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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.
Zimmer Biomet is recalling 429 units of nondegradable soft tissue fixation fasteners because the implant shaft may shift and fall out during device opening.
ZOLL Medical is recalling specific adult defibrillator electrodes that may cause R Series devices to deliver pediatric energy levels instead of adult levels.
Diagnostica Stago is recalling 1,636 Neoplastine Cl Plus kits due to a defect causing inaccurate prothrombin time test results.
Alden Optical is recalling Alden Classic 55 Toric Daily Wear Soft contact lenses because they lack sterility assurance. The recall affects units distributed in the US and Canada.
Becton Dickinson is recalling specific lots of BD Vacutainer K2 EDTA blood collection tubes because they may contain insufficient anticoagulant, potentially causing erroneous test results.
Cook Inc. is recalling 601,778 Fixed Core Wire Guides because the labels failed to state that the products are heparin-coated.
Zimmer Biomet is recalling 13,227 knee implants because LDPE packaging may leave residue on the polished surface.
Howmedica Osteonics Corp. is recalling 255 Accolade and Restoration hip products because the inner and outer sterile barriers were not fully sealed.
Hyphen BioMed is voluntarily recalling ZYMUTEST HIA IgGAM and MonoStrip assays because they may produce false positive results.
Zimmer Biomet is recalling 13,227 Versus 8 Inch Beaded hip implants because LDPE packaging may leave residue on the polished surface.
Vygon MFG, Inc. is recalling IV Start Convenience Kits because the iodine prep pads failed stability testing for their expiration date.
Cook Inc. is recalling 3,369 Coons Interventional Wire Guides because the label fails to state that the product is heparin-coated.
Zimmer Biomet is recalling 23 units of 36mm Modular Hip Heads because one piece was incorrectly etched with the wrong offset size.
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 hip and knee implants because LDPE bag packaging may leave residue on the polished surfaces.
Zimmer Biomet is recalling 13,227 Natural-Knee Flex System femoral components because LDPE packaging may leave residue on the polished implant surface.
Arrow International is recalling 23,904 central venous catheter kits because some may be missing stickers with lot, expiration, and UDI information.
Zimmer Biomet is recalling specific knee prostheses because the packaging bags may leave residue on the implant surface.
Cook Inc. is recalling 56 Left Atrial Catheter Sets because the labels failed to state that the product is heparin-coated.
Cook Inc. is recalling 648 Amplatz Extra Stiff Whisker Wire Guides because the labels fail to state that the product is heparin-coated.
Becton Dickinson & Co. is recalling 216 bottles of Difco Agar Noble because the product was mislabeled and inadvertently sold as Noble Agar.
Zimmer Biomet is recalling 13,227 Natural-Knee II knee implants because LDPE packaging may leave residue on the polished implant surfaces.
Cook Inc. is recalling 2,210 Fixed Core Bentson devices because the labels fail to state that the product is heparin-coated.
Diagnostica Stago is recalling STA Neoplastine Cl Plus reagent vials due to a confirmed homogeneity defect that may cause inaccurate prothrombin time test results.
Stryker is recalling 155 Collagen Meniscus Implants shipped to the Netherlands without required temperature control packaging, potentially exposing them to elevated temperatures.
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