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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.
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.
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.
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.
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.
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.
Ortho-Clinical Diagnostics is recalling VITROS Chemistry FS Diluent Pack 3, Lot 01-1645, because it may produce negatively biased results when used with CRP slides, potentially affecting patient diagnosis and care.
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.
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.
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.
Beckman Coulter DxI 9000 immunoassay analyzers may produce false or delayed test results due to pneumatic tubing disconnection during operation. Nine instruments are affected across the US and Europe.
HORIBA recalled 4 Fluorolog-QM fluorescence instruments due to a laser safety defect. A plastic cap instead of a proper beam stop may allow a Class 4 laser beam to exit the protective enclosure.
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.
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.
Applied Medical Technology is recalling 74 units of the AMT Initial Placement Dilator Set (Model IP-DIL) due to incorrect guidewire labeling. The labeling error could result in improper guidewire selection during gastrostomy placement procedures.
Medline Industries is recalling 12,588 sterile surgical convenience kits due to weak seals on Pure Pouch components that may breach sterility. Products were distributed nationwide across 23 states.
Medline sterile surgical kits are being recalled nationwide due to weak seals in the Pure Pouch component that may allow sterility breach. The recall affects 12,588 units distributed across 23 states.
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.
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.
Siemens ARTIS icono angiography systems with specific detector configurations may deliver higher radiation doses than intended in rare cases. The issue occurs during the first X-ray exposure after patient registration.
Medline is recalling Neuro IR surgical convenience kits due to weak seals in the Pure Pouch component that may compromise sterility. The recall affects 12,588 kits distributed nationwide.
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.
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.
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.
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