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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.
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.
Medline Convenience kits containing recalled Swan-Ganz catheters may leak or break at the proximal injectate lumen hub, 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.
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.
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.
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.
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.
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.
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.
Mentor Texas LP is recalling a single lot of expired 10cc Luer Lok syringes distributed to California, Florida, and Pennsylvania due to a distribution system control failure.
RayCare 2024A SP4 oncology information system may lose data or fail to notify users when beam set delivery notes are modified simultaneously or updated during treatment sessions.
Masimo Corporation is recalling Radius VSM ECG pre-connected sets because the ECG electrode assembly may incorrectly detect extreme bradycardia or tachycardia and trigger false alarms on patients with normal heart rates, potentially distracting clinicians from true positive alarms and delaying treatment.
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.
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.
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.
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.
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.
Bard Access Systems is recalling Provena Midline Catheters because lidocaine ampoules used in manufacturing were produced under deficient manufacturing practices by a supplier.
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.
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.
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.
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.
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.
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.
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.
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