FDA Device recall Z-0933-2025
ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE ARMY RETR (SET OF 2) STER CS25, Model Number 96-2243
- 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: 1) ECONO STERILE ARMY RETR (SET OF 2) STER CS25, Model Number 96-2243 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-0933-2025 |
| 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: 1) ECONO STERILE ARMY RETR (SET OF 2) STER CS25, Model Number 96-2243; 2) ECONO STERILE ARMY RETR (SET OF 2)STRL CS/25, Model Number 96-2243M; 3) ECONO STERILE SENN RETR DE BL 6.25"STRLCS/25, Model Number 96-2267; 4) ECONO STERILE SENN RETR DE BL 6.25"STRLCS/25, Model Number 96-2267A; 5) ECONO STERILE SENN RETR DE SH 6.25"STRLCS/25, Model Number 96-2269A; 6) ECONO STERILE MINI HOHMANN 6MM 6.5" STERCS25, Model Number 96-2959; retractors
Reason
Reports of various packaging issues that may result in a breach of the sterile barrier.
Identifiers
| code_info | 1) 96-2243, UDI/DI 50649111493087Lot codes: SK-115, SK-116, SK-129; 2) 96-2243M, UDI/DI 50649111448605Lot codes: SK-…1) 96-2243, UDI/DI 50649111493087Lot codes: SK-115, SK-116, SK-129; 2) 96-2243M, UDI/DI 50649111448605Lot codes: SK-129; 3) 96-2267, UDI/DI 50649111448698Lot codes: SK-117; 4) 96-2267A, UDI/DI 50649111487604Lot codes: SK-112; 5) 96-2269A, UDI/DI 50649111487611Lot codes: SK-112; 6) 96-2959, UDI/DI 50649111493070Lot codes: SK-118. |
|---|
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-0933-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.