACK, Medline Kit Number/SKU DYNJ22052I; 2) Product Name AV SHUNT PACK-MARYVIEW, Medline Kit Number/SKU DYNJ24528N; 3) Product Name AV SHUNT PACK-MARYVIEW, Medline Kit Number/SKU DYNJ24528O; 4) Product Name AV SHUNT PACK-MARYVIEW, Medline Kit Number/SKU DYNJ24528P; 5) Product Name CATH LAB ENDO AAA, Medline Kit Number/SKU DYNJ35312J; 6) Product Name CATH LAB ENDO AAA, Medline Kit Number/SKU DYNJ35312K; 7) Product Name OPEN HEART PACK, Medline Kit Number/SKU DYNJ43937; 8) Product Name OPEN HEART PACK, Medline Kit Number/SKU DYNJ80549D; 9) Product Name CV PART 1 AND 2, Medline Kit Number/SKU DYNJ908879; 10) Product Name CV PART 1 AND 2, Medline Kit Number/SKU DYNJ908879C; 11) Product Name CARDIAC SURGERY, Medline Kit Number/SKU DYNJ911589A; 12) Product Name AV SHUNT-MARYVIEW, Medline Kit Number/SKU DYNJ911710; 13) Product Name CARDIAC ACCESSORY PACK, Medline Kit Number/SKU DYNJT7607.

