Sklar Instruments Recalls ECONO STERILE Surgical Retractors Due to Packaging Issues
Sklar Instruments is recalling 1,050 ECONO STERILE surgical retractors nationwide due to packaging defects that may compromise sterility. The affected kits have potential breaches in their sterile barriers.
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 with no reported illnesses or injuries. The hazard is theoretical—potential sterile barrier breach from packaging issues—with no confirmed harm. Per the rubric, recalls with theoretical hazards and no reported harm score at most 3 (High).
Plain-English summary
Sklar Instruments is recalling 1,050 ECONO STERILE medical procedure kits containing surgical retractors due to packaging issues that may result in a breach of the sterile barrier. The recalled products are distributed nationwide and include six distinct retractor models with specific lot codes.
The packaging defects create a risk that the sterile barrier may be compromised, potentially allowing the surgical instruments to become contaminated. These kits are used in medical procedures where sterility is critical.
Healthcare facilities and medical professionals who have received these kits should immediately cease use and contact Sklar Instruments for guidance on replacement or return. The specific model numbers and lot codes affected are detailed in the manufacturer's recall notice.
The recalled product
- 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
- Manufacturer
- Sklar Instruments
- Affected units
- 1,050
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 (14)
- 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
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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