Medline Industries, LP: 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.

Recall number

Z-2486-2026

Recalling firm

Medline Industries, LP

Product

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.

Status

Open, Classified

Initiated

2026-05-04

Posted

2026-06-17

Terminated

not on file

Reason

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.

Root cause

Nonconforming Material/Component

Action

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.

Quantity

4801 units

Distribution

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

Lot, serial or model codes

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

510(k) numbers

not on file

PMA numbers

not on file

Product code

OES

Firm FEI

1417592

Firm city

Northfield

Firm state

IL

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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