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RecallWatchMedical Device Safety
Class IIOngoingZ-2486-2026

Medline Industries, LP recalls MEDLINE Medical Procedure Kits labeled as: 1) BASIC HEART PACK

Medline Industries, LPNorthfield, IL, United StatesReported Jun 24, 2026 · 24 days ago
Legal News Analyst ·

Reason for recall

During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

MEDLINE Medical Procedure Kits labeled as: 1) BASIC HEART PACK, Medline Kit/SKU DYNJ67331B; 2) CARDIAC SURGERY, Medline Kit/SKU DYNJ911589A; 3) CAROTID ENDARTECOMY, Medline Kit/SKU DYNJ36211D; 4) CHLA ECMO / CARDIAC PACK, Medline Kit/SKU DYNJ87973; 5) CHLA ECMO / CARDIAC PACK, Medline Kit/SKU DYNJ87973A; 6) CV PART 1 AND 2, Medline Kit/SKU DYNJ908879; 7) CV PART 1 AND 2, Medline Kit/SKU DYNJ908879C; 8) FEM POP CDS, Medline Kit/SKU CDS983670K; 9) LAP BASIN TRAY, Medline Kit/SKU DYNJ50908B; 10) OPEN HEART LTX CATHETERS KIT, Medline Kit/SKU DYNJ0049032A; 11) OPEN HEART PACK, Medline Kit/SKU DYNJ80549C; 12) OPEN HEART PACK, Medline Kit/SKU DYNJ80549D; 13) RR-ADULT ECMO PACK, Medline Kit/SKU DYNJ69742B; 14) TAVR, Medline Kit/SKU DYNJ906509C.

