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.
GE Healthcare is recalling 18 Millennium MC units because a detector can detach and fall.
GE Healthcare is recalling 276 Millennium MyoSIGHT Nuclear Cardiology Imaging Systems because a detector can detach and fall.
AROA Biosurgery is recalling OviTex 1S Reinforced BioScaffold mesh devices because the suture material degraded, causing them to fail burst specifications.
Zimmer Biomet is recalling 2,163 Affixus Hip Fracture Nails because the set screw cannot advance or reverse from its original position.
Virtual Imaging is recalling 253 RadPRO Mobile 40kW Digital X-Ray Systems because the tube head may separate and fall off the unit.
Stryker is recalling 20,030 Spirit Plus hospital beds with high rail siderails due to non-compliance with safety standards and a potential risk of patient entrapment.
R82 A/S is recalling 687 Heron toilet and bath chairs because they contain aluminum gas spring heads. The recall is a replacement campaign for these specific units.
AROA Biosurgery is recalling OviTex 1S Reinforced BioScaffold 16x20cm devices because the PGA suture material degraded, causing them to fail burst specifications.
AROA Biosurgery is recalling OviTex 1S Reinforced BioScaffold devices because the suture material degraded, causing them to fail burst specifications.
Arthrex, Inc. is recalling 832 units of the 3.2mm Proximal Reamer/Cannulated Drill because the instrument may break during use.
American Contract Systems is recalling 1,180 kits of powdered surgical gloves because they are an FDA banned substance.
Zimmer Biomet is recalling 2,163 Affixus Hip Fracture Nails because the set screw cannot advance or reverse from its original position.
Luminex Corporation is recalling 12,700 trays of Verigene Blood Culture Gram-Positive Nucleic Acid Kits due to a potential for false negative results.
AROA Biosurgery is recalling OviTex 2S Reinforced BioScaffold devices because the suture material degraded, causing them to fail burst specifications after 18 months.
AROA Biosurgery is recalling OviTex 2S Reinforced BioScaffold mesh devices because the suture material degraded, causing them to fail burst specifications.
Tosoh Bioscience is recalling 393 AIA-900 Analyzers because a pickup arm malfunction can stop the device from testing patient samples, causing delays in results.
Zimmer Biomet is recalling Affixus Hip Fracture Nails because the set screw cannot advance or reverse from its original position.
AROA Biosurgery is recalling OviTex 2S Reinforced BioScaffold devices because the suture material may degrade, causing them to fail burst specifications.
Invivo Corporation is recalling 76 units of the Xper Flex Cardio Physiomonitoring System due to a software defect that causes Invasive Blood Pressure values to freeze on the display.
AROA Biosurgery is recalling OviTex 1S Reinforced BioScaffold mesh devices because the suture material degraded, causing some units to fail burst specifications.
AROA Biosurgery is recalling OviTex 1S Reinforced BioScaffold 4x8cm devices because the PGA suture material degraded, causing the devices to fail burst specifications.
AROA Biosurgery is recalling OviTex Reinforced BioScaffold mesh devices because the suture material degraded, causing them to fail burst specifications.
AROA Biosurgery is recalling OviTex 1S Reinforced BioScaffold devices because the suture material degraded, causing them to fail burst specifications.
AROA Biosurgery is recalling OviTex Reinforced BioScaffold mesh devices because the suture material degraded, causing some units to fail burst specifications.
AROA Biosurgery is recalling OviTex 2S Reinforced BioScaffold devices because the suture material degraded, causing them to fail burst specifications.
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