Medical devices recalls – page 7

• COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model recall
  FDA August 12, 2026 · Tissium Sa · Class II
• COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model recall
  FDA August 12, 2026 · Tissium Sa · Class II
• COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model recall
  FDA August 12, 2026 · Tissium Sa · Class II
• COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model recall
  FDA August 12, 2026 · Tissium Sa · Class II
• COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model recall
  FDA August 12, 2026 · Tissium Sa · Class II
• COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model recall
  FDA August 12, 2026 · Tissium Sa · Class II
• COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model recall
  FDA August 12, 2026 · Tissium Sa · Class II
• COAPTIUM Connect Product Name: COAPTIUM Connect Model recall
  FDA August 12, 2026 · Tissium Sa · Class II
• GEM Premier 5000 PAK Part Numbers: 00055360010 00055360011 00055407504… recall
  FDA August 12, 2026 · Instrumentation Laboratory · Class II
• GEM Premier 7000 with iQM3 Part Numbers: 00077407508 00077407510… recall
  FDA August 12, 2026 · Instrumentation Laboratory · Class II
• U2 Total Knee System Product Name: Femoral offset bushing… recall
  FDA August 12, 2026 · United Orthopedic Corp. · Class II
• U2 Total Knee System Product Name: Femoral offset bushing… recall
  FDA August 12, 2026 · United Orthopedic Corp. · Class II
• 5-PLASMA Bivalirudin Control, Model Number 5D-44905 recall
  FDA August 12, 2026 · Aniara Diagnostica LLC · Class II
• 5-PLASMA Bivalirudin Calibrator, Model Number 5D-46905 recall
  FDA August 12, 2026 · Aniara Diagnostica LLC · Class II
• 5-PLASMA Bivalirudin AMR Verification Kit, Model Number 5D-45905 recall
  FDA August 12, 2026 · Aniara Diagnostica LLC · Class II
• Philips Allura, Cardio Vascular-Allura Centron recall
  FDA August 12, 2026 · Philips Medical Systems Nederland B.V. · Class II
• Philips Azurion under the following System Descriptions and corresponding… recall
  FDA August 12, 2026 · Philips Medical Systems Nederland B.V. · Class II
• Philips Allura under the following System Descriptions and corresponding… recall
  FDA August 12, 2026 · Philips Medical Systems Nederland B.V. · Class II
• Atellica CH Urine Albumin recall
  FDA August 12, 2026 · Siemens Healthcare Diagnostics, Inc. · Class II
• REF # D23354, MicroScan LabPro V5.03 Panel Update 11 DVD Kit (US) on the… recall
  FDA August 12, 2026 · Beckman Coulter, Inc. · Class II
• REF # D23352, MicroScan LabPro V5.03 Panel Update 11 (US)… recall
  FDA August 12, 2026 · Beckman Coulter, Inc. · Class II
• HardyDisk AST Cefiderocol 30¿g (FDC30) recall
  FDA August 12, 2026 · Hardy Diagnostics · Class II
• U2 Total Knee System Product Name: Femoral valgus offset adaptor, 2mm… recall
  FDA August 12, 2026 · United Orthopedic Corp. · Class II
• U2 Total Knee System Product Name: Femoral valgus adaptor… recall
  FDA August 12, 2026 · United Orthopedic Corp. · Class II
• USTAR II Knee System Product Name: Hinge Box Trial, L… recall
  FDA August 12, 2026 · United Orthopedic Corp. · Class II
• U2 Total Knee System Product Name: PSA Box Trial, L… recall
  FDA August 12, 2026 · United Orthopedic Corp. · Class II
• Happiest Baby, Inc Pre-loved SNOO Smart Sleeper Model:S1000 recall
  FDA August 12, 2026 · Happiest Baby, Inc · Class II
• Syva Emit tox Serum Tricyclic Antidepressant Calibrator/Controls SMN… recall
  FDA August 12, 2026 · Siemens Healthcare Diagnostics, Inc. · Class III
• Syva Emit Disopyramide Assay Enzyme Immunoassay, Lidocaine SMN 10445370 recall
