Medical devices recalls – page 10

• Orthofix MINIRAIL, STANDARD LENGTHENER Model recall
  FDA July 22, 2026 · Orthofix U.S. LLC · Class II
• Optima XR240amx, Mobile Digital Radiographic System recall
  FDA July 22, 2026 · GE Medical Systems, LLC · Class II
• Optima XR220amx, Mobile Digital-Ready Radiographic System recall
  FDA July 22, 2026 · GE Medical Systems, LLC · Class II
• Optima XR200amx, Mobile Digital-Ready Radiographic System recall
  FDA July 22, 2026 · GE Medical Systems, LLC · Class II
• Rapid Refill Continuous Injection System, UPN M00566001 recall
  FDA July 22, 2026 · Boston Scientific Corporation · Class II
• ICU Medical Plum Solo Precision IV Pump, v1.0.3, Item Number 400010401 recall
  FDA July 22, 2026 · ICU Medical, Inc. · Class II
• ICU Medical Plum Duo Infusion Pump, v1.2.3: 1) Item Number 400020401 and… recall
  FDA July 22, 2026 · ICU Medical, Inc. · Class II
• da Vinci SP Instrument Arm Drape, SP, 1-PACK, Part Number: 430013-13… recall
  FDA July 22, 2026 · Intuitive Surgical, Inc. · Class II
• Olympus Glass Body for 194 Ellik Evacuator recall
  FDA July 22, 2026 · Olympus Corporation of the Americas · Class II
• Olympus Ellik Evacuator Includes Glass Body… recall
  FDA July 22, 2026 · Olympus Corporation of the Americas · Class II
• Olympus Toomey Evacuator 50cc with Adaptor recall
  FDA July 22, 2026 · Olympus Corporation of the Americas · Class II
• Olympus Toomey Evacuator 30cc with Adaptor recall
  FDA July 22, 2026 · Olympus Corporation of the Americas · Class II
• Bone Marrow Tray recall
  FDA July 22, 2026 · Argon Medical Devices, Inc · Class I
• Arterial Line Kit 20ga x 6 recall
  FDA July 22, 2026 · Argon Medical Devices, Inc · Class I
• T-Lok Bone Marrow Tray recall
  FDA July 22, 2026 · Argon Medical Devices, Inc · Class I
• General Biospy Tray recall
  FDA July 22, 2026 · Argon Medical Devices, Inc · Class I
• One-Piece Introducer Tray recall
  FDA July 22, 2026 · Argon Medical Devices, Inc · Class I
• Transvenous Pacing Electrode Tray w/ Bipolar Balloon Pacing Electrode 5F recall
  FDA July 22, 2026 · Argon Medical Devices, Inc · Class I
• ABIOMED Intro Kit, 14Fr x 13 and 25 cm, PKGD, JP… recall
  FDA July 22, 2026 · Abiomed, Inc. · Class I
• ABIOMED Insertion Kit, Pkgd, JP, Pump Set Code 0052-0011-JP recall
  FDA July 22, 2026 · Abiomed, Inc. · Class I
• ABIOMED Impella CP Set, Pump Set Code 0048-0044 recall
  FDA July 22, 2026 · Abiomed, Inc. · Class I
• ABIOMED Impella CP Smart Assist Set, JP, Pump Set Code 0048-0024-JP recall
  FDA July 22, 2026 · Abiomed, Inc. · Class I
• ABIOMED Impella CP Set, Pump Set Code 0048-0014 recall
  FDA July 22, 2026 · Abiomed, Inc. · Class I
• ABIOMED Impella 5.5 SmartAssist S2 Set, JP, Pump Set Codes 1000459, 1000460 recall
  FDA July 22, 2026 · Abiomed, Inc. · Class I
• ABIOMED Impella 5.5 Smart Assist Set, JP, Pump Set Codes 1000211, 1000212 recall
  FDA July 22, 2026 · Abiomed, Inc. · Class I
• ABIOMED Impella CP Introducer Kit 14 Fr, 25 cm, Pump Set Code 0052-0039… recall
  FDA July 22, 2026 · Abiomed, Inc. · Class I
• ABIOMED Impella CP Introducer Kit 14 Fr, 13 cm, Pump Set Code 0052-0038… recall
  FDA July 22, 2026 · Abiomed, Inc. · Class I
• ABIOMED Introducer Kit 23 Fr, 11 cm, Pump Set Code 1000441… recall
  FDA July 22, 2026 · Abiomed, Inc. · Class I
• ABIOMED Impella CP Introducer Kit 14 Fr, 13 and 25 cm… recall
  FDA July 22, 2026 · Abiomed, Inc. · Class I
• ABIOMED Impella CP Set, Pump Set Code 0048-0003… recall
  FDA July 22, 2026 · Abiomed, Inc. · Class I
• ABIOMED Impella RP Flex with SmartAssist Set, Pump Set Code 1000323… recall
