Strabismus Surgical Scissors Kits Recalled Due to Sterile Barrier Packaging Issues
Sklar Instruments is recalling 350 strabismus surgical scissors kits nationwide due to packaging issues that may compromise the sterile barrier.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall involving potential compromise of sterile packaging on surgical instruments. The source describes a theoretical risk—the packaging may breach the sterile barrier—with no reported injuries or illnesses documented. Per the severity rubric, this qualifies as Score 3 (High): a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Sklar Instruments is recalling 350 strabismus surgical scissors kits distributed nationwide due to reports of packaging issues that may result in a breach of the sterile barrier. The recalled products include models 96-2540, 96-2541, 96-2542, and 96-2542M.
Sterile surgical instrument kits must maintain an intact sterile barrier to prevent contamination of the instruments before use. Packaging defects can compromise this barrier, potentially allowing contamination to occur.
Facilities and individuals with these kits should review the recall information and contact Sklar Instruments for guidance.
The recalled product
- 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 STRABISM
- Manufacturer
- Sklar Instruments
- Hazard
- packaging-defect
- sterile-barrier-breach
- contamination
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (12)
- 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
- 4) 96-2542M
- UDI/DI 50649111440685
- Lot codes: MSS10.
Distribution
Distributed nationwide across the United States.
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