FDA Device recall Z-0789-2025
Medline custom medical procedure kits labeled as: 1) MICRODISECTOMY PACK, REF DYNJ80585A
- 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) MICRODISECTOMY PACK, REF DYNJ80585A 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-0789-2025 |
| 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) MICRODISECTOMY PACK, REF DYNJ80585A; 2) MICRODISECTOMY PACK, REF DYNJ80585B.
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 DYNJ80585A, UDI/DI 10195327063948 (EA) 40195327063949 (CS), Lot Numbers: 22ABF513, 22DBK159, 22DBL699, 22FBQ597…1) REF DYNJ80585A, UDI/DI 10195327063948 (EA) 40195327063949 (CS), Lot Numbers: 22ABF513, 22DBK159, 22DBL699, 22FBQ597; 2) REF DYNJ80585B, UDI/DI 10195327211158 (EA), 40195327211159 (CS), Lot Numbers: 22GBV101, 22HBG177, 22HBU871, 23ABD760, 23BBE037, 23GBL753, 23GBV443, 23HBU815, 23IBJ525, 23JBO457, 23LBD006, 24BBC495, 24CBI323, 24DBJ068, 24DBP653, 24EBP712, 24FBM276, 24IBG473. |
|---|
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-0789-2025%22
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