Medline Shoulder Repair Pack-LF — Class II medical device recall Z-0534-2025
Ongoing recall by MEDLINE INDUSTRIES, LP - Northfield, reported 2024-12-04, distributed nationwide. Some of the suture packages within the convenience kits contain the incorrect needle type/size and suture diam
| Recall number | Z-0534-2025 |
|---|---|
| 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 | 2024-10-15 |
| Classified | 2024-11-25 |
| Reported by FDA | 2024-12-04 |
| Distributed | Nationwide (US) |
| Quantity | 48 kits |
| UPC / GTIN / UDI-DI | 10195327198930, 40195327198931 |
| Lot numbers | 24ABO552 |
| Model numbers | DYNJ82607 |
| Expiration dates | 2025-09-30 |
Product
Medline Shoulder Repair Pack-LF, REF DYNJ82607, 2 kits/case, sterile.
Reason for recall
Some of the suture packages within the convenience kits contain the incorrect needle type/size and suture diameter/length.
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-0534-2025. 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.