Gynecological Speculum Kits Recalled for Potential Sterile Barrier Breach
Sklar Instruments is recalling ECONO STERILE gynecological speculum kits due to packaging issues that may compromise sterility. No injuries have been reported.
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 of sterile surgical instruments with reports of packaging issues that could compromise the sterile barrier. The rubric criterion for risk-of-harm products applies here, and no illnesses or injuries have been reported, placing this at the High level per the rule that theoretical hazards without reported harm score at most 3.
Plain-English summary
Sklar Instruments is recalling nine models of ECONO STERILE gynecological speculum kits. The affected products, distributed nationwide with lot code SK-119, total 475 units and include Graves and Pederson specula in multiple sizes.
The FDA classified this recall as Class II due to reports of packaging issues that may result in a breach of the sterile barrier. Instruments with compromised sterile barriers may no longer be appropriate for use in sterile medical procedures.
Healthcare facilities that have received these kits should identify them by model number and lot code SK-119, and contact Sklar Instruments or the FDA for instructions on returning or properly disposing of the affected products. No illnesses or injuries have been reported in connection with this recall.
The recalled product
- Product
- ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE GRAVES SPEC STRL SM BX/25, Model Number 96-2603; 2) ECONO STERILE GRAVES SPEC STRL MD BX/25, Model Number 96-2605; 3) ECONO STERILE GRAVES SPEC STRL LG BX/25, Model Number 96-2607; 4) ECONO STERILE PEDER
- Manufacturer
- Sklar Instruments
- Hazard
- sterile-barrier-breach
- packaging-defect
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 (20)
- 1) 96-2603
- UDI/DI 50649111067233
- Lot Codes: SK-119
- 2) 96-2605
- UDI/DI 50649111067622
- 3) 96-2607
- UDI/DI 50649111067967
- 4) 96-2613
- UDI/DI 50649111068964
- 5) 96-2615
- UDI/DI 50649111069343
- 6) 96-2616
- UDI/DI 50649111069572
- 7) 96-2617
- UDI/DI 50649111069886
- 8) 96-3001
- UDI/DI 50649111133884
- 9) 96-3002
- UDI/DI 50649111134058
- Lot Codes: SK-119.
Distribution
Distributed nationwide across the United States.
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