Category
FDA recalls of medical devices including diagnostics, implants, and consumer health hardware.
Medical device recalls are the FDA's highest-volume stream. They cover implantable devices like pacemakers and joint replacements, hospital diagnostics and lab analyzers, surgical instruments, software-as-a-medical-device, and consumer-facing hardware like CPAP machines, blood-pressure cuffs, and glucose monitors. The volume comes from the wide range of products in scope and from the FDA's broad definition of 'corrective action' — software updates, IFU revisions, and labeling corrections all show up as recalls.
For Class I device recalls, the device's defect creates a reasonable risk of serious injury or death — these are the urgent ones. Class II covers issues that may cause temporary or medically reversible harm, often around accuracy or calibration. Class III is for products that don't comply with FDA rules but pose no real safety risk; in practice many software-update letters are Class III.
If you depend on a recalled device for ongoing care, don't disconnect or stop using it before talking to the prescribing clinician — interrupting therapy for a CPAP or a continuous glucose monitor can be more dangerous than the recall it's responding to. Almost every device recall offers a remedy that doesn't require you to surrender the device first.
Straumann USA is recalling 61 units of Emdogain because product intended for demonstration purposes only could be placed in patients.
B. Braun Medical is recalling 11,650 extension sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.
B. Braun Medical is recalling 30,250 extension sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.
B. Braun Medical is recalling 126,050 units iv administration sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.
Pivotal Health Solutions is recalling 34 Quantum Intersegmental Tables, model Q400, because damage to the heat function components can lead to overheating and smoldering.
B. Braun Medical is recalling 10,536 units anesthesia iv sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.
B. Braun Medical is recalling 15,250 units iv administration sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.
B. Braun Medical is recalling 32,500 Caresite extension sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.
B. Braun Medical is recalling 58,752 anesthesia IV sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.
B. Braun Medical is recalling 23,160 units iv administration sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.
B. Braun Medical is recalling 1,861,111 units iv administration sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.
B. Braun Medical is recalling 28,344 units iv administration sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.
B. Braun Medical is recalling 61,423 units extension sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.
B. Braun Medical is recalling 10,896 units iv administration sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.
B. Braun Medical is recalling 5,100 IV administration sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.
B. Braun Medical is recalling 11,800 units extension sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.
B. Braun Medical is recalling 43,900 ADDitIV primary gravity sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.
B. Braun Medical is recalling 1,200 units extension sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.
B. Braun Medical is recalling 27,480 extension sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.
B. Braun Medical is recalling 65,232 IV administration sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.
B. Braun Medical is recalling iv administration set catalog number 490566 over the potential for medication backflow from secondary piggyback containers and an inability to prime.
B. Braun Medical is recalling 4,438 CARESAFE sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.
B. Braun Medical is recalling 65,904 units iv administration sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.
Mindray is recalling 148 Sevoflurane V90 Electronic Vaporizers used with the A9 Anesthesia System over the potential for anesthesia leakage.
B. Braun Medical is recalling 63,192 units iv administration sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.
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