Lot / code information

Lot #
23JBM539; Medline Kit Number/SKU DYNJ67331B: UDI/DI 10195327013837 (each), 40195327013838 (case)
Lot #
23IBF088; Medline Kit Number/SKU DYNJ67331B: UDI/DI 10195327013837 (each), 40195327013838 (case)
Lot #
23FBM203; Medline Kit Number/SKU DYNJ67331B: UDI/DI 10195327013837 (each), 40195327013838 (case)
Lot #
22JBK233; Medline Kit Number/SKU DYNJ67331B: UDI/DI 10195327013837 (each), 40195327013838 (case)
Lot #
22JBB115; Medline Kit Number/SKU DYNJ67331B: UDI/DI 10195327013837 (each), 40195327013838 (case)
Lot #
22IBO304; Medline Kit Number/SKU DYNJ67331B: UDI/DI 10195327013837 (each), 40195327013838 (case)
Lot #
22HBR331; Medline Kit Number/SKU DYNJ67331B: UDI/DI 10195327013837 (each), 40195327013838 (case)
Lot #
22FBM460; Medline Kit Number/SKU DYNJ67331B: UDI/DI 10195327013837 (each), 40195327013838 (case)
Lot #
22DBS093; Medline Kit Number/SKU DYNJ67331B: UDI/DI 10195327013837 (each), 40195327013838 (case)
Lot #
22CBJ072; Medline Kit Number/SKU DYNJ67331B: UDI/DI 10195327013837 (each), 40195327013838 (case)
Show 79 more code fields
Lot #
22BBX288; Medline Kit Number/SKU DYNJ67331B: UDI/DI 10195327013837 (each), 40195327013838 (case)
Lot #
21LBU240; Medline Kit Number/SKU DYNJ67331B: UDI/DI 10195327013837 (each), 40195327013838 (case)
Lot #
21JBP452; Medline Kit Number/SKU DYNJ911589A: UDI/DI 10198459646102 (each), 40198459646103 (case)
Lot #
26CBD487; Medline Kit Number/SKU DYNJ36211D: UDI/DI 10889942885657 (each), 40889942885658 (case)
Lot #
24EBB811; Medline Kit Number/SKU DYNJ36211D: UDI/DI 10889942885657 (each), 40889942885658 (case)
Lot #
24ABV035; Medline Kit Number/SKU DYNJ36211D: UDI/DI 10889942885657 (each), 40889942885658 (case)
Lot #
23LBG394; Medline Kit Number/SKU DYNJ36211D: UDI/DI 10889942885657 (each), 40889942885658 (case)
Lot #
23KBA664; Medline Kit Number/SKU DYNJ36211D: UDI/DI 10889942885657 (each), 40889942885658 (case)
Lot #
23HBC987; Medline Kit Number/SKU DYNJ36211D: UDI/DI 10889942885657 (each), 40889942885658 (case)
Lot #
23GBQ638; Medline Kit Number/SKU DYNJ36211D: UDI/DI 10889942885657 (each), 40889942885658 (case)
Lot #
23EBM118; Medline Kit Number/SKU DYNJ36211D: UDI/DI 10889942885657 (each), 40889942885658 (case)
Lot #
23DBB008; Medline Kit Number/SKU DYNJ36211D: UDI/DI 10889942885657 (each), 40889942885658 (case)
Lot #
22KBR412; Medline Kit Number/SKU DYNJ87973: UDI/DI 10198459085031 (each), 40198459085032 (case)
Lot #
24HMH646; Medline Kit Number/SKU DYNJ87973A: UDI/DI 10198459159633 (each), 40198459159634 (case)
Lot #
24JMG070; Medline Kit Number/SKU DYNJ908879: UDI/DI 10195327203429 (each), 40195327203420 (case)
Lot #
22HBX489; Medline Kit Number/SKU DYNJ908879C: UDI/DI 10195327690885 (each), 40195327690886 (case)
Lot #
24KBD462; Medline Kit Number/SKU DYNJ908879C: UDI/DI 10195327690885 (each), 40195327690886 (case)
Lot #
24IBQ955; Medline Kit Number/SKU DYNJ908879C: UDI/DI 10195327690885 (each), 40195327690886 (case)
Lot #
24GBA028; Medline Kit Number/SKU DYNJ908879C: UDI/DI 10195327690885 (each), 40195327690886 (case)
Lot #
24FBI615; Medline Kit Number/SKU CDS983670K: UDI/DI 10193489952568 (each), 40193489952569 (case)
Lot #
26BBJ555; Medline Kit Number/SKU CDS983670K: UDI/DI 10193489952568 (each), 40193489952569 (case)
Lot #
26BBB853; Medline Kit Number/SKU CDS983670K: UDI/DI 10193489952568 (each), 40193489952569 (case)
Lot #
25LBA306; Medline Kit Number/SKU CDS983670K: UDI/DI 10193489952568 (each), 40193489952569 (case)
