Class II medical devices recalls – page 2

• SCORPIO + MOBILE BEARING PCS 78-5-0910 SYSTEM ONE BIPOLAR 40MM 6074-4022… recall
  FDA September 23, 2026 · Howmedica Osteonics Corp. · Class II
• TRIDENT 0¿ POLY INSERT 28mm ID 620-00-28D Orthopaedic implant components… recall
  FDA September 23, 2026 · Howmedica Osteonics Corp. · Class II
• SCORPIO RECESSED METAL BACKED PATELLA 3045-0026 3045-0028 3045-0030… recall
  FDA September 23, 2026 · Howmedica Osteonics Corp. · Class II
• BEARING AND AXLE BUSHING ASSY STD ELBOW C-M113-1-301 KRH REV TIB INS 16mm… recall
  FDA September 23, 2026 · Howmedica Osteonics Corp. · Class II
• ACETABULAR CUP UHMWPE 61-3258 ALL POLY CONSTRAINED INSERT 44MM 69-2244 ALL… recall
  FDA September 23, 2026 · Howmedica Osteonics Corp. · Class II
• DURACON XL ANGLED TIB INS 11/14MM C-M064-1-300 SELF-PRESSURIZING GLENOID… recall
  FDA September 23, 2026 · Howmedica Osteonics Corp. · Class II
• ABG I ACETABULAR INSERT HOODED 28mm ID X 48mm C-M079-2-801 ARC2F… recall
  FDA September 23, 2026 · Howmedica Osteonics Corp. · Class II
• TRIATHLON HINGE INSERT SIZE 4 11MM 5612-P-411 TRIATHLON HINGE INSERT SIZE… recall
  FDA September 23, 2026 · Howmedica Osteonics Corp. · Class II
• ALL POLY CONSTRAINED INSERT 54MM 69-2854 NRG KNEE CR 82-2-0512 82-2-0518… recall
  FDA September 23, 2026 · Howmedica Osteonics Corp. · Class II
• OMNIFIT SERIES I ACET. INSERT 10¿ 22mm ID recall
  FDA September 23, 2026 · Howmedica Osteonics Corp. · Class II
• AXLE PIN ASSY LARGE ELBOW COBALT CHROME recall
  FDA September 23, 2026 · Howmedica Osteonics Corp. · Class II
• Captus 4000e Thyroid Uptake System, Models: 1. 5430-30151, 2… recall
  FDA September 23, 2026 · Mirion Technologies (Capintec), Inc. · Class II
• Et Control, Software option for anesthesia gas machine to achieve and… recall
  FDA September 23, 2026 · Datex-Ohmeda, Inc. · Class II
• Aisys CS2 with Et Control, Datex-Ohmeda anesthesia system… recall
  FDA September 23, 2026 · Datex-Ohmeda, Inc. · Class II
• Aisys CS2, Datex-Ohmeda anesthesia system, Part Number 1011-9055-000 recall
  FDA September 23, 2026 · Datex-Ohmeda, Inc. · Class II
• Aisys, Datex-Ohmeda anesthesia system, Part Number 1011-9050-000 recall
  FDA September 23, 2026 · Datex-Ohmeda, Inc. · Class II
• Boston Scientific Corporation StoneSmart Connect Console Contents: (1)… recall
  FDA September 23, 2026 · Boston Scientific Corporation · Class II
• REF:B5ST Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/STABILITY… recall
  FDA September 23, 2026 · Stryker Sustainability Solutions · Class II
• REF:B5LT Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/STABILITY… recall
  FDA September 23, 2026 · Stryker Sustainability Solutions · Class II
• REF:B12LT Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/STABILITY… recall
  FDA September 23, 2026 · Stryker Sustainability Solutions · Class II
• REF:B11LT Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/STABILITY… recall
  FDA September 23, 2026 · Stryker Sustainability Solutions · Class II
• REF:2B5ST Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/OPTIVIEW… recall
  FDA September 23, 2026 · Stryker Sustainability Solutions · Class II
• REF:2B5LT Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/OPTIVIEW… recall
  FDA September 23, 2026 · Stryker Sustainability Solutions · Class II
• Blood Culture Collection Venipuncture Kit 20/Cs recall
  FDA September 23, 2026 · Medical Action Industries, Inc. 306 · Class II
• EWO_02513 ( recall
  FDA September 23, 2026 · embecta Medical II LLC · Class II
• EWO_02512 ( recall
  FDA September 23, 2026 · embecta Medical II LLC · Class II
• Kinos Axiom Total Ankle System with Axiom PSR, Flat-cut (Cut Guide) recall
  FDA September 23, 2026 · restor3d Inc. · Class II
• HEMOSPRAY ENDOSCOPIC HEMOSTAT Product Name: HEMOSPRAY ENDOSCOPIC HEMOSTAT… recall
