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Learning how to check iud recall paragard model information is one of the first things women do after a device breaks during removal. The confusion is understandable. Millions of American women use an intrauterine device, and news of thousands of lawsuits makes many assume a recall must have happened. In most cases, that assumption is wrong. As of 2026, the Paragard copper IUD has not been recalled by the U.
S. Food and Drug Administration. However, that single fact does not end the inquiry. There was a real recall in 2014, there are lot-specific issues, and there are label changes that matter to your case. This guide walks through how to check iud recall paragard model records yourself, using free government databases. It also explains what a “no recall” answer means for your legal rights, because the two questions are not the same.
What a Recall Actually Means, and Why It Matters Less Than You Think
A recall is a manufacturer action, not a court finding. The FDA classifies device recalls into three levels. Class I means a reasonable probability of serious injury or death. Class II means temporary or reversible health consequences. Class III means a technical violation unlikely to cause harm. Most device recalls are voluntary and initiated by the company itself.
Here is the key point for anyone researching how to check iud recall paragard model status. A product does not need to be recalled for you to file a lawsuit. Product liability law focuses on whether the device was defectively designed, defectively manufactured, or sold without adequate warnings. For example, thousands of women have sued over Paragard breakage even though the device remains legally on the market today.
There was one genuine Paragard recall. In April 2014, Teva Pharmaceuticals voluntarily pulled specific lots because the devices failed to meet federal sterility standards. Non-sterile IUDs can cause serious pelvic infections. That recall covered only certain batches shipped to hospitals, clinics, and gynecology offices. It did not cover the breakage problem that drives today’s litigation.
How to Check IUD Recall Paragard Model Records in Four Steps
You can verify your device yourself in under an hour. No lawyer is needed for this part. Follow these steps in order.
Step one: get your insertion record. Request your medical chart from the clinic that placed the IUD. Under HIPAA, providers must respond within 30 days. Ask specifically for the insertion note, the device sticker or label, and the lot number. Many clinics peel the device label directly into the chart. That sticker is the single most valuable document for anyone learning how to check iud recall paragard model details, because it lists the manufacturer, lot, and expiration date.
Step two: search the FDA recall database. Go to the FDA Medical Device Recall Database and search “intrauterine” or “Paragard.” Enter your lot number if you have it. The database returns the recall class, the recalling firm, the affected lot ranges, and the reason. Records go back decades, so a 2014 entry will still appear.
Step three: check adverse event reports. The FDA MAUDE database collects injury reports from patients, doctors, and manufacturers. Search by brand name. Reports of Paragard fracturing number in the thousands, and in 2023 alone the FDA logged at least 934 adverse incident reports involving the device breaking during removal.
Step four: call the manufacturer. CooperSurgical, which acquired Paragard from Teva in 2017, maintains a product line at 1-877-PARAGARD. Have your lot number ready. Typically, a representative can confirm whether that lot was ever subject to a field action.
Current Status of Common IUD Models
The table below summarizes where the major devices stand. Anyone working through how to check iud recall paragard model questions should compare their own device against this list first.
| Device | Manufacturer | Recall status | Litigation status |
|---|---|---|---|
| Paragard (copper T 380A) | CooperSurgical (formerly Teva) | 2014 sterility recall on limited lots; no breakage recall | MDL 2974, N.D. Georgia |
| Mirena | Bayer | No FDA recall | Two MDLs, both closed by December 2020 |
| Liletta | Medicines360 / Organon | No FDA recall | Individual claims only |
| Kyleena | Bayer | No FDA recall | Individual claims only |
| Skyla | Bayer | No FDA recall | Individual claims only |
The Paragard litigation is consolidated as In re: Paragard IUD Products Liability Litigation, MDL No. 2974, before Judge Leigh Martin May in the U.S. District Court for the Northern District of Georgia. As of mid-2026, roughly 4,111 cases were pending, out of about 4,409 filed since the MDL was created in December 2020. The first bellwether trial produced a defense verdict for Teva in February 2026. The next trial was scheduled for late September 2026. There is no global settlement.
Label history matters too. The FDA approved updated Paragard labeling in 2019 that added information about breakage during removal. The label was revised again in 2024 to address retained fragments. Plaintiffs argue those changes came far too late. That timing argument is central to failure-to-warn claims, so noting your insertion date while you research how to check iud recall paragard model status is worth the extra minute.
What to Do Next If Your Device Broke
Act on the medical side first. If a piece of the device remains inside you, ask your gynecologist about imaging. Ultrasound and X-ray are both used. Retained copper fragments have required hysteroscopy, laparoscopy, and in some documented cases hysterectomy.
Preserve the evidence. If your doctor removed a broken arm or stem, ask for it in writing before the specimen is discarded. Photograph it. Keep the operative report, the pathology report, and every bill. These documents carry more weight than anything you will find while learning how to check iud recall paragard model records online.
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Watch your filing deadline. The statute of limitations is set by state law and it is unforgiving. California and Texas generally allow two years for personal injury. Florida moved from four years to two years for negligence claims accruing on or after March 24, 2023.
Tennessee and Louisiana are among the shortest at one year. New York and North Carolina generally allow three years. Missouri allows five. Many states also apply a discovery rule, which starts the clock when you knew or reasonably should have known the device caused your injury. As a result, two women injured on the same day can face different deadlines.
Finally, understand that a lawsuit is not a recall claim. There is no manufacturer refund program for Paragard. Compensation in these cases comes through settlement or verdict, and it typically covers surgical costs, lost wages, pain and suffering, and in some cases loss of fertility.
Frequently Asked Questions
Was Paragard ever recalled by the FDA?
Not for breakage. However, Teva voluntarily recalled certain lots in April 2014 over sterility failures. For example, that action pulled specific batches from clinics but left the product on the market.
Can I still sue if my lot was never recalled?
Yes. In most cases, recall status is irrelevant to whether a claim survives. Anyone finishing the process of how to check iud recall paragard model records should treat a “no recall” result as expected, not as a rejection.
How do I find my lot number years after insertion?
Request the full chart from your inserting provider, including the device sticker. If the clinic closed, try the hospital system that absorbed it. Typically, pharmacy or supply records also retain lot data.
Does the September 2026 trial affect my case?
Bellwether trials guide settlement talks for the whole MDL. However, a single verdict does not bind your individual claim. As a result, most cases remain pending while both sides read the results.
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Official Sources & Resources
For verified mass tort and legal information:
- JPML (Case Data): jpml.uscourts.gov
- U.S. Department of Justice: justice.gov
- Cornell Law Institute: law.cornell.edu
- NCSL (State Laws): ncsl.org
- FDA Recalls & Safety: fda.gov
Content last reviewed September 2026. If you notice any outdated information, please contact us.
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Attorney Advertising. The information on this page is provided for general informational purposes only and does not constitute legal advice. No attorney-client relationship is created by accessing or using this content. Every case is unique, and results depend on the specific facts and circumstances involved. Past settlement amounts and case outcomes do not guarantee similar results in your case. If you believe you have a legal claim, you should consult with a licensed attorney in your jurisdiction who can evaluate your specific situation.