  FDA July 22, 2026 · Abiomed, Inc. · Class I
• Abiomed REF: 0052-3006, Introducer Kit for Impella Hemostatic Peel Away… recall
  FDA July 22, 2026 · Oscor Inc. · Class I
• Abiomed REF: 0052-3021, Introducer Kit for Impella Hemostatic Peel Away… recall
  FDA July 22, 2026 · Oscor Inc. · Class I
• Abiomed REF: 0052-3025, Introducer Kit for Impella Hemostatic Peel Away… recall
  FDA July 22, 2026 · Oscor Inc. · Class I
• Versius Surgical System US Product Name: Vesius Surgeon Console US Model recall
  FDA July 15, 2026 · Cmr Surgical Limited · Class II
• TMINI Femur Tracking Array recall
  FDA July 15, 2026 · Think Surgical, Inc. · Class II
• VITEK 2 AST-N447 TEST KIT Product reference 424620 recall
  FDA July 15, 2026 · Biomerieux Inc · Class II
• OmniTract Surgical Retractor System, which includes 633 of the firm s… recall
  FDA July 15, 2026 · Integra LifeSciences Corp. (NeuroSciences) · Class II
• GSP Neonatal GALT Kit recall
  FDA July 15, 2026 · Wallac Oy · Class II
• Geneva Product Name: Brachytherapy Applicator Product Description: The… recall
  FDA July 15, 2026 · Elekta, Inc. · Class II
• Brachytherapy Applicator Product Name: Advanced Gynecological Applicator… recall
  FDA July 15, 2026 · Elekta, Inc. · Class II
• Fletcher CT/MR Shielded Applicator Set Product Name: Intracavitary Remote… recall
  FDA July 15, 2026 · Elekta, Inc. · Class II
• Atellica CH Enzymatic Hemoglobin A1c (A1c_E) recall
  FDA July 15, 2026 · Siemens Healthcare Diagnostics, Inc. · Class II
• 5008X Blood Tubing Set, 24 units per case recall
  FDA July 15, 2026 · Fresenius Medical Care Holdings, Inc. · Class II
• EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 11L 14MM, VE Model recall
  FDA July 15, 2026 · Encore Medical, LP · Class II
• EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 11L 14MM, VE Model recall
  FDA July 15, 2026 · Encore Medical, LP · Class II
• KL Owen Custom Orthodontic Solution, model/catalog number CIAS-800033 recall
  FDA July 15, 2026 · Klowen Braces · Class II
• MiniMed 780G Insulin Pump recall
  FDA July 15, 2026 · Medtronic MiniMed, Inc. · Class II
• Medline Convenience Kits: 1) OPEN HEART PEDS PACK, Model Number: DYNJ88569 recall
  FDA July 15, 2026 · Medline Industries, LP · Class II
• Medline Convenience Kits: 1) OPEN HEART PEDS PACK, Model Number: DYNJ88569D recall
  FDA July 15, 2026 · Medline Industries, LP · Class II
• Medline Convenience Kits: 1) ANESTHESIA KIT PEDS 90-LF… recall
  FDA July 15, 2026 · Medline Industries, LP · Class II
• Intracept Access Instruments, Description recall
  FDA July 15, 2026 · Boston Scientific Neuromodulation Corporation · Class II
• Aquacel Ag Surgical SP recall
  FDA July 15, 2026 · ConvaTec, Inc · Class II
• Olympus Single Use Distal Cover recall
  FDA July 15, 2026 · Olympus Corporation of the Americas · Class II
• Sterile Tourniquet Hoses Product Name: A.T.S¿ 4000 TS Tourniquet Systems… recall
  FDA July 8, 2026 · Zimmer Surgical Inc · Class II
• Sterile Tourniquet Hoses Product Name: A.T.S¿ 4000 TS Tourniquet Systems… recall
  FDA July 8, 2026 · Zimmer Surgical Inc · Class II
• GORE¿ TAG¿ Thoracic Branch Endoprosthesis Side Branch Component recall
  FDA July 8, 2026 · W L Gore & Associates, Inc. · Class II
• Radius VSM Disposable NIBP Cuff recall
  FDA July 8, 2026 · Masimo Corporation · Class II
• Radius VSM ECG pre-connected Set recall
  FDA July 8, 2026 · Masimo Corporation · Class II
• Solar GI System (Water Perfusion) recall
  FDA July 8, 2026 · Laborie Medical Technologies Corp · Class II