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 DYNJ911589A, UDI/DI 10198459646102 (each) 40198459646103 (case), Lot Number 26CBD487; Medline product number/SKU DYNJ911710, UDI/DI 10198459515705 (each) 40198459515706 (case), Lot Number 26BLA622; Medline product number/SKU DYNJ35312K, UDI/DI 10198459311574 (each) 40198459311575 (case), Lot Number 26ADA368; Medline product number/SKU DYNJT7607, UDI/DI 10198459639470 (each) 40198459639471 (case), Lot Number 26ABP608; Medline product number/SKU DYNJ911710, UDI/DI 10198459515705 (each) 40198459515706 (case), Lot Number 25KLA755; Medline product number/SKU DYNJ35312K, UDI/DI 10198459311574 (each) 40198459311575 (case), Lot Number 25KDA055; Medline product number/SKU DYNJ911710, UDI/DI 10198459515705 (each) 40198459515706 (case), Lot Number 25JLA081; Medline product number/SKU DYNJ80549D, UDI/DI 10198459389610 (each) 40198459389611 (case), Lot Number 25JBQ932; Medline product number/SKU DYNJ35312K, UDI/DI 10198459311574 (each) 40198459311575 (case), Lot Number 25IDA242; Medline product number/SKU DYNJ80549D, UDI/DI 10198459389610 (each) 40198459389611 (case), Lot Number 25HBV035; Medline product number/SKU DYNJ24528P, UDI/DI 10198459129537 (each) 40198459129538 (case), Lot Number 25ELA868; Medline product number/SKU DYNJ35312K, UDI/DI 10198459311574 (each) 40198459311575 (case), Lot Number 25EDA603; Medline product number/SKU DYNJ24528P, UDI/DI 10198459129537 (each) 40198459129538 (case), Lot Number 25BLA807; Medline product number/SKU DYNJ24528P, UDI/DI 10198459129537 (each) 40198459129538 (case), Lot Number 25BLA545; Medline product number/SKU DYNJ24528P, UDI/DI 10198459129537 (each) 40198459129538 (case), Lot Number 25ALA107; Medline product number/SKU DYNJ35312J, UDI/DI 10195327209810 (each) 40195327209811 (case), Lot Number 24LDA717; Medline product number/SKU DYNJ35312J, UDI/DI 10195327209810 (each) 40195327209811 (case), Lot Number 24LDA627; Medline product number/SKU DYNJ24528P, UDI/DI 10198459129537 (each) 40198459129538 (case), Lot Number 24KLA675; Medline product number/SKU DYNJ908879C, UDI/DI 10195327690885 (each) 40195327690886 (case), Lot Number 24KBD462; Medline product number/SKU DYNJ24528P, UDI/DI 10198459129537 (each) 40198459129538 (case), Lot Number 24JLA497; Medline product number/SKU DYNJ908879C, UDI/DI 10195327690885 (each) 40195327690886 (case), Lot Number 24IBQ955; Medline product number/SKU DYNJ24528O, UDI/DI 10195327164836 (each) 40195327164837 (case), Lot Number 24HLA074; Medline product number/SKU DYNJ35312J, UDI/DI 10195327209810 (each) 40195327209811 (case), Lot Number 24HDA135; Medline product number/SKU DYNJ24528O, UDI/DI 10195327164836 (each) 40195327164837 (case), Lot Number 24GLA306; Medline product number/SKU DYNJ908879C, UDI/DI 10195327690885 (each) 40195327690886 (case), Lot Number 24GBA028; Medline product number/SKU DYNJ24528O, UDI/DI 10195327164836 (each) 40195327164837 (case), Lot Number 24FLA524; Medline product number/SKU DYNJ908879C, UDI/DI 10195327690885 (each) 40195327690886 (case), Lot Number 24FBI615; Medline product number/SKU DYNJ35312J, UDI/DI 10195327209810 (each) 40195327209811 (case), Lot Number 24EDA934; Medline product number/SKU DYNJ24528O, UDI/DI 10195327164836 (each) 40195327164837 (case), Lot Number 24BLA262; Medline product number/SKU DYNJ24528O, UDI/DI 10195327164836 (each) 40195327164837 (case), Lot Number 23LLA290; Medline product number/SKU DYNJ35312J, UDI/DI 10195327209810 (each) 40195327209811 (case), Lot Number 23LDA007; Medline product number/SKU DYNJ35312J, UDI/DI 10195327209810 (each) 40195327209811 (case), Lot Number 23KDB898; Medline product number/SKU DYNJ35312J, UDI/DI 10195327209810 (each) 40195327209811 (case), Lot Number 23KDB325; Medline product number/SKU DYNJ24528O, UDI/DI 10195327164836 (each) 40195327164837 (case), Lot Number 23ILA783; Medline product number/SKU DYNJ35312J, UDI/DI 10195327209810 (each) 40195327209811 (case), Lot Number 23IDB477; Medline product number/SKU DYNJ24528O, UDI/DI 10195327164836 (each) 40195327164837 (case), Lot Number 23HLA825; Medline product number/SKU DYNJ24528O, UDI/DI 10195327164836 (each) 40195327164837 (case), Lot Number 23HLA102; Medline product number/SKU DYNJ22052I, UDI/DI 10195327355012 (each) 40195327355013 (case), Lot Number 23EMA351; Medline product number/SKU DYNJ35312J, UDI/DI 10195327209810 (each) 40195327209811 (case), Lot Number 23EDC422; Medline product number/SKU DYNJ24528O, UDI/DI 10195327164836 (each) 40195327164837 (case), Lot Number 23DLA106; Medline product number/SKU DYNJ22052I, UDI/DI 10195327355012 (each) 40195327355013 (case), Lot Number 23CME779; Medline product number/SKU DYNJ24528O, UDI/DI 10195327164836 (each) 40195327164837 (case), Lot Number 23CLA041; Medline product number/SKU DYNJ35312J, UDI/DI 10195327209810 (each) 40195327209811 (case), Lot Number 23CDB348; Medline product number/SKU DYNJ35312J, UDI/DI 10195327209810 (each) 40195327209811 (case), Lot Number 23BDB876; Medline product number/SKU DYNJ35312J, UDI/DI 10195327209810 (each) 40195327209811 (case), Lot Number 23BDA883; Medline product number/SKU DYNJ24528O, UDI/DI 10195327164836 (each) 40195327164837 (case), Lot Number 23ALA790; Medline product number/SKU DYNJ24528O, UDI/DI 10195327164836 (each) 40195327164837 (case), Lot Number 22KLB130; Medline product number/SKU DYNJ24528O, UDI/DI 10195327164836 (each) 40195327164837 (case), Lot Number 22JLA337; Medline product number/SKU DYNJ24528O, UDI/DI 10195327164836 (each) 40195327164837 (case), Lot Number 22ILA503; Medline product number/SKU DYNJ24528O, UDI/DI 10195327164836 (each) 40195327164837 (case), Lot Number 22HLB081; Medline product number/SKU DYNJ908879, UDI/DI 10195327203429 (each) 40195327203420 (case), Lot Number 22HBX489; Medline product number/SKU DYNJ43937, UDI/DI 10888277077966 (each) 40888277077967 (case), Lot Number 22HBR302; Medline product number/SKU DYNJ24528O, UDI/DI 10195327164836 (each) 40195327164837 (case), Lot Number 22GLA012; Medline product number/SKU DYNJ43937, UDI/DI 10888277077966 (each) 40888277077967 (case), Lot Number 22FBR986; Medline product number/SKU DYNJ24528N, UDI/DI 10195327125257 (each) 40195327125258 (case), Lot Number 22DLA370; Medline product number/SKU DYNJ24528N, UDI/DI 10195327125257 (each) 40195327125258 (case), Lot Number 22CLA935; Medline product number/SKU DYNJ43937, UDI/DI 10888277077966 (each) 40888277077967 (case), Lot Number 22CBY756; Medline product number/SKU DYNJ43937, UDI/DI 10888277077966 (each) 40888277077967 (case), Lot Number 21VBC303; Medline product number/SKU DYNJ43937, UDI/DI 10888277077966 (each) 40888277077967 (case), Lot Number 21LBE903; Medline product number/SKU DYNJ43937, UDI/DI 10888277077966 (each) 40888277077967 (case), Lot Number 21LBD590; Medline product number/SKU DYNJ43937, UDI/DI 10888277077966 (each) 40888277077967 (case), Lot Number 21BBO692; Medline product number/SKU DYNJ43937, UDI/DI 10888277077966 (each) 40888277077967 (case), Lot Number 21BBK081; Medline product number/SKU DYNJ43937, UDI/DI 10888277077966 (each) 40888277077967 (case), Lot Number 21ABW871; Medline product number/SKU DYNJ43937, UDI/DI 10888277077966 (each) 40888277077967 (case), Lot Number 21ABB682.

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: Spinal CDS 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: 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 Other Medical Devices recalls

All 13,929

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21 Oct 2026Device	CLASS II	Rapicide PA Part A High-Level Disinfectant recalled by Steris	Steris	Other	Nationwide
21 Oct 2026Device	CLASS II	NeuroStar Advanced Therapy System recalled by Neuronetics	Neuronetics	Other	Nationwide
21 Oct 2026Device	CLASS II	TS Misc. Instruments Tray, Triathlon recalled by Howmedica Osteonics	Howmedica Osteonics	Sterility	NJ
21 Oct 2026Device	CLASS II	BD Phoenix Panel Nmic recalled by Becton Dickinson	Becton Dickinson	Device Malfunction	Nationwide
21 Oct 2026Device	CLASS II	BD Phoenix Panel Nmic recalled by Becton Dickinson	Becton Dickinson	Device Malfunction	Nationwide