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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.
Wright Medical Technology is recalling 16 Evolve Stem 8.5mm implants because they lack sterility assurance. The recall covers units distributed in the US and several international countries.
GE Healthcare is recalling four NM/CT 860 SPECT/CT systems because rotor bearing screws were found loose on the detector.
Irvine Biomedical is recalling 40 units of Inquiry Steerable Diagnostic Catheters because packages were mislabeled with the wrong model and lot numbers, potentially causing procedure delays.
Medline Industries is recalling Central Line Dressing Change Trays because incomplete seals may compromise sterility. The recall affects kits distributed in Minnesota and Texas.
LivaNova is recalling 102 Perceval Single Use Accessory Kits because the Dual Collapser component may fail to reduce the heart valve diameter, preventing implantation.
Hologic is recalling 607 Panther Fusion Tube Trays because they may leak, potentially invalidating patient results or causing false negatives in flu and RSV assays.
LivaNova is recalling specific lots of the Perceval Dual Collapser because complaints indicate the device may fail to collapse the heart valve during implantation.
LivaNova is recalling specific lots of Perceval Single Use Accessory Kits because the Dual Collapser component may fail to reduce the heart valve diameter during implantation.
GE Healthcare is recalling 25 NM 830 detectors because rotor bearing screws were found loose. The devices are distributed in the US and internationally.
ArthroCare is recalling Speed Stitch Needle Cassettes because a supplier error may have resulted in needles made of titanium instead of stainless steel, posing a risk of breakage during use.
Bio-Rad is recalling BioPlex 2200 Syphilis Total & RPR kits because of increased RPR reactivity levels in the kit material.
GE Healthcare is recalling 15 NM/CT 870 CZT systems because rotor bearing screws were found loose on the detector.
GE Healthcare is recalling 31 NM/CT 870 DR systems because rotor bearing screws were found loose on the detector.
GE Healthcare is recalling nine Discovery NM670 Pro units because rotor bearing screws were found loose on the detector.
GE Healthcare is recalling 25 NM/CT 850 systems because rotor bearing screws were found loose on the detector.
Irvine Biomedical is recalling 15 units of Inquiry Steerable Diagnostic Catheters because packages were mislabeled with the wrong model and batch numbers.
Beckman Coulter is recalling 32 DxA 5000 automated sample handling systems because the instructions for use may be confusing regarding the re-use of sample IDs, leading to undetected barcode re-use.
GE Healthcare is recalling 20 Discovery 670 DR units because rotor bearing screws were found loose on the detector.
Beckman Coulter is recalling Access Unconjugated Estriol assay systems because alkaline phosphatase interference may cause falsely elevated results.
OraSure Technologies is recalling CVS Advanced Wart Remover Kits because unit boxes were not properly sealed. The recall covers 23,400 units distributed in the US, Canada, and Brazil.
OraSure Technologies is recalling 3,000 units of Personelle OTC Skin Tag Remover because unit boxes were not properly sealed.
OraSure Technologies is recalling Pointts skin tag removal systems because unit boxes were not properly sealed. The recall affects 23,220 units distributed in the US, Canada, and Brazil.
DNA Genotek Inc. is recalling 74 units of the PrepIT Q2A Kit because reagents were shipped after their expiration dates.
Randox Laboratories is recalling 143 kits of AM1015 Ammonia reagents due to a positive bias of up to 140 µmol/L observed in patient samples.
Inpeco S.A. is recalling Aptio Automation systems with Sysmex Interface Modules because a firmware defect may mis-associate sample IDs, leading to incorrect or delayed clinical chemistry results.
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