Lot #
25IBD419; Medline Kit Number/SKU CDS983670K: UDI/DI 10193489952568 (each), 40193489952569 (case)
Lot #
25HBM069; Medline Kit Number/SKU CDS983670K: UDI/DI 10193489952568 (each), 40193489952569 (case)
Lot #
25GBT806; Medline Kit Number/SKU CDS983670K: UDI/DI 10193489952568 (each), 40193489952569 (case)
Lot #
25GBB405; Medline Kit Number/SKU CDS983670K: UDI/DI 10193489952568 (each), 40193489952569 (case)
Lot #
25DBE889; Medline Kit Number/SKU CDS983670K: UDI/DI 10193489952568 (each), 40193489952569 (case)
Lot #
25CBT575; Medline Kit Number/SKU CDS983670K: UDI/DI 10193489952568 (each), 40193489952569 (case)
Lot #
25ABT789; Medline Kit Number/SKU CDS983670K: UDI/DI 10193489952568 (each), 40193489952569 (case)
Lot #
25ABJ907; Medline Kit Number/SKU CDS983670K: UDI/DI 10193489952568 (each), 40193489952569 (case)
Lot #
24LBI235; Medline Kit Number/SKU CDS983670K: UDI/DI 10193489952568 (each), 40193489952569 (case)
Lot #
24KBQ247; Medline Kit Number/SKU CDS983670K: UDI/DI 10193489952568 (each), 40193489952569 (case)
Lot #
24JBT379; Medline Kit Number/SKU CDS983670K: UDI/DI 10193489952568 (each), 40193489952569 (case)
Lot #
24IBT329; Medline Kit Number/SKU CDS983670K: UDI/DI 10193489952568 (each), 40193489952569 (case)
Lot #
24IBE008; Medline Kit Number/SKU CDS983670K: UDI/DI 10193489952568 (each), 40193489952569 (case)
Lot #
24GBP229; Medline Kit Number/SKU CDS983670K: UDI/DI 10193489952568 (each), 40193489952569 (case)
Lot #
24EBG109; Medline Kit Number/SKU CDS983670K: UDI/DI 10193489952568 (each), 40193489952569 (case)
Lot #
24ABH254; Medline Kit Number/SKU CDS983670K: UDI/DI 10193489952568 (each), 40193489952569 (case)
Lot #
23JBN022; Medline Kit Number/SKU CDS983670K: UDI/DI 10193489952568 (each), 40193489952569 (case)
Lot #
23JBK038; Medline Kit Number/SKU CDS983670K: UDI/DI 10193489952568 (each), 40193489952569 (case)
Lot #
23IBI955; Medline Kit Number/SKU CDS983670K: UDI/DI 10193489952568 (each), 40193489952569 (case)
Lot #
23IBI647; Medline Kit Number/SKU CDS983670K: UDI/DI 10193489952568 (each), 40193489952569 (case)
Lot #
23FBL595; Medline Kit Number/SKU CDS983670K: UDI/DI 10193489952568 (each), 40193489952569 (case)
Lot #
23EBJ571; Medline Kit Number/SKU CDS983670K: UDI/DI 10193489952568 (each), 40193489952569 (case)
Lot #
23BBE613; Medline Kit Number/SKU CDS983670K: UDI/DI 10193489952568 (each), 40193489952569 (case)
Lot #
23ABL478; Medline Kit Number/SKU CDS983670K: UDI/DI 10193489952568 (each), 40193489952569 (case)
Lot #
22KBN690; Medline Kit Number/SKU CDS983670K: UDI/DI 10193489952568 (each), 40193489952569 (case)
Lot #
22IBQ223; Medline Kit Number/SKU CDS983670K: UDI/DI 10193489952568 (each), 40193489952569 (case)
Lot #
22IBQ222; Medline Kit Number/SKU CDS983670K: UDI/DI 10193489952568 (each), 40193489952569 (case)
Lot #
22GDB282; Medline Kit Number/SKU CDS983670K: UDI/DI 10193489952568 (each), 40193489952569 (case)
Lot #
21JDB263; Medline Kit Number/SKU CDS983670K: UDI/DI 10193489952568 (each), 40193489952569 (case)
Lot #
21HDA837; Medline Kit Number/SKU DYNJ50908B: UDI/DI 10193489997620 (each), 40193489997621 (case)
Lot #
22JDA804; Medline Kit Number/SKU DYNJ50908B: UDI/DI 10193489997620 (each), 40193489997621 (case)
Lot #
21KDA239; Medline Kit Number/SKU DYNJ0049032A: UDI/DI 10889942046683 (each), 40889942046684 (case)
Lot #
22EMI334; Medline Kit Number/SKU DYNJ0049032A: UDI/DI 10889942046683 (each), 40889942046684 (case)
