FDA Medical devices recall ·
ECONO STERILE brand medical procedure kits labeled as: 1) ECONO STERILE… recall
- Recall number
- Z-0926-2025
- 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
- 125 units
- Hazard tags
- Sterility
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
ECONO STERILE brand medical procedure kits labeled as: 1) ECONO STERILE FREER ELEV DE S/B 7.25" CS/25, Model Number 96-2483 (multiple purpose); 2) ECONO STERILE LOCKE ELEV #94 NARROW STER 25, Model Number 96-2484 (foot procedures)
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) 96-2483, UDI/DI 50649111449053, Lot codes: FSS5; 2) 96-2484, UDI/DI 50649111492950, Lot codes: SK-115
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-0926-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.