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.

• Origio Sperm Wash Medium Pack of Five 60ml bottles - Intended for washing of spermatozoa
  FDA Device · Class II · 2024-10-02 · Coopersurgical
• AGILE ESO OTW PC 23MM X 15.0CM IN 18.5 F-Agile Esophageal Partially Covered (PC) and Fully Covered (FC) OTW Stent System is intended for ma…
  FDA Device · Class II · 2024-10-02 · Boston Scientific
• Biodesign Fistula Plug C-FPS-0.2 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas
  FDA Device · Class II · 2024-10-02 · Cook Biotech
• WALLFLEX FC ESO STENT RMV 23X155MM- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintaining…
  FDA Device · Class II · 2024-10-02 · Boston Scientific
• WALLFLEX ESOPHAGEAL FC 23/28MMX10CM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended for maintaining esoph…
  FDA Device · Class II · 2024-10-02 · Boston Scientific
• eakin Cohesive seal, small, Model Number 839002, ostomy barrier seal
  FDA Device · Class III · 2024-10-02 · T G Eakin
• Vaginal Delivery, ASDV25B
  FDA Device · Class II · 2024-10-02 · American Contract Systems
• AGILE ESO OTW PC 23MM X 10.1CM IN 18.5 F-Agile Esophageal Partially Covered (PC) and Fully Covered (FC) OTW Stent System is intended for ma…
  FDA Device · Class II · 2024-10-02 · Boston Scientific
• Karl Storz - Endoskope , REF: 27292AMA, Hopkins Telescope 6, Rx only, CE 0123
  FDA Device · Class II · 2024-10-02 · Karl Storz Endoscopy
• Ingenia Elition X- For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal str…
  FDA Device · Class II · 2024-10-02 · Philips North America
• Pacemaker, COPM11B
  FDA Device · Class II · 2024-10-02 · American Contract Systems
• Good Vibrations Ultrasonic Cleaner Solution, JorVet J0382G Ultrasonic Instrument Cleaning Solution, SpecClean Ultrasonic Cleaner Solution,…
  FDA Device · Class II · 2024-10-02 · Microcare Medical
• Open Shoulder, LWOS39L
  FDA Device · Class II · 2024-10-02 · American Contract Systems
• MR 5300 - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of…
  FDA Device · Class II · 2024-10-02 · Philips North America
• Origio Sperm Wash Medium Pack of Ten 10ml bottles - Intended for washing of spermatozoa Part Number: 84051010A
  FDA Device · Class II · 2024-10-02 · Coopersurgical
• Biodesign Fistula Plug C-FPS-0.7 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas
  FDA Device · Class II · 2024-10-02 · Cook Biotech
• CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate intra-aortic balloons
  FDA Device · Class I · 2024-10-02 · Datascope
• WALLFLEX ESOPHAGEAL FC 23/28MMX12CM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended for maintaining esoph…
  FDA Device · Class II · 2024-10-02 · Boston Scientific
• Biodesign Fistula Plug C-FPS-0.4-2 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas
  FDA Device · Class II · 2024-10-02 · Cook Biotech
• Hand Pack, AKHD97C
  FDA Device · Class II · 2024-10-02 · American Contract Systems
• Biodesign Recto-Vaginal Fistula Plug RVP-0.7 - For implantation to reinforce soft tissue for repair of recto-vaginal fistulas
  FDA Device · Class II · 2024-10-02 · Cook Biotech
• Biodesign Fistula Plug C-FPS-0.2-2 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas
  FDA Device · Class II · 2024-10-02 · Cook Biotech
• GE Healthcare Centricty PACS, V2, V3, V4, V6, V7
  FDA Device · Class II · 2024-10-02 · Ge Healthcare
• Ivenix Infusion System (IIS), LVP Software
