CooperSurgical recalls PARAGARD T380A intrauterine copper contraceptives due to non-sterility risk. One unit per carton with insertion tube and white rod is affected. No remedy specified in official notice.
📍Recalling firmCooperSurgical, Inc825 Wurlitzer Dr · North Tonawanda, NY 14120-3041
✎ GovInfoNow plain-language explainer
CooperSurgical has recalled one unit per carton of PARAGARD T380A intrauterine copper contraceptives because of a non-sterility hazard. This recall affects specific units sold with an insertion tube and solid white rod. The hazard means the product may not be sterile, which could lead to infections. No remedy is stated in the official recall notice. Read more at govinfonow.com/recall/35241-coopers-paragard-t380a-intrauterine-copper-contraceptive-recall-non-sterility-hazard.
“CooperS: PARAGARD T380A Intrauterine Copper Contraceptive Recall - Non-sterility Hazard.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/35241-coopers-paragard-t380a-intrauterine-copper-contraceptive-recall-non-sterility-hazard. Based on FDA recall #D-0643-2022 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0643-2022%22&limit=1).
CooperSurgical, Inc recalled PARAGARD T380A intrauterine copper contraceptives due to non-sterility risks, the FDA said on Feb. 4, 2022. The Class I recall affects 48,645 cartons distributed nationwide.
The recall addresses non-sterility in PARAGARD T380A units packaged with an insertion tube and solid white rod. The FDA classified the hazard as Class I.
Context
GovInfoNow's records show CooperSurgical, Inc has issued 37 other recalls since Oct. 6, 2017. Recent brand recalls include a Neonatal CPAP Replacement Set with loose tubing on Aug. 11, 2026, and HSG Procedure Tray non-sterile iodine pouches on June 11, 2025. Other recent recalls of similar products include Sterile Lubricant Dry Eye Relief Eye Drops (Sept. 11, 2026) and K.C. Pharmaceuticals Ultra Lubricating Eye Drops (March 3, 2026).
How to tell if you have this one
Check for PARAGARD T380A with an insertion tube and solid white rod in a Tyvek polyethylene pouch. The product is sold with a specific lot number (517001) and expiration date (1/2024).
Brand
CooperSurgical
Category
Drug
Based on the official FDA remedy
What to do — step by step
Check Product Details
Look for PARAGARD T380A with an insertion tube and solid white rod in a Tyvek polyethylene pouch.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “US Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 12 months after the firm started it.
1Firm started the recall
2Published in FDA’s Enforcement Report
3FDA classified it Class I
4FDA terminated the recall
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 #D-0643-2022 (February 4, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0643-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 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.