FDA Device recall Z-0950-2025
Medical procedure kits labeled as: 1) ECONO STERILE STRABIS SCISS STR 4.5"STER 50, Model Number 96-2540
- FDA Device
- Class II
- ongoing
- Published 2025-01-22
On 2025-01-22 the FDA classified a Class II recall of Medical procedure kits labeled as: 1) ECONO STERILE STRABIS SCISS STR 4.5"STER 50, Model Number 96-2540 by Sklar Instruments, citing reports of various packaging issues that may result in a breach of the sterile barrier.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0950-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-12-03 |
| Published | 2025-01-22 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Sklar Instruments |
| Distribution | US |
Product
Medical procedure kits labeled as: 1) ECONO STERILE STRABIS SCISS STR 4.5"STER 50, Model Number 96-2540; 2) ECONO STERILE STRABIS SCISS CVD 4.5"STER 50, Model Number 96-2541; 3) ECONO STERILE STRABIS SCISS STR 4.5"STER 25, Model Number 96-2542; 4) ECONO STERILE STRABISMUS SCISS STR4.5"CS/25, Model Number 96-2542M; eye surgery
Reason
Reports of various packaging issues that may result in a breach of the sterile barrier.
Identifiers
| code_info | 1) 96-2540, UDI/DI 50649111054967, Lot codes: FSS8, FSS10; 2) 96-2541, UDI/DI 50649111055087, Lot codes: FSS10; 3)…1) 96-2540, UDI/DI 50649111054967, Lot codes: FSS8, FSS10; 2) 96-2541, UDI/DI 50649111055087, Lot codes: FSS10; 3) 96-2542, UDI/DI 50649111055391, Lot codes: FSS10; 4) 96-2542M, UDI/DI 50649111440685, Lot codes: MSS10. |
|---|
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-0950-2025%22
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