FDA Device recall Z-0940-2025
ECONO STERILE medical procedure kits labeled as: ECONO STERILE BLAKE GALLSTONE FCP CVD 8"CS25, Model Number 96-4921A
- FDA Device
- Class II
- ongoing
- Published 2025-01-22
On 2025-01-22 the FDA classified a Class II recall of ECONO STERILE medical procedure kits labeled as: ECONO STERILE BLAKE GALLSTONE FCP CVD 8"CS25, Model Number 96-4921A 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-0940-2025 |
| 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
ECONO STERILE medical procedure kits labeled as: ECONO STERILE BLAKE GALLSTONE FCP CVD 8"CS25, Model Number 96-4921A
Reason
Reports of various packaging issues that may result in a breach of the sterile barrier.
Identifiers
| code_info | 96-4921A, UDI/DI 50649111493278, Lot codes: FSF20 |
|---|
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-0940-2025%22
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