  FDA September 23, 2026 · Wilson-Cook Medical Inc. · Class II
• Happiest Baby, Inc recall
  FDA September 23, 2026 · Happiest Baby, Inc · Class II
• Happiest Baby, Inc SNOO Sleep Sack, X-Small Model recall
  FDA September 23, 2026 · Happiest Baby, Inc · Class II
• VERIQA; Product Name: RT MonteCarlo 3D v3; Model/Catalog Number:… recall
  FDA September 23, 2026 · Ptw Freiburg · Class II
• GM Helix Implant recall
  FDA September 23, 2026 · Straumann USA LLC · Class II
• SunMed Tracheal Tube, Size 2.5 recall
  FDA September 23, 2026 · Well Lead Medical CO. Ltd · Class II
• Core Services Hub V8, a set of backend services including Cross Enterprise… recall
  FDA September 23, 2026 · GE Healthcare · Class II
• Workflow Core Services V8, intended to provide set of services for storage… recall
  FDA September 23, 2026 · GE Healthcare · Class II
• Centricity PACS Server V7, intended for managing digital medical images… recall
  FDA September 23, 2026 · GE Healthcare · Class II
• Centricity PACS V2, V3, V4, V6, V7, software product is intended for the… recall
  FDA September 23, 2026 · GE Healthcare · Class II
• Enterprise Archive V8, software product for receiving, archiving… recall
  FDA September 23, 2026 · GE Healthcare · Class II
• Centricity Enterprise Archive V2, V3, and V4… recall
  FDA September 23, 2026 · GE Healthcare · Class II
• NOxBOXi Nitric Oxide Delivery System recall
  FDA September 23, 2026 · Noxbox Ltd · Class II
• DASH Rapid PCR Instrument Product Name: DASH Rapid PCR Instrument Model recall
  FDA September 23, 2026 · Nuclein LLC · Class II
• IV Sets with drip chambers recall
  FDA September 23, 2026 · ICU Medical, Inc. · Class II
• IV Sets with drip chambers recall
  FDA September 23, 2026 · ICU Medical, Inc. · Class II
• IV Sets with drip chambers recall
  FDA September 23, 2026 · ICU Medical, Inc. · Class II
• IV Sets with drip chambers recall
  FDA September 23, 2026 · ICU Medical, Inc. · Class II
• Oncology sets with drip chambers recall
  FDA September 23, 2026 · ICU Medical, Inc. · Class II
• Oncology sets with drip chambers recall
  FDA September 23, 2026 · ICU Medical, Inc. · Class II
• IV Non-Dedicated Gravity Administration Sets with drip chambers recall
  FDA September 23, 2026 · ICU Medical, Inc. · Class II
• Plum administration sets recall
  FDA September 23, 2026 · ICU Medical, Inc. · Class II
• MEDRAD¿ Stellant FLEX Syringe Kit used with Stellant FLEX CT Injection… recall
  FDA September 23, 2026 · Bayer Medical Care, Inc. · Class II
• Percutaneous Insertion Kit (PIK), dilator set L… recall
  FDA September 23, 2026 · Maquet Cardiopulmonary Gmbh · Class II
• Percutaneous Insertion Kit (PIK), Guidewire 150 cm… recall
  FDA September 23, 2026 · Maquet Cardiopulmonary Gmbh · Class II
• Percutaneous Insertion Kit (PIK), Guidewire 100 cm… recall
  FDA September 23, 2026 · Maquet Cardiopulmonary Gmbh · Class II
• Carescape Central Station CSCS V3 MAS800 Desktop Part Number 5867474-04… recall
  FDA September 23, 2026 · GE Medical Systems Information Technologies Inc · Class II
• Philips PIC iX Essentials recall
  FDA September 23, 2026 · Philips North America Llc · Class II
• Philips Patient Information Center iX recall
  FDA September 23, 2026 · Philips North America Llc · Class II
• Medline Convenience Kit: OPEN HEART A PACK, Product Number DYNJ43008N recall
  FDA September 23, 2026 · Medline Industries, LP · Class II
• AMS Convenience Kit: DSAEK Pack - RX, Part Number AMS12394B recall
  FDA September 16, 2026 · Windstone Medical Packaging, Inc. · Class II
• Citric Complete Liquid Citric Acid Concentrate recall
  FDA September 16, 2026 · Nipro Renal Soultions USA, Corporation · Class II
• Citric Complete Dry Citric Acid Concentrate recall
  FDA September 16, 2026 · Nipro Renal Soultions USA, Corporation · Class II