Gynecological dilator kits recalled for potential sterile barrier compromise
Sklar Instruments is recalling ECONO STERILE gynecological dilator kits nationwide due to packaging issues that may breach the sterile barrier, potentially affecting product safety.
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 a Class II recall for a risk-of-harm product where no illnesses or injuries have been reported. The packaging defects pose a theoretical risk to product sterility but have not resulted in documented harm.
Plain-English summary
Sklar Instruments is recalling seven models of ECONO STERILE gynecological dilator kits due to packaging issues that may breach the sterile barrier. These are single-use, sterile medical devices intended for gynecological procedures.
The packaging defects may compromise the sterile barrier of the product, potentially affecting the safety and effectiveness of the kits. Approximately 75 units were distributed nationwide.
Consumers, healthcare providers, and medical facilities that have these products should not use them. Affected parties should contact Sklar Instruments regarding returns or replacements.
The recalled product
- Product
- ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE HEGAR DILATOR 11&12MM STRLCS25Model Number 96-0960; 2) ECONO STERILE HEGAR DILATOR 9&10MM STRL CS25Model Number 96-0961; 3) ECONO STERILE HEGAR DILATOR 7&8MM STRL CS25Model Number 96-0962; 4) ECONO…
- 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 (16)
- 1) 96-0960
- UDI/DI 50649111474796
- Lot codes: FSS5
- 2) 96-0961
- UDI/DI 50649111474802
- 3) 96-0962
- UDI/DI 50649111474819
- 4) 96-0963
- UDI/DI 50649111474826
- 5) 96-0964
- UDI/DI 50649111474833
- 6) 96-0965
- UDI/DI 50649111474840
- 7) 96-0966
- UDI/DI 50649111474857
- Lot codes: SK-119.
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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