Class II medical devices recalls – page 6

• GLIDESHEATH SLENDER A-KIT 6F 10CM .021GW. 5 units per box recall
  FDA August 19, 2026 · Terumo Medical Corporation · Class II
• GM Helix Implant, Endosseous Dental Implant Article No recall
  FDA August 19, 2026 · Straumann USA LLC · Class II
• Allura Xper FD. Model Numbers: 722026, 722027, 722028, 722029, 722035… recall
  FDA August 19, 2026 · Philips Medical Systems Nederland B.V. · Class II
• Thermo Fisher Diagnostics Neisseria meningitidis Gp C 2ml/VL… recall
  FDA August 19, 2026 · Remel Europe Ltd. · Class II
• Medline Micro-Kill Bleach Germicidal Bleach Wipes, 12" x 12"… recall
  FDA August 19, 2026 · Medline Industries, LP · Class II
• Medline Micro-Kill Bleach Germicidal Bleach Wipes, 12" x 12", 110 Count… recall
  FDA August 19, 2026 · Medline Industries, LP · Class II
• Medline Micro-Kill Bleach Germicidal Bleach Wipes, 6" x 5", 150 count… recall
  FDA August 19, 2026 · Medline Industries, LP · Class II
• Medline Micro-Kill Bleach Germicidal Bleach Wipes,7" x 8", 150 count… recall
  FDA August 19, 2026 · Medline Industries, LP · Class II
• Surgipro II S8698GX SURGIPRO II BL 5/0 18 P-13 S8698GX recall
  FDA August 19, 2026 · Covidien, LP · Class II
• Surgipro SP-623 SURGIPRO* 2-0 BLU 75CM SC2 X36 SP-623 recall
  FDA August 19, 2026 · Covidien, LP · Class II
• Dermalon 88861757-31 DERMALON* 4-0 BLU 75CM C13 88861757-31 88861799-31… recall
  FDA August 19, 2026 · Covidien, LP · Class II
• V-Loc 180 Absorbable Wound Closure Device BOX BEDSIDE STAPLING IS KING… recall
  FDA August 19, 2026 · Covidien, LP · Class II
• V-Loc 90 Absorbable Wound Closure Device VLOC 90 0 VL 22 GS-21 VLOCM0336… recall
  FDA August 19, 2026 · Covidien, LP · Class II
• Boston Scientific Enhance Transcarotid/Peripheral Access Kit recall
  FDA August 19, 2026 · Galt Medical Corporation · Class II
• Xhibit Product Name: Xhibit Central Station Model recall
  FDA August 19, 2026 · Spacelabs Healthcare, Inc. · Class II
• GORE VIABIL Short Wire Biliary Endoprosthesis, Model No recall
  FDA August 19, 2026 · W L Gore & Associates, Inc. · Class II
• GORE VIABIL Short Wire Biliary Endoprosthesis, Model No recall
  FDA August 19, 2026 · W L Gore & Associates, Inc. · Class II
• navify Digital Pathology (on-prem) v2.5, Material Number 10092343001… recall
  FDA August 19, 2026 · Ventana Medical Systems, Inc. · Class II
• BOBBY Balloon Guide Catheter recall
  FDA August 19, 2026 · Microvention Inc. · Class II
• Neuroguard IEP 3 in 1 Carotid Stent and Post-Dilation Balloon System with… recall
  FDA August 12, 2026 · Contego Medical, Inc · Class II
• Blom-Singer Classic Indwelling Voice Prosthesis, 16Fr/10 mm recall
  FDA August 12, 2026 · Freudenberg Medical, LLC · Class II
• Blom-Singer Classic Indwelling Voice Prosthesis, 16Fr/10 mm recall
  FDA August 12, 2026 · Freudenberg Medical, LLC · 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
• 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
• 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