Class II medical devices recalls – page 33

• Beckman Coulter UniCel Dxl 800, Part numbers: 973100, A71456, A71457… recall
  FDA January 14, 2026 · Beckman Coulter, Inc. · Class II
• Beckman Coulter UniCel Dxl 600, Part numbers: A71460, A71461, A30260 recall
  FDA January 14, 2026 · Beckman Coulter, Inc. · Class II
• Revogene C. difficile, in vitro diagnostic assay intended for use with the… recall
  FDA January 14, 2026 · Meridian Bioscience Inc · Class II
• Kii Low Profile, Bladed Dual Pack , Qty recall
  FDA January 14, 2026 · Applied Medical Resources Corp · Class II
• The Elecsys Anti-TSHR immunoassay is a three-step competitive immunoassay… recall
  FDA January 14, 2026 · Roche Diagnostics Operations, Inc. · Class II
• Philips Incisive CT recall
  FDA January 14, 2026 · Philips Healthcare (Suzhou) Co., Ltd. · Class II
• LUMINOS Lotus Max, Model 11574100 and Luminos dRF Max, Model 10762471 recall
  FDA January 14, 2026 · Siemens Medical Solutions USA, Inc · Class II
• The AlignRT InBore system contains six Class 1 lasers which enables the… recall
  FDA January 14, 2026 · Vision RT Ltd · Class II
• BVI Leos Laser and Endoscopy System recall
  FDA January 7, 2026 · Beaver-Visitec International, Inc. · Class II
• Philips EPIQ Ultrasound Systems (various models) used in conjunction with… recall
  FDA January 7, 2026 · Philips Ultrasound, Inc · Class II
• Sheathes3D Seamless Viral Barrier, Latex-Free… recall
  FDA January 7, 2026 · Sheathing Technologies Inc · Class II
• Mastisol Liquid Adhesive Product Name: Liquid Adhesive Model recall
  FDA January 7, 2026 · Ferndale Laboratories, Inc. · Class II
• Vortex Surgical 25ga Illuminated Flex-Tip Laser Probe recall
  FDA January 7, 2026 · Vortex Surgical Inc. · Class II
• Material Processing Laser Products recall
  FDA January 7, 2026 · Shenzhen Atomstack Technologies · Class II
• BECKMAN COULTER BICARBONATE recall
  FDA December 31, 2025 · Beckman Coulter Ireland, Inc. · Class II
• Restore Clinician Programmer Application (CP App)… recall
  FDA December 31, 2025 · Medtronic Neuromodulation · Class II
• R¿sch-Uchida Transjugular Liver Access Sets… recall
  FDA December 31, 2025 · Cook Incorporated · Class II
• Ring Transjugular Intrahepatic Access Sets… recall
  FDA December 31, 2025 · Cook Incorporated · Class II
• Flexor Check-Flo Introducers and Sets, Reference Part Numbers: 1)… recall
  FDA December 31, 2025 · Cook Incorporated · Class II
• Diasol Product Name: 100425-10-DEX100, Liquid Concentrate for Bicarbonate… recall
  FDA December 31, 2025 · Diasol, Inc · Class II
• Diasol Product Name: 100325-10-DEX100, Liquid Concentrate for Bicarbonate… recall
  FDA December 31, 2025 · Diasol, Inc · Class II
• Diasol Product Name: 100230-10-DEX100, Liquid Concentrate for Bicarbonate… recall
  FDA December 31, 2025 · Diasol, Inc · Class II
• Diasol Product Name: 100220-10-DEX100, Liquid Concentrate for Bicarbonate… recall
  FDA December 31, 2025 · Diasol, Inc · Class II
• Diasol Product Name: 100125-10-DEX100, Liquid Concentrate for Bicarbonate… recall
  FDA December 31, 2025 · Diasol, Inc · Class II
• Diasol Product Name: 100225-10-DEX100, Liquid Concentrate for Bicarbonate… recall
  FDA December 31, 2025 · Diasol, Inc · Class II
• LYFO DISK, Campylobacter jejuni subsp recall
  FDA December 31, 2025 · Microbiologics Inc · Class II
• KWIK-STIK 6-Pack, Campylobacter jejuni subsp recall
  FDA December 31, 2025 · Microbiologics Inc · Class II
• KWIK-STIK 2-Pack, Campylobacter jejuni subsp recall
  FDA December 31, 2025 · Microbiologics Inc · Class II
• Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade… recall
  FDA December 31, 2025 · Zimmer, Inc. · Class II
• Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade… recall
  FDA December 31, 2025 · Zimmer, Inc. · Class II
• Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade… recall
  FDA December 31, 2025 · Zimmer, Inc. · Class II
• Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade… recall
  FDA December 31, 2025 · Zimmer, Inc. · Class II
• Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade… recall
  FDA December 31, 2025 · Zimmer, Inc. · Class II
• Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade… recall
  FDA December 31, 2025 · Zimmer, Inc. · Class II
• Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade… recall
  FDA December 31, 2025 · Zimmer, Inc. · Class II
• Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade… recall
  FDA December 31, 2025 · Zimmer, Inc. · Class II
• Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade… recall
  FDA December 31, 2025 · Zimmer, Inc. · Class II
• Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade… recall
  FDA December 31, 2025 · Zimmer, Inc. · Class II
• Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade… recall
  FDA December 31, 2025 · Zimmer, Inc. · Class II
• Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade… recall
  FDA December 31, 2025 · Zimmer, Inc. · Class II
• Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade… recall
  FDA December 31, 2025 · Zimmer, Inc. · Class II
• Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade… recall
  FDA December 31, 2025 · Zimmer, Inc. · Class II
• Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade… recall
  FDA December 31, 2025 · Zimmer, Inc. · Class II
• Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade… recall
  FDA December 31, 2025 · Zimmer, Inc. · Class II
• Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade… recall
  FDA December 31, 2025 · Zimmer, Inc. · Class II
• LifeShield Drug Library Management (DLM), LifeShield Infusion Safety… recall
  FDA December 31, 2025 · ICU Medical, Inc. · Class II
• LifeShield Drug Library Management (DLM) recall
  FDA December 31, 2025 · ICU Medical, Inc. · Class II
• da Vinci 5, Surgeon Console Column Motor Connector recall
  FDA December 31, 2025 · Intuitive Surgical, Inc. · Class II
• The Stryker CranialMask Tracker is a single-use device consisting of a… recall
  FDA December 31, 2025 · Howmedica Osteonics Corp. · Class II
• BD Pyxis MedStation ES recall
  FDA December 31, 2025 · CareFusion 303, Inc. · Class II
• AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic Common… recall
  FDA December 31, 2025 · AGFA Healthcare Corp. · Class II
• Alinity ci-series System Control Module (SCM) recall
  FDA December 24, 2025 · Abbott Laboratories · Class II
• Xpert¿ BCR-ABL Ultra Model recall
  FDA December 24, 2025 · Cepheid · Class II
• Xpert¿ BCR-ABL Ultra Model recall
  FDA December 24, 2025 · Cepheid · Class II
• InPen App, Model/CFN Number: MMT-8061 (Android Users) recall
  FDA December 24, 2025 · Medtronic MiniMed, Inc. · Class II
• BIOSURE HA SCREW, 6MM x 20 MM. Threaded metallic bone fixation fastener recall
  FDA December 24, 2025 · Smith & Nephew, Inc. · Class II
• Myosa for Kids KS1 recall
  FDA December 24, 2025 · Myofunctional Research Company USA · Class II
• Rocket Product Name: Rocket 20Fg Seldinger Catheter Procedure Tray Model recall
  FDA December 24, 2025 · Rocket Medical Plc · Class II
• Rocket Product Name: Rocket 16Fg Seldinger Catheter Procedure Tray Model recall
  FDA December 24, 2025 · Rocket Medical Plc · Class II
• Rocket Product Name: Rocket 18Fg Seldinger Catheter with Safety Guard Model recall
  FDA December 24, 2025 · Rocket Medical Plc · Class II