FDA Device recall Z-0780-2025
Medline custom medical procedure kits labeled as: 1) UMC DR. BAKER SUPPLEMENT, REF DYNJ69476
- FDA Device
- Class II
- ongoing
- Published 2025-01-08
On 2025-01-08 the FDA classified a Class II recall of Medline custom medical procedure kits labeled as: 1) UMC DR. BAKER SUPPLEMENT, REF DYNJ69476 by Medline Industries Northfield, citing custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin contamination.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0780-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-11-21 |
| Published | 2025-01-08 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Medline Industries Northfield |
| Distribution | US |
Product
Medline custom medical procedure kits labeled as: 1) UMC DR. BAKER SUPPLEMENT, REF DYNJ69476; 2) DIEP FLAP, REF DYNJ910120
Reason
Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin contamination.
Identifiers
| code_info | 1) REF DYNJ69476, UDI/DI 10193489947786 (EA) 40193489947787 (CS), Lot Numbers: 21HDB296; 2) REF DYNJ910120, UDI/DI…1) REF DYNJ69476, UDI/DI 10193489947786 (EA) 40193489947787 (CS), Lot Numbers: 21HDB296; 2) REF DYNJ910120, UDI/DI 10195327589202 (EA) 40195327589203 (CS), Lot Numbers: 24CMH776. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0780-2025%22
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