The Recall Desk
HighFDA (Devices)·Z-0130-2022·Announced 2021-10-27

Foundation Kit Tenaculum Devices Recalled for Manufacturing Non-Compliance

Stradis Medical recalled 790 Foundation Kits because the manufacturer cannot confirm tenaculum devices met 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 medical device recall for manufacturing and design standards non-compliance. This constitutes a risk-of-harm product where no injuries have been reported, meeting the criteria for High severity.

Plain-English summary

Stradis Medical, LLC dba Stradis Healthcare is recalling the Foundation Kit, which includes tenaculum devices used in medical procedures. The recall was initiated because the manufacturer is unable to confirm that the tenaculum devices were produced in accordance with required design and manufacturing standards.

A total of 790 kits have been affected by this recall. These kits were distributed nationwide to healthcare facilities in VA, SC, CA, PA, MA, FL, TN, NJ, GA, AZ, IL, OH, OK, WA, NY, NV, MO, MD, IN, TX, CO, RI, NC, KY, MT, VI, KS, MI, AK, ID, SD, UT, and internationally to Canada.

No injuries or illnesses related to this product have been reported. Healthcare facilities and other recipients of this product should contact the manufacturer for instructions regarding the return or destruction of affected units.

The recalled product

Product
Foundation Kit
Manufacturer
Stradis Medical, LLC dba Stradis Healthcare
Category
Medical Device — Surgical Instruments
Hazard
  • manufacturing-defect
  • design-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: A10

Distribution

Distributed nationwide across the United States.

Related recalls

Same category