Sklar Instruments IUD Extractor Kits Recalled for Sterile Barrier Packaging Issues
Sklar Instruments is recalling ECONO STERILE IUD Extractor kits (Model 96-4146A) due to packaging defects that may compromise the sterile barrier. Nationwide distribution.
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: FDA Class II device with no reported illnesses or injuries. Per the rubric, risk-of-harm products where injury has not yet been reported score High (3). The theoretical hazard—potential sterile barrier breach on a sterile surgical instrument—qualifies as a risk-of-harm product.
Plain-English summary
Sklar Instruments is recalling ECONO STERILE IUD Extractor kits, Model 96-4146A, Lot SK-136, that were distributed nationwide. The recall addresses reports of various packaging issues that may result in a breach of the sterile barrier.
A breach in the sterile barrier could allow contamination of the medical device during storage and handling, compromising its sterility for clinical use in IUD extraction procedures.
Healthcare facilities and medical professionals who have received this product should discontinue use of the affected lot and contact Sklar Instruments or the FDA for further guidance and return instructions.
The recalled product
- Product
- ECONO STERILE medical procedure kits labeled as: ECONO STERILE IUD EXTRACTOR DBL HK 10.5"CS25, Model Number 96-4146A
- Manufacturer
- Sklar Instruments
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 (3)
- 96-4146A
- UDI/DI 50649111492707
- Lot Codes: SK-136
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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