FDA Device · 2024

FDA Device recalls in 2024

RecallRadar indexes 3,393 FDA Device recall notices published in 2024. By classification: 392 Class I, 2,970 Class II, 31 Class III.

• impression coping, repositionable, short, screw-retained, PF 4.0
  FDA Device · Class II · 2024-03-27 · Thommen Medical Ag
• Abbott Point of Care Control Control i-STAT¿ Level 1 10 X 1.7 mL
  FDA Device · Class II · 2024-03-27 · Mckesson Medical Surgical Corporate Office
• NautilusTM Smart ECMO Module with Balance Biosurface-used in extracorporeal life support procedures to oxygenate blood, remove carbon dioxi…
  FDA Device · Class II · 2024-03-27 · Mc3
• MINI STICK MAX 5F X 10 CM STD .018 SS/SS NON-ECHO 2.75" PG- Used for the percutaneous introduction of a guidewire into the vascular system
  FDA Device · Class II · 2024-03-27 · Angiodynamics
• Directional Laser Probe with Alcon / Lumenis connector (27 gauge / 0.4 mm)
  FDA Device · Class II · 2024-03-27 · D O R C Dutch Opthalmic Research Center Intl B V
• Convatec EsteemBody Soft Convex, Drainable Pouch, Product codes (REF): a) 423643, b) 423658, c) 423659, d) 423664, e) 423666, f) 423645, g)…
  FDA Device · Class II · 2024-03-27 · Convatec
• CLEARLINK Non-DEHP Solution Set Luer Lock Adapter, Product Code 2R8401
  FDA Device · Class II · 2024-03-20 · Baxter Healthcare
• CERENOVUS CEREBASE DA Guide Sheath, Part Numbers: a) GS9080SD
  FDA Device · Class I · 2024-03-20 · Medos International Sarl
• D-Clip Standard/Mini Applier, 210mm bayonet, jaw rigid, double action
  FDA Device · Class II · 2024-03-20 · Peter Lazic
• ADVIA Centaur Erythropoietin (EPO) Assay (100 Test)
  FDA Device · Class II · 2024-03-20 · Siemens Healthcare Diagnostics
• CVS Health Waterproof Wound Tracking Dressing, REF CVS690330, immediate package contains 1 sterile dressing, 4 in. x 4 in., 4 dressings per…
  FDA Device · Class II · 2024-03-20 · Medline Industries Northfield
• STERIS Boot Assembly, Traction Device, OT 1000, Part Number REF 10009192
  FDA Device · Class II · 2024-03-20 · Baxter Healthcare
• Atellica IM Erythropoietin (EPO) Assay (100 Test)
  FDA Device · Class II · 2024-03-20 · Siemens Healthcare Diagnostics
• EasyPoint Needle, 25G x 5/8", REF: 82091
  FDA Device · Class II · 2024-03-20 · Retractable Technologies
• SPII Model Lubinus, Hip Prosthesis Stem XL Neck, cemented
  FDA Device · Class II · 2024-03-20 · Waldemar Link And Kg Mfg Site
• D-Clip Standard/Mini Applier, 190mm bayonet, jaw rigid, double action
  FDA Device · Class II · 2024-03-20 · Peter Lazic
• SPII Model Lubinus, Long Stem Prosthesis Standard Neck, cemented
  FDA Device · Class II · 2024-03-20 · Waldemar Link And Kg Mfg Site
• L-Aneurysm Clip TITANIUM Paddle-Clip, permanent, 11 mm straight, Non-Sterile
  FDA Device · Class II · 2024-03-20 · Peter Lazic
• LVP software of the Ivenix Infusion System (IIS)
  FDA Device · Class II · 2024-03-20 · Fresenius Kabi Usa
• L-Aneurysm Clip TITANIUM Paddle-Clip, permanent, 11 mm straight, Sterile
  FDA Device · Class II · 2024-03-20 · Peter Lazic
• SPII Model Lubinus, Hip Prosthesis Stem Standard Neck, cemented
  FDA Device · Class II · 2024-03-20 · Waldemar Link And Kg Mfg Site
• D-Clip Standard/Mini Applier, 230mm bayonet, jaw rigid, double action
  FDA Device · Class II · 2024-03-20 · Peter Lazic
• CARTO VIZIGO Bi-Directional Guiding Sheath, REF D128502 The CARTO VIZIGOTM Bi-Directional Guiding Sheath is designed to provide accessibili…
  FDA Device · Class II · 2024-03-20 · Biosense Webster
• SPII Model Lubinus, Long Stem Prosthesis XL Neck, cemented
  FDA Device · Class II · 2024-03-20 · Waldemar Link And Kg Mfg Site
