MEDLINE Medical Procedure Kits labeled as: 1) BASIC HEART PACK — Class II medical device recall Z-2486-2026

Ongoing recall by Medline Industries, LP, reported 2026-06-24, distributed nationwide. During an internal review, Medline identified representative samples did not meet applicable performance speci

Recall number	`Z-2486-2026`
Product type	Medical device
Classification	Class II
Status	Ongoing
Voluntary or mandated	Voluntary
Recalling firm	Medline Industries, LP, Northfield, IL, United States
Recall initiated	2026-05-04
Classified	2026-06-17
Reported by FDA	2026-06-24
Distributed	Nationwide (US)
Quantity	4,801 units
Reason classes	device malfunction
UPC / GTIN / UDI-DI	`10193489952568`, `10193489997620`, `10195327013837`, `10195327136888`, `10195327203429`, `10195327690885`, `10198459085031`, `10198459154775`, `10198459159633`, `10198459389610`, `10198459646102`, `10198459660573`, `10889942046683`, `10889942885657`, `40193489952569`, `40193489997621`, `40195327013838`, `40195327136889`, `40195327203420`, `40195327690886`, `40198459085032`, `40198459154776`, `40198459159634`, `40198459389611`, `40198459646103` and 3 more
Lot numbers	`21HDA837`, `21IBJ641`, `21JBP452`, `21JDB263`, `21KDA239`, `21LBU240`, `22ABF009`, `22BBX288`, `22CBJ072`, `22DBS093`, `22EMI334`, `22FBM460`, `22GDB282`, `22HBR331`, `22HBX489`, `22HMD314`, `22IBO304`, `22IBQ222`, `22IBQ223`, `22JBB115`, `22JBK233`, `22JDA804`, `22JME362`, `22KBN690`, `22KBR412`, `22OBH265`, `23ABL478`, `23BBE613`, `23DBB008`, `23EBJ571`, `23EBM118`, `23FBL595`, `23FBM203`, `23GBQ638`, `23HBC987`, `23IBF088`, `23IBI647`, `23IBI955`, `23JBK038`, `23JBM539` and 49 more

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.

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2486-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.