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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.
Siemens recalled 24 units of the Luminos dRF Max X-ray display system because the support arm may unintentionally lower, potentially injuring personnel positioned beneath the equipment.
Philips IntelliVue patient monitors shipped or updated with software that removes monitoring capabilities, potentially delaying or resulting in incorrect treatment.
American Contract Systems is recalling 224 Biopsy Drape Pack convenience kits due to insufficient aeration time during sterilization, which may have compromised the sterility of affected units. Lot 981241 distributed in CA, KS, ME, MN, MO, NE, and SD is affected.
Olympus Corporation is recalling the Soltive Pro SuperPulsed Laser System due to difficulties pairing its wireless footswitch, which could delay surgical procedures. The recall affects 253 units worldwide.
Olympus Corporation of the Americas is recalling 1,838 units of the Soltive SuperPulsed Laser System Wireless Footswitch due to pairing difficulties that may delay surgical procedures.
The Soltive Premium SuperPulsed Laser System may experience difficulties pairing its wireless footswitch, potentially delaying surgical procedures. The recall affects units distributed worldwide.
Lineage Biomedical is recalling NavaClick Syringe and Needle Model LIN02 due to an incorrect GTIN number on carton packaging. The recall affects 215 cartons distributed in Michigan and South Carolina.
The BIOFIRE BCID2 Panel may produce false positive Serratia marcescens results when used with certain culture media bottles, potentially leading to inappropriate changes in patient therapy.
Beckman Coulter's DxC 500 AU analyzer has two software bugs that may cause erroneous patient results due to misreported calibrations or expired reagents. No injuries or illnesses have been reported.
Some lots of the Capio SLIM suture capturing device may fail to consistently catch sutures during surgery, potentially requiring extended procedures or additional medical intervention.
Arctic Sun Temperature Management Systems may fail to reach target temperature and critically fail to alert clinicians. The software defect affects approximately 10,507 units worldwide and risks hypothermia or hyperthermia.
Boston Scientific is recalling some lots of Capio SLIM Suture Capturing Devices because they may not consistently catch sutures during surgery, potentially requiring prolonged procedures or additional medical intervention.
Becton Dickinson has recalled certain BD Insyte Autoguard BC IV catheters due to potential holes in the catheter tubing that could cause leakage during insertion. The recall involves 26,400 units distributed in the United States.
Zimmer hip replacement prostheses are recalled due to increased risk of postoperative femoral fracture. Affected devices are distributed nationwide; patients should consult their surgeon.
The SlideView VS200 slide viewer has a broken laser fuse caused by a short circuit from a poorly positioned cable. This prevents the shutter from operating properly, leaving it stuck in an open or closed position.
Angiodynamics recalls SOFT-VU KUMPE diagnostic catheters because inner pouch labels may show incorrect catheter length information, while the outer box label is accurate. 519 boxes distributed nationwide.
Angiodynamics is recalling SOFT-VU KUMPE 5F X 65CM angiographic catheters (595 boxes nationwide) because inner pouch labels may show information for a different catheter model while shelf-box labels are correct.
Medtronic Xomed is recalling NIM Vital Nerve Monitoring systems because they may fail to detect nerve damage or dysfunction. Approximately 7,804 units were distributed worldwide.
Olympus is recalling 86 ESG-410 Electrosurgical Generators because they may fail to power on during use, potentially delaying treatment or prolonging surgery.
Abbott Infinity 5 implantable pulse generators have inaccurate end-of-service dates in labeling, which may result in loss of therapy. Approximately 5,900 units are affected and distributed worldwide.
Radiometer Medical ABL800 FLEX blood gas analyzers (models 393-800, 393-801) may report inaccurate pH results due to bacterial growth in calibration solution bottles. Approximately 27,127 units distributed worldwide are affected.
B Braun is recalling Perfusor Space syringe pumps because manufacturing changes to Cardinal Health Monoject syringes may cause incompatibility, resulting in dosing errors or delayed treatment.
Abbott is recalling 1198 Infinity 7 Implantable Pulse Generators due to potentially incorrect service life indicators and end-of-service dates in product labeling, which could result in loss of therapy.
Siemens' Sensis Vibe cardiac imaging system software may crash when documentation functionality is used during diagnostic event recording. Two affected systems have been recalled nationwide.
B Braun Medical's Perfusor Space Syringe Pump may not properly recognize Cardinal Health Monoject syringes due to manufacturing changes, risking medication overdose, underdose, or therapy delays.
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