CLASS I Drug recall · Reported 23 Feb 2022 · FDA Enforcement Report
Paragard T380A (intrauterine copper contraceptive) recalled
CooperSurgical is recalling Paragard T380A (intrauterine copper contraceptive) per carton together with an insertion, distributed nationwide in the US. The recall was initiated on 4 Feb 2022 and the FDA has classified it as Class I.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0643-2022
- FDA event ID
- 89462
- Recalling firm
- CooperSurgical, North Tonawanda, NY
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 4 Feb 2022
- FDA classified
- 1 Mar 2022
- Reported
- 23 Feb 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Hormones & Birth Control
Timeline
| 4 Feb 2022 | Recall initiated by company | |
| 23 Feb 2022 | Published in enforcement report | +19 days |
| 1 Mar 2022 | Classified by FDA | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Non-sterility
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
PARAGARD T380A (intrauterine copper contraceptive), 1 unit per carton together with an insertion tube and solid white rod in a Tyvek polyethylene pouch, Rx Only, Manufactured by Teva Women's Health Inc. a subsidiary of Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 51285-204-01
Where it was distributed
US Nationwide
Questions about this recall
Why was it recalled?
Non-sterility
Which lots are affected?
Lot # 517001,Exp 1/2024
Where was it sold?
US Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from CooperSurgical
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|---|---|---|---|---|---|
| Device | CLASS II | HSG Procedure Tray recalled by CooperSurgical | CooperSurgical | Sterility | Nationwide |
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| Device | CLASS II | Endosee System Convenience Kit with IV Tube recalled by CooperSurgical | CooperSurgical | Sterility | Nationwide |
| Device | CLASS II | K-Systems R65 Trolley recalled by CooperSurgical | CooperSurgical | Temperature Abuse | 14 states |
| Device | CLASS II | K-Systems T47 Warming Plate recalled by CooperSurgical | CooperSurgical | Temperature Abuse | 14 states |