Medical devices recalls – page 85

• ALTRUA 2 DR Pacemaker, SL (Model Number S702) and EL (Model Number S722) recall
  FDA January 22, 2025 · Boston Scientific Corporation · Class I
• ESSENTIO DR Pacemaker, SL (Model Number L101, SL MRI (Model Number L111)… recall
  FDA January 22, 2025 · Boston Scientific Corporation · Class I
• PROPONENT DR Pacemaker, SL (Model Number L201)… recall
  FDA January 22, 2025 · Boston Scientific Corporation · Class I
• ACCOLADE DR Pacemaker, SL (Model Number L301), SL MRI (Model Number L311)… recall
  FDA January 22, 2025 · Boston Scientific Corporation · Class I
• Neo-Tee T-Piece Resuscitator, for pediatric emergency respiratory support… recall
  FDA January 22, 2025 · Mercury Medical · Class I
• Medline Fluid Delivery Set with Drip Chamber: 1)… recall
  FDA January 22, 2025 · Medline Industries, LP · Class I
• Medline Fluid Delivery Set with Drip Chamber: 1)… recall
  FDA January 22, 2025 · Medline Industries, LP · Class I
• Sheath, 18 Fr., 160 mm ( recall
  FDA January 22, 2025 · Trokamed GmbH · Class I
• Sheath, 18 Fr., 130 mm ( recall
  FDA January 22, 2025 · Trokamed GmbH · Class I
• Sheath, 20 Fr., 160 mm ( recall
  FDA January 22, 2025 · Trokamed GmbH · Class I
• Sheath, 20 Fr., 130 mm ( recall
  FDA January 22, 2025 · Trokamed GmbH · Class I
• 3B Medical, Inc recall
  FDA January 15, 2025 · 3B Medical, Inc. · Class II
• Citric Complete - Dry Citric Acid Concentrate Model Number: DCA+225-25 recall
  FDA January 15, 2025 · Nipro Renal Soultions USA, Corporation · Class II
• AMT Mini Enteral Extension Set, 12" Right Angle Feeding Set with Y-Port recall
  FDA January 15, 2025 · Applied Medical Technology Inc · Class II
• Tec 850 SEV Anesthesia Vaporizer, Reference Number 1177-9850-SEV recall
  FDA January 15, 2025 · GE Medical Systems, LLC · Class II
• Tec 850 ISO Anesthesia Vaporizer, Reference Number 1177-9850-ISO recall
  FDA January 15, 2025 · GE Medical Systems, LLC · Class II
• Tec 820 SEV Anesthesia Vaporizer, Reference Number 1177-9820-SEV recall
  FDA January 15, 2025 · GE Medical Systems, LLC · Class II
• Tec 820 ISO Anesthesia Vaporizer, Reference Number 1177-9820-ISO recall
  FDA January 15, 2025 · GE Medical Systems, LLC · Class II
• Tec 6 Plus Anesthesia Vaporizer, Reference Numbers 1107-9601-000… recall
  FDA January 15, 2025 · GE Medical Systems, LLC · Class II
• GE Healthcare Optima XR240amx, Mobile Digital Radiographic System… recall
  FDA January 15, 2025 · GE Medical Systems, LLC · Class II
• GE Healthcare Optima XR220amx, Mobile Digital Radiographic System… recall
  FDA January 15, 2025 · GE Medical Systems, LLC · Class II
• GE Healthcare Optima XR200amx, Mobile Digital Radiographic System… recall
  FDA January 15, 2025 · GE Medical Systems, LLC · Class II
• Xhibit Telemetry Receiver with Software, Model 96280… recall
  FDA January 15, 2025 · Spacelabs Healthcare, Inc. · Class II
• Xhibit Telemetry Receiver, Model 96280, with Service Manual recall
  FDA January 15, 2025 · Spacelabs Healthcare, Inc. · Class II
• Aerin Medical VivAer Stylus recall
  FDA January 15, 2025 · Aerin Medical, Inc. · Class II
• 100V NEPTUNE 3 ROVER JAPANESE (0703-003-000) 120V NEPTUNE S ROVER… recall
  FDA January 15, 2025 · Stryker Corporation · Class II
• EnVisio Patient Pad Transition Cushion, Model recall
  FDA January 15, 2025 · Elucent Medical Inc · Class II
• The FastPack IP Sex Hormone Binding Globulin Immunoassay, Part #25000081… recall
  FDA January 15, 2025 · Qualigen Inc · Class III
• Smaxel Fractional CO2 Laser, a Class IV medical laser system recall
  FDA January 15, 2025 · Ids Ltd · Class II
• Access Intact PTH assay, a paramagnetic particle… recall
  FDA January 15, 2025 · Beckman Coulter, Inc. · Class II
• VACUETTE SAFELINK recall
