Class II medical devices recalls – page 55

• REF: 381434 BD Insyte Autoguard Shielded IV Catheter… recall
  FDA July 2, 2025 · Becton Dickinson Infusion Therapy Systems, Inc. · Class II
• REF: 381923 BD Insyte Autoguard Winged Shielded IV Catheter… recall
  FDA July 2, 2025 · Becton Dickinson Infusion Therapy Systems, Inc. · Class II
• REF: 382544 BD Insyte Autoguard Shielded IV Catheter… recall
  FDA July 2, 2025 · Becton Dickinson Infusion Therapy Systems, Inc. · Class II
• REF: 381811, BD Insyte Autoguard BC Pro Winged Shielded IV Catheter… recall
  FDA July 2, 2025 · Becton Dickinson Infusion Therapy Systems, Inc. · Class II
• REF: 382944, BD Insyte Autoguard BC Pro Winged Shielded IV Catheter… recall
  FDA July 2, 2025 · Becton Dickinson Infusion Therapy Systems, Inc. · Class II
• REF: 381433, BD Insyte Autoguard Shielded IV Catheter… recall
  FDA July 2, 2025 · Becton Dickinson Infusion Therapy Systems, Inc. · Class II
• REF: 381533, BD Insyte Autoguard Winged, Shielded IV Catheter… recall
  FDA July 2, 2025 · Becton Dickinson Infusion Therapy Systems, Inc. · Class II
• REF: 382633, BD Insyte Autoguard BC Winged… recall
  FDA July 2, 2025 · Becton Dickinson Infusion Therapy Systems, Inc. · Class II
• REF: 381423, BD Insyte Autoguard, Shielded IV Catheter… recall
  FDA July 2, 2025 · Becton Dickinson Infusion Therapy Systems, Inc. · Class II
• LUCAS 2, 3 and 3.1 LUCAS chest compression System is to be used for… recall
  FDA July 2, 2025 · Jolife AB · Class II
• Bigfoot Unity Diabetes Management System SW-300689-01 Bigfoot Inject v1… recall
  FDA July 2, 2025 · Bigfoot Biomedical · Class II
• DxI 9000 Access Immunoassay Analyzer C11137 recall
  FDA July 2, 2025 · Beckman Coulter, Inc. · Class II
• Medline UMBILICAL TRAY W/3.5&5FR CATH recall
  FDA July 2, 2025 · Medline Industries, LP · Class II
• Model: Description recall
  FDA July 2, 2025 · Barco N.V. · Class II
• STA - Owren Koller recall
  FDA June 25, 2025 · Diagnostica Stago, Inc. · Class II
• 5008X HDF Hemodialysis Blood Tubing Set, 24 units per case… recall
  FDA June 25, 2025 · Fresenius Medical Care Holdings, Inc. · Class II
• ICU Medical Plum Solos, Item number 400011001 recall
  FDA June 25, 2025 · ICU Medical, Inc. · Class II
• ICU Medical Plum Duo, Item numbers: 1) 400020401, 2) 400021001… recall
  FDA June 25, 2025 · ICU Medical, Inc. · Class II
• Prestige Coil System REFs/UDI-DI codes: PRES0153CXPPLT 00810068567311… recall
  FDA June 25, 2025 · Balt USA, LLC · Class II
• Optima Coil System REFs/UDI-DI codes: OPTI0156BLK 00810068568875… recall
  FDA June 25, 2025 · Balt USA, LLC · Class II
• Biomet 3i Certain-compatible 4.1 mm Milled Ti Abutment recall
  FDA June 25, 2025 · Preat Corp · Class II
• SURGIMESH WN, Polymeric Surgical Mesh, 14cm x 15cm Flat Sheet, Model recall
  FDA June 25, 2025 · Chamberlain Technologies LLC · Class II
• SURGIMESH XB, Polymeric Surgical Mesh, X-Large Ellipse Barrier Mesh, Model recall
  FDA June 25, 2025 · Chamberlain Technologies LLC · Class II
• SURGIMESH XB, Polymeric Surgical Mesh, 14m x 15cm Flat Sheet with Silicone… recall
  FDA June 25, 2025 · Chamberlain Technologies LLC · Class II
• SURGIMESH WN, Polymeric Surgical Mesh, Large Flat Sheet, Model recall
  FDA June 25, 2025 · Chamberlain Technologies LLC · Class II
• UROSKOP Omnia Max recall
  FDA June 25, 2025 · Siemens Medical Solutions USA, Inc · Class II
• UROSKOP Omnia recall
  FDA June 25, 2025 · Siemens Medical Solutions USA, Inc · Class II
• GCE HEALTHCARE Zen-O lite, Portable Oxygen Concentrator, Model RS-00608-X-S recall
  FDA June 25, 2025 · Ohio Medical Corporation · Class II
• Pluslife SARS-CoV-2 Card Product Name: SARS-CoV-2 Nucleic Acid Testing… recall
