IUD Insertion Kit Tenaculum Devices Recalled for Manufacturing Standards Non-Compliance
Stradis Medical recalled 14,959 IUD Insertion Kits nationwide after being unable to confirm the tenaculum devices were manufactured according to required design and manufacturing standards.
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: FDA Class II recall of surgical instruments with unconfirmed manufacturing standards compliance. As risk-of-harm medical devices used in clinical procedures, manufacturing non-compliance could affect device performance and patient safety, meeting the rubric criterion for High severity despite no reported adverse events.
Plain-English summary
Stradis Medical, LLC dba Stradis Healthcare has recalled approximately 14,959 IUD Insertion Kits with Part Number 935K. The firm was unable to confirm that the tenaculum devices included in these kits were manufactured in accordance with required design and manufacturing standards.
The tenaculum is a component used during intrauterine device (IUD) insertion procedures. The recall addresses uncertainty regarding manufacturing standards compliance during device production.
The affected kits were distributed nationwide to medical facilities and healthcare providers across more than 30 U.S. states and internationally to Canada.
For questions or to report issues with affected kits, contact the manufacturer directly or consult guidance from the U.S. Food and Drug Administration.
The recalled product
- Product
- IUD Insertion Kit
- Manufacturer
- Stradis Medical, LLC dba Stradis Healthcare
- Hazard
- design-defect
- manufacturing-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 (1)
- Part Number: 935K
Distribution
Distributed nationwide across the United States.
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