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.
Cook Inc. is recalling 266 femoral artery pressure monitoring sets because the labels fail to state that the product is heparin-coated.
Zimmer Biomet is recalling specific Versus hip prostheses because LDPE packaging may leave residue on the polished implant surface.
Zimmer Biomet is recalling 13,227 hip implants because LDPE packaging may leave residue on the polished surface.
Zimmer Biomet is recalling 13,227 hip implants because LDPE packaging may leave residue on the polished surface.
Laerdal Medical Corporation is recalling 204 LCSU 4 suction units that were refused entry into the U.S. by the FDA because they lacked necessary CDRH approvals.
Zimmer Biomet is recalling specific hip and knee implants because the packaging bags may leave residue on the polished surfaces.
Zimmer Biomet is recalling 13,227 hip and knee implants because LDPE packaging may leave residue on the polished surface.
Cook Inc. is recalling Newton Wire Guides because the labels do not state that the product is heparin-coated.
Arrow International is recalling 23,904 central venous catheter kits because some units may be missing stickers with lot, expiration, and UDI information.
Zimmer Biomet is recalling 13,227 hip and knee implants because LDPE packaging may leave residue on the polished surfaces.
Cook Inc. is recalling 45 Bentson Cerebral Wire Guides because the labels fail to state that the product is heparin-coated.
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 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 packaging may leave residue on the polished surfaces.
Cook Inc. is recalling Rosen Curved Wire Guides because the labels fail to state that the product is heparin-coated.
Zimmer Biomet is recalling specific hip implants because LDPE packaging may leave residue on the polished 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 specific Versus hip prostheses because LDPE packaging may leave residue on the polished implant surface.
Zimmer Biomet is recalling 13,227 knee implants because LDPE packaging may leave residue on the polished surface.
3M is recalling Futuro and ACE ankle supports because they contain natural latex rubber but lack the required caution statement.
DePuy Orthopaedics is recalling 85 units of the Global Unite Platform Shoulder System because an inverted screw may cause the humeral stem to sit proud, potentially delaying surgery.
Zimmer Biomet is recalling 13,227 knee implants because LDPE packaging may leave residue on the polished surface.
Cook Inc. is recalling 32,340 Amplatz Stiff Wire Guides because the labels fail to state that the product is heparin-coated.
Hyphen BioMed is voluntarily recalling ZYMUTEST HIA assays because they may produce false positive results. The recall affects specific lots distributed in the US, Austria, and France.
Zimmer Biomet is recalling 30 units of DELTA CER FEM HD 32/0MM T1 hip arthroplasty components because the sterile packaging may be melted upon opening.
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