Data Foundry

Medical device recalls 2025

DIEP FLAP Convenience kit — Class II medical device recall Z-0719-2025

Ongoing recall by MEDLINE INDUSTRIES, LP - Northfield, reported 2025-01-01, distributed nationwide. Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to contain higher-th

Recall numberZ-0719-2025
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmMEDLINE INDUSTRIES, LP - Northfield, Northfield, IL, United States
Recall initiated2024-11-06
Classified2024-12-20
Reported by FDA2025-01-01
DistributedNationwide (US)
Countries outside the USCA
Quantity26 kits
Reason classessterility
UPC / GTIN / UDI-DI10195327589202, 40195327589203
Lot numbers24CMH776

Product

DIEP FLAP Convenience kit, SKU DYNJ910120. Convenience kits used for various procedures.

Reason for recall

Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to contain higher-than-expected levels of endotoxin within the raw material used to produce sterile Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in those finished goods

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-0719-2025. 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.