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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.
Wondfo USA is recalling 102,500 units of IMCO Strep A Rapid Test Kits due to unauthorized distribution for at-home, over-the-counter, and direct-to-consumer use.
GE Medical Systems is recalling MyoSPECT cardiac imaging systems due to service handles on internal lead covers that could loosen or release, potentially causing the cover to drop and injure service personnel. The recall affects 133 devices distributed worldwide.
B Braun Medical Inc is recalling 108,811 units of Stimuplex A anesthesia needles because the devices are labeled as DEHP-free but the glue contains traces of DEHP.
Wondfo USA has recalled 170,000 units of Clarity Strep A Rapid Test kits due to unauthorized distribution for at-home use, non-prescription use, over-the-counter use, and direct-to-consumer sales. The recall affects test kits distributed nationwide.
Canon Medical MRI systems are being recalled because the terminal block securing the power cable may disconnect, potentially causing electrical arcing and fire. 153 units are affected across the United States and Puerto Rico.
Fresenius is recalling 4 hemodialysis water purification devices for pressure control malfunctions. When concentrate pressure exceeds the 19.9 bar limit, the device stops supplying water and halts dialysis treatment.
Wondfo USA has recalled Streptococcal A rapid test kits that are being sold for unauthorized at-home and direct-to-consumer use. The kits should not be used outside professional healthcare settings.
B Braun Medical Inc is recalling Stimuplex A injection needles because the devices are labeled as DEHP-free, but the glue used contains traces of DEHP. The recall affects 20,850 units distributed in the US and Canada.
Wondfo USA recalls Areta Strep A test kits (Lot E03920802) distributed for unauthorized at-home and over-the-counter use. The recall affects 75,000 units distributed nationwide.
Young Dental Manufacturing is recalling 534 units of Darby Prophylaxis Paste with 1.23% Fluoride Ion (Lot 248607) due to incorrect part number labeling. The product was labeled as part number 045032 instead of the correct 040032.
Avanos Medical is recalling NEOMED Pharmacy Syringes because expiration dates were not printed on the outer shipping labels. Approximately 37,476 cases of various syringe sizes were distributed worldwide.
Avanos Medical is recalling NEOMED oral syringes because expiration dates were not printed on outer shipping labels, allowing expired units to reach customers.
Wondfo USA is recalling approximately 1.2 million Preview Strep A rapid test kits (Part Numbers PRE-STA-25 and PRE-STA-A-10) that were distributed for at-home and direct-to-consumer use. The device is intended for professional channels only.
Avanos Medical recalls NEOMED nonsterile pharmacy syringes because expiration dates were not printed on outer shipping labels, resulting in expired products being distributed.
Stimuplex A nerve block needles labeled as DEHP-free contain trace amounts of DEHP in the adhesive. B Braun is recalling approximately 1.78 million units distributed in the US and Canada.
Megadyne Medical Products is recalling its MEGA SOFT Pediatric Patient Return Electrode due to reports of patient burns during electrosurgical use. Approximately 1,270 units distributed worldwide are affected.
The FDA recalled 3,138 Arrow Ultra 8 intra-aortic balloon catheter kits globally due to potential balloon inflation failure and helium pathway damage that could compromise critical cardiac support.
Arrow International is recalling intra-aortic balloon catheter kits due to potential inflation failure, catheter damage, and helium loss that could cause serious health consequences.
Arrow International is recalling its UltraFlex Intra-Aortic Balloon Catheter Kit because of infrequent device malfunction that could lead to serious health consequences. 44,807 units are affected worldwide.
Getinge's sevoflurane vaporizer component may degrade into hydrogen fluoride, posing inhalation and skin exposure risks to healthcare workers and patients. The FDA Class I recall affects 120 units distributed across six U.S. states.
Atrium Medical is recalling ADVANTA VXT vascular grafts following complaints of separation between the slider component and swivel core.
Atrium Medical is recalling ADVANTA VXT vascular grafts due to reported separation of the slider mechanism from the core component, which could compromise device integrity.
Atrium Medical Corporation recalled 53,308 ADVANTA VXT vascular grafts worldwide due to reported separation of the Slider GDS Swivel Rod from the Swivel Core. Patients should consult their healthcare provider regarding appropriate follow-up care.
CORENTEC's LOSPA Patella Component knee implants are recalled due to an unsupported 10-year expiration date. Thirty-five units were distributed nationwide.
Atrium Medical recalls ADVANTA VXT vascular grafts due to reported separation of the slider swivel rod from its core, creating a gap between components. No injuries reported.
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