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.
X7-2 Transducer Probes are the subject of a recall issued to provide clarification and labelling defining the useful life of ultrasound transducers in the field.
S5-2 Transducer Probes are the subject of a recall issued to provide clarification and labelling defining the useful life of ultrasound transducers in the field.
L12-3 Transducer Probes are the subject of a recall issued to provide clarification and labelling defining the useful life of ultrasound transducers in the field.
X8-2t Transducer Probes are the subject of a recall issued to provide clarification and labelling defining the useful life of ultrasound transducers in the field.
V6-2 Transducer Probes are the subject of a recall issued to provide clarification and labelling defining the useful life of ultrasound transducers in the field.
S4-1 Lumify Transducer Probes are the subject of a recall issued to provide clarification and labelling defining the useful life of ultrasound transducers in the field.
C9-5ec Transducer Probes are the subject of a recall issued to provide clarification and labelling defining the useful life of ultrasound transducers in the field.
mC12-3 Transducer Probes are the subject of a recall issued to provide clarification and labelling defining the useful life of ultrasound transducers in the field.
S12-4 Transducer Probes are the subject of a recall issued to provide clarification and labelling defining the useful life of ultrasound transducers in the field.
ENDOTAK RELIANCE G/SG defibrillation leads with the 4-SITE connector are recalled because affected models may show gradually rising LVSI measurements linked to calcification of the defibrillation coils.
RELIANCE 4-FRONT defibrillation leads are recalled because affected models may show gradually rising LVSI measurements linked to calcification of the defibrillation coils, which may lead to early lead replacement.
Hamilton C6 ventilators are recalled over a mechanical defect on a printed circuit board that may cause the device to fail at startup or interrupt ventilation during use. 1,040 systems are affected.
ENDOTAK RELIANCE G/SG transvenous defibrillation leads are recalled because affected models may show gradually rising LVSI measurements linked to calcification of the defibrillation coils.
The ESG-410 Electrosurgical Generator is recalled because it may display an E0662 System Error followed by a single automatic reboot or a continuous reboot loop. 155 units are affected.
OtoLase Starter Kits, UPN AC-2003748, batches 32644549 and 32769567, are recalled because finished product labeled as sterile may not have been sterilized. 13 units are affected.
Burr Hole Cover Kits used with the Vercise Deep Brain Stimulation System are recalled because resistance closing the retaining clip may cause procedural delay or lead migration requiring further surgery. 24,583 units are affected.
The ESG-410 Legacy Electrosurgical Generator, model WA91307C, is recalled because it may display an E0662 System Error followed by a single automatic reboot or a continuous reboot loop. 434 units are affected.
Estrone RIA kits, catalog number DSL8700, are recalled because certain lots may rarely give falsely high or falsely low patient results. 279 units are affected.
Bayonet Luer-Lock injection needles, models 50-353-23 and 50-345-23, are recalled because affected product showed elevated cytotoxicity values, which may present a risk of intolerance or allergic reaction.
Pentax Medical EPK-i8020c video processors are recalled after reports of darkened images, smoke-like steam and a hot endoscope light guide that may cause thermal injury to the patient's mucous membrane. 144 units are affected.
VITROS Chemistry Products Ca Slides, catalog number 145 0261, generations 67 and above, are recalled because calibration failures on VITROS XT systems delay calcium test results. 174,215 units are affected.
Dynex Agility Sample Tips, model 67910 lot 863366, are recalled because the internal rack label reads reagent tip rack, causing the instrument to misidentify the tips and preventing their use. 237 units are affected.
DRS Vascular is recalling 264 Q-Stop Suture Retention Devices. The FDA enforcement record for this action carries a placeholder in place of a stated reason for the recall.
Clearview Strep A Exact II Dipstick Respiratory Kits are recalled because a classification error in the inventory system sent devices to customers without the required license to buy them. 5 kits are affected.
Ambu is recalling 87,156 SPUR II adult resuscitators because the manometer port may be blocked, leaving the manometer non-functional. The FDA classified the action as Class I.
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