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.
Windstone Medical Packaging is recalling 765 Hernia Packs because the included Medtronic gloves may contain splits or holes that compromise sterility.
Windstone Medical Packaging is recalling 50 laparoscopy kits because the disposable gloves included may contain splits or holes that compromise sterility.
Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES are being recalled because splits or holes may compromise sterility.
Windstone Medical Packaging is recalling 985 general surgery kits because the Medtronic gloves included may have splits or holes that compromise sterility.
Windstone Medical Packaging is recalling C-Section kits because the included Medtronic gloves may have splits or holes that compromise sterility.
Windstone Medical Packaging is recalling 168 General Surgery Packs because the included Medtronic gloves may contain splits or holes that compromise sterility.
Windstone Medical Packaging is recalling 40 Lipo Pack kits because the included Medtronic gloves may have splits or holes that compromise sterility.
Windstone Medical Packaging is recalling 16 surgical Set Up Packs because they may contain defective gloves that compromise sterility.
Windstone Medical Packaging is recalling 92 Ortho Pack kits because they may contain defective gloves with splits or holes that compromise sterility.
Windstone Medical Packaging is recalling Virginia Custom Pack kits because the included Medtronic gloves may have splits or holes that compromise sterility.
Windstone Medical Packaging recalled 56 custom surgery kits because the included Medtronic gloves may contain splits or holes, compromising sterility.
ConMed is recalling CORE Suction Irrigation Handpieces because a crease in the packaging seal may create an open channel that compromises the product's sterility.
US Endoscopy is voluntarily recalling one lot of Vari-Safe Injection Needles because the lot was incorrectly distributed with different internal catheter components.
Ortho-Clinical Diagnostics is recalling VITROS Chemistry LAC Slides because N-Acetylcysteine (NAC) can interfere with the assay results.
ConMed is recalling CORE Suction Irrigation Handpieces because creases in the packaging seal may create open channels that compromise the product's sterility.
Randox Laboratories is recalling 18 units of Lipase test kits due to carryover interference when run near LDL or Triglycerides assays.
ConMed is recalling CORE Trumpet Handpieces because a crease in the packaging seal may create an open channel that compromises the product's sterility.
Zimmer Biomet is recalling five Vanguard Distal Femoral Augments because the product inside the carton does not match the label. The mismatched size is easily identified during surgery.
ConMed is recalling CORE Suction Irrigation Handpieces because a crease in the packaging seal may compromise the product's sterility.
Hand Biomechanics Lab Inc is recalling 65 Agee WristJack Fracture Reduction Systems because a molded beam is slightly larger than optimal, which may make surgical adjustments difficult.
Stryker Instruments is voluntarily recalling 225 Sagittal Blades due to a potential sterile barrier breach in the packaging.
Ortho-Clinical Diagnostics is recalling VITROS URIC Slides because N-Acetylcysteine (NAC) can interfere with the assay results.
Becton, Dickinson and Company is recalling 14 units of CD79b PE antibody reagent due to contamination with a FITC conjugate of unknown specificity.
ConMed Corporation is recalling CORE Suction Irrigation Handpieces because packaging seal creases may compromise sterility. The recall covers units distributed in the US and internationally.
Ortho-Clinical Diagnostics is recalling VITROS GLU Slides because certain substances, including N-Acetylcysteine, may interfere with glucose measurements.
Looking for a different category? Browse all recalls.