  FDA August 12, 2026 · Siemens Healthcare Diagnostics, Inc. · Class III
• INFINION CX LEAD KIT, 50CM, Model: SC-2317-50, Material: M365SC2317500 recall
  FDA August 12, 2026 · Boston Scientific Neuromodulation Corporation · Class I
• GE Healthcare Portrait Core Services SW V 1.2.0 recall
  FDA August 12, 2026 · GE Medical Systems Information Technologies Inc · Class II
• FilmArray NGDS Warrior Panel recall
  FDA August 12, 2026 · Biofire Defense · Class II
• GE Healthcare MAC VU360 recall
  FDA August 12, 2026 · GE Medical Systems Information Technologies Inc · Class II
• Merge OrthoPACS, medical imaging diagnostic workstation recall
  FDA August 12, 2026 · Merge Healthcare, Inc. · Class II
• Merge PACS, medical imaging diagnostic workstation recall
  FDA August 12, 2026 · Merge Healthcare, Inc. · Class II
• Intramedullary Bone Saw Blade Assembly Model recall
  FDA August 12, 2026 · Biomet, Inc. · Class II
• Intramedullary Bone Saw Blade Assembly Model recall
  FDA August 12, 2026 · Biomet, Inc. · Class II
• Intramedullary Bone Saw Blade Assembly Model recall
  FDA August 12, 2026 · Biomet, Inc. · Class II
• Intramedullary Bone Saw Blade Assembly Model recall
  FDA August 12, 2026 · Biomet, Inc. · Class II
• Intramedullary Bone Saw Blade Assembly Model recall
  FDA August 12, 2026 · Biomet, Inc. · Class II
• STRYKER PKG., STRYKEFLOW SUCTION/IRRIGATOR PS recall
  FDA August 12, 2026 · Stryker Corporation · Class II
• STRYKER PKG., SINGLE SPIKE TUBE SET recall
  FDA August 12, 2026 · Stryker Corporation · Class II
• STRYKER AHTO DUAL SPIKE TUBE SET PACKAGING recall
  FDA August 12, 2026 · Stryker Corporation · Class II
• STRYKER AHTO TUBE SET WITH TIP PACKAGING recall
  FDA August 12, 2026 · Stryker Corporation · Class II
• STRYKER AHTO TUBE SET PACKAGING recall
  FDA August 12, 2026 · Stryker Corporation · Class II
• DASH Rapid PCR Instrument Product Name: DASH Rapid PCR Instrument Model recall
  FDA August 12, 2026 · Nuclein LLC · Class II
• Flow Anesthesia Machine Flow-i C20 6677200 Flow-i C30 6677300 Flow-i C40… recall
  FDA August 12, 2026 · Maquet Critical Care AB · Class II
• Anti-Torque, Vector, Part: LS-749 part of Vector Pedicle Screw System recall
  FDA August 12, 2026 · Innovasis, Inc · Class II
• Medical Action Industries Product Name: Dialysis Change Tray Clear… recall
  FDA August 12, 2026 · Medical Action Industries, Inc. 306 · Class II
• OXOS Medical, Inc Product Name: MC2 Portable X-Ray System Model recall
  FDA August 12, 2026 · Oxos Medical Inc · Class II
• munevo DRIVE and munevo DRIVE r-net Powered Wheelchair Hands-Free Control… recall
  FDA August 12, 2026 · Munevo Gmbh · Class II
• Nerivio Infinity recall
  FDA August 12, 2026 · Theranica Bioelectronics Ltd · Class II
• WASPLab Product Name: WASPLab Model recall
  FDA August 12, 2026 · Copan WASP · Class II
• Quantum Rehab Product Name: Quantum Rival Model recall
  FDA August 12, 2026 · Pride Mobility Products Corp. · Class II
• Quantum Rehab Product Name: 4Front Model recall
  FDA August 12, 2026 · Pride Mobility Products Corp. · Class II
• Quantum Rehab Product Name: Quantum 4Front 2HD Model recall
  FDA August 12, 2026 · Pride Mobility Products Corp. · Class II
• Quantum Rehab Product Name: Q6 Edge 4 Model recall
  FDA August 12, 2026 · Pride Mobility Products Corp. · Class II
• Quantum Rehab Product Name: Q6 Edge 3 Model recall
  FDA August 12, 2026 · Pride Mobility Products Corp. · Class II
• Quantum Rehab Product Name: Q6 Edge 2.0 (ilevel) Model recall
  FDA August 12, 2026 · Pride Mobility Products Corp. · Class II
• Quantum Rehab Product Name: Quantum 1450 Model recall
  FDA August 12, 2026 · Pride Mobility Products Corp. · Class II