Surgical Retractor Kits Recalled for Potential Sterile Barrier Breach
Sklar Instruments is recalling ECONO STERILE surgical retractor kits due to packaging defects that may result in a breach of the sterile barrier. 75 units nationwide have been affected.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 medical device recall involving a potential sterile barrier breach on surgical instruments, representing a risk-of-harm product. No hospitalizations, injuries, or illnesses have been reported. Per the severity rubric, recalls with theoretical hazards and no reported harm score at most 3.
Plain-English summary
Sklar Instruments is recalling ECONO STERILE surgical retractor kits due to packaging issues that may result in a breach of the sterile barrier. The affected products are multiple models of Weitlaner and Holzheimer retractors.
The kits were distributed nationwide in the United States. The recall affects lot codes SK-115, SK-120, and SK-130 across eight product models with model numbers ranging from 96-2201A to 96-2242A. A total of 75 units are affected.
Customers who have received these kits should stop using affected units and contact Sklar Instruments for replacement or return instructions.
The recalled product
- Product
- ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE WEITLANER RETR SH 2X3 4.5"CS25, Model Numbers: 96-2201A; 2) ECONO STERILE WEITLANER RETR BL 2X3 4.5"CS25, Model Numbers: 96-2203A; 3) ECONO STERILE WEITLANER RETR BL 3X4 5.5"CS25, Model Numbers…
- Manufacturer
- Sklar Instruments
- Affected units
- 75
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 (19)
- 1) 96-2201A
- UDI/DI 50649111493100
- Lot Codes: SK-120
- 2) 96-2203A
- UDI/DI 50649111493094
- 3) 96-2207A
- UDI/DI 50649111493117
- 4) 96-2208A
- UDI/DI 50649111493124
- Lot Codes: SK-120 5) 96-2209A
- UDI/DI 50649111493155
- 6) 96-2210A
- UDI/DI 50649111493162
- Lot Codes: SK-130
- 7) 96-2241A
- UDI/DI 50649111492820
- Lot Codes: SK-115
- 8) 96-2242A
- UDI/DI 50649111492837
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 30 recalled by Sklar Instruments under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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