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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.
Certain Zyno Medical Z800 series infusion pumps contain faulty power supply modules that cannot charge the rechargeable battery. When unplugged from AC power, affected pumps may lack sufficient charge to operate.
Beckman Coulter is recalling 116 DxI 9000 Immunoassay Analyzers due to a software defect that fails to properly validate calibrator barcodes, potentially resulting in incorrect calibration curves and erroneous patient test results.
BD Pyxis automated dispensing cabinets were shipped with socket-outlet power strips that lack IEC electrical certification, potentially exposing users to leakage currents and electric shock.
MicroPort's EVOLUTION MP knee implants recalled due to one confirmed case where a Size 3 left-side component was packaged in a Size 4 right-side box. No injuries reported; distribution is limited to China with no U.S. inventory.
A software issue in BD Alaris System Manager version 12.5.1 may prevent the PC unit from connecting to the server, potentially affecting wireless data transmission. CareFusion 303, Inc. is recalling the affected software version nationwide.
Siemens ARTIS icono angiography systems with certain detectors may deliver higher-than-intended radiation doses in rare cases. The issue occurs when incorrect copper prefiltration is applied during initial x-ray exposure after patient registration.
Medline is recalling 12,588 sterile surgical kits with Pure Pouch components that have weak seals, potentially compromising sterility and exposing patients and surgical teams to non-sterile instruments.
Philips is recalling Avalon ultrasound transducers used for monitoring fetal heart rate. The device may produce inaccurate measurements when monitoring multiple fetuses, potentially delaying detection of fetal distress.
Stryker Sustainability Solutions is recalling 6 units of BW Lasso 2515 NAV eco Variable Diagnostic EP Catheters because they do not meet FDA testing requirements. The devices were distributed to Japan.
SeaSpine Orthopedics recalls Fathom Pedicle-Based Retractor C/C Blades due to manufacturing defects that could cause bone fracture or damage during surgery. 21 units were distributed nationwide.
Stryker Corporation has recalled expired sterile cannula devices distributed nationwide. The devices were past their expiration date, potentially compromising sterility and device safety.
A bolt securing the positioning arm on First Source iQ Flex M X-ray carts may come loose and fall onto patients. The recall involves 137 units distributed across the US, Korea, and Serbia.
Medline is recalling approximately 12,588 sterile surgical kits used for childbirth procedures because weak seals on Pure Pouch components may fail and compromise sterility.
Angiodynamics is recalling IsoLoc Prostate Immobilization Balloons (ISO-100, Lot 5402) for mislabeling. Devices have 100cc fill volume but are labeled as ISO-60 (60cc).
First Source Inc is recalling the First Source Vision M portable X-ray cart because the bolt securing the positioning arm to the gas spring may come loose and fall onto a patient.
Stryker recalled its Curved Cement Delivery Needle (Lot 6659783) due to expired product distribution. Three units were distributed to customers in Arkansas, California, Colorado, Florida, and Michigan.
Ortho-Clinical Diagnostics is recalling a calibrator kit with an incorrect expiration date that could bias lab results if used past its true expiration date.
Olympus has recalled 227 EasySuite 4K operating room systems worldwide due to incomplete documentation of earth leakage testing, which is required to confirm electrical current levels are within safety standards.
WOM Tube Set for Irrigation (1700 units, Lots 4030902 and 4030903) is recalled due to incorrect RFID tag data that causes an error message preventing use in endoscopic surgeries, potentially resulting in surgical delays.
The Life2000 Ventilator may fail to charge or experience intermittent charging behavior due to damage to the battery charger dongle. This FDA Class I recall affects approximately 2,510 units distributed nationwide.
Philips recalled 14 SENSE XL Torso Coils worldwide due to potential overheating. The coils could heat up during use and cause patient burn injuries.
Philips is recalling 307 SENSE XL TORSO COIL 3.0T units used in MR imaging systems worldwide due to potential for coils to overheat and cause patient burn injuries.
Inspire Medical Systems recalls the Model 3028 Implantable Pulse Generator due to a manufacturing defect causing electrical leakage and system malfunction that requires revision surgery. The recall affects 24 devices distributed in the US and Germany.
Philips is recalling SENSE XL TORSO COIL units used in MRI imaging because the coils may heat up excessively and cause patient burns. This FDA Class I recall affects 729 units distributed worldwide.
Medtronic is recalling 36 COBALT DR MRI SureScan implantable cardioverter defibrillators due to a weld crack manufacturing defect. The defect was identified during manufacturing quality checks.
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