Class II medical devices recalls – page 4

• Medline Convenience Kits: 1) BLOOD CULTURE TRAY PEDIATRIC… recall
  FDA September 9, 2026 · Medline Industries, LP · Class II
• Medline Convenience Kits: 1) IV START KIT LAB DRAW-SH… recall
  FDA September 9, 2026 · Medline Industries, LP · Class II
• Medline Convenience Kits: 1) ARTERIAL LINE INSERTION KIT… recall
  FDA September 9, 2026 · Medline Industries, LP · Class II
• Medline Convenience Kits: 1) IV START KIT recall
  FDA September 9, 2026 · Medline Industries, LP · Class II
• Medline Convenience Kits: 1) ULTRASOUND BREAST PACK… recall
  FDA September 9, 2026 · Medline Industries, LP · Class II
• Medline Convenience Kits: 1) COLORECTAL ME, Model Number: DYNJ906437D recall
  FDA September 9, 2026 · Medline Industries, LP · Class II
• Medline Convenience Kits: 1) IVS BLOOD CULTURE KIT, Model Number: DYNDH1920 recall
  FDA September 9, 2026 · Medline Industries, LP · Class II
• Medline Convenience Kits: 1) DYKM1414 recall
  FDA September 9, 2026 · Medline Industries, LP · Class II
• Medline Convenience Kits: 1) CDS840396X recall
  FDA September 9, 2026 · Medline Industries, LP · Class II
• Medline Convenience Kits: 1) DRAWER 9 CRICOTHYROTOMY KIT… recall
  FDA September 9, 2026 · Medline Industries, LP · Class II
• STA Staclot Protein S, Model recall
  FDA September 9, 2026 · Diagnostica Stago, Inc. · Class II
• Halyard medical convenience kits labeled as: 1) A-P PACK - 205936… recall
  FDA September 9, 2026 · AVID Medical, Inc. · Class II
• 1) NEURO, (kit) ACNE73-01 recall
  FDA September 9, 2026 · AVID Medical, Inc. · Class II
• Halyard medical convenience kits labeled as: 1) ENT… recall
  FDA September 9, 2026 · AVID Medical, Inc. · Class II
• Philips Brilliance CT 64: Brilliance CT 64 Channel Product Code: 728231… recall
  FDA September 9, 2026 · Philips North America Llc · Class II
• Philips Ingenuity CT Product Codes: Ingenuity CT Upgrades 728327… recall
  FDA September 9, 2026 · Philips North America Llc · Class II
• Philips IQon Spectral CT Product Codes: IQon Spectral CT 728332… recall
  FDA September 9, 2026 · Philips North America Llc · Class II
• Philips Brilliance recall
  FDA September 9, 2026 · Philips North America Llc · Class II
• FRU (Field replaceable unit), PORTRAIT CORE SERVICES SW RELOAD V1.1… recall
  FDA September 2, 2026 · GE Medical Systems Information Technologies Inc · Class II
• PORTRAIT CORE SERVICES SOFTWARE V1.0.5, Ref# 5697353 recall
  FDA September 2, 2026 · GE Medical Systems Information Technologies Inc · Class II
• PORTRAIT COMPUTE AND CORE SERVICES V1.2, Ref# 5700592 recall
  FDA September 2, 2026 · GE Medical Systems Information Technologies Inc · Class II
• PORTRAIT CORE SERVICES SOFTWARE V1.1, Ref# 5700209 recall
  FDA September 2, 2026 · GE Medical Systems Information Technologies Inc · Class II
• POWERSEAL 5 MM (in diameter) 23 CM (long), Curved Jaw Sealer & Divider… recall
  FDA September 2, 2026 · Olympus Corporation of the Americas · Class II
• ORT300, operating room table, ORT300 Modular Table Main Unit Assy Part… recall
  FDA September 2, 2026 · IMRIS Imaging Inc · Class II
• ORT200, operating room table, including the ORT200 Covered Table Assembly… recall
  FDA September 2, 2026 · IMRIS Imaging Inc · Class II
• healthmark ProChek-W Protein Test for Robotic Arms recall
  FDA September 2, 2026 · Healthmark Industries Co., Inc. · Class II
• healthmark ProChek-II, Model Number PT-313, PT-201-12 recall
  FDA September 2, 2026 · Healthmark Industries Co., Inc. · Class II
• FUJIFILM Synapse PACS software v7.4.310 recall
  FDA September 2, 2026 · FUJIFILM Healthcare Americas Corporation · Class II
• Medline convenience kits labeled as: 1) LAMI FUSION… recall
  FDA September 2, 2026 · Medline Industries, LP · Class II
