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.
Fenwal Inc is recalling 6,564 units in certain lots of Amicus apheresis kits because centrifuge packs may develop a stress leak. No illnesses or injuries have been reported.
Bard Peripheral Vascular is recalling certain Bard Mission Disposable Core Biopsy Instrument Kits due to sizing incompatibility between the biopsy instrument and coaxial needle, which could cause procedural delays or needle breakage.
Synthes recalled TFN-Advanced Femoral Nails because some units have incorrect dimensions: nails labeled 200mm may measure 170mm, while those labeled 170mm may measure 200mm. This dimensional mismatch could compromise surgical fixation.
Securitas Healthcare is recalling the Arial mobile application for Android devices because the app does not load or function properly. Users should stop using the app immediately.
Siemens is recalling Dimension Tacrolimus diagnostic test cartridges (lots GA2286, GA3047, GA3171) due to confirmed measurement imprecision that could lead to incorrect drug dosing and potential organ failure or toxicity.
Stryker's Power-PRO 2 ambulance cots may separate at head or foot due to insufficient epoxy. Four affected units in NY and VA should be removed from service immediately.
Brainlab ExacTrac Dynamic software used in charged-particle radiation therapy systems may not properly execute Deep Inspiration Breath Hold (DIBH) functionality, a heart-protection technique. The issue affects 56 systems across the United States.
Synthes TFN-Advanced Femoral Nails labeled as 200mm may measure 170mm, and vice versa. Healthcare providers should verify actual dimensions before surgical use.
Becton Dickinson is recalling 45,000 units of BD Ultra-Fine Insulin Syringes (catalog 326679, lot 2164338) due to nonsterile manufacturing that could expose patients to pathogenic microorganisms and local infection. Distribution was worldwide.
Beckman Coulter is recalling approximately 4,100 laboratory immunoassay analyzers due to defective nut bands that may cause operational failures and erroneous patient test results.
Scientia Vascular is recalling Plato 17 Microcatheters due to manufacturing defects that may introduce loose particles into the catheter lumen, potentially causing blood vessel blockage or inflammatory reactions.
BD Insulin Syringes (Catalog 329420) are being recalled due to nonsterile conditions that could expose patients to pathogenic microorganisms and increase infection risk. The recall affects 961,000 units distributed worldwide.
Becton Dickinson is recalling 686,500 units of BD insulin syringes due to a nonsterile condition that may expose patients to pathogenic microorganisms and risk of infection.
Becton Dickinson recalled 1,472,400 BD Ultra-Fine II insulin syringes due to a sterility defect. The nonsterile syringes pose a risk of local infection at injection sites.
Limacorporate recalled 5 TEMA Axle Small elbow prostheses due to inclusion of a component not cleared for U.S. marketing. Affected systems were distributed to Texas.
Fenwal Inc is recalling certain batches of the Amicus MNC Apheresis Kit due to a potential for centrifuge packs to develop stress leaks. Affected units were distributed nationwide and internationally.
Becton Dickinson recalls 1.9 million BD Insulin Syringes due to a nonsterility defect that could expose patients to pathogenic microorganisms and local infection risk.
Synthes (USA) Products LLC is recalling TFN-Advanced Femoral Nails because labeled measurements do not match actual dimensions. Nails labeled 200mm may be 170mm and vice versa.
Maquet Cardiovascular is recalling one Fusion Bioline Vascular Graft from lot 25162546 that failed straightness testing. The graft could reduce blood flow or cause tension, potentially leading to bleeding and pseudo-aneurysm.
Becton Dickinson is recalling approximately 1.1 million BD Ultra-Fine Insulin Syringes due to nonsterility concerns. The affected syringes may expose patients to pathogenic microorganisms and risk of local infection.
Becton Dickinson is recalling BD Ultra-Fine Insulin Syringes (Catalog Number 326719) due to a nonsterile condition that could expose patients to pathogenic microorganisms and local infection. Approximately 80,500 units distributed worldwide are affected.
Intuitive Surgical recalls Patient Side Carts for da Vinci X and Xi surgical systems due to ballscrew failure risk. The failure could cause uncontrolled carriage movement leading to potential tissue injury during surgery. 9 units affected.
Becton Dickinson & Company is recalling 1.17 million BD Ultra-Fine Insulin Syringes due to a nonsterile manufacturing defect that could expose patients to pathogenic microorganisms and increase infection risk.
OMM Imports' Recreo Hair Growth Laser Comb is being recalled because 1,620 units lack required safety labels, warnings, and certification documentation. Missing labels create risk for users of the Class 3R laser device.
BioFire Diagnostics is recalling BioFire Respiratory Panel 2.1 (RP2.1) diagnostic kits due to temperature excursions during shipping that may reduce device performance.
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