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 Versys hip prostheses because LDPE packaging may leave residue on the polished implant surface.
Zimmer Biomet is recalling specific hip prostheses because LDPE packaging may leave residue on the polished implant surface.
Zimmer Biomet is recalling specific knee implant models because LDPE packaging may leave residue on the polished surface.
Cook Inc. is recalling 18,398 units of Disposable Reuter Tip Deflecting Wire Guides because the labels fail to state that the product is heparin-coated.
Zimmer Biomet is recalling NEXGEN LPS-FLEX knee implants because LDPE packaging may leave residue on the polished surface.
Zimmer Biomet is recalling 13,227 Natural-Knee Flex femoral components because LDPE packaging may leave residue on the polished implant surface.
Zimmer Biomet is recalling 13,227 patella femoral joint implants because LDPE bag packaging may leave residue on the polished surface.
Cook Inc. is recalling 10,367 Double Flexible Tipped Wire Guides because the labels fail to state that the product is heparin-coated.
Cook Inc. is recalling 55 Reuter Tip Deflecting Wire Guides because the labels fail to state that the product is heparin-coated.
Cook Inc. is recalling Bentson Wire Guides because the labels fail to state that the product is heparin-coated.
Diagnostica Stago, Inc. is recalling STA Neoplastine Cl reagent vials because a homogeneity defect may cause inaccurate prothrombin time test results.
Zimmer Biomet is recalling 13,227 Versys hip prostheses because LDPE packaging may leave residue on the polished implant surface.
Cook Inc. is recalling 21,913 Movable Core Wire Guides because the labels failed to state that the products are heparin-coated.
Zimmer Biomet is recalling 13,227 Versys hip prostheses because LDPE packaging may leave residue on the polished implant surface.
Zimmer Biomet is recalling 13,227 CR-FLEX knee implants because LDPE packaging may leave residue on the polished surface.
Zimmer Biomet is recalling six 6.5mm x 125mm x 16mm Cannulated Screws because they were mislabeled as 3.5mm x 24mm Cortical Locking screws.
Randox is recalling 450 kits of Liquid Cardiac Control CQ5053 because the product does not meet its shelf-life claim, potentially causing test results to fall outside control ranges.
Cook Inc. is recalling the Bentson Plus Wire Guide because the label fails to state that the product is heparin-coated.
Howmedica Osteonics Corp. is recalling 255 Accolade and Restoration hip products because the inner and outer sterile barriers were not fully sealed.
Zimmer Biomet is recalling 13,227 hip and knee implants because LDPE bag packaging may leave residue on the polished surface.
Zimmer Biomet is recalling specific Versys hip prostheses because LDPE packaging may leave residue on the polished implant surface.
Zimmer Biomet is recalling 13,227 hip and knee implants because LDPE packaging may leave residue on the polished surface.
Zimmer Biomet is recalling 13,227 Versus hip stems because LDPE packaging may leave residue on the polished implant surface.
Zimmer Biomet is recalling 13,227 hip and knee implants because LDPE packaging may leave residue on the polished surfaces.
Zimmer Biomet is recalling 13,227 patello-femoral joint implants because LDPE bag packaging may leave residue on the highly polished implant surfaces.
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