  FDA June 25, 2025 · Guangzhou Pluslife Biotech Co., Ltd. · Class II
• MiniDock Product Name: Integrated Nucleic Acid Testing Device Model recall
  FDA June 25, 2025 · Guangzhou Pluslife Biotech Co., Ltd. · Class II
• REF: 99-709245, Fitbone Trochanteric Nail L245mm, D9mm, Sterile recall
  FDA June 25, 2025 · Orthofix Srl · Class II
• Ami HTX recall
  FDA June 25, 2025 · Spectral Instruments Inc · Class II
• Lago X recall
  FDA June 25, 2025 · Spectral Instruments Inc · Class II
• SmartRelease ESTR (Endoscopic soft tissue release system)… recall
  FDA June 18, 2025 · MicroAire Surgical Instruments, LLC · Class II
• BD TEXIUM CLOSED MALE LUER WITH FEMALE CAP recall
  FDA June 18, 2025 · Bd Switzerland Sarl · Class II
• BD TEXIUM CLOSED MALE LUER WITH FEMALE CAP recall
  FDA June 18, 2025 · Bd Switzerland Sarl · Class II
• BD Texium: 3 mL recall
  FDA June 18, 2025 · Bd Switzerland Sarl · Class II
• BD Texium Needle-Free Syringe: 3 mL recall
  FDA June 18, 2025 · Bd Switzerland Sarl · Class II
• Alaris Pump Infusion Set: SmartSite Bag Access Non-Vented Bonded Texium… recall
  FDA June 18, 2025 · Bd Switzerland Sarl · Class II
• Azurion R1.x and R2.x systems recall
  FDA June 18, 2025 · Philips Medical Systems Nederland B.V. · Class II
• Guardian 2 System Product Name: Guardian System 2 Controller Model recall
  FDA June 18, 2025 · Turncare, Inc · Class II
• Guardian 2 System Product Name: Guardian System 2 Controller Model recall
  FDA June 18, 2025 · Turncare, Inc · Class II
• Allon 2001. Part Number: 200-00263 recall
  FDA June 18, 2025 · Belmont Instrument LLC · Class II
• iBOT PMD with software version 01.05.24. Personal Mobility Device recall
  FDA June 18, 2025 · Mobius Mobility LLC · Class II
• Baxter Novum IQ Syringe Pump, product code 40800BAXUS recall
  FDA June 18, 2025 · Baxter Healthcare Corporation · Class II
• Microtek Patient Drape ECOLAB AP6MMN Patient Drape, 6mm Adapter Plug Kit recall
  FDA June 18, 2025 · Microtek Medical, Inc. · Class II
• 2.5 V replacement rechargeable batteries for Hillrom WELCH ALLYN… recall
  FDA June 18, 2025 · Baxter Healthcare Corporation · Class II
• KWIK-STICK, Quality control kit for culture media recall
  FDA June 18, 2025 · Microbiologics Inc · Class II
• Contamac, Nutrifill Physiologic formula, Contact Lens Insertion solution recall
  FDA June 18, 2025 · Contamac Solutions, Inc. · Class II
• Tecfen Medical Product Name: 3.2mm Slit Knife, Angled Model recall
  FDA June 18, 2025 · Tecfen Medical · Class II
• Tecfen Medical Product Name: 2.0mm Crescent Knife Angled Bevel Up Model recall
  FDA June 18, 2025 · Tecfen Medical · Class II
• Tecfen Medical Product Name: 20G (1.2mm) MVR Sideport Knife Straight Model recall
  FDA June 18, 2025 · Tecfen Medical · Class II
• Tecfen Medical Product Name: 2.8mm Slit Knife, Angled Model recall
  FDA June 18, 2025 · Tecfen Medical · Class II
• Tecfen Medical Product Name: 2.4mm Slit Knife, Angled Model recall
  FDA June 18, 2025 · Tecfen Medical · Class II
• Tecfen Medical Product Name: 2.2mm Slit Knife, Angled Model recall
  FDA June 18, 2025 · Tecfen Medical · Class II
• Tecfen Medical Product Name: 15 degree Stab Knife Model recall
  FDA June 18, 2025 · Tecfen Medical · Class II
• Solana¿ Bordetella Complete Assay Product Name: Solana Bordetella kit Model recall
  FDA June 18, 2025 · Ortho-Clinical Diagnostics, Inc. · Class II
• Thermo SCIENTIFIC Sensititre Cation Adjusted AutoRead Mueller-Hinton Broth… recall
  FDA June 18, 2025 · Remel, Inc · Class II
• Femoral Nail, RIGHT T2 GTN 8x300 mm recall
  FDA June 18, 2025 · Stryker GmbH · Class II
• Femoral Nail, LEFT T2 GTN 8x300 mm recall
  FDA June 18, 2025 · Stryker GmbH · Class II