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.
Medline Industries is recalling convenience kits containing Swan-Ganz catheters due to leaks and breakage of the proximal injectate lumen hub, which may cause infection, medication loss, or blood loss.
Bard Access Systems is recalling Power-Trialysis Short-Term Dialysis Catheters with triple-lumen design due to lidocaine ampoules manufactured under deficient manufacturing practices. The recall affects approximately 8,795 units distributed nationwide and internationally.
Bard Access Systems is recalling PowerMidline Catheter 4 Fr Dual-Lumen catheters because lidocaine ampoules were manufactured under deficient manufacturing practices.
Bard Access Systems is recalling PowerPICC Provena Catheters due to lidocaine ampoules manufactured under deficient manufacturing practices. The recall affects 29,490 units distributed nationwide and in Belgium.
Bard Access Systems, Inc. is recalling multiple PowerPICC catheter models due to lidocaine ampoules being manufactured under deficient manufacturing practices by the supplier.
Bard Access Systems is recalling lidocaine ampoules used with DuoGlide Short-Term Dialysis Catheters due to deficient manufacturing practices by the supplier. The catheters are used for temporary vascular access for hemodialysis.
Covidien LLC is recalling Shiley Disposable Decannulation Plug devices because the product labeling incorrectly indicates the product does not contain DEHP, when in fact the product contains 30 to 35% DEHP.
Boston Scientific is recalling the CRE Pro Wireguided 15-18mm 240cm device due to a potential sterile breach of the product pouches. The breach may compromise device sterility.
Bard Access Systems is recalling Power-Trialysis Slim-Cath short-term dialysis catheters due to lidocaine ampoules manufactured under deficient manufacturing practices. The recall affects multiple product models distributed nationwide and internationally.
Siemens Medical Solutions is recalling ARTIS icono ceiling Model 11328100 because screws in the Display ceiling suspension (DCS Fix XL) that hold the monitor may gradually loosen over time, potentially causing the monitor to detach.
Siemens is recalling 85 units of the ARTIS icono biplane (Model 11327600) due to potential loss of detector movement capability when adjusted to maximum or minimum lift height limits.
Zimmer Surgical Inc is recalling A.T.S 4000 TS Tourniquet Systems Single Hose units due to a potential sterility breach in the sealing area of the sterile pouch. If used, the compromised sterility may result in moderate localized infection.
Boston Scientific Corporation is recalling the CRE Wireguided 15-18mm 240cm device due to a potential sterile breach in the packaging pouches. The affected devices were distributed worldwide.
Medline Industries is recalling Imaging Biopsy Tray and Breast Biopsy Pack kits containing Huons Lidocaine HCL Injection USP due to quality issues identified during an FDA manufacturing inspection.
Masimo Corporation is recalling Radius VSM Disposable NIBP Cuffs (blood pressure cuffs) with lot numbers 21G6S through 25ADF because they may contain rough edges that could cause skin irritation or redness.
BD Switzerland SARL is recalling a Medline 111 Gravity Set with 3 Needle Free Y-Sites (Catalog Number SAM2461, Lot 25X445) because engineering samples labeled "Not for Human Use" were inadvertently shipped to the U.S. market.
Medline Convenience Kits containing Huons Lidocaine HCL Injection USP 1% ampules are being recalled due to quality issues identified during an FDA manufacturing inspection. Affected kits have been distributed nationwide.
Bard Access Systems is recalling Provena Midline Catheters because lidocaine ampoules used in manufacturing were produced under deficient manufacturing practices by a supplier.
Bard Access Systems is recalling Poly Midline Catheters because lidocaine ampoules were manufactured under deficient manufacturing practices.
Medline Industries is recalling three models of circumcision trays containing Lidocaine ampules due to quality issues identified during an FDA inspection of the drug manufacturer.
Boston Scientific Corporation is recalling CRE Wireguided 8-10mm 240cm devices worldwide due to potential sterile breaches in the packaging pouches that could compromise device sterility.
Medline Industries is recalling 15,662 Convenience Kits containing Huons Lidocaine HCL Injection USP due to quality issues identified during an FDA manufacturing inspection of the drug supplier's facility.
Boston Scientific Corporation is recalling CRE Wireguided 12-15mm 240cm devices due to a potential sterile breach in the pouches containing the devices. The breach could compromise device sterility.
Bard Access Systems, Inc. is recalling three models of thoracentesis and paracentesis trays due to lidocaine ampoules being manufactured under deficient manufacturing practices. The devices are used for fluid removal procedures and have been distributed nationwide and in Belgium.
Medline Industries is recalling two convenience kits (Arterial Line Kit and Ultrasound Guided IV Securement Set) due to quality issues with included Lidocaine Ampules identified during an FDA inspection.
Looking for a different category? Browse all recalls.