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.
American Surgical Company is recalling 7 boxes of non-strung cotton balls due to packaging defects that compromise sterility. The affected lots were distributed worldwide.
American Surgical Company is recalling Americot Blue sponges because defective packaging may compromise sterility. The recall affects 262 boxes distributed worldwide.
Biomet, Inc. is recalling various trauma and sports medicine instruments and implants because insufficient seal strength on sterile barrier packaging could compromise sterility and lead to infection.
American Surgical Company is recalling Americot Blue sponges because defective packaging may compromise sterility. The recall covers 54 cases distributed worldwide.
American Surgical Company is recalling Ray-Cot sponges because defective packaging may compromise sterility. The recall covers 209 boxes distributed worldwide.
GE Medical Systems is recalling 25 Discovery IGS 740 systems due to potential non-recoverable loss of image acquisition during procedures.
American Surgical Company is recalling 27 boxes of Delicot-J sponges because defective packaging may compromise sterility.
American Surgical Company is recalling Ultracot sponges because defective packaging may compromise sterility. The recall covers products distributed in the US and 20 other countries.
American Surgical Company is recalling 33 boxes of Americot Blue sponges because defective packaging may compromise sterility.
American Surgical Company is recalling 11 boxes of Ultracot sponges because defective packaging may compromise sterility. The products were distributed worldwide.
American Surgical Company is recalling Uniqcot sponges because defective packaging may compromise sterility. The recall covers 15 cases distributed worldwide.
American Surgical Company is recalling 689 boxes of Delicot sponges because defective packaging may compromise sterility.
American Surgical Company is recalling 33 boxes of Delicot-J sponges because defective packaging may compromise sterility.
Biomet, Inc. is recalling 22 PerFuse Decompression Instruments because missing Trocar and Plunger Assemblies could delay surgery by more than 30 minutes.
RaySearch Laboratories is recalling RayStation Therapy Treatment Planning System software due to a bug that can cause views to become unsynchronized with stored data.
Accriva Diagnostics is recalling APTT Cuvettes for the Hemochron Jr. system because the clot activating reagent may be mis-positioned or absent, causing test errors or high results.
Synthes (USA) Products LLC is recalling 1,274 sterile 3.2 mm radiolucent drill bits because the protective cap may not be secured, risking puncture of the sterile barrier.
Leica Microsystems is recalling Novocastra Calretinin antibodies because they may show reduced staining when used with specific diluent lots.
Stryker Sustainability Solutions is recalling 18 reprocessed diagnostic electrophysiology catheters because they were mislabeled for size.
American Surgical Company is recalling 338 boxes of Delicot sponges because defective packaging compromises sterility. The products were distributed worldwide.
Volcano Corporation is recalling specific cardiology imaging systems due to a software incompatibility that can cause unexpected reboots when encountering specific hospital network data.
Synthes (USA) Products LLC is recalling 7,363 sterile 3.2 mm three-fluted drill bits because the protective cap may not be secured, allowing the tip to puncture the sterile barrier.
Elekta, Inc. is recalling 20 iGUIDE Systems due to a software issue that may allow pre-treatment imaging to be performed before the HexaPOD is in the correct position.
Roche is recalling 8 kits of cobas EGFR Mutation Test v2 and cfDNA Sample Preparation due to errors in the Hungarian translated instructions for use.
Monteris Medical Corp is recalling 121 NeuroBlate System SideFire Select 2.2 mm Directional Laser Probes because a sapphire lens fractured during a procedure, introducing CO2 into a patient's brain.
Looking for a different category? Browse all recalls.