FDA Medical Devices
U.S. Food and Drug Administration — Medical device recalls
26,000 recalls · Page 23 of 520
Low Sep 3, 2025
C9-4 Transducer Probe
Philips Ultrasound, Inc
Moderate Aug 27, 2025
Brand Name: Q-Stop Product Name: Suture Retention Device Model/Catalog Number: QS Software Version: N/A Product Description: The DRS Vascular Q-Stop …
Drs Vascular, Inc
Moderate Aug 27, 2025
Electrosurgical, Cutting and Coagulation and Accessories. Electrosurgical Generator ESG-410 Surgical Energy Platform (SEP). Model Number: WA91327U. …
Olympus Corporation of the Americas
Moderate Aug 27, 2025
Burr Hole Cover Kit, REF: M365DB4600C0; Burr Hole Cover Spares Kit, REF: M365DB4605C0. Components of Vercise Deep Stimulation System used with the S…
Boston Scientific Neuromodulation Corporation
Moderate Aug 27, 2025
Clearview Strep A Exact II Dipstick Respiratory Kit, CLIA Waived. Catalog Number: 4581225020
Mckesson Medical-Surgical Inc. Corporate Office
Moderate Aug 27, 2025
Injection needle, bayonet, Luer-Lock, 1. Model no. 50-353-23, working length 25 cm, total length 31cm, nonsterile; 2. Model no. 50-345-23, work…
Spiggle & Theis Mt Gmbh
Critical Aug 27, 2025
ENDOTAK RELIANCE G/SG with 4-SITE Connector, transvenous defibrillation lead, Permanent Defibrillator Electrodes; Model Nos. 0282, 0283, 0285, 0286, …
Boston Scientific Corporation
Critical Aug 27, 2025
RELIANCE 4-FRONT, endocardial cardioversion/defibrillation and pace/sense lead, Permanent Defibrillator Electrodes; Model Nos. 0654, 0655, 0657, 0658…
Boston Scientific Corporation
Moderate Aug 27, 2025
Pentax Medical Video Processor; Model Number: EPK-i8020c;
Pentax of America Inc
Moderate Aug 20, 2025
GE Signa Artist, Nuclear Magnetic Resonance Imaging System
GE Medical Systems, LLC
Moderate Aug 20, 2025
GE SIGNA Premier Elite (China Only), Nuclear Magnetic Resonance Imaging System
GE Medical Systems, LLC
Low Aug 20, 2025
Zvu Anorectal Manometry Procedure Kit, REF: HRAM-PROC-10
Diversatek Healthcare
Moderate Aug 20, 2025
Brand Name: PERLA ¿ TL MIS Product Name: CANNULATED FENESTRATED POLYAXIAL SCREW Model/Catalog Number: MPF-PS 55 45-S Software Version: Not Applica…
SPINEART SA
Critical Aug 20, 2025
Baxter Novum IQ Large Volume Pump, Product Code REF 40700BAXUS
Baxter Healthcare Corporation
Moderate Aug 20, 2025
GE SIGNA Premier XT (China Only), Nuclear Magnetic Resonance Imaging System
GE Medical Systems, LLC
Moderate Aug 20, 2025
Brand Name: Ultra IABP Catheter Kit Product Name: Ultra IABP Catheter Kit Model/Catalog Number: IMU7F-40, IMU7F-35, IMU7F-30, IMU7F-25, and IMU7F-2…
Insightra Medical Inc
Moderate Aug 20, 2025
Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEETM INS, 4L 16MM, VE Model/Catalog Number: 341-16-704 Software Versio…
Encore Medical, LP
Moderate Aug 20, 2025
Brand Name: Carefree Surgical Specialties Product Name: Robotic/Laparoscopy Kittner Rolls Gauze Medium 4 Long X-Ray Detectable 5/pk 25pk/CS Model…
Carefree Surgical Specialties
Moderate Aug 20, 2025
GE Signa Voyager, Nuclear Magnetic Resonance Imaging System
GE Medical Systems, LLC
Moderate Aug 20, 2025
Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEETM INS, 7R 16MM, VE Model/Catalog Number: 342-16-707 Software Versio…
Encore Medical, LP
Moderate Aug 20, 2025
Brand Name: Carefree Surgical Specialties Product Name: Robotic/Laparoscopy Kittner Roll Gauze + Tail Medium 4 Long X-Ray Detectable 5pk 25pk/CS Ro…
Carefree Surgical Specialties
Critical Aug 20, 2025
Ambu SPUR II Labeled as the following: 1 SPUR II Adult Resuscitator, Adult, Catalog Number: 523211000 2 SPUR II Adult Resuscitator w/Mercury Filter, …
Ambu Inc.
