Recalls in September 2025 – page 5

• Smiths Medical CADD" Medication Cassette Reservoir with flow stop… recall
  FDA September 10, 2025 · ICU Medical, Inc. · Class II
• Smiths Medical CADD" Yellow Medication Cassette Reservoir with flow stop… recall
  FDA September 10, 2025 · ICU Medical, Inc. · Class II
• Smiths Medical CADD Medication Cassette Reservoir with clamp and female… recall
  FDA September 10, 2025 · ICU Medical, Inc. · Class II
• Smiths Medical CADD Medication Cassette Reservoir with clamp and female… recall
  FDA September 10, 2025 · ICU Medical, Inc. · Class II
• MI Cancer Seek recall
  FDA September 10, 2025 · Caris Life Sciences · Class II
• Orthopedic Pack, Model: 88041-12 AC2424601B 09/02/2029 Universal Pack… recall
  FDA September 10, 2025 · O&M Halyard, Inc. · Class II
• 900-00218 Sterile Cover 10-Pack Shipper Box Assembly Product Name:… recall
  FDA September 10, 2025 · Lumicell, Inc. · Class II
• Merge Hemo, Model RCSV2, Model recall
  FDA September 10, 2025 · Merge Healthcare, Inc. · Class II
• FloPatch FP120 recall
  FDA September 10, 2025 · Flosonics Medical (R/A 1929803 ONTARIO CORP.) · Class III
• TOPS Inserter, part of the TOPS System Instrument Set used for… recall
  FDA September 10, 2025 · Premia Spine Ltd · Class II
• Platelia Toxo IgM recall
  FDA September 10, 2025 · Bio-Rad Laboratories, Inc. · Class II
• NobelBiocare Tri-Lobe-compatible WP X 6.0mm Engaging Titanium Base recall
  FDA September 10, 2025 · Preat Corp · Class II
• Medshape Universal Joints recall
  FDA September 10, 2025 · Medshape, INC. · Class II
• CVS Honey Pad Product Name: CVS Honey Pad Model recall
  FDA September 10, 2025 · Integra LifeSciences Corp. (NeuroSciences) · Class II
• MediHoney¿ Product Name: MediHoney¿ HCS Surgical Adhesive Sheet Model recall
  FDA September 10, 2025 · Integra LifeSciences Corp. (NeuroSciences) · Class II
• MediHoney¿ Product Name: MediHoney¿ Hydrogel Adhesive Sheet Model recall
  FDA September 10, 2025 · Integra LifeSciences Corp. (NeuroSciences) · Class II
• MediHoney¿ Product Name: MediHoney¿ Hydrogel Model recall
  FDA September 10, 2025 · Integra LifeSciences Corp. (NeuroSciences) · Class II
• MediHoney¿ Product Name: MediHoney¿ Adhesive Hydrogel Sheet Dressing Model recall
  FDA September 10, 2025 · Integra LifeSciences Corp. (NeuroSciences) · Class II
• MediHoney¿ Product Name: MediHoney¿ HCS Sheet Dressing with Leptospermum… recall
  FDA September 10, 2025 · Integra LifeSciences Corp. (NeuroSciences) · Class II
• MediHoney ¿ Product Name: MediHoney ¿ Tube Model recall
  FDA September 10, 2025 · Integra LifeSciences Corp. (NeuroSciences) · Class II
• MediHoney ¿ Product Name: MediHoney¿ Paste Model recall
  FDA September 10, 2025 · Integra LifeSciences Corp. (NeuroSciences) · Class II
• Interventional Fluoroscopic X-Ray System - Philips Allura Xper Series recall
  FDA September 10, 2025 · Philips Medical Systems Nederland B.V. · Class II
• Philips Allura System configured with a 1 Phase UPS… recall
  FDA September 10, 2025 · Philips Medical Systems Nederland B.V. · Class II
• Philips Azurion System configured with a 1 Phase UPS… recall
  FDA September 10, 2025 · Philips Medical Systems Nederland B.V. · Class II
• Blood Uric Acid Monitoring System Each kit contains 1 meter… recall
  FDA September 10, 2025 · Visgeneer, Inc. · Class II
• Blood Uric Acid Monitoring System Each kit contains 1 meter… recall
  FDA September 10, 2025 · Visgeneer, Inc. · Class II
• LIFEPAK CR2 Part recall
  FDA September 10, 2025 · Physio-Control, Inc. · Class II
• LIFEPAK 1000 Part recall
  FDA September 10, 2025 · Physio-Control, Inc. · Class II
• LIFEPAK 15 Part recall
  FDA September 10, 2025 · Physio-Control, Inc. · Class II
• InPen App, CFN: MMT-8060 (iOS Users) and MMT-8061 (Android Users) recall
