The Recall Desk
HighFDA (Devices)·Z-0131-2022·Announced 2021-10-27

IUD Insertion Kit Recalled Over Manufacturing Standards Verification Issues

Stradis Healthcare is recalling its Standard IUD Insertion Kit (280 units) after being unable to confirm the tenaculum devices meet 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: This is a Class II recall of a medical device component used in invasive procedures where the manufacturer cannot confirm compliance with design and manufacturing standards. This constitutes a risk-of-harm product where no injuries have been reported, per the severity rubric.

Plain-English summary

Stradis Medical, LLC dba Stradis Healthcare is recalling the Standard IUD Insertion Kit (Part Number M20). The kit contains tenaculum devices, surgical instruments used in IUD insertion procedures.

The manufacturer has been unable to confirm that the tenaculum devices were produced in accordance with required design and manufacturing standards.

The recall affects 280 kits distributed to healthcare facilities across multiple U.S. states and to Canada.

The recalled product

Product
Standard IUD Insertion Kit
Manufacturer
Stradis Medical, LLC dba Stradis Healthcare
Category
Medical Device — Gynecological
Hazard
  • manufacturing-defect
  • device-malfunction

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: M20

Distribution

Distributed nationwide across the United States.

Related recalls

Same category