Recalls distributed in Puerto Rico – page 10

• FEM-FLEX II Product Name: Femoral Arterial Cannula Model recall
  FDA July 16, 2025 · Edwards Lifesciences, LLC · Class I
• Optisite Arterial Cannula Product Name: Optisite Arterial Cannula Model recall
  FDA July 16, 2025 · Edwards Lifesciences, LLC · Class I
• Optisite Arterial Cannula Product Name: Optisite Arterial Cannula Model recall
  FDA July 16, 2025 · Edwards Lifesciences, LLC · Class I
• REF: 666289 , BD FACS, 7-Color Setup Beads, 25 Runs, CE, IVD… recall
  FDA July 9, 2025 · Becton, Dickinson and Company, BD Bio Sciences · Class II
• REF: 335775 , BD FACS, 7-Color Setup Beads, 25 setups per kit, Rx Only… recall
  FDA July 9, 2025 · Becton, Dickinson and Company, BD Bio Sciences · Class II
• HardyCHROM CRE, selective and differential culture medium for… recall
  FDA July 9, 2025 · Hardy Diagnostics · Class II
• BiPAP A40 Ventilator recall
  FDA July 9, 2025 · Philips Respironics, Inc. · Class I
• BiPAP A30 Ventilators recall
  FDA July 9, 2025 · Philips Respironics, Inc. · Class I
• BiPAP V30 Auto Ventilator recall
  FDA July 9, 2025 · Philips Respironics, Inc. · Class I
• Servo-u MR Ventilator System recall
  FDA July 9, 2025 · Maquet Critical Care AB · Class I
• Servo-n Ventilator System recall
  FDA July 9, 2025 · Maquet Critical Care AB · Class I
• Servo-u Ventilator System recall
  FDA July 9, 2025 · Maquet Critical Care AB · Class I
• Product Name [ recall
  FDA July 2, 2025 · CareFusion 303, Inc. · Class II
• 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
• Extended Tip Applicator 8CM, Box of 1 recall
  FDA July 2, 2025 · Integra LifeSciences Corp. (NeuroSciences) · Class I
• Extended Tip Applicator, 15 CM, Box of 5 recall
  FDA July 2, 2025 · Integra LifeSciences Corp. (NeuroSciences) · Class I
• Extended Tip Applicator, 8CM, Box of 5 recall
  FDA July 2, 2025 · Integra LifeSciences Corp. (NeuroSciences) · Class I
• STA - Owren Koller recall
  FDA June 25, 2025 · Diagnostica Stago, Inc. · Class II
• iBOT PMD with software version 01.05.24. Personal Mobility Device recall
  FDA June 18, 2025 · Mobius Mobility LLC · Class II
• OBM00002 OBM DAB (Digital Acquisition Box) Product Name: OBM00002 OBM DAB… recall
  FDA June 18, 2025 · Excel Tech. · Class II
• Newport HT70 Ventilator recall
  FDA June 18, 2025 · Covidien, LP · Class I
• HKBKF04 1/11.25 OZ. EA Created Fresh Breakfast Bowl-Southwest ALL LOT CODES recall
  FDA June 18, 2025 · Sysco Corporation · Class I
• KITGREEKPASTA5 1/5# EAST COAST FRESH PC-Greek Pasta Salad Kit 1/5lb… recall
  FDA June 18, 2025 · Sysco Corporation · Class I
• RTSALSA1LB 1# EAST COAST FRESH Salsa Cup - 1 lb ALL LOT CODES SAL20 5#… recall
  FDA June 18, 2025 · Sysco Corporation · Class I
• HKSAN169 1/5.76OZ CREATED FRESH Sub- Egg Salad on Everything Ficelle ALL… recall
  FDA June 18, 2025 · Sysco Corporation · Class I
• HKSAN167 1/5.76 OZ. EA CREATED FRESH Sub- Tuna Salad on Everything Ficelle… recall
  FDA June 18, 2025 · Sysco Corporation · Class I
• HKSAC168 6/5.76 OZ. CS CREATED FRESH Sub- Chicken Salad on Everything… recall
  FDA June 18, 2025 · Sysco Corporation · Class I
