Class II medical devices recalls – page 67

• Augustine Surgical Inc recall
  FDA February 26, 2025 · Augustine Temperature Management, LLC · Class II
• Augustine Surgical Inc recall
  FDA February 26, 2025 · Augustine Temperature Management, LLC · Class II
• Sertera Biopsy Device Product Name: Sertera Biopsy Device Model recall
  FDA February 19, 2025 · Hologic, Inc · Class II
• Vios Monitoring System Bedside Monitor, Model BSM2050… recall
  FDA February 19, 2025 · Murata Vios, Inc. · Class II
• MediHoney¿ Gel Product Name: MediHoney¿ Wound & Burn Dressing Gel Model recall
  FDA February 19, 2025 · Integra LifeSciences Corp. · Class II
• Alteon XLE Item Number / Product Description: 140-22-70 NV EHXL NTL LNR… recall
  FDA February 19, 2025 · Exactech, Inc. · Class II
• Novation XLE Item Number / Product Description: 140-22-70 NV EHXL NTL LNR… recall
  FDA February 19, 2025 · Exactech, Inc. · Class II
• AcuMatch XLE Item Number / Product Description: 140-28-27 AM EHXL 0¿ LNR G… recall
  FDA February 19, 2025 · Exactech, Inc. · Class II
• Microbiologics Multi-Strain Human Papillomavirus (HPV) Verification Panel… recall
  FDA February 19, 2025 · Microbiologics Inc · Class II
• Microbiologics Multi-Strain Human Papillomavirus (HPV) Control Panel… recall
  FDA February 19, 2025 · Microbiologics Inc · Class II
• MOSAIQ Oncology Information System recall
  FDA February 19, 2025 · Elekta, Inc. · Class II
• Biological, Bio52 HealthFirst Mail In Monitoring System, 52 Tests… recall
  FDA February 19, 2025 · HF Acquisition Co LLC · Class II
• The Guardian System Product Name: The Guardian Model recall
  FDA February 19, 2025 · Angel Medical Systems, Inc. · Class II
• stryker Precision Thin recall
  FDA February 19, 2025 · Stryker Corporation · Class II
• stryker Precision Thin recall
  FDA February 19, 2025 · Stryker Corporation · Class II
• Cardinal Health Presource Kits: 1) ACDF PACK recall
  FDA February 19, 2025 · Cardinal Health 200, LLC · Class II
• Cardinal Health Presource Kits: 1) OPHTHALMOLOGY ENDO DCR XTRS PK recall
  FDA February 19, 2025 · Cardinal Health 200, LLC · Class II
• Cardinal Health Presource Kits: 1) CHI STD SPINE OPTION 1 recall
  FDA February 19, 2025 · Cardinal Health 200, LLC · Class II
• Cardinal Health Presource Kits: 1) CHI STD NEURO CRANI OPT 1 recall
  FDA February 19, 2025 · Cardinal Health 200, LLC · Class II
• Cardinal Health Presource Kits: 1) KIT,ROBOTIC HYSTERECTOMY recall
  FDA February 19, 2025 · Cardinal Health 200, LLC · Class II
• Cardinal Health Presource Kits: 1) KIT,NASAL SEPTOPLASTY,FAIRVIEW recall
  FDA February 19, 2025 · Cardinal Health 200, LLC · Class II
• Cardinal Health Presource Kits: 1) LARYNGOSCOPY PACK recall
  FDA February 19, 2025 · Cardinal Health 200, LLC · Class II
• Cardinal Health Presource Kits: 1) KIT,MAXILLOFACIAL,PRESBYTERIAN recall
  FDA February 19, 2025 · Cardinal Health 200, LLC · Class II
• Cardinal Health Presource Kits: 1) KIT, CAROTID ENDARTERECTOMY recall
  FDA February 19, 2025 · Cardinal Health 200, LLC · Class II
• Cardinal Health Presource Kits: 1) UROLOGY ROBOTIC PACK recall
  FDA February 19, 2025 · Cardinal Health 200, LLC · Class II
• Cardinal Health Presource Kits: 1) KIT,NEURO LAMI,MD ANDERSON recall
  FDA February 19, 2025 · Cardinal Health 200, LLC · Class II
• Cardinal Health Presource Kits: 1) KIT,DIEP FLAP recall
  FDA February 19, 2025 · Cardinal Health 200, LLC · Class II
• BD Pyxis MedStation 4000 recall
  FDA February 19, 2025 · CareFusion 303, Inc. · Class II
• BD Pyxis MedStation Auxiliary 4000 recall
  FDA February 19, 2025 · CareFusion 303, Inc. · Class II
• BD Pyxis MedStation Auxiliary ES recall
