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.
Cardinal Health is recalling Genius 2 tympanic thermometers because readings may drift upward over time, potentially exceeding the stated accuracy range.
Wright Medical Technology is recalling two lots of EVOLVE Modular Radial Heads because the product size in the package may be incorrect. Both labels and laser markings are wrong.
Pacific Medical Group Inc. is recalling GE Corometrics Nautilus Ultrasound units because fetal transducers were distributed before receiving required FDA and international clearances.
Cardinal Health is recalling Genius 2 tympanic thermometers because readings may drift upward over time, potentially exceeding the stated accuracy range.
Pacific Medical Group Inc. is recalling 261 fetal transducers distributed in the U.S. and abroad before receiving required FDA and international clearances.
Pacific Medical Group is recalling 772 fetal transducers distributed in the U.S. and abroad before receiving required FDA 510(k) and international clearances.
Microbiologics Inc is recalling 9 units of the Vaginal Verification Panel Lot 8208-11 because Pool 2 contains the wrong organism, Candida krusei.
Pacific Medical Group Inc. is recalling 678 fetal ultrasound transducers because they were distributed before receiving required FDA 510(k) and international clearances.
Zimmer Biomet is recalling 133 Jamshidi Bone Marrow Aspiration Needles because the outer expiration date may exceed the inner label date.
Pacific Medical Group Inc. is recalling 225 ultrasound transducers distributed before receiving required FDA and international clearances.
Wright Medical Technology is recalling 39 EVOLVE Modular Radial Heads because the product size inside the package does not match the label or laser marking.
Randox Laboratories is recalling Liquid Clinical Chemistry Control lot 1021 UE due to a transcription error in the Lipase value.
Jjgc Industria E Comercio De Materials Dentarios Sa is recalling two Neodent Tapered Guided Surgery Drills because the laser engraving incorrectly identifies the model.
Radiometer Medical ApS is recalling AQURE basic system software versions 2.3.5 and below due to a potential patient data mix-up risk when connected to third-party devices.
Haemonetics is recalling specific Cell Saver bowl sets because they may leak, potentially trapping fluid and causing incomplete washing.
Custom Healthcare Systems is recalling 240 inpatient dialysis kits because a component contains latex that was not listed on the product labels.
Haemonetics is recalling Cell Saver bowl sets because cracks in the inner core may cause leaks and incomplete blood washing.
LivaNova USA Inc is recalling 106 Cyberonics VNS Therapy AspireHC Model 105 generators due to electrical leakage causing premature battery depletion.
Haemonetics is recalling 739 Cell Saver bowl sets because cracks in the inner core can cause leaks and incomplete blood washing.
Mindray is recalling six ABS800 Chemistry Analyzers due to a potential gas spring failure that poses a low risk of impact injury to users.
Haemonetics is recalling CS Elite Processing Sets because cracks in the bowl core may cause fluid trapping and incomplete washing.
Vitreq Bv is recalling VitreQ 23G Silicone Tipped Cannulas because microscopic tears in the sterile pouch may compromise sterility.
Vitreq Bv is recalling VitreQ 20G Blunt and Brush Needles because microscopic tears in the sterile pouch may compromise sterility.
Vitreq Bv is recalling VitreQ 23G VFI Cannulas because microscopic tears in the sterile pouch may compromise sterility.
Vitreq Bv is recalling VitreQ 25G VFI Cannulas because microscopic tears in the sterile pouch may compromise sterility.
Looking for a different category? Browse all recalls.