FDA Device recall Z-0534-2025
Medline Shoulder Repair Pack-LF, REF DYNJ82607, 2 kits/case, sterile
- FDA Device
- Class II
- ongoing
- Published 2024-12-04
On 2024-12-04 the FDA classified a Class II recall of Medline Shoulder Repair Pack-LF, REF DYNJ82607, 2 kits/case, sterile by Medline Industries Northfield, citing some of the suture packages within the convenience kits contain the incorrect needle type/size and suture diameter/length.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0534-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-10-15 |
| Published | 2024-12-04 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Medline Industries Northfield |
| Distribution | US |
Product
Medline Shoulder Repair Pack-LF, REF DYNJ82607, 2 kits/case, sterile.
Reason
Some of the suture packages within the convenience kits contain the incorrect needle type/size and suture diameter/length.
Identifiers
| code_info | Lot number 24ABO552, exp. 9/30/2025, UDI-DI each 10195327198930, UDI-DI case 40195327198931. |
|---|
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-0534-2025%22
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