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.
CooperSurgical, Inc. is recalling the Stainless Steel Sims Uterine Sound (Part Number 64-601) because some units were laser-marked with incorrect part numbers during manufacturing. No injuries have been reported.
Karl Storz Endoscope nephroscopes (REF: 27840KA) are being recalled because their instructions for use contain reprocessing methods that have not been reviewed or approved by the FDA for safety and efficacy.
Philips Ingenia 3.0T CX MRI machines may have loose screws in the RF carrier assembly that could protrude and interfere with the tabletop mechanism, potentially delaying patient scans.
Karl Storz is recalling the Hopkins Telescope 6 endoscope because its Instructions for Use contain reprocessing procedures that have not been FDA-reviewed or approved. The recall affects 1,982 units distributed nationwide.
GE Healthcare Centricity PACS versions V2-V7 may fail to store medical images when reaching maximum unique image identifiers, potentially resulting in incomplete imaging studies. No injuries have been reported.
Cook Biotech is recalling Biodesign Inguinal Hernia Graft units because products expire before their labeled expiration date, potentially affecting surgical outcomes.
Stryker Spine recalled the electronic Instructions for Use revision 5 for the AVS Anchor-C Cervical Cage System because specific indications language for the US and Canada was inadvertently removed.
Baxter is recalling EXACTAMIX compounding device inlets due to particulate matter observed in sterile fluid pathways before use. Approximately 5.8 million units affected worldwide.
Baxter Healthcare Corporation is recalling EXACTAMIX Inlet components due to particulate matter found in sterile fluid path tubing. Approximately 1.5 million units were distributed worldwide.
Baxter Healthcare is recalling EXACTAMIX Inlet components (H938173 and related codes) due to particulate matter contamination observed in the sterile fluid path before use. Approximately 3.58 million units distributed worldwide are affected.
Baxter Healthcare is recalling ExactaMix pharmaceutical compounding device inlets due to increased reports of particulate matter in the sterile fluid path before use. The recall involves 2,140,046 units with worldwide distribution.
B. Braun Medical is recalling 19,050 AET36 Anesthesia Extension Sets due to potential product leakage from the Spin Lock Connector caused by excess solvent migration during manufacturing.
B Braun is recalling SL BLOODLINE FOR FMC 2008 SERIES hemodialysis tubing nationwide due to incomplete connector insertion that may cause blood flow restrictions during treatment.
Boston Scientific is recalling Flexima Regular Kit Nephrostomy Catheter System kits due to potential holes in the sterile barrier pouch that may compromise device sterility.
Boston Scientific is recalling VTC Regular Kit Nephrostomy Catheter System kits due to potential holes in the sterile barrier of the device pouch, which may compromise device sterility.
Beckman Coulter is recalling the DxI 9000 Access Immunoassay Analyzer due to undersized pneumatic tubing in the reagent storage module, which can cause air leaks and compressor failures, potentially leading to test errors and delayed results.
Tornier, Inc. is recalling one lot of the Stryker TORNIER PERFORM HUMERAL SYSTEM - STEMLESS shoulder implant due to bacterial endotoxin exceeding safety specifications. The 5 affected units were distributed in Illinois, Wisconsin, Arizona, Nevada, and South Dakota.
Endo retrieval pouches are recalled because the tube may detach and fall into the surgical site during use. Approximately 81,241 units distributed in Georgia, Missouri, and Pennsylvania are affected.
B. Braun is recalling approximately 4.98 million STREAMLINE FRESENIUS FOR DAVITA hemodialysis bloodline tubes due to risk of improper connector insertion, which could cause blood flow occlusion during dialysis treatment.
CareFusion is recalling approximately 192,964 Alaris Pump Module Model 8100 infusion pumps that may have bent female connectors preventing device operation and delaying patient treatment.
Carbon Medical Technologies is recalling the BiomarC EX Fiducial Marker System because patients did not receive the required MRI Insert component needed for safe use during MRI procedures.
Safeguard US Operating LLC is recalling the HAWK Warming Grid (Item 59-300) due to an incorrect expiration date. The affected units may not function safely if used beyond the actual expiration date.
GE Healthcare ViewPoint 6 medical imaging systems contain a software vulnerability (CVE-2023-43208) in Mirth Connect that could allow unauthorized access and patient data manipulation. 574 units are affected and distributed nationwide.
B Braun's STREAMLINE FRESENIUS bloodline tubing used in hemodialysis may have a design issue where incomplete insertion of the patient connector prevents proper blood flow during certain procedures. Patients receiving dialysis may experience treatment delays.
Boston Scientific is recalling Flexima Biliary Catheter System Kit (Lot #33512376) due to potential holes in the device pouch's sterile barrier, which could compromise device sterility. No illnesses or injuries have been reported.
Looking for a different category? Browse all recalls.