ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE… — Class II medical device recall Z-0929-2025
Ongoing recall by Sklar Instruments, reported 2025-01-22, distributed nationwide. Reports of various packaging issues that may result in a breach of the sterile barrier.
| Recall number | Z-0929-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Sklar Instruments, West Chester, PA, United States |
| Recall initiated | 2024-12-03 |
| Classified | 2025-01-16 |
| Reported by FDA | 2025-01-22 |
| Distributed | Nationwide (US) |
| Quantity | 75 units |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 50649111492820, 50649111492837, 50649111493094, 50649111493100, 50649111493117, 50649111493124, 50649111493155, 50649111493162 |
| Lot numbers | SK-115, SK-120, SK-130 |
| Model numbers | 96-2201A, 96-2203A, 96-2207A, 96-2208A, 96-2209A, 96-2210A, 96-2241A, 96-2242A |
Product
ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE WEITLANER RETR SH 2X3 4.5"CS25, Model Numbers: 96-2201A; 2) ECONO STERILE WEITLANER RETR BL 2X3 4.5"CS25, Model Numbers: 96-2203A; 3) ECONO STERILE WEITLANER RETR BL 3X4 5.5"CS25, Model Numbers: 96-2207A; 4) ECONO STERILE WEITLANER RETR SH 3X4 5.5"CS25, Model Numbers: 96-2208A; 5) ECONO STERILE WEITLANER RETR 3X4 SH 8" CS/10, Model Numbers: 96-2209A; 6) ECONO STERILE WEITLANER RETR 3X4 BL 8" CS/10 , Model Numbers: 96-2210A; 7) ECONO STERILE HOLZHEIMER RETR 4PRG SH 4"CS25, Model Numbers: 96-2241A; 8) ECONO STERILE HOLZHEIMER RETR 4PRG BL 4"CS25, Model Numbers: 96-2242A; surgical retractor
Reason for recall
Reports of various packaging issues that may result in a breach of the sterile barrier.
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-0929-2025. 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.