• BVI Visitec Irrigation Handle (20/SP)- Intended to be fit with a cannula for irrigation of the eye Catalog Number: 581012
  FDA Device · Class II · 2024-03-20 · Beaver Visitec International
• LVP software of the Ivenix Infusion System (IIS), LVP-SW-0004
  FDA Device · Class II · 2024-03-20 · Fresenius Kabi Usa
• Shimadzu, Trinias, Digital Angiography System
  FDA Device · Class II · 2024-03-20 · Shimadzu Medical Systems Division
• VITROS 3600 Immunodiagnostic System Catalog Nos. 6802783 (regular) and 6802914 (refurbished)
  FDA Device · Class II · 2024-03-13 · Ortho Clinical Diagnostics
• VITROS 5600 Integrated System Catalog Nos. 6802413 (regular) and 6802915 (refurbished)
  FDA Device · Class II · 2024-03-13 · Ortho Clinical Diagnostics
• TFNA Femoral Nail 11mm, right, 130¿, L 235mm-Intended for temporary fixation and stabilization of proximal femur fractures
  FDA Device · Class II · 2024-03-13 · Synthes Usa Products
• ConvaTec Natura Stomahesive Post-Operative / Surgical Ostomy System, REF 416938, 1 3/4 in. 45mm, Sterile
  FDA Device · Class II · 2024-03-13 · Convatec
• Synapse PACS - Version 7.2.100
  FDA Device · Class II · 2024-03-13 · Fujifilm Healthcare Americas
• X3 TRIATHLON CS INSERT NO 6 10 MM
  FDA Device · Class II · 2024-03-13 · Howmedica Osteonics
• Synapse PACS - Version 7.2.200
  FDA Device · Class II · 2024-03-13 · Fujifilm Healthcare Americas
• X3 TRIATHLON CS INSERT NO 7 9 MM
  FDA Device · Class II · 2024-03-13 · Howmedica Osteonics
• TFNA Femoral Nail 9mm, right, 130¿, L 235mm-Intended for temporary fixation and stabilization of proximal femur fractures
  FDA Device · Class II · 2024-03-13 · Synthes Usa Products
• VITROS 5600 Integrated System (New and Refurbished)
  FDA Device · Class II · 2024-03-13 · Ortho Clinical Diagnostics
• Invacare Homecare Series Bed and Invacare G-Series Beds Containing Component Model Numbers: (1) G50 (2) G53 (3) G54 (4) BAR5490IVC (5) BAR5…
  FDA Device · Class II · 2024-03-13 · Invacare
• DISP.HASSON TROCAR 10/110MM, Product Code EK230SU. For use in laparoscopic procedures
  FDA Device · Class II · 2024-03-13 · Aesculap
• Opal, Intervertebral Cage, 10x32mm, h 11mm, Revolvable-Indicated for degenerative spine disease Part Number: 08.803.231S
  FDA Device · Class II · 2024-03-13 · Synthes Usa Products
• 1.5MM Drill Bit/QC/85MM Sterile-surgical, orthopedic, pneumatic powered & accessory/attachment Part Number: 310.15S
  FDA Device · Class II · 2024-03-13 · Synthes Usa Products
• VITROS 3600 Immunodiagnostic System (New and Refurbished)
  FDA Device · Class II · 2024-03-13 · Ortho Clinical Diagnostics
• VITROS 5600 Integrated System Catalog Nos. 6802413 (regular) and 6802915 (refurbished)
  FDA Device · Class II · 2024-03-13 · Ortho Clinical Diagnostics
• DISP.TROCAR W. DILATING PIN 10/110MM, Product Code EK224SU. For use in laparoscopic procedures
  FDA Device · Class II · 2024-03-13 · Aesculap
• DISP.TROCAR W.DILATING PIN 12/110MM, Product Code EK234SU. For use in laparoscopic procedures
  FDA Device · Class II · 2024-03-13 · Aesculap
• Embrace Drill Tower, Wedged (25mm)
  FDA Device · Class II · 2024-03-13 · Waldemar Link And Kg Mfg Site
• The Apollo Onyx Delivery Microcatheter (AOMC) is a DMSO-compatible, single-lumen, end hole catheter designed for the infusion of the Onyx l…
  FDA Device · Class II · 2024-03-13 · Micro Therapeutics
• NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 11 MM
  FDA Device · Class II · 2024-03-13 · Howmedica Osteonics
• Synapse PACS - Version 7.2.000
  FDA Device · Class II · 2024-03-13 · Fujifilm Healthcare Americas
• NO 3 TRIATHLON TS PLUS TIB INS X3 POLY 11 MM
  FDA Device · Class II · 2024-03-13 · Howmedica Osteonics