  FDA September 10, 2025 · Medtronic MiniMed, Inc. · Class II
• RayStation with the following product descriptions: 1… recall
  FDA September 10, 2025 · Raysearch Laboratories Ab · Class II
• RayStation with the following product descriptions: 1… recall
  FDA September 10, 2025 · Raysearch Laboratories Ab · Class II
• RayStation with the following product descriptions: 1… recall
  FDA September 10, 2025 · Raysearch Laboratories Ab · Class II
• RayStation with the following product descriptions: 1… recall
  FDA September 10, 2025 · Raysearch Laboratories Ab · Class II
• RayStation with the following product descriptions: 1… recall
  FDA September 10, 2025 · Raysearch Laboratories Ab · Class II
• RayStation with the following product descriptions: 1… recall
  FDA September 10, 2025 · Raysearch Laboratories Ab · Class II
• RayStation with the following product descriptions: 1… recall
  FDA September 10, 2025 · Raysearch Laboratories Ab · Class II
• RayStation with the following product descriptions: 1… recall
  FDA September 10, 2025 · Raysearch Laboratories Ab · Class II
• RayStation with the following product descriptions: 1… recall
  FDA September 10, 2025 · Raysearch Laboratories Ab · Class II
• RefleXion X1 Model RXM1000 UDI Codes: (01)00860003983812(11)230504(21)X1100… recall
  FDA September 10, 2025 · Reflexion Medical, Inc. · Class II
• Superion IDS Kit Superion Indirect Decompression System 8MM… recall
  FDA September 10, 2025 · Boston Scientific Neuromodulation Corporation · Class II
• DLP Left Heart Vent Catheter Malleable body and vented connector… recall
  FDA September 10, 2025 · Medtronic Perfusion Systems · Class I
• DLP Left Heart Vent Catheter Malleable body and vented connector… recall
  FDA September 10, 2025 · Medtronic Perfusion Systems · Class I
• DLP Left Heart Vent Catheter Malleable body and vented connector… recall
  FDA September 10, 2025 · Medtronic Perfusion Systems · Class I
• IDM-ARLITE-R. Electrical wheelchair component recall
  FDA September 10, 2025 · mo-Vis BVBA · Class I
• All-round Joystick R-net Light recall
  FDA September 10, 2025 · mo-Vis BVBA · Class I
• IDM-MULTI-R. Electrical wheelchair component recall
  FDA September 10, 2025 · mo-Vis BVBA · Class I
• IDM-MICRO-R. Electrical wheelchair component recall
  FDA September 10, 2025 · mo-Vis BVBA · Class I
• Multi Joystick R-net recall
  FDA September 10, 2025 · mo-Vis BVBA · Class I
• Micro Joystick R-net recall
  FDA September 10, 2025 · mo-Vis BVBA · Class I
• Dexcom ONE+ Continuous Glucose Monitoring System Product Name: Dexcom ONE+… recall
  FDA September 10, 2025 · Dexcom, Inc. · Class I
• Dexcom ONE+ Continuous Glucose Monitoring System Product Name: Dexcom ONE+… recall
  FDA September 10, 2025 · Dexcom, Inc. · Class I
• Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM… recall
  FDA September 10, 2025 · Dexcom, Inc. · Class I
• Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM… recall
  FDA September 10, 2025 · Dexcom, Inc. · Class I
• Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM… recall
  FDA September 10, 2025 · Dexcom, Inc. · Class I
• WATCHMAN TruSteer Access System, US, Material Number (UPN)… recall
  FDA September 10, 2025 · Boston Scientific Corporation · Class I
• WATCHMAN FXD Curve Access System Dbl, US, Material Number (UPN) M635TU80020 recall
  FDA September 10, 2025 · Boston Scientific Corporation · Class I
• WATCHMAN FXD Curve Access System Sgl, US, Material Number (UPN) M635TU80010 recall
  FDA September 10, 2025 · Boston Scientific Corporation · Class I
• WATCHMAN TruSeal Access System ANT, US, Material Number (UPN) M635TU70040 recall
  FDA September 10, 2025 · Boston Scientific Corporation · Class I
• WATCHMAN TruSeal Access System DBL, US, Material Number (UPN) M635TU70020 recall
  FDA September 10, 2025 · Boston Scientific Corporation · Class I