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.
GE HealthCare is recalling 151 SIGNA Architect AIR (China Only) MRI systems because the planned maintenance step that checks the patient table caster locks may not have been performed.
GE HealthCare is recalling 1,372 Optima MR450w 1.5T MRI systems because the planned maintenance step that checks the patient table caster locks may not have been performed.
GE Discovery MR750w 3.0T MR systems are being recalled because planned maintenance steps to check the functionality of the caster locks on the MR patient table may not have been performed. 519 units affected.
GE SIGNA Premier MAX MR systems are being recalled because planned maintenance steps to check the functionality of the caster locks on the MR patient table may not have been performed.
BD is recalling 6,076 Pyxis MedBank and MedBank Mini automated dispensing cabinets after reports of delayed access to medication caused by the override and Add Item workflow.
Bartels ELISA Legionella Urinary Antigen kits are being recalled because two lots have the potential to contain particulate matter. 968 kits are affected.
GE HealthCare is recalling SIGNA Premier Elite (China Only) MRI systems because the planned maintenance step that checks the patient table caster locks may not have been performed.
HemosIL LMW Heparin Controls, part number 0020300200, are recalled after complaints of lower than expected quality control recovery. 41,824 units are affected.
GE HealthCare is recalling 760 Signa Artist MRI systems because the planned maintenance step that checks the patient table caster locks may not have been performed.
GE HealthCare is recalling 19 Discovery MR450 1.5T MRI systems because the planned maintenance step that checks the patient table caster locks may not have been performed.
Insightra Ultra IABP Catheter Kits are being recalled because the device carries indications and compatibility claims not reviewed by the FDA, and its instructions are inconsistent with product training.
GE HealthCare is recalling 280 Signa Voyager MRI systems because the planned maintenance step that checks the patient table caster locks may not have been performed.
GE HealthCare is recalling 97 SIGNA PET/MR imagers because the planned maintenance step that checks the patient table caster locks may not have been performed.
GE HealthCare is recalling 138 SIGNA Artist Evo MRI systems because the planned maintenance step that checks the patient table caster locks may not have been performed.
GE HealthCare is recalling SIGNA Voyager AIR (China Only) MRI systems because a planned maintenance step checking the patient table caster locks may not have been performed.
GE SIGNA Hero XT MR systems are being recalled because planned maintenance steps to check the functionality of the caster locks on the MR patient table may not have been performed.
GE HealthCare is recalling SIGNA PET/MR AIR (China Only) systems because the planned maintenance step that checks the patient table caster locks may not have been performed.
GE SIGNA Hero Elite MR systems are being recalled because planned maintenance steps to check the functionality of the caster locks on the MR patient table may not have been performed.
GE HealthCare is recalling 56 SIGNA Hero MRI systems because the planned maintenance step that checks the patient table caster locks may not have been performed.
Prosthesis Head B, 28 mm with 7 mm neck length, is being recalled because of inconsistent size terminology and colour coding used on the labeling. 46 units are affected.
GE SIGNA Premier XT MR systems are being recalled because planned maintenance steps to check the functionality of the caster locks on the MR patient table may not have been performed. 2 units affected.
GE SIGNA Hero MAX MR systems are being recalled because planned maintenance steps to check the functionality of the caster locks on the MR patient table may not have been performed.
Zvu Anorectal Manometry Procedure Kits are being recalled because the outer kit label carries an incorrect expiration date, with the manufacturing date used in its place. 8 kits are affected.
GE HealthCare is recalling 758 SIGNA Architect MRI systems because the planned maintenance step that checks the patient table caster locks may not have been performed.
GE HealthCare is recalling SIGNA PET/MR AIR Plus (China Only) systems because the planned maintenance step that checks the patient table caster locks may not have been performed.
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