• VITROS 4600 Chemistry System Catalog Nos. 6802445 (regular) and 6900440 (refurbished)
  FDA Device · Class II · 2024-03-13 · Ortho Clinical Diagnostics
• NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 16 MM
  FDA Device · Class II · 2024-03-13 · Howmedica Osteonics
• Synapse PACS - Version 7.1.000
  FDA Device · Class II · 2024-03-13 · Fujifilm Healthcare Americas
• VA-LCP Clavicle Plate 2.7, shaft, CS1, right-Intended for fixation of clavicle bone fragments
  FDA Device · Class II · 2024-03-13 · Synthes Usa Products
• 2.5MM DRILL BIT/QC/GOLD/110MM STERILE-surgical, orthopedic, pneumatic powered & accessory/attachment Product Code: 310.25S
  FDA Device · Class II · 2024-03-13 · Synthes Usa Products
• VITROS XT 3400 Chemistry System, Catalog No. 6844458
  FDA Device · Class II · 2024-03-13 · Ortho Clinical Diagnostics
• DISP.HASSON TROCAR 12/110MM, Product Code EK240SU. For use in laparoscopic procedures
  FDA Device · Class II · 2024-03-13 · Aesculap
• BD Pyxis: MedStation ES, REF: 323
  FDA Device · Class II · 2024-03-13 · Carefusion 303
• Vantage Titan, Model: MRT-1504
  FDA Device · Class II · 2024-03-13 · Canon Medical System Usa
• MRI system: Vantage Elan, Model: MRT-2020
  FDA Device · Class II · 2024-03-13 · Canon Medical System Usa
• VITROS XT 7600 Integrated System, Catalog No. 6844461
  FDA Device · Class II · 2024-03-13 · Ortho Clinical Diagnostics
• VITROS 4600 Chemistry System Catalog Nos. 6802445 (regular) and 6900440 (refurbished)
  FDA Device · Class II · 2024-03-13 · Ortho Clinical Diagnostics
• Synapse PACS - Version 7.1.000US
  FDA Device · Class II · 2024-03-13 · Fujifilm Healthcare Americas
• MIC* Gastric-Jejunal Feeding Tube, Endoscopic/Radiologic Placement, GJ-Tube: a) MIC* Gastric-Jejunal Feeding Tube Kit - Endoscopic/Radiolog…
  FDA Device · Class I · 2024-03-13 · Avanos Medical
• DISP.TROCAR W.DILATING PIN 12/110MM, Product Code EK236SU. For use in laparoscopic procedures
  FDA Device · Class II · 2024-03-13 · Aesculap
• Synapse PACS - Version 7.3.000
  FDA Device · Class II · 2024-03-13 · Fujifilm Healthcare Americas
• Phantom TTC Nail, 10.0 X 200mm, Right
  FDA Device · Class II · 2024-03-13 · Paragon 28
• VITROS XT 3400 Chemistry System, Catalog No. 6844458
  FDA Device · Class II · 2024-03-13 · Ortho Clinical Diagnostics
• VITROS XT 7600 Integrated System, Catalog No. 6844461
  FDA Device · Class II · 2024-03-13 · Ortho Clinical Diagnostics
• Phantom TTC Nail, TTC Nail, 10.0 X 150mm, RIGHT , REF: P31-600-175L
  FDA Device · Class II · 2024-03-13 · Paragon 28
• RAPIDSORB IPS Battery Pack, Sterile-Intended for use in non-load bearing fracture repair and reconstructive procedures of the craniofacial…
  FDA Device · Class II · 2024-03-13 · Synthes Usa Products
• MRI system: Vantage Orian, Vantage Fortian, Model: MRT-1550
  FDA Device · Class II · 2024-03-13 · Canon Medical System Usa
• X3 TRIATHLON CS INSERT NO 6 11 MM
  FDA Device · Class II · 2024-03-13 · Howmedica Osteonics
• X3 TRIATHLON CS INSERT NO 3 10 MM
  FDA Device · Class II · 2024-03-13 · Howmedica Osteonics
• Embrace Drill Tower, Standard/Lateral (25mm)
  FDA Device · Class II · 2024-03-13 · Waldemar Link And Kg Mfg Site
• Phantom TTC Nail, TTC Nail, 11.5 X 250mm, RIGHT, REF: P31-615-250R
  FDA Device · Class II · 2024-03-13 · Paragon 28
• VITROS XT7600 Integrated System
  FDA Device · Class II · 2024-03-13 · Ortho Clinical Diagnostics
• NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 16 MM
  FDA Device · Class II · 2024-03-13 · Howmedica Osteonics
• 13 mm Titanium Hindfoot Arthrodesis Cannulated Nails EX, sterile -Intended to facilitate tibiotalocalcaneal arthrodesis to treat severe foo…
