Category
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 is recalling 70 Ysio radiographic systems due to a software error that may cause unintended tube stand movement and create collision risk.
Baxter Healthcare Corporation is recalling 1,399 Liko Universal Twinbar 670 QRH patient lift accessories due to an incorrect center bolt used during assembly. The defect could cause a patient to fall during use.
Diagnos Inc is recalling CARA retinal analysis software version 4.7.2 because some AI-based features may lack appropriate FDA market approval. Users are advised to revert to a prior software version.
Mevion S250 and S250i Proton Therapy Systems hand pendants may malfunction, causing unintended motion of the therapy couch and nozzle. This poses a risk of patient injury if they contact moving equipment.
Human Care USA, Inc. is recalling the Hanger-Bar 2P 45cm because the set screw may loosen due to a manufacturing defect, creating a fall hazard.
Roche is recalling 14 Cobas Liat analyzer units due to detector noise causing false positive Influenza B results. Affected units were distributed in seven U.S. states and three countries.
Avanos Medical is recalling BALLARD Multi-Access Port Catheters because they were distributed with incorrect expiration dates on the packaging. The recall includes 6,280 devices.
Ansell is recalling Gammex Non-Latex PI Green surgical gloves (size 7 1/2) because the product was not submitted for required FDA inspection at the border. Distribution included Arizona, California, Nevada, Texas, Utah, and Washington.
Baxter Healthcare is recalling 498 units of MiniCap Extended Life PD Transfer Sets because they were distributed without FDA regulatory clearance. Affected units were distributed in 16 U.S. states.
CareFusion endoscopic equipment packages did not contain required instructions for use. The recall affects 152 units distributed to healthcare facilities in the US and internationally.
Avanos Medical is recalling BALLARD Seal Cassette Replacement MAP catheter devices due to incorrect expiration dates on product labels. Affected lot 30143745 was distributed in the United States and internationally.
Microbiologics Inc recalls the Pneumonia (33 Targets) Control Panel due to a shelf-life discrepancy. The product's shelf-life was determined to be 6 months instead of the labeled 18 months.
ROi CPS LLC is recalling 1,750 Regard Custom Procedure Kits containing BD Luer Lok Access Devices distributed nationwide in Missouri.
Philips Respironics recalls 229,353 respiratory ventilators because polyester-polyurethane foam may degrade and release particles. Foam degradation could compromise ventilator function.
Ace Surgical Supply is recalling NuOss Collagen Blocks because some units were mistakenly packaged with Collatene Fibrillar Collagen instead, which may result in suboptimal bone repair during dental and maxillofacial procedures.
Baxter Healthcare is recalling the Compella Therapy Air Supply Unit due to potential power cord damage that could expose electrical conductors and create a shock risk. The recall affects 6,022 units distributed worldwide.
BIOMET Trauma DVR CROSSLOCK surgical implant plates may have packaging that does not maintain sterile barrier integrity, posing a risk of infection.
Biomet is recalling surgical implant reamers due to packaging that may lose sterile barrier integrity, risking post-surgical infection.
Integra LifeSciences is recalling Codman Cranial Access Kits due to incorrect extended expiration dates printed on outer box labels. Using expired kits may result in pain, infection, or adverse tissue reaction.
B. Braun is recalling 6 Perfusor Space infusion pump units that may not function properly due to inadequate inspection, potentially causing incorrect medication dosing and therapy delays.
Outset Medical is recalling Tablo hemodialysis consoles (models PN-0003000 and PN-0006000) nationwide due to a component that may cause heat-related damage to the device.
Baxter Healthcare is recalling the Compella Bariatric Bed System due to potential power cord damage that could expose electrical conductors, creating a shock hazard. Approximately 5186 units worldwide are affected.
Integra LifeSciences is recalling 1,161 Codman Cranial Access Kits due to incorrect expiration dates on the outer box labels. Using the product past its correct expiration date may cause pain, infection, or adverse tissue reaction.
Biomet is recalling TRAUMA Drill Bits, Taps, and Guide Pins due to packaging that may not seal properly, potentially compromising sterile barrier integrity and posing a risk of surgical site infection.
Philips Azurion R2.1 systems have a software defect that causes the Patient Type to change unexpectedly when starting a procedure, potentially affecting dose control settings without user notification.
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