  FDA January 15, 2025 · Greiner Bio-One GmbH · Class II
• Dialyzer Optiflux 160NRe recall
  FDA January 15, 2025 · Fresenius Medical Care Holdings, Inc. · Class II
• JMC5A Ni/TruAire-5 Oxygen Concentrator, Model: O2C5L recall
  FDA January 15, 2025 · Jiangsu Jumao X-Care Medical Equipment CO Ltd · Class I
• Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004 recall
  FDA January 15, 2025 · Fresenius Kabi USA, LLC · Class I
• Vasoview Hemopro 2 (w/Vasoshield) Endoscopic Vessel Harvesting System recall
  FDA January 15, 2025 · Maquet Cardiovascular, LLC · Class I
• VasoView HemoPro 2 Endoscopic Vessel Harvesting System recall
  FDA January 15, 2025 · Maquet Cardiovascular, LLC · Class I
• Ivalon Anatomical Nasal Packing with Airway Tube and String… recall
  FDA January 8, 2025 · Carwild Corporation · Class II
• Ivalon CELLULOSE SURGICAL SPEAR- Intended To Be Used During Ophthalmic… recall
  FDA January 8, 2025 · Carwild Corporation · Class II
• Ivalon Eye Wick 20cm- Intended to be used for the removal and collection… recall
  FDA January 8, 2025 · Carwild Corporation · Class II
• 3M Unitek Transbond Plus Self-Etching Primer recall
  FDA January 8, 2025 · 3M Unitek Corporation · Class II
• SUC-4300S, Rigid Intracardiac Sucker Fluted Tip recall
  FDA January 8, 2025 · Med Michigan Holding Llc · Class II
• Medline custom medical procedure kits labeled as: 1) CRANI recall
  FDA January 8, 2025 · Medline Industries, LP · Class II
• Medline custom medical procedure kits labeled as: 1) CERVICAL PACK-LF recall
  FDA January 8, 2025 · Medline Industries, LP · Class II
• Medline custom medical procedure kits labeled as: 1) ENSEMBLE RACHIS-LF recall
  FDA January 8, 2025 · Medline Industries, LP · Class II
• Medline custom medical procedure kits labeled as: DEEP BRAIN STIMULATION… recall
  FDA January 8, 2025 · Medline Industries, LP · Class II
• See DocMan recall
  FDA January 8, 2025 · Medline Industries, LP · Class II
• Medline custom medical procedure kits labeled as: 1) MICRODISECTOMY PACK recall
  FDA January 8, 2025 · Medline Industries, LP · Class II
• See DocMan recall
  FDA January 8, 2025 · Medline Industries, LP · Class II
• Medline custom medical procedure kits labeled as: 1) NEURO BASIN PACK-LF recall
  FDA January 8, 2025 · Medline Industries, LP · Class II
• Medline custom medical procedure kits labeled as: 1) MEM MAXILLOFACIAL… recall
  FDA January 8, 2025 · Medline Industries, LP · Class II
• Medline custom medical procedure kits labeled as: 1) PANENDOSCOPY-LF recall
  FDA January 8, 2025 · Medline Industries, LP · Class II
• Medline custom medical procedure kits labeled as: 1) ENDOSCOPIC SKULL BASE recall
  FDA January 8, 2025 · Medline Industries, LP · Class II
• Medline custom medical procedure kits labeled as: 1) FREE FLAP BASIC… recall
  FDA January 8, 2025 · Medline Industries, LP · Class II
• See DocMan recall
  FDA January 8, 2025 · Medline Industries, LP · Class II
• Medline custom medical procedure kits labeled as: 1) NASAL PACK recall
  FDA January 8, 2025 · Medline Industries, LP · Class II
• Medline custom medical procedure kits labeled as: 1) UMC DR… recall
  FDA January 8, 2025 · Medline Industries, LP · Class II
• Medline custom medical procedure kits labeled as: 1) VP SHUNT CDS recall
  FDA January 8, 2025 · Medline Industries, LP · Class II
• Medline custom medical procedure kits labeled as: 1) OPEN HEART CDS-LF… recall
  FDA January 8, 2025 · Medline Industries, LP · Class II
• Medline custom medical procedure kits labeled as: 1) CATH LAB PACK-LF recall
  FDA January 8, 2025 · Medline Industries, LP · Class II
• Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8)… recall
  FDA January 8, 2025 · Baxter Healthcare Corporation · Class II