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, Inc. is recalling 412 units of VER2 Handle, Pin Rework, LT Nonsterile because the handle may fail to remain assembled to the rasp during use.
Ortho-Clinical Diagnostics is recalling VITROS CA 19-9 Reagent Packs and Calibrators, Lot 1320, because they may produce positively biased results on specific VITROS systems.
Zimmer, Inc. is recalling 412 nonsterile Double Offset Rasp Handles because the handle may fail to remain assembled to the rasp during use.
Zimmer, Inc. is recalling 412 units of VER2 DBL OFFSET RASP HANDLE, LT Nonsterile because the handle may fail to remain assembled to the rasp during use.
Gambro Renal Products is recalling Prisma HF1000 presets because connector breakages can cause leakage of liquid or blood.
Integra LifeSciences is recalling four units of the NewPort MIS System because demonstration components may have been mixed with surgical components.
Zimmer, Inc. is recalling 412 units of Double Offset Rasp Handles because the handles may fail to remain assembled to the rasp during use.
Zimmer, Inc. is recalling 412 units of Double Offset Rasp Handles because the handle may fail to remain assembled to the rasp during use.
Brainlab AG is recalling 17 Navigation Spine & Trauma 3D software systems worldwide due to a defect in automatic CT image registration.
Nellcor Puritan Bennett Inc. is recalling Vital Sync software due to a mismatch between alarm priorities on medical devices and the monitoring system.
Gambro Renal Products is recalling Prismaflex TPE 2000 sets because connector breakages can cause leakage of liquid or blood.
Medtronic MiniMed is recalling 764 Implantable Insulin Pumps due to reports of pump malfunction causing insulin delivery to stop before the device's 7-year useful life ends.
Gambro Renal Products is recalling Prisma TPE 2000 sets because connector breakages can cause liquid or blood leakage.
Zimmer, Inc. is recalling 412 units of the VER2 Handle, Pin Rework, RT Nonsterile because the handle may fail to remain assembled to the rasp during use.
Biosound Esaote, Inc. is recalling 1,301 PA230E ultrasound transducers because they may exceed maximum allowable surface temperature limits under specific settings.
Medical Positioning Inc. is recalling 17 Rapid Response HUT tables because a defective component may cause the table to drop into the Trendelenburg position more rapidly than normal under excessive weight.
Siemens Medical Solutions is recalling 160 linear accelerators because automatic treatment movements could cause the machine to collide with patients.
Medtronic is recalling specific lots of Ascenda Intrathecal Catheters and Revision Kits because a retainer ring component may not meet specifications, risking catheter disconnection.
Zimmer, Inc. is recalling 412 Double Offset Rasp Handles because the handle may fail to remain assembled to the rasp during use.
Gambro Renal Products is recalling X-MARS Sets because connector breakages can cause leakage of liquid or blood.
BioMerieux SA is recalling 2,160 units of VIDAS D-Dimer Exclusion II tests due to complaints of non-repeatable results that may cause false negatives.
Gambro Renal Products is recalling Prismaflex HF 1400 dialysis sets because connector breakages can cause leakage of liquid or blood.
Agfa Healthcare is recalling 17 DX-D 600 imaging packages because the overhead tube crane may move uncontrolled. Customers should stop using the equipment.
Zimmer, Inc. is recalling 412 units of nonsterile orthopedic rasps because the handle may fail to remain assembled during use.
Medical Positioning Inc. is recalling Model # 1219 HUT tables because a defective component may cause the table to drop rapidly into the Trendelenburg position under excessive weight.
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