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
- Affected units
- 14,959
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
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.
See all 6 products in this recall →Related recalls
Same manufacturer · Stradis Medical, LLC dba Stradis Healthcare
See all →- HighStradis Healthcare Venous Access Pack Recalled for Potential Sterility Breach
FDA (Devices) · 2022-12-21
- HighGeneral Surgery Procedure Kit Recalled for Sterility Concerns
FDA (Devices) · 2022-12-21
- HighStradis Healthcare Vein RF Pack surgical trays recalled for incomplete outer bag seal
FDA (Devices) · 2022-12-21
- HighSurgical Procedure Kits Recalled by Stradis Healthcare for Sealing Defect
FDA (Devices) · 2022-12-21
- HighStradis Healthcare Curved Tip Syringes Recalled Due to Incomplete Sterile Sealing
FDA (Devices) · 2022-12-21
Same hazard · design defect
See all →- HighUnited Orthopedic Recalls U2 Total Knee System Femoral Offset Bushings
FDA (Devices) · 2026-08-12
- SevereBioFlo DuraMax catheters recalled as Class I over sheath introducer defect
FDA (Devices) · 2026-04-01
- SevereMerit 16F splittable sheath introducer recalled as Class I bulk product
FDA (Devices) · 2026-04-01
- SevereProGuide chronic dialysis catheters recalled as Class I over sheath introducer defect
FDA (Devices) · 2026-04-01
- SevereCentrosFLO hemodialysis catheters recalled as Class I over sheath introducer defect
FDA (Devices) · 2026-04-01