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 78 Affixus Hip Fracture Nails because sterile packaging was found open during surgery.
Zimmer Biomet is recalling 68 Affixus Hip Fracture Nails because sterile packaging was found open during surgery. The recall covers units distributed in the US and two foreign countries.
CryoLife, Inc. is recalling one CryoPatch SG Pulmonary Hemi-Artery graft because the conduit and branch lengths were switched on the product labeling.
Zimmer Biomet is recalling 50 Affixus Hip Fracture Nails because complaints indicated the sterile packaging was already open when the products were opened in surgery.
Zimmer Biomet is recalling 20 Affixus Hip Fracture Nails because complaints indicated the sterile packaging was already open when the product was opened in surgery.
Baxter is recalling Spectrum IQ Infusion Systems because a software error prevents operators from programming certain infusions.
Zimmer Biomet is recalling 14 Affixus Hip Fracture Nails because complaints indicated the sterile packaging was already open when the product was opened in surgery.
OriGen Biomedical is recalling 452 units of Reinforced Dual Lumen Cannulas due to missing barium sulfate and incorrect tip length markings.
Zimmer Biomet is recalling 27 Affixus Hip Fracture Nails because sterile packaging was found open during surgery. The recall covers units distributed in the US and abroad.
Siemens is recalling Atellica Solution software version 1.13 and lower due to five behavioral issues that may cause incorrect test results or sample handling errors.
Helena Laboratories is recalling three Protein S ELISA Antigen Kits because internal components were mislabeled, causing the Substrate and Protein S Conjugate to be swapped.
Zimmer Biomet is recalling 27 Affixus Hip Fracture Nails because sterile packaging was found open during surgery.
Zimmer Biomet is recalling 25 Affixus Hip Fracture Nails because sterile packaging was found open during surgery. The recall covers units distributed in the US and abroad.
Orthosensor, Inc. is recalling 37 VERASENSE sensors for Zimmer Biomet Persona CR E-F/3-11 Right knees because fluid was reported inside the posterior lateral corner post-surgery.
Sterilmed, Inc. is recalling 218 reprocessed Agilis Steerable Introducers because they may not meet endotoxin requirements. The devices were distributed in California, Colorado, Minnesota, and Washington.
Orthosensor, Inc. is recalling 41 VERASENSE sensors for Zimmer Biomet Persona CR E-F/3-11 Left knees because fluid was reported inside the posterior lateral corner after surgery.
Medline Industries is recalling Unna Boot Compression Wraps because sporadic reports identified common mold on certain lots.
Bayer is recalling Codan Filters used in IV administration sets because the dust cap may generate particulate that enters the fluid path.
Neomed Inc is recalling NeoMed Enteral Feeding Tubes because the tethered plug may inadvertently open after closure, potentially compromising the device's seal.
Orthosensor, Inc. is recalling 68 VERASENSE sensors for Zimmer Biomet Persona CR G-H/7-12 Right because fluid was reported inside the posterior lateral corner post-surgery.
Ortho-Clinical Diagnostics is recalling VITROS 5600 Integrated Systems because they may dispense insufficient sample volume without suppressing potentially incorrect results.
Orthosensor, Inc. is recalling 36 VERASENSE sensors for Zimmer Biomet Persona CR C-D/3-9 Right knees because fluid was reported inside the posterior lateral corner post-surgery.
CooperSurgical is recalling Colpo-Pneumo Occluder devices because the sterile pouch seal may be compromised, increasing the risk of infection.
Orthosensor, Inc. is recalling 84 VERASENSE sensors for Zimmer Biomet Persona CR G-H/7-12 Left because fluid was reported inside the posterior lateral corner post-surgery.
Orthosensor, Inc. is recalling 56 VERASENSE sensors for Zimmer Biomet Persona CR C-D/3-9 Left because some were reported to have fluid inside the posterior lateral corner post-surgery.
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