Yes — you can still sue a device maker after an FDA-linked recall. A recall does not shield the company from liability for injuries the product already caused. A recall is a manufacturer's correction or removal of a device that violates FDA law, is defective, or poses a health risk. This article explains what a recall proves, where federal law limits lawsuits, and what injured consumers can do next.
Official resources:
- Read the official notice from FDA — Use this primary source to verify the official announcement.
- Read the official notice from FDA — Use this primary source to verify the official announcement.
Table of Contents
- What does a recall actually mean?
- Does a recall prove your case?
- When can federal approval block a claim?
- What should you do after a recall injury?
What does a recall actually mean?
Most device recalls are voluntary actions by manufacturers to protect public health from products that present injury risk, deception, or defect. The U.S. Food and Drug Administration describes these actions as corrections or removals handled under 21 CFR Part 7 in its device recall process guide. FDA classifies recalls as Class I, II, or III based on health hazard.
Class I is the most serious. It means FDA found a reasonable probability that use or exposure will cause serious health harm or death. A recall can cover implanted devices, home-use equipment, test kits, and hospital tools. The class and recall notice help show how serious FDA considered the hazard.
Does a recall prove your case?
No. A recall can support a case as evidence of defect or notice, but it does not automatically prove liability. FindLaw states that plaintiffs must still prove a defect and show it directly caused injury or illness in its drug and device recall guide.
That means you still need medical proof linking the device to your harm. A hospital record, explant report, or treating doctor's opinion often carries more weight than the recall letter alone. Keep the device, packaging, implant card, and recall notice if you can. Do not return or discard the product before getting legal advice about testing and storage.
When can federal approval block a claim?
The answer depends on how FDA cleared the device. For premarket-approved Class III devices, state tort claims that challenge safety or effectiveness are generally preempted under Riegel v. Medtronic, 552 U.S. 312, decided Feb. 20, 2008. The main exception is a claim premised on violation of federal requirements. The Cornell Legal Information Institute publishes the decision in its copy of Riegel v.
Medtronic. The barrier is narrower for 510(k)-cleared devices. Under Medtronic v. Lohr, 518 U.S. 470, decided June 26, 1996, substantial-equivalence clearance does not impose preemptive federal requirements, so related state claims generally may proceed. That distinction is published in its copy of Medtronic v. Lohr.
What should you do after a recall injury?
Act quickly to protect both health and a possible claim. Talk to your doctor about whether to stop using, remove, replace, or keep the device in place. Bring the recall notice, implant card, medication list, and photos to that first call.
- Save the device, packaging, receipts, and recall letters.
- Write down implant dates, symptoms, doctor visits, and missed work.
- Ask your provider to note the device name and failure in your chart.
- Get a legal review before signing a release or joining a settlement.