  FDA Device · Class II · 2024-03-13 · Synthes Usa Products
• RIA Tube Assembly, minimum 520 mm length, sterile- intended for use in adults and adolescents (12-21 years) to clear the medullary canal of…
  FDA Device · Class II · 2024-03-13 · Synthes Usa Products
• VITROS 3600 Immunodiagnostic System Catalog Nos. 6802783 (regular) and 6802914 (refurbished)
  FDA Device · Class II · 2024-03-13 · Ortho Clinical Diagnostics
• The Apollo Onyx Delivery Microcatheter (AOMC) is a DMSO-compatible, single-lumen, end hole catheter designed for the infusion of the Onyx l…
  FDA Device · Class II · 2024-03-13 · Micro Therapeutics
• MIC* Gastric-Jejunal Feeding Tube with ENFit Connectors: a) MIC* Gastric-Jejunal Feeding Tube Kit with ENFit Connector - Endoscopic/Radiolo…
  FDA Device · Class I · 2024-03-13 · Avanos Medical
• AirLife Adult Manual Resuscitator, Oxygen Reservoir Bag, without Mask, REF 2K8000
  FDA Device · Class I · 2024-03-06 · Vyaire Medical
• Centurion Kits, trays, and packs labeled as follows: MAINTENANCE FLUSH KIT/BLOOD DRAW, REF DT19335A
  FDA Device · Class I · 2024-03-06 · Medline Industries Northfield
• Colonoscope, Model Number CF-Q180AL
  FDA Device · Class II · 2024-03-06 · Olympus
• Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, Lumbar Catheter, REF 46917, Sterile EO, Rx Only
  FDA Device · Class I · 2024-03-06 · Medtronic Neurosurgery
• Ref No: INSHITHND / Integra¿ Cranial access kit (without Prep solutions) Bit and Guard
  FDA Device · Class II · 2024-03-06 · Integra Lifesciences
• VOCSN Patient Breathing Package (Pediatric, Active, Oxygen, Blue) REF PRT-01013-000 with pouch REF PRT-00802-001)
  FDA Device · Class I · 2024-03-06 · Ventec Life Systems
• Tensive Conductive Adhesive Gel, Product Ref. 22-60. 12, 1 case contains 12 inner boxes with 50g tubes packaged in each
  FDA Device · Class II · 2024-03-06 · Parker Laboratories
• Ref No: INSHITH / Integra¿ Cranial Access Kit
  FDA Device · Class II · 2024-03-06 · Integra Lifesciences
• Zyno Medical Z800 Large Volume Infusion Pumps -Intended to provide intravenous infusion of parenteral fluids, blood and blood products to a…
  FDA Device · Class II · 2024-03-06 · Zyno Medical
• AirLife Adult Manual Resuscitator, 40" (1.0m) Oxygen Reservoir Tubing, Adult Mask, REF 2K8005
  FDA Device · Class I · 2024-03-06 · Vyaire Medical
• USTAR II Knee System Cemented curved stem, RHS, Non Coated for the following reference numbers: REF: PE25153109 - 9x125mm, PE25153209 - 9x1…
  FDA Device · Class II · 2024-03-06 · United Orthopedic
• Medline Kits, trays, and packs labeled as follows: C-SECTION, REF DYNJ904653G
  FDA Device · Class I · 2024-03-06 · Medline Industries Northfield
• Ref No: INS7270 / Integra¿ Cranial Access Kit
  FDA Device · Class II · 2024-03-06 · Integra Lifesciences
• MEDLINE Kits, trays, and packs labeled as follows: CATHETERIZATION KIT, REF DYNDA2939
  FDA Device · Class I · 2024-03-06 · Medline Industries Northfield
• Wash station: M1000 Wash Station Assembly & DITI Slide, REF 04J72-28* (*This part number is a spare to the M2000sp.)
  FDA Device · Class III · 2024-03-06 · Abbott Molecular
• Colonoscope, Model Number PCF-HQ190L
  FDA Device · Class II · 2024-03-06 · Olympus
• MEDLINE Kits, trays, and packs labeled as follows: SERUM TEAR KIT, REF DYNDA1545
  FDA Device · Class I · 2024-03-06 · Medline Industries Northfield

Other years

2026 (2,088) · 2025 (2,908) · 2024 (3,393) · 2023 (2,477) · 2022 (2,191) · 2021 (2,303) · 2020 (3,055) · 2019 (2,801) · 2018 (3,757) · 2017 (2,615) · 2016 (3,246) · 2015 (2,495) · 2014 (3,059) · 2013 (2,249) · 2012 (1,310)