  FDA Device · Class I · 2024-10-02 · Fresenius Kabi Usa
• (a) CardinalHealth Salem Sump Dual Lumen Stomach Tube with Anti-Reflux Valve, 12 Fr/Ch (4.0 mm) x 48 in. (122 cm), Model #8888266114, Steri…
  FDA Device · Class II · 2024-10-02 · Cardinal Health 200
• Shoulder, SESH18I
  FDA Device · Class II · 2024-10-02 · American Contract Systems
• Biodesign Fistula Plug C-FPB-0.7 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas
  FDA Device · Class II · 2024-10-02 · Cook Biotech
• GE Giraffe Warmer, Model/Catalog Number M1118179-01090979
  FDA Device · Class II · 2024-10-02 · Wipro Ge Healthcare Private
• Essentia MAJ Laparotomy Std Pack, ESLT53B
  FDA Device · Class II · 2024-10-02 · American Contract Systems
• Biodesign Inguinal Hernia Graft C-IHM-10X15 - To reinforce soft tissues in the inguinal floor to repair inguinal hernias
  FDA Device · Class II · 2024-10-02 · Cook Biotech
• Arthroscopy Pack, MSKA45A
  FDA Device · Class II · 2024-10-02 · American Contract Systems
• Karl Storz - Endoskope , REF: 27293AA, Hopkins Telescope 6, Rx only, CE 0123
  FDA Device · Class II · 2024-10-02 · Karl Storz Endoscopy
• Biodesign Fistula Plug C-FPS-0.4 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas
  FDA Device · Class II · 2024-10-02 · Cook Biotech
• Creatine Kinase (CK) used on cobas c 311/501/502 and COBAS INTEGRA 400 plus-In vitro test for the quantitative determination of creatine ki…
  FDA Device · Class II · 2024-10-02 · Roche Diagnostics Operations
• Ingenia Elition S -For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal str…
  FDA Device · Class II · 2024-10-02 · Philips North America
• Biodesign Fistula Plug C-FPB-0.4 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas
  FDA Device · Class II · 2024-10-02 · Cook Biotech
• AGILE ESO FC RMV 23MM X 6.2CM IN 18.5 FR-Agile Esophageal Partially Covered (PC) and Fully Covered (FC) OTW Stent System is intended for ma…
  FDA Device · Class II · 2024-10-02 · Boston Scientific
• IR Procedure Pack, CEAT19W
  FDA Device · Class II · 2024-10-02 · American Contract Systems
• ACUSON Redwood 1.0 and 2.0 Diagnostic Ultrasound Systems, REF: 11503314, with software
  FDA Device · Class II · 2024-10-02 · Siemens Medical Solutions Usa
• GE Healthcare Centricity Universal Viewer Zero Footprint Client, Model Numbers: a) 2110344-008
  FDA Device · Class II · 2024-09-25 · Ge Healthcare
• General Purpose Syringe McKesson 60 mL Luer Lock Tip Without Safety, Catalog Number 869662, McKesson Brand Catalog Number: 102-S60C
  FDA Device · Class II · 2024-09-25 · Cypress Medical Products
• Atellica CH Microalbumin_2 (¿ALB_2)-For in vitro diagnostic use in the quantitative measurement of microalbumin in human urine on ADVIA Che…
  FDA Device · Class II · 2024-09-25 · Siemens Healthcare Diagnostics
• 2090 Programmers with serial number prefixes PKK0 and PKK1: a) 2090, Product Description: PRGM 2090 PROGRAMMER-PORTABLE CRM
  FDA Device · Class II · 2024-09-25 · Medtronic
• TxHA PEEK IBF/TxTiHA IBF System REF BTA-151 i. TxHA The Innovasis TxHA PEEK IBF System is an intervertebral body fusion device intended to…
  FDA Device · Class II · 2024-09-25 · Innovasis
• Marodyne-LiV, part number 3045-133, Low intensity vibration exerciser supporting osteoporosis treatment
  FDA Device · Class II · 2024-09-25 · Btt Health
• STREAMLINE BLOODLINE LONG VERSION, FMC-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodialysis
