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.
Zimmer Biomet is recalling 16 Vanguard 360 Revision Knee System tibial block augments because the sterile packages contained one bolt instead of the required two.
Tosoh Bioscience Inc is recalling eight G8 Automated HPLC Analyzers because they were distributed with software that lacks a 510(k).
Zimmer Biomet is recalling 16 Vanguard 360 Revision Knee System tibial block augments because the sterile packages contained only one bolt instead of the required two.
Medtronic is recalling 250 units of DxTerity TRA 5F Diagnostic Catheters because the inner pouch may incorrectly display a 6 French size indicator instead of the correct 5 French size.
Zimmer Biomet is recalling 217 units of Biomet Sports Medicine Juggerknot Long Flex Drill Bits because the expiration date is incorrectly listed on the label.
Ventana Medical Systems is recalling 468 units of CINtec p16 Histology reagent because leaking dispensers may cause false negative test results.
Pro-Med Instruments is recalling 31 DORO LUCENT Transitional Members because mixing design revisions may cause the headrest system to malfunction.
Ventana Medical Systems is recalling 354 units of Anti-Pan Keratin Primary Antibody due to leaking and sticking dispensers that may cause false negative IHC results.
Ventana Medical Systems is recalling iView DAB Detection Kits due to leaking and sticking reagent dispensers that may cause false negative immunohistochemistry results.
Ventana Medical Systems is recalling CONFIRM anti-Progesterone Receptor antibodies due to leaking and sticking dispensers that may cause false negative IHC results.
Pro-Med Instruments is recalling 30 DORO LUCENT Headrest Systems because mixing design revisions may cause malfunction during surgery.
Fresenius Medical Care is recalling 80 hemodialysis systems because a power failure during cleaning may allow disinfectant to remain in the machine and be delivered to patients.
Pro-Med Instruments is recalling 31 DORO LUCENT Locking Transitional Members because mixing design revisions may cause the headrest system to malfunction.
Ventana Medical Systems is recalling 195 units of the INFORM HPV III Fam 16 Probe due to leaking and sticking dispensers that may cause false negative test results.
Ventana Medical Systems is recalling ISH Protease 3 reagents due to leaking and sticking dispensers that may cause false negative IHC results.
Ventana Medical Systems is recalling 559 units of the ISH iView Blue Detection Kit because the reagent dispensers may leak or stick.
Ventana Medical Systems is recalling 120 units of CINtec Histology reagents worldwide because leaking dispensers may cause false negative test results.
Ventana Medical Systems is recalling NEXES VEN IVIEW DAB Detection Kits due to leaking and sticking reagent dispensers that may cause false negative IHC results.
Ventana Medical Systems is recalling anti-Helicobacter Pylori reagents because leaking dispensers may cause false negative test results.
Ventana Medical Systems is recalling OptiView Amplification Kits due to leaking dispensers that may cause false negative IHC results.
Ventana Medical Systems is recalling OptiView DAB IHC Detection Kits because leaking dispensers may cause false negative test results.
Ventana Medical Systems is recalling 8,211 units of the ultraView Universal Alkaline Phosphatase Red Detection Kit due to leaking and sticking dispensers that may cause false negative IHC results.
Ventana Medical Systems is recalling 96 units of the ultraView SISH DNP Detection Kit because leaking and sticking dispensers may cause false negative IHC results.
Ventana Medical Systems is recalling CONFIRM anti-Estrogen Receptor antibodies due to leaking and sticking dispensers that may cause false negative IHC results.
Ventana Medical Systems is recalling iVIEW Blue Plus Detection Kits because leaking dispensers may cause false negative IHC results.
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