KIT — Class II medical device recall Z-0725-2025
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 number | Z-0725-2025 |
|---|---|
| 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 | 2024-11-06 |
| Classified | 2024-12-20 |
| Reported by FDA | 2025-01-01 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 160 kits |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 10193489408508, 40193489408509 |
| Lot numbers | 20LBO883, 20WBE707, 21CBS664, 21EBG271 |
Product
KIT,SPINE LH Convenience kit, SKU DYNJ906448A.
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-0725-2025. 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.