Medline custom medical procedure kits labeled as: 1) OPEN HEART CDS-LF — Class II medical device recall Z-0778-2025

Ongoing recall by MEDLINE INDUSTRIES, LP - Northfield, reported 2025-01-08, distributed nationwide. Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical St

Recall number	`Z-0778-2025`
Product type	Medical device
Classification	Class II
Status	Ongoing
Voluntary or mandated	Voluntary
Recalling firm	MEDLINE INDUSTRIES, LP - Northfield, Northfield, IL, United States
Recall initiated	2024-11-21
Classified	2024-12-30
Reported by FDA	2025-01-08
Distributed	Nationwide (US)
Countries outside the US	AE, CA
Quantity	2,344 units
Reason classes	sterility
UPC / GTIN / UDI-DI	`10193489202564`, `10193489947526`, `10195327106881`, `10195327167097`, `10195327173838`, `10195327417574`, `10889942572526`, `40193489202565`, `40193489947527`, `40195327106882`, `40195327167098`, `40195327173839`, `40195327417575`, `40889942572527`
Lot numbers	`19BKA270`, `19CKC053`, `19EKD526`, `19FKC478`, `19HKA796`, `19JKB417`, `19KKA783`, `19LKA454`, `19LKB868`, `20AKB109`, `20BKA558`, `20DKB147`, `20FKA993`, `20FKB171`, `20IKA397`, `20LKA831`, `21BKA583`, `21DKA592`, `21GMB734`, `21GME287`, `21JMH613`, `22AMB438`, `22CMD928`, `22CMF425`, `22EMF242`, `22FBC663`, `22FMG716`, `22GMH022`, `22IBR002`, `22IMD195`, `22JBV571`, `22JBW937`, `22KBB923`, `22LBK562`, `22OBM278`, `23ABC493`, `23AMB881`, `23DME044`, `23DME245`, `23EMI884` and 18 more
Model numbers	`CDS840451M`, `DYNJ41516M`, `DYNJ54242B`, `DYNJ901203C`, `DYNJ901203D`, `DYNJ906681B`, `DYNJ906681C`

Product

Medline custom medical procedure kits labeled as: 1) OPEN HEART CDS-LF, REFCDS840451M; 2) NEURO PACK, REFDYNJ41516M; 3) RFD- AAA PACK, REFDYNJ54242B; 4) OPEN HEART A&B, REFDYNJ901203C; 5) OPEN HEART A&B, REFDYNJ901203D; 6) ACDF-LF, REFDYNJ906681B; 7) ACDF-LF, REFDYNJ906681C.

Reason for recall

Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin contamination.

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-0778-2025. 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.