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.
Howmedica Osteonics Corp. is recalling specific LFIT Anatomic CoCr Femoral Heads because of a higher than expected number of complaints regarding disassociation from the hip stem.
FHC, Inc. is recalling the Depth Stop Adapter because over-tightening the screw can damage implanted leads, requiring surgical replacement.
FHC, Inc. is recalling the microTargeting Drive System Depth Stop Adapter because over-tightening the screw can damage implanted leads, requiring replacement.
FHC, Inc. is recalling microTargeting Lead Adapters because over-tightening the depth stop screw can damage implanted leads, requiring replacement.
FHC, Inc. is recalling the Depth Stop Adapter because over-tightening the screw can damage the implanted lead, requiring removal and replacement.
Zimmer Biomet is recalling specific M/L Taper Hip Prostheses because black residue was found in the polyethylene packaging. The firm states the residue is biocompatible, but it may cause surgical delays or wear-related intervention.
Beaver Visitec is recalling Safety Sideport Knives because blades may fall out of handles due to non-cured epoxy. The defect poses a risk during ophthalmic surgery.
Zimmer Biomet is recalling M/L Taper Hip Prostheses manufactured before October 2015 due to potential black residue in the packaging. The residue is biocompatible but may cause surgical delays or wear-related intervention.
Howmedica Osteonics Corp. is recalling specific lots of LFIT Anatomic CoCr Femoral Heads due to higher-than-expected complaints of femoral head/hip stem disassociation.
Zimmer Biomet is recalling M/L Taper Hip Prostheses manufactured before October 2015 due to potential black residue in the packaging. The residue is described as biocompatible, but may cause surgical delays or wear-related intervention.
Zimmer Biomet is recalling specific M/L Taper Hip Prostheses manufactured before October 2015 due to potential black residue in the packaging. The residue is described as biocompatible, but risks include surgical delays or wear-related intervention.
Howmedica Osteonics Corp. is recalling specific LFIT Anatomic CoCr Femoral Heads because of a higher than expected number of complaints regarding disassociation from the hip stem.
Howmedica Osteonics Corp. is recalling LFIT Anatomic CoCr Femoral Heads due to a higher than expected number of complaints about disassociation from the hip stem.
Zimmer Biomet is recalling M/L Taper Hip Prostheses manufactured before October 2015 due to black residue in the packaging. The residue is biocompatible but may cause surgical delays or wear-related intervention.
Howmedica Osteonics Corp. is recalling specific lots of LFIT Anatomic CoCr Femoral Heads due to a higher than expected number of complaints about femoral head and hip stem disassociation.
Howmedica Osteonics Corp. is recalling specific lots of LFIT Anatomic CoCr Femoral Heads due to a higher than expected number of complaints about femoral head and hip stem disassociation.
Zimmer Biomet is recalling 58 M/L Taper Hip Prostheses distributed to Japan due to black residue in the packaging. The residue is biocompatible but may cause surgical delays or wear-related intervention.
Zimmer Biomet is recalling specific M/L Taper Hip Prostheses manufactured before October 2015 because black residue may be present in the packaging.
Zimmer Biomet is recalling specific M/L Taper Hip Prostheses manufactured before October 2015 because black residue was found in the packaging. The residue is a mix of titanium and polyethylene.
Zimmer Biomet is voluntarily recalling 24 hip prosthesis units distributed solely to Japan. The recall was initiated in May 2018 and terminated in May 2020.
Zimmer Biomet is recalling specific M/L Taper Hip Prostheses manufactured before October 2015 due to black residue found in the packaging. The residue is biocompatible but may cause surgical delays or wear-related intervention.
Zimmer Biomet is recalling 84 M/L Taper Hip Prostheses with Kinective Technology due to black residue in the packaging. The residue is biocompatible but may cause surgical delays or wear-related intervention.
Howmedica Osteonics Corp. is recalling LFIT Anatomic CoCr Femoral Heads because of a higher than expected number of complaints regarding disassociation from the hip stem.
FHC, Inc. is recalling microTargeting Lead Adapters because over-tightening the depth stop screw can damage the lead and stylet, potentially requiring surgical replacement.
Intuitive Surgical is recalling 35 da Vinci X Surgical Systems because defective Arm Controller Joint boards have a high rate of failure.
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