Gynecological Procedure Kits Recalled for Potential Sterile Barrier Packaging Defects
Sklar Instruments is recalling ECONO STERILE gynecological procedure kits due to packaging issues that may compromise the sterile barrier. The affected kits may no longer maintain their sterile condition.
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 medical device recall with no reported illnesses or injuries. The hazard presents a risk of harm to patients, but the recall is based on potential risk rather than reported adverse events. Per the rubric, this meets the criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
The FDA is recalling ECONO STERILE gynecological procedure kits (Model Number 96-4142A) manufactured by Sklar Instruments due to reports of various packaging issues that may result in a breach of the sterile barrier. These are sterile medical devices distributed nationwide for gynecological procedures.
Approximately 40 units with Lot Code HSI (UDI/DI 50649111488014) are affected by this recall. If the sterile barrier is breached, the medical devices may no longer maintain their sterile condition during storage or use.
Healthcare facilities and providers should verify whether they have received the recalled product and take appropriate precautions to prevent use of any affected kits. The recall was issued by the FDA with agency recall number Z-0945-2025.
The recalled product
- Product
- ECONO STERILE medical procedure kits labeled as: ECONO STERILE KOGAN ENDOCERV SPEC STER CS/5, Model Number 96-4142A, gynecological procedures
- Manufacturer
- Sklar Instruments
- Affected units
- 40
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)
- 96-4142A
- UDI/DI 50649111488014
- Lot Codes: HSI
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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