• Medline convenience kits labeled as: 1) CMH LITHO MINOR PACK-LF… recall
  FDA September 2, 2026 · Medline Industries, LP · Class II
• Medline convenience kits labeled as: 1) LAVH, Medline Kit SKU CDS982273U recall
  FDA September 2, 2026 · Medline Industries, LP · Class II
• Medline convenience kits labeled as: 1) C-SECTION… recall
  FDA September 2, 2026 · Medline Industries, LP · Class II
• Medline convenience kits labeled as: 1) GYN ROBOTIC CDS… recall
  FDA September 2, 2026 · Medline Industries, LP · Class II
• Medline convenience kits labeled as: 1) MAJOR GYN PACK… recall
  FDA September 2, 2026 · Medline Industries, LP · Class II
• Medline convenience kits labeled as: LTP CDS-LF, Medline kit SKU CDS980375M recall
  FDA September 2, 2026 · Medline Industries, LP · Class II
• Medline convenience kits labeled as: 1) MAJOR PROCEDURE… recall
  FDA September 2, 2026 · Medline Industries, LP · Class II
• Medline convenience kits labeled as: MAJOR HEAD AND NECK PPS… recall
  FDA September 2, 2026 · Medline Industries, LP · Class II
• Medline convenience kits labeled as: 1) OPEN HEART PACK… recall
  FDA September 2, 2026 · Medline Industries, LP · Class II
• Medline convenience kits labeled as: 1) FEMORAL PACK… recall
  FDA September 2, 2026 · Medline Industries, LP · Class II
• CONMED Linvatec GENESYS CrossFT Suture Anchor with Disposable Driver recall
  FDA September 2, 2026 · ConMed Corporation · Class II
• Fresenius Medical Care, 2008T BlueStar Hemodialysis Machine… recall
  FDA September 2, 2026 · Fresenius Medical Care Renal Therapies Group, LLC · Class II
• Grandio Universal Nano-Hybrid Restorative Material - Capsules 0.25Gm… recall
  FDA September 2, 2026 · Henry Schein Inc. · Class II
• Structur 2 SC Temporary Resin Cartridge Refill 75Gm… recall
  FDA September 2, 2026 · Henry Schein Inc. · Class II
• Alphenix Models INFX-8000C INFX-8000F INFX-8000V This device is a digital… recall
  FDA September 2, 2026 · Canon Medical System, USA, INC. · Class II
• Midmark Digital ECG HD+12, HD+15, Model recall
  FDA September 2, 2026 · Midmark Corporation · Class II
• Midmark IQecg Digital ECG, Model recall
  FDA September 2, 2026 · Midmark Corporation · Class II
• Halyard TOTAL JOINT Model recall
  FDA September 2, 2026 · AVID Medical, Inc. · Class II
• Halyard TOTAL JOINT Model recall
  FDA September 2, 2026 · AVID Medical, Inc. · Class II
• Halyard TOTAL JOINT Model recall
  FDA September 2, 2026 · AVID Medical, Inc. · Class II
• Halyard TOTAL JOINT Model recall
  FDA September 2, 2026 · AVID Medical, Inc. · Class II
• Halyard TOTAL JOINT Model recall
  FDA September 2, 2026 · AVID Medical, Inc. · Class II
• Halyard TOTAL JOINT Model recall
  FDA September 2, 2026 · AVID Medical, Inc. · Class II
• Halyard Product Name: DAVINCI TRUCUSTOM BUNDLE containing TRAY FOLEY 16FR… recall
  FDA September 2, 2026 · AVID Medical, Inc. · Class II
• Merge PACS and Merge OrthoPACS, medical imaging diagnostic workstation recall
  FDA September 2, 2026 · Merge Healthcare, Inc. · Class II
• American Contract System Convenience Kit, D & C PACK, Model recall
  FDA September 2, 2026 · American Contract Systems Inc · Class II
• American Contract System Convenience Kits, CV B PACK, Model recall
  FDA September 2, 2026 · American Contract Systems Inc · Class II
• American Contract System Convenience Kit, CV B PACK, Model recall
  FDA September 2, 2026 · American Contract Systems Inc · Class II
• American Contract System Convenience Kit, CV B PACK, Model recall
  FDA September 2, 2026 · American Contract Systems Inc · Class II
• Medline medical convenience kit labeled as: TRACH TUBE KIT… recall
  FDA September 2, 2026 · Medline Industries, LP · Class II
• Onli 17cm Hydrophilic Urethral Intermittent Catheter… recall
  FDA September 2, 2026 · Hollister Ulc · Class II