UnratedMedical device recall · FDA · Published September 10, 2021
Stradis Healthcare Foundation Kit Recall: Design Standards Not Confirmed
Stradis Healthcare recalls Foundation Kit (Part A10) due to unconfirmed compliance with design and manufacturing standards. Consumers should check product details and follow official instructions.
“Stradis Healthcare Foundation Kit Recall: Design Standards Not Confirmed.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61804-stradis-healthcare-foundation-kit-recall-design-standards-not-confirmed. Based on FDA recall #Z-0130-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0130-2022%22&limit=1).
Stradis Medical, LLC dba Stradis Healthcare recalled its Foundation Kit (Part Number A10) on Sept. 10, 2021, according to the FDA. The firm cannot confirm the tenaculum devices met required design and manufacturing standards.
How to tell if you have it
Brand: Stradis Healthcare
Product: Foundation Kit
Part Number: A10
Quantity: 790 kits
The hazard
The firm is unable to confirm that the tenaculum devices were produced in accordance with required design and manufacturing standards, according to the FDA.
Context
GovInfoNow's records show Stradis Medical, LLC dba Stradis Healthcare has had four other recalls since Oct. 28, 2021. Other recent recalls of similar products include the Angio Pack Recall (Nov. 2, 2022), the Scissors Recall (July 25, 2022), and the Surgicare Neuro Pack Recall (Feb. 25, 2022).
How to tell if you have this one
Check for the Foundation Kit with Part Number A10. This product was sold by Stradis Healthcare and may be used in medical procedures.
Brand
Stradis Healthcare
Category
Medical device
FDA recall event · 6 products
All 6 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Ongoing
Distribution
Distributed nationwide to 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, GA, KS, MI, AK, ID, SD, UT and internationally to Canada.
Recall number
Product, codes & lots
Quantity
Z-0126-2022
Tenaculum, Plastic; Part Number: 356T
2483 kits
Z-0127-2022
IUD Insertion Pack; Part Number: 618-034
20 kits
Z-0128-2022
IUD Insertion Kit; Part Number: 935K
14959 kits
Z-0129-2022
Endometrial Biopsy Kit; Part Number: 936K
1639 kits
Z-0130-2022
Foundation Kit; Part Number: A10
790 kits
Z-0131-2022
Standard IUD Insertion Kit; Part Number: M20
280 kits
Based on the official FDA remedy
What to do — step by step
Check Product Details
Identify if your Foundation Kit has Part Number A10.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 31 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “Distributed nationwide to 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, GA, KS, MI, AK, ID, SD, UT and internationally to Canada.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alaska, Arizona, California, Colorado, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Maryland, Massachusetts, Michigan, Missouri, Montana, Nevada, New Jersey, New York, North Carolina, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington.
Recall timeline
FDA published this recall 47 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0130-2022 (September 10, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0130-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.