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.
Mako Surgical Corporation is recalling 12 units of Mako Hip End Effectors due to a characterization issue that may cause discrepancies during bone preparation in certain Mako Total Hip procedures.
CareFusion 303, Inc. is recalling Alaris Syringe Module Model 8110 units because cleaning agents may damage connectors, potentially interrupting infusion therapy or monitoring.
Boston Scientific is recalling Captivator Polypectomy Snares because they may fail to cut and remove polyps, potentially causing tissue damage or bleeding.
CareFusion 303, Inc. is recalling Alaris SpO2 Modules because cleaning agents may damage connectors, causing infusion or monitoring interruptions.
CareFusion is recalling Alaris System PC Unit Model 8000 infusion pumps because loose or missing screws may cause power loss and therapy interruption.
Boston Scientific is recalling specific lots of Captivator Polypectomy Snares because they may fail to cut and remove polyps, potentially leading to prolonged procedures or tissue damage.
CareFusion is recalling Alaris System PC Unit Model 8015 infusion pumps because loose or missing screws may cause power loss and therapy interruption.
Becton Dickinson is recalling BD MAX SARS-CoV-2 Reagents due to elevated rates of potential false positive results, which could delay diagnosis and increase exposure risk.
Boston Scientific is recalling Captivator Polypectomy Snares because they may fail to cut and remove polyps, potentially causing prolonged procedures or tissue damage.
Boston Scientific is recalling Captivator Polypectomy Snares because they may fail to cut and remove polyps, potentially causing tissue damage or bleeding.
Boston Scientific is recalling specific lots of Captivator Polypectomy Snares because they may fail to cut and remove polyps, potentially causing tissue damage or bleeding.
CareFusion 303, Inc. is recalling Alaris System PC Unit Model 8015 infusion pumps because cleaning agents may damage connectors, potentially interrupting therapy or monitoring.
Siemens Medical Solutions is recalling 477 Luminos Agile Max units due to software defects that may cause system collisions or incorrect diagnostic images.
Smiths Medical is recalling Medfusion Syringe Pump Model 3500 units because inaccurate delivery can occur after an interrupted Bolus or Loading dose.
Siemens is recalling 194 Uroskop Omnia Max units due to software issues that may cause system collisions or incorrect diagnostic images.
Boston Scientific is recalling specific lots of Captiflex Snares because they may fail to cut polyps, potentially causing tissue damage or bleeding.
CareFusion 303, Inc. is recalling Alaris EtCO2 Module Model 8300 units because cleaning agents may damage connectors, potentially interrupting infusion therapy or monitoring.
Randox Laboratories is recalling specific batches of Lipase R2 Substrate due to confirmed imprecision in quality control and patient samples.
Teleflex Medical Inc. is recalling Pleur-Evac chest drainage devices because sterile packaging may be compromised, potentially affecting sterility.
Siemens Healthcare is recalling 1,800 DCA Vantage Handheld Barcode Scanners because they may fail to verify check digits or incorrectly process barcodes, potentially leading to data errors.
Randox Laboratories is recalling specific batches of Lipase Colorimetric R1 Buffer due to confirmed imprecision in quality control and patient samples.
Randox Laboratories is recalling specific batches of Lipase Colorimetric Reagent due to confirmed imprecision in quality control and patient samples.
Smith & Nephew is recalling 868 units of SUTUREFIX ULTRA Suture because a packaging error caused an XL drill to be included instead of the correct S drill.
Sutter Medizintechnik GmbH is recalling 1,337 units of Sutter Swyng non-stick bipolar forceps because the package insert incorrectly displays the Ethylene Oxide sterilization symbol instead of the irradiation symbol.
Teleflex Medical is recalling Rusch Greenlite laryngoscopes because the welded joint may break. The recall covers 20,600 units distributed nationwide.
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