Lot #
22OBH265; Medline Kit Number/SKU DYNJ0049032A: UDI/DI 10889942046683 (each), 40889942046684 (case)
Lot #
22ABF009; Medline Kit Number/SKU DYNJ0049032A: UDI/DI 10889942046683 (each), 40889942046684 (case)
Lot #
21IBJ641; Medline Kit Number/SKU DYNJ80549C: UDI/DI 10198459154775 (each), 40198459154776 (case)
Lot #
25FBD953; Medline Kit Number/SKU DYNJ80549C: UDI/DI 10198459154775 (each), 40198459154776 (case)
Lot #
25FBD164; Medline Kit Number/SKU DYNJ80549C: UDI/DI 10198459154775 (each), 40198459154776 (case)
Lot #
25DBD868; Medline Kit Number/SKU DYNJ80549C: UDI/DI 10198459154775 (each), 40198459154776 (case)
Lot #
25CBE259; Medline Kit Number/SKU DYNJ80549C: UDI/DI 10198459154775 (each), 40198459154776 (case)
Lot #
25CBA809; Medline Kit Number/SKU DYNJ80549C: UDI/DI 10198459154775 (each), 40198459154776 (case)
Lot #
25BBS521; Medline Kit Number/SKU DYNJ80549C: UDI/DI 10198459154775 (each), 40198459154776 (case)
Lot #
25BBA187; Medline Kit Number/SKU DYNJ80549C: UDI/DI 10198459154775 (each), 40198459154776 (case)
Lot #
25BBB135; Medline Kit Number/SKU DYNJ80549C: UDI/DI 10198459154775 (each), 40198459154776 (case)
Lot #
24KBG706; Medline Kit Number/SKU DYNJ80549C: UDI/DI 10198459154775 (each), 40198459154776 (case)
Lot #
24JBN408; Medline Kit Number/SKU DYNJ80549D: UDI/DI 10198459389610 (each), 40198459389611 (case)
Lot #
26DBK306; Medline Kit Number/SKU DYNJ80549D: UDI/DI 10198459389610 (each), 40198459389611 (case)
Lot #
26BBS911; Medline Kit Number/SKU DYNJ80549D: UDI/DI 10198459389610 (each), 40198459389611 (case)
Lot #
26ABL878; Medline Kit Number/SKU DYNJ80549D: UDI/DI 10198459389610 (each), 40198459389611 (case)
Lot #
25KBN563; Medline Kit Number/SKU DYNJ80549D: UDI/DI 10198459389610 (each), 40198459389611 (case)
Lot #
25JBQ932; Medline Kit Number/SKU DYNJ80549D: UDI/DI 10198459389610 (each), 40198459389611 (case)
Lot #
25HBV035; Medline Kit Number/SKU DYNJ69742B: UDI/DI 10195327136888 (each), 40195327136889 (case)
Lot #
22JME362; Medline Kit Number/SKU DYNJ69742B: UDI/DI 10195327136888 (each), 40195327136889 (case)
Lot #
22HMD314; Medline Kit Number/SKU DYNJ906509C: UDI/DI 10198459660573 (each), 40198459660574 (case)
Lot #
26CDA666; Medline Kit Number/SKU DYNJ906509C: UDI/DI 10198459660573 (each), 40198459660574 (case)
Lot #
26BDA740

What the firm is doing

Medline Industries issued two URGENT MEDICAL DEVICE RECALL notice on 5/4/2026 to its consignees, one to its catheter and catheter tray consignees, and the other to the kit consignees via USPS and email. Both notices explained the issue and potential risk. The catheter and catheter tray consignees were directed to respond to the notice and destroy the affected products. The kit consignees were directed to respond to the notice and apply additional labeling (over-labels) to affix to the kits which instruct the user to remove and destroy the affected component. Both notices direct distributors or those who further distributing the products to notify their customers. For questions, contact the Recall Department at 866-359-1704 or recalls@medline.com.

DistributionShow details

Worldwide distribution - US Nationwide and the countries of AE, BB, BM, BS, CA, CY, GU, NL, PA, QA, SA, VI.

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.

Taylor Coteus
Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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