Moderate Aug 20, 2025
GE Discovery MR750 3.0T, Nuclear Magnetic Resonance Imaging System
GE Medical Systems, LLC
Moderate Aug 20, 2025
GE Discovery MR450 1.5T, Nuclear Magnetic Resonance Imaging System
GE Medical Systems, LLC
Moderate Aug 20, 2025
Sparrow Ascent Patient Controller, REF's: 11-110-K, 11-310-K, 11-320-K, 11-321-K, 11-310-K-28, 11-320-K-28, 11-321-K-28
Spark Biomedical Inc
Moderate Aug 20, 2025
GE SIGNA Hero XT (China Only), Nuclear Magnetic Resonance Imaging System
GE Medical Systems, LLC
Moderate Aug 20, 2025
Bartels ELISA Legionella Urinary Antigen. Model Number: B1029-440. In Vitro Diagnostic test kit for the presumptive diagnosis of past or current L…
Trinity Biotech USA
Moderate Aug 20, 2025
HemosIL LMW Heparin Controls; Part Number: 0020300200;
Instrumentation Laboratory
Critical Aug 20, 2025
DreamStation Auto BiPAP. Non-Continuous Ventilator.
Philips Respironics, Inc.
Moderate Aug 20, 2025
FARAWAVE 1.0 Pulsed Field Ablation Catheter, Product ID M004PF41M401
Boston Scientific Corporation
Critical Aug 20, 2025
DreamStation Auto. Non-Continuous Ventilator.
Philips Respironics, Inc.
Moderate Aug 20, 2025
GE SIGNA Artist Evo, Nuclear Magnetic Resonance Imaging System
GE Medical Systems, LLC
Low Aug 20, 2025
Description/REF: BD PYXIS MEDBANK MINI 1FH-1FM/169-137, BD PYXIS MEDBANK MINI 4HM/169-113, BD PYXIS MEDBANK MINI 4HH/169-112, BD PYXIS MEDBANK …
CareFusion 303, Inc.
Moderate Aug 20, 2025
Brand Name: Carefree Surgical Specialties Product Name: Robotic/Laparoscopy Kittner Rolls Gauze Medium 4 Long X-Ray Detectable 5/pk 25pk/CS Model…
Carefree Surgical Specialties
Moderate Aug 20, 2025
Brand Name: PERLA ¿ TL MIS Product Name: CANNULATED FENESTRATED POLYAXIAL SCREW Model/Catalog Number: MPF-PS 65 40-S Software Version: Not Applica…
SPINEART SA
Moderate Aug 20, 2025
GE SIGNA PET/MR AIR (China Only), Nuclear Magnetic Resonance Imaging System
GE Medical Systems, LLC
Critical Aug 20, 2025
Brand Name: HeartMate Product Name: Mobile Power Unit, AC Power Cord Model/Catalog Number: 107760 Software Version: N/A Product Description: The …
Thoratec LLC
Moderate Aug 20, 2025
GE SIGNA PET/MR, Tomographic Imager Combining Emission Computed Tomography with Nuclear Magnetic Resonance
GE Medical Systems, LLC
Moderate Aug 20, 2025
Prosthesis Head B, 28 mm, 7 mm neck length. Item Number: 198-828/04.
Waldemar Link GmbH & Co. KG (Mfg Site)
Moderate Aug 20, 2025
GE SIGNA Hero Elite (China Only), Nuclear Magnetic Resonance Imaging System
GE Medical Systems, LLC
Moderate Aug 20, 2025
GE SIGNA Voyager AIR (China Only), Nuclear Magnetic Resonance Imaging System
GE Medical Systems, LLC
Moderate Aug 20, 2025
GE SIGNA PET/MR AIR Plus (China Only), Nuclear Magnetic Resonance Imaging System
GE Medical Systems, LLC
Moderate Aug 20, 2025
Custom Manifold Kit: REF: K09-02239C, K09-02249UP, K09-09110B, K09-10294A, K09-11227A, K09-11456B, K09-12123B, K09-13342AP, K09-13391BP, K09-13548, …
Merit Medical Systems, Inc.
Moderate Aug 20, 2025
GE SIGNA Hero MAX (China Only), Nuclear Magnetic Resonance Imaging System
GE Medical Systems, LLC
Moderate Aug 20, 2025
Brand Name: Carefree Surgical Specialties Product Name: Robotic/Laparoscopy Kittner + Tail Large 4 Long X-Ray Detectable 5pk 25pk/CS Roll Gauzes M…
Carefree Surgical Specialties
Moderate Aug 20, 2025
GE SIGNA Architect AIR (China Only), Nuclear Magnetic Resonance Imaging System
GE Medical Systems, LLC
Critical Aug 20, 2025
DreamStation Auto CPAP. Non-Continuous Ventilator.
Philips Respironics, Inc.
Moderate Aug 20, 2025
Custom Tubing Kit: REF: K04-00417, K04-00963, K04-01029
Merit Medical Systems, Inc.
Moderate Aug 20, 2025
High Pressure Tubing: REF: 502211002, HP9720E/C, HP9721E/C
Merit Medical Systems, Inc.
Moderate Aug 13, 2025
UIBC (Unsaturated Iron Binding Capacity), REF: OSR61205,
Beckman Coulter Inc.