FDA Medical devices recall ·
ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE ARMY… recall
- Recall number
- Z-0933-2025
- Date
- (initiated December 3, 2024)
- Company / brand
- Sklar Instruments
1333 Lenape Rd, West Chester, PA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 1050 units
- Hazard tags
- Sterility
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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
Why was it recalled?
Reports of various packaging issues that may result in a breach of the sterile barrier.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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.
Distribution
Domestic: Nationwide Distribution
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0933-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.