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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.
GE Medical Systems' Discovery XR656HD X-Ray imaging systems can allow radiation exposures to exceed the Automatic Exposure Control limit without blocking further exposure. Approximately 3,149 units are affected worldwide, including 1,697 in the United States.
Philips IntelliVue Patient Monitor MX500 units may fail to generate "No Device Data" alarms when a Hamilton ventilator disconnects, potentially delaying notification of loss of connectivity. 45 units distributed in the US and internationally.
US Endodontics is recalling endodontic files due to irradiation above specification, which may compromise package integrity. The recall affects 789,729 devices distributed in the US and internationally.
Philips recalls AD7 and AD7X patient tables in Allura and Azurion systems due to finger entrapment risk during manual repositioning. Operators and service personnel could suffer finger injuries.
Philips patient tables on Azurion and Allura imaging systems can trap fingers between the tabletop and rails during manual repositioning. Operators and service personnel are at risk of finger injury.
Hologic Rapid fFN Specimen Collection Tubes from three lots may contain incorrect amounts of extraction buffer, potentially causing invalid test results or diagnostic errors in preterm delivery assessment.
The Philips Allura CV20 System patient tables (AD7 and AD7X models) pose a finger entrapment hazard during manual repositioning. Fingers can become caught between the tabletop and guiding rails, potentially injuring operators and service personnel.
Physio-Control is recalling 245 LIFEPAK 35 ECG cables (Lot 0224) because the shipped instructions do not include proper cleaning and disinfection procedures, creating potential cross-contamination risks.
The IntelliBridge EC10 Module may fail to sound an alarm when a Hamilton ventilator is disconnected. This could allow unnoticed disconnections that could affect patient monitoring.
GE Medical Systems is recalling the Discovery XR656 HD X-ray imaging system due to a malfunction in the Automatic Exposure Control (AEC) feature. The defect allows continued X-ray exposure beyond intended limits without requiring operator acknowledgment.
Philips Azurion 5 M20 x-ray system patient tables can trap fingers between the tabletop and guiding rails during repositioning. The hazard may cause finger injury to operators and service personnel.
Philips IntelliVue Patient Monitor MX400 may fail to alarm when a Hamilton ventilator is disconnected. 28 units affected in the US and internationally.
Nobel Biocare recalled N1 TiUltra TCC dental implants due to a manufacturing defect that may puncture the sterile blister packaging. The defect is a sharp pin created during injection molding that could compromise product sterility.
Philips AlluraXper FD20 operating room tables can trap fingers during manual repositioning, risking injury. The hazard affects both operators and service personnel worldwide.
Sysmex PS-10 Sample Preparation Systems may produce false test results due to sporadic omission of the probe wash step during antibody pipetting. Thirty-two units have been recalled nationwide.
GE Medical Systems is recalling Definium 656HD and Discovery XR656HD X-Ray systems due to an Automatic Exposure Control defect that may allow radiation exposure to exceed intended safety limits.
The Belmont Medical 3-Spike Disposable Set may leak during priming due to a crack in its female quick connector, potentially delaying warmed infusions in hospital settings.
Philips AlluraXper FD20 Biplane patient tables may cause finger entrapment between the tabletop and guiding rails during manual repositioning, affecting operators and service personnel.
Philips IntelliVue Patient Monitor MX450 units may fail to sound an alarm when a Hamilton ventilator becomes disconnected, potentially delaying detection of the disconnection.
Philips is recalling Azurion 7 M12 and Allura patient tables used in medical imaging systems due to a finger entrapment hazard during manual repositioning. Operators and service personnel may suffer finger injury if fingers are caught between the tabletop and guiding rails.
Philips is recalling Azurion 7 B20 patient tables due to a finger entrapment hazard between the tabletop and guiding rails during manual repositioning. Operators and service personnel could suffer finger injury.
Philips Azurion 5 M12 patient imaging systems pose a finger entrapment hazard during manual tabletop repositioning. Operators and service personnel risk finger injury from the longitudinal guiding rails.
Philips Azurion patient tables used in medical imaging systems can trap fingers between the tabletop and rails during manual repositioning, potentially causing finger injury to operators and service personnel.
Philips IntelliVue Patient Monitor MX550 units may fail to generate an alarm when a Hamilton ventilator is disconnected, creating a patient safety risk. The monitor could remain silent without alerting clinical staff.
Ethicon is recalling PROLENE polypropylene sutures because some packages have open seals due to a manufacturing defect. Defective seals may allow pathogens to contaminate the sterile sutures, potentially causing infection.
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