  FDA February 19, 2025 · CareFusion 303, Inc. · Class II
• BD Pyxis MedStation ES (Med ES Main) recall
  FDA February 19, 2025 · CareFusion 303, Inc. · Class II
• MicoVention Terumo, LVIS Intraluminal Support Device recall
  FDA February 19, 2025 · Microvention Inc. · Class II
• (1) BD Pyxis MedStation ES recall
  FDA February 19, 2025 · CareFusion 303, Inc. · Class II
• (1) Pyxis MedStation ES recall
  FDA February 19, 2025 · CareFusion 303, Inc. · Class II
• The MSOT Acuity Echo is a Class 4 medical laser device recall
  FDA February 19, 2025 · Ithera Medical Gmbh · Class II
• UNiD" Adaptive Spine Intelligence UNiD Spine Analyzer Product Number… recall
  FDA February 12, 2025 · Medicrea International · Class II
• Beckman Coulter DxI 9000 Access Immunoassay Analyzer, catalog number C11137 recall
  FDA February 12, 2025 · Beckman Coulter, Inc. · Class II
• Brasseler ESR Rotary/Reciprocating Endodontic File Device SKU AP120213PK… recall
  FDA February 12, 2025 · US Endodontics, LLC · Class II
• Sysmex PS-10 Sample Preparation System with software version 1.5 and 1.6 recall
  FDA February 12, 2025 · Sysmex America, Inc. · Class II
• Access PCT Reagent Pack recall
  FDA February 12, 2025 · Beckman Coulter, Inc. · Class II
• Temporary Titanium Abutments recall
  FDA February 12, 2025 · DDS Lab · Class II
• IntelliVue Patient Monitor MX550. Model Number: 866066 recall
  FDA February 12, 2025 · Philips North America Llc · Class II
• IntelliVue Patient Monitor MX500. Model Number: 866064 recall
  FDA February 12, 2025 · Philips North America Llc · Class II
• IntelliVue Patient Monitor MX450. Model Number: 866062 recall
  FDA February 12, 2025 · Philips North America Llc · Class II
• IntelliVue Patient Monitor MX400. Model Number: 866060 recall
  FDA February 12, 2025 · Philips North America Llc · Class II
• IntelliBridge EC10 Module recall
  FDA February 12, 2025 · Philips North America Llc · Class II
• NeiMed NasoGel for DRY NOSES UDI-DI recall
  FDA February 12, 2025 · Neilmed Pharmaceuticals Inc · Class II
• Integra Miltex Cryosolutions Cartridges 4 Pack (23.5g N2O each)… recall
  FDA February 12, 2025 · New Medical Technologies Gmbh · Class II
• Integra Miltex CryoSolutions Cartridges 10 Pack (23.5g N2O each)… recall
  FDA February 12, 2025 · New Medical Technologies Gmbh · Class II
• LIFEPAK 35 ECG cable recall
  FDA February 12, 2025 · Physio-Control, Inc. · Class II
• Nobel Biocare N1 TiUltra TCC RP 4.0x9mm . Nobel Biocare N1 TiUltra TCC RP… recall
  FDA February 12, 2025 · Nobel Biocare · Class II
• Belmont Medical 3-Spike Disposable Set used with the Belmont Rapid Infuser… recall
  FDA February 12, 2025 · Belmont Instrument LLC · Class II
• ETHIBOND EXCEL Polyester Suture recall
  FDA February 12, 2025 · Ethicon, LLC · Class II
• PERMA-HAND Silk Suture recall
  FDA February 12, 2025 · Ethicon, LLC · Class II
• PROLENE Polypropylene Suture recall
  FDA February 12, 2025 · Ethicon, LLC · Class II
• The Rapid fFN Specimen Collection Tube (PN: 71550-001) is a component of… recall
  FDA February 12, 2025 · Hologic, Inc · Class II
• Azurion 7 M20 System code: (1) 722224 (2) 722079 (3) 722234 (4) 722282… recall
  FDA February 12, 2025 · Philips Medical Systems Nederland B.V. · Class II
• Azurion 7 M12 System Code: (1) 722078 (2) 722223 (3) 722233 recall
  FDA February 12, 2025 · Philips Medical Systems Nederland B.V. · Class II
• Azurion 7 B20 System Code: (1) 722068 (2) 722226 (3) 722236 recall
  FDA February 12, 2025 · Philips Medical Systems Nederland B.V. · Class II
• Azurion 7 B12 System Code: (1) 722067 (2) 722225 (3) 722235 recall
  FDA February 12, 2025 · Philips Medical Systems Nederland B.V. · Class II