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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.
DJO Cold Form Wrap products are recalled because microwave heating instructions can cause the wrap to leak, rupture, or reach temperatures that cause second-degree burns.
B. Braun Medical Inc is recalling IV Administration Sets due to potential backflow of medication and inability to prime.
The FDA is recalling DermaSensor Model 10101 because it may not meet performance specifications, potentially causing incorrect diagnostic results or delayed referrals for patients with suspected skin cancer.
B Braun Medical is recalling IV Administration Sets due to potential medication backflow from secondary containers into primary containers and inability to prime the line. Approximately 187,464 units are affected worldwide.
B Braun Medical is recalling Extension Sets used in IV administration systems due to potential backflow of medication from secondary IV containers into primary containers, which could also cause inability to prime the line.
B Braun Medical is recalling CARESAFE IV administration sets due to potential medication backflow from secondary to primary containers and inability to prime. Approximately 4,438 units are affected worldwide.
B Braun Medical Inc is recalling 164,568 Blood Administration Sets due to potential backflow of medication from secondary IV containers into primary containers and inability to prime. The affected sets are used in gravity and pump-based IV administration systems.
B Braun IV administration sets used with gravity and pump infusion systems may allow medication to flow backward from secondary containers into primary containers and prevent proper priming. Discontinue use and contact the manufacturer.
B Braun Medical Inc is recalling 7,240 Burette Sets used in IV administration due to potential medication backflow from secondary containers and inability to prime. The affected catalog number 490159 was distributed worldwide.
B Braun Medical's Caresite injection sites in IV administration sets may allow medication to flow backward from secondary containers into primary containers and prevent proper line priming. Approximately 2.8 million units affected worldwide.
Pivotal Health Solutions is recalling the Quantum Intersegmental Table Model Q400 because the heat function may become damaged when patients press on component areas, potentially causing overheating and smoldering of the vinyl cushion.
B Braun Medical recalls 41,400 ULTRASITE IV administration sets worldwide due to potential backflow of medication from secondary IV containers and inability to prime.
B Braun Medical Inc is recalling 30,250 Extension Sets used with infusion pumps due to potential medication backflow from secondary IV containers into primary containers and inability to prime the line.
B.Braun IV administration sets used with certain infusion pumps are recalled due to potential medication backflow from secondary containers into primary containers and inability to prime. No illnesses reported.
Stryker Corporation is recalling the NICO Myriad Illumination Pack because tape used in packaging contains latex despite the product being labeled as latex-free. Latex may cause allergic reactions in sensitive individuals.
B Braun Medical Inc is recalling approximately 2,352 Outlook IV administration sets due to potential backflow of medication into primary containers and inability to prime. No injuries have been reported.
B. Braun Medical Inc is recalling 24,072 IV administration sets used with multiple pump models due to potential backflow of medication from secondary containers into primary containers and inability to prime.
B Braun Medical Inc recalls 407,800 IV administration sets for potential backflow of medication and occlusion. The defect may prevent proper medication delivery in gravity and pump administration systems.
B. Braun IV Administration Sets used with multiple infusion pumps are being recalled due to potential for medication backflow from secondary into primary IV containers and inability to prime properly.
B Braun Medical is recalling IV Administration Sets due to a risk of medication backflow from secondary to primary IV containers and inability to prime. Affected catalog numbers 477002 and 477017 were distributed worldwide.
B Braun Medical IV administration sets used with certain infusion pumps may allow medication to flow backward from secondary containers into primary containers and fail to prime. This could result in incorrect medication delivery.
B. Braun Medical Inc is recalling 32,500 Extension Sets used in IV administration due to potential backflow of medication and inability to prime the infusion lines.
B Braun Medical Inc is recalling approximately 200,917 IV administration sets with SafeDAY components due to potential medication backflow between IV containers and blockage that may prevent line preparation.
Medtronic's Catalyft spinal interbody cages may lose height or collapse during use, which could lead to implant migration, subsidence, and neurological injury. Updated surgical techniques and instructions are being provided to mitigate this risk.
B Braun Medical Inc recalls 24,624 blood administration sets due to potential medication backflow and priming failures. The defect may allow secondary IV medications to flow backward into primary lines, affecting IV therapy delivery.
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