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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.
Siemens Medical Solutions is recalling 119 units of the ARTIS icono ceiling (Model 11328100) due to potential loss of movement capability when the detector lift height is adjusted to its maximum or minimum limits.
Teleflex LLC is recalling Pilling Wecksorb Neurosponges and Neurosponge Strips due to out-of-specification or potentially out-of-specification endotoxin levels. The cotton surgical sponges are used in brain and spine surgery.
Siemens Medical Solutions is recalling 30 units of the ARTIS icono floor (Model 11327700) due to potential loss of detector movement capability when adjusted to maximum or minimum height limits.
Boston Scientific is recalling CRE Pro Wireguided 6-8mm 240cm catheters worldwide due to a potential sterile breach in the packaging pouches, which could compromise device sterility.
Medline 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.
Medline Industries is recalling convenience kits containing Swan-Ganz catheters due to defects in the proximal injectate lumen hub that may leak or break, risking infection, medication loss, and blood loss.
Boston Scientific is recalling CRE Pro Wireguided 12-15mm 240cm esophageal stents due to a potential sterile breach in the device packaging. Affected units were distributed worldwide.
Hamilton Medical AG is recalling the IntelliCuff portable automatic cuff pressure controller due to a reported "Cuff System Leakage" error that may cause the motor to pump continuously and fail to maintain user-set cuff pressure.
RayCare 2024A SP1 oncology software may lose data if beam set delivery notes are modified simultaneously or updated during treatment sessions, with users not notified of changes.
Boston Scientific is recalling CRE Pro Wireguided 8-10mm 240cm devices worldwide due to a potential sterile breach of the product packaging pouches. The breach could compromise the sterility of the devices.
Boston Scientific Corporation is recalling the CRE Pro Wireguided 10-12mm 240cm device due to potential sterile breach of the pouches in which devices are packaged. The affected product has been distributed worldwide.
Baxter Healthcare is recalling an Adapter for Head Positioning (Model 1739994) used on operating tables because it may become loose and unintentionally move during patient positioning.
Medline is recalling convenience kits containing Swan-Ganz catheters with a defective proximal injectate lumen hub that may leak, break, or cause infection and blood loss.
Remel, Inc is recalling GC Agar Base culture media because some strains of Neisseria gonorrhoeae may not be recovered or may show reduced recovery on the product.
Boston Scientific is recalling CRE Pro Wireguided 18-20mm 240cm esophageal stents due to potential sterile breach of product pouches. The breach could allow contamination of sterile devices.
Medline Convenience kits containing Swan-Ganz catheters recalled by Becton Dickinson are being recalled due to leaks and breakage of the proximal injectate lumen hub, which may result in infection, medication loss, or blood loss.
Bard Access Systems is recalling PowerPICC SV Catheters because lidocaine ampoules supplied with the product were manufactured under deficient practices.
Medline Industries is recalling 1,512 Convenience Kits nationwide that contain Lidocaine HCL Injection USP ampules due to quality issues identified during an FDA manufacturing inspection of the supplier's facility.
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.
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.
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 Poly Midline Catheters because lidocaine ampoules were manufactured under deficient manufacturing practices.
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 Groshong NXT ClearVue Catheters (4 Fr Single-Lumen) due to lidocaine ampoules manufactured under deficient practices. The product is distributed nationwide and internationally.
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