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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 Vivid ultrasound systems may display incorrect patient information due to slow DICOM response times. Seven affected units were distributed to healthcare facilities in IL, MA, NM, NY, and OK.
Fresenius Medical Care recalls a blood pump rotor spare part used in dialysis systems in Canada due to reports of loose or dislodged guide sheaves after use. No injuries have been reported.
American Contract Systems Inc is recalling 129 units of ARTHO KNEE BAPTIST SOUTH PACK Procedure trays (lot numbers 953241, 882241) due to ethylene oxide and ethylene chlorohydrin sterilization residuals exceeding safe limits for permanent-contact medical devices.
American Contract Systems Inc is recalling its ORIF HIP IM RODDING FEMUR-Procedure Kit (28 units) because ethylene oxide and ethylene chlorohydrin residuals in the cast padding exceeded safe limits for permanent implants.
Fresenius is recalling 17 Blood Pump Rotor spare parts nationwide due to loose or dislodged guide sheaves that develop after use. The affected rotor components are used in K@HOME dialysis machines.
American Contract Systems Inc is recalling HAND WRIST FOREARM-LF Procedure trays due to ethylene oxide sterilization residues exceeding safe limits for permanent exposure devices.
American Contract Systems Inc is recalling the HAND PACK-Procedure Kit (catalog WEHD16C) due to ethylene oxide and ethylene chlorohydrin residuals exceeding safety limits.
MICROspecialties is recalling the Synergetics I Pack Injection Kit because sterilization cannot be confirmed, potentially causing post-operative wound or injection site infections. Affected units are lot P62764979R distributed in Missouri.
American Contract Systems Inc is recalling a knee surgery procedure kit (24 units, Lot 939241) due to ethylene oxide sterilization residues in the cast padding exceeding safety exposure limits for permanent-implant devices.
Braun Thermoscan PRO 6000 ear thermometers may have been shipped with outdated Instructions for Use on an included CD. Approximately 265,647 units were distributed globally.
Barco display units may lose HDMI connectivity and become unusable when a specific Molex network module is installed in the ETH0 slot of affected models.
Silkprousa LLC is recalling the Pink Luminous Breast transilluminator because the device was marketed and distributed without FDA premarket approval. All 2,000 units distributed nationwide are subject to recall.
American Contract Systems is recalling TOTAL KNEE procedure trays because sterilization gas residuals on the cast padding component exceed regulatory safety limits. No injuries have been reported.
American Contract Systems Inc recalls the TOTAL KNEE Procedure Kit due to Ethylene Oxide and Ethylene Chlorohydrin residuals exceeding regulatory limits. No illnesses reported.
American Contract Systems Inc recalled a knee surgery procedure kit (Catalog RGTK10K) due to ethylene oxide and ethylene chlorohydrin residuals exceeding safety limits on the cast padding component.
Megadyne is recalling the MEGA 2000 Patient Return Electrode due to identified potential risk of patient burns. Use is now restricted to patients aged 12 or older.
Megadyne Medical recalls MEGA SOFT reusable patient return electrodes (Model 0830) due to identified burn risk. Use is restricted to patients aged 12 and older.
MEGADYNE MEGA SOFT Dual Reusable Patient Return Electrodes are recalled due to an identified risk of patient burns. Use should be restricted to patients aged 12 or older.
Medline Industries recalls 7,673 surgical convenience kits due to weak Pure Pouch seals that may compromise sterility. Kits were distributed nationwide to healthcare facilities.
Exactech is recalling Acumatch L-Series hip implant liners because some units were packaged without the specified protective ethylene vinyl alcohol (EVOH) layer, which is required for proper device protection.
BD Pyxis MEDBANK medication cabinets contain power strips not certified to electrical safety standards, potentially exposing users to leakage currents. The recall affects 677 units distributed nationwide.
Siemens is recalling ARTIS angiography systems where the first X-ray after patient registration may use incorrect copper prefiltration, potentially resulting in higher radiation doses than intended.
Medline recalled 7,673 surgical convenience kits nationwide due to weak seals in the Pure Pouch component that may compromise sterility of surgical instruments. No injuries have been reported.
Abbott Liberta RC implantable pulse generators used for deep brain stimulation may unexpectedly turn off approximately every 50 days after activation, resulting in loss of therapy. Approximately 302 units have been recalled nationwide.
SeaSpine Orthopedics is recalling Fathom Pedicle-Based Retractor C/C Blades due to manufacturing defects that could cause bone fracture. The recall affects 31 units distributed across nine US states.
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