• 5185 2/7.125# EAST COAST FRESH AUTHENTIC GREEK SALAD (4070 2/7.125# ALL… recall
  FDA June 18, 2025 · Sysco Corporation · Class I
• 3909520 2/5# IMPERIAL FRESH CUCUMBER DICED 3/8 SK-ON ALL LOT CODES 480414… recall
  FDA June 18, 2025 · Sysco Corporation · Class I
• Ezetimibe and Simvastatin Tablets, 10mg/40mg, 90-count bottle, Rx only… recall
  FDA June 18, 2025 · Glenmark Pharmaceuticals Inc., USA · Class III
• Celecoxib Capsules, 200 mg, 500-count bottle, Rx only… recall
  FDA June 18, 2025 · Alembic Pharmaceuticals Limited · Class II
• Sample probe sucks a sample dispensed into a tube or cup and discharges… recall
  FDA June 11, 2025 · Beckman Coulter Mishima K.K. · Class II
• Sample probe sucks a sample dispensed into a tube or cup and discharges… recall
  FDA June 11, 2025 · Beckman Coulter Mishima K.K. · Class II
• GNC Women's 30+ Vitapak, Carton of 30 Sachets recall
  FDA June 11, 2025 · GNC Holdings LLC · Class III
• Catalog No. 8888160648; Umbilical Vessel Catheter 5 French triple lumen recall
  FDA June 4, 2025 · Cardinal Health 200, LLC · Class II
• Catalog No. 8888160556; Umbilical Vessel Catheter 5 French dual lumen recall
  FDA June 4, 2025 · Cardinal Health 200, LLC · Class II
• Catalog No. 8888160341; Umbilical Vessel Catheter 5 French single lumen recall
  FDA June 4, 2025 · Cardinal Health 200, LLC · Class II
• Catalog No. 8888160333; Umbilical Vessel Catheter 3.5 French single lumen recall
  FDA June 4, 2025 · Cardinal Health 200, LLC · Class II
• Catalog No. 8888160325; Umbilical Vessel Catheter 2.5 French single lumen recall
  FDA June 4, 2025 · Cardinal Health 200, LLC · Class II
• Catalog No. 8888160119; Umbilical Vessel Catheter Insertion Tray with 2.5… recall
  FDA June 4, 2025 · Cardinal Health 200, LLC · Class II
• ADVIA Centaur HCY Calibrator (2 Pack) recall
  FDA June 4, 2025 · Siemens Healthcare Diagnostics, Inc. · Class II
• Atellica IM Homocysteine Calibrator (2 Pack) recall
  FDA June 4, 2025 · Siemens Healthcare Diagnostics, Inc. · Class II
• Bard¿ Single Intragastric Linton Balloon Tube recall
  FDA May 28, 2025 · C.R. Bard Inc · Class I
• Bard¿ Blakemore Esophageal-Nasogastric Tube (Intermediate) recall
  FDA May 28, 2025 · C.R. Bard Inc · Class I
• Bard¿ Blakemore Esophageal-Nasogastric Tube (Child) recall
  FDA May 28, 2025 · C.R. Bard Inc · Class I
• Bard Blakemore Esophageal-Nasogastric Tube (Adult) recall
  FDA May 28, 2025 · C.R. Bard Inc · Class I
• Bard Minnesota Four Lumen Esophagogastric Tamponade Tube recall
  FDA May 28, 2025 · C.R. Bard Inc · Class I
• DxC 500 AU Clinical Chemistry Analyzer recall
  FDA May 21, 2025 · Beckman Coulter, Inc. · Class II
• MedicaLyte Liquid Bicarbonate Concentrate recall
  FDA May 21, 2025 · Nipro Renal Soultions USA, Corporation · Class I
• Microstream Advance Neonatal-Infant Intubated CO2 Filter Line marketed as… recall
  FDA May 14, 2025 · Philips North America Llc · Class II
• CODMAN Craniotomy Kit, Disposable Perforator Cranio-blade Wire Pass Drill… recall
  FDA May 14, 2025 · Integra LifeSciences Corp. (NeuroSciences) · Class I
• CODMAN Disposable Perforator, 14mm recall
  FDA May 14, 2025 · Integra LifeSciences Corp. (NeuroSciences) · Class I