FDAFDA recall Z-0169-2027 · Oct 21, 2026

Medline Industries, LP: 1) Product Name AUD OPEN HEART PACK recall

Recall found

Product

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.

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.

What to do

FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.

Recall details

FDA classification: Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Status: Ongoing
Codes, lots and dates: 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.
Quantity: 1834 kits
Distribution: US Nationwide distribution.
Recalling firm: Medline Industries, LP, Northfield, IL
Voluntary or mandated: Voluntary: Firm initiated
Recall started: 2026-09-02

Source: openFDA enforcement record Z-0169-2027 · search recall number Z-0169-2027 in FDA's Enforcement Report.

Copied from the agency record without changes. Data as of Oct 26, 2026, 8:14 PM EDT. The agency notice is the final word.