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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.
Boston Scientific is recalling CRE Wireguided 10-12mm 240cm medical devices due to a potential sterile breach in the product packaging. The breach could compromise device sterility and affect patient safety.
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.
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.
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.
DePuy Synthes is recalling ATTUNE Revision Hinge Knee Insert Components distributed to Minnesota, North Carolina, and Texas because external sterile packaging was found adhered to internal sterile packaging, potentially compromising sterility.
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.
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.
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.
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.
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.
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.
Medacta USA is recalling Short Monobloc Stem Broaches used in shoulder replacement surgery due to positioning misalignment that may increase risk of fracture in the upper arm bone.
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.
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.
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.
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.
Boston Scientific Corporation is recalling CRE Wireguided 18-20mm 240cm devices worldwide due to a potential sterile breach of the pouches in which the devices are packaged.
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.
DePuy Synthes is recalling ATTUNE Revision Hinge Knee Housing Components because external sterile packaging was found adhered to internal packaging, potentially compromising sterility. The recall affects 66 units distributed to Minnesota, North Carolina, and Texas.
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.
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.
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 12-15mm 240cm esophageal stents due to a potential sterile breach in the device packaging. Affected units were distributed worldwide.
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.
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