Endometrial Biopsy Kit Recalled Due to Manufacturing Standards Non-Conformance
Stradis Medical is recalling 1,639 Endometrial Biopsy Kits nationwide because the manufacturer cannot confirm the tenaculum devices meet required design and manufacturing standards.
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 FDA medical device recall based on design and manufacturing standards non-conformance. No injuries or illnesses have been reported. The hazard is theoretical, fitting the rubric criterion for high-risk products where injury has not yet been reported.
Plain-English summary
Stradis Medical, LLC dba Stradis Healthcare is recalling 1,639 Endometrial Biopsy Kits. The kits were distributed nationwide to multiple medical facilities and internationally to Canada.
The recalled kits contain Part Number 936K tenaculum devices. The manufacturer is unable to confirm that these devices were produced in accordance with required design and manufacturing standards.
Healthcare providers who have received these kits should cease using them and contact the manufacturer for instructions on how to proceed.
The recalled product
- Product
- Endometrial Biopsy Kit
- Manufacturer
- Stradis Medical, LLC dba Stradis Healthcare
- Affected units
- 1,639
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 (1)
- Part Number: 936K
Distribution
Part of a larger recall action
This product is one of 6 recalled by Stradis Medical, LLC dba Stradis Healthcare 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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