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.
Siemens is recalling three Mammomat Inspiration mammography systems due to a potential malfunction that could cause patient bruising during specific imaging procedures.
Fresenius Medical Care is recalling 5,480 units of the Liberty Cycler Set due to a risk of cassette leakage during setup or treatment.
Biomet is recalling 26 Oxford Fixed Bearing Partial Knee components due to a design flaw that may cause anterior impingement.
Biomet is recalling 25 Oxford Fixed Bearing Partial Knee components due to a design flaw that may cause anterior impingement.
Boston Scientific is recalling 15 NephroMax high pressure nephrostomy Balloon Catheter Kits because an incorrectly sized renal sheath was packaged with the device.
Biomet is recalling 26 Oxford Fixed Bearing Partial Knee components because the tibial bearing design may cause anterior impingement between bone and the poly bearing.
Biomet is recalling 24 Oxford Fixed Bearing Partial Knee components due to a design flaw that may cause anterior impingement between bone and the poly bearing.
Biomet is recalling 24 Oxford Fixed Bearing Partial Knee components due to a design defect that may cause anterior impingement.
Biomet is recalling 22 Oxford Fixed Bearing Partial Knee components because a design flaw creates a potential for anterior impingement between bone and the poly bearing.
Intuitive Surgical is recalling 30 da Vinci Si Surgeon Side Carts because factory testing may not comply with UL standards due to a malfunctioning test device.
AngioDynamics is recalling 13 RITA Main Cables because they contain incorrect Instructions for Use. The cables are used with RITA RF Generators and electrosurgical devices.
SagaTech Electronics is recalling 152 Finger Sensors for Remmers Recorders because the outer jacket is receding prematurely from the black sensor.
Zimmer, Inc. is removing one lot of Bigliani/Flatow Humeral Provisional Stems because 14mm devices were incorrectly etched and packaged as 12mm.
Baxter Healthcare is recalling 356,728 units of Four Lead TUR irrigation sets because pinholes in the packaging could compromise sterile barrier properties.
Baxter Healthcare Corp. is recalling Four Lead Arthroscopic Irrigation Sets because pinholes in the packaging could compromise sterile barrier properties.
Boston Scientific is recalling 27 NephroMax high pressure nephrostomy balloon catheters because they were packaged with incorrectly sized renal sheaths.
Intuitive Surgical is recalling 30 da Vinci Si Vision System Carts because factory testing may not have complied with UL standards due to a malfunctioning test device.
Toshiba American Medical Systems is recalling 153 Kalare Diagnostic X-Ray Systems because the large focus heats up unexpectedly, causing brighter images than expected.
Intuitive Surgical is recalling 30 da Vinci Dual Camera Controllers because factory testing may not have complied with UL standards due to a malfunctioning test device.
Baxter Healthcare is recalling Two Lead Arthroscopic Irrigation Sets because pinholes in the packaging could compromise sterile barrier properties.
Intuitive Surgical is recalling 30 da Vinci Instrument Control Boxes because factory testing may not have met UL standards due to a malfunctioning test device.
Boston Scientific is recalling 91 units of the Rigiflex Single-Use Achalasia Balloon Dilator because they were labeled with an incorrect expiration date.
DJO, LLC is recalling VenaFlow Elite 30B-B and 30BI-B compression pumps due to a potential battery leakage issue that could cause a fire.
Clorox Healthcare Holdings is recalling 772,600 units of Argent Surgical Systems Biopsy Punches because they were not sterilized.
Ortho-Clinical Diagnostics is recalling 101 VITROS 5,1 FS Chemistry Systems because an electrical short can cause heat accumulation and melted wiring.
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