  FDA Device · Class II · 2024-09-25 · B Braun Medical
• regard Clinical Packaging Solutions, HT00376I - SPECIAL PROCEDURE, Item Number 800223009
  FDA Device · Class II · 2024-09-25 · Roi Cps
• DIAMOND POINT, BOTH ENDS K-WIRE, REF 128042, metallic bone fixation fastener
  FDA Device · Class II · 2024-09-25 · Smith And Nephew
• DIAMOND POINT, BOTH ENDS K-WIRE, REF 128062, metallic bone fixation fastener
  FDA Device · Class II · 2024-09-25 · Smith And Nephew
• HAWK Warming Grid, Item Number: 59-300
  FDA Device · Class II · 2024-09-25 · Safeguard Us Operating
• System Name: 722059 Allura Xper FD20/15 OR Table 722058 Allura Xper FD20/15 722039 Allura Xper FD20/20 OR Table 722038 Allura Xper FD20/20…
  FDA Device · Class II · 2024-09-25 · Philips Medical Systems Nederland B V
• BinaxNOW Respiratory Strep A Test Kit, CLIA Waived, Catalog Number 730025
  FDA Device · Class II · 2024-09-25 · Cypress Medical Products
• Beckman Coulter DxI 9000 Access Immunoassay Analyzer, Model Number C21510, RSM Pneumatic Tubing Kit item #2, REF C11137
  FDA Device · Class II · 2024-09-25 · Beckman Coulter
• Seer Home System is an ambulatory electroencephalograph (EEG) system intended for at-home use for extended EEG and video EEG (vEEG) recordi…
  FDA Device · Class II · 2024-09-25 · Seer Medical
• Flexima APDL Drainage Catheter System and Kit, Material Numbers: a) REF M001271960, b) REF M001271970
  FDA Device · Class II · 2024-09-25 · Boston Scientific
• VariSoft Infusion Set, Single Use
  FDA Device · Class II · 2024-09-25 · Unomedical A S
• BiomarC EX Fiducial Marker System, Catalog Number 040165
  FDA Device · Class III · 2024-09-25 · Carbon Medical Technologies
• Alaris System PC Unit Model 8015 - a modular infusion pump and monitoring system
  FDA Device · Class II · 2024-09-25 · Carefusion 303
• Kits of Convenience containing 1 of the 2 Item Numbers: 1. Item Number: 59-300 HAWK Warming Grid, 2. Item Number: 59-320 HAWK Advanced Hypo…
  FDA Device · Class II · 2024-09-25 · Safeguard Us Operating
• Alaris EtCO2 Module Model 8300, a modular infusion pump and monitoring system
  FDA Device · Class II · 2024-09-25 · Carefusion 303
• AET36 ANESTH EXT SET - Anesthesia Extension Set - Normally Closed Dual Manifold, Four-way Stopcock, Model/Catalog Number: 472036
  FDA Device · Class II · 2024-09-25 · B Braun Medical
• ViewPoint 6, Model Numbers: a) H47581RJ, b) H47591MA, c) H47591MT, d) H47591PE, e) H47591PR, f) H47591RA, g) H47591SD, h) H47591YA
  FDA Device · Class II · 2024-09-25 · Ge Healthcare
• Alaris Pump Module Model 8100, a modular infusion pump and monitoring system
  FDA Device · Class II · 2024-09-25 · Carefusion 303
• Medline Contro-Bulb Syringe, REF DYND20125
  FDA Device · Class II · 2024-09-25 · Medline Industries Northfield
• Baxter EXACTAMIX Inlet, Vented, Syringe Inlet, REF H938176, for use in a pharmaceutical compounding device
  FDA Device · Class I · 2024-09-25 · Baxter Healthcare
• ERIC Retrieval Device REF: ER173020 ER174030 ER176044 The ERIC Retrieval Device is a mechanical thrombectomy device designed to restore blo…
  FDA Device · Class II · 2024-09-25 · Microvention
• Mazor X. Model Number REF TPL0059
  FDA Device · Class II · 2024-09-25 · Mazor Robotics
• ADVIA Chemistry Microalbumin_2 (¿ALB_2) -For in vitro diagnostic use in the quantitative measurement of microalbumin in human urine on ADVI…
  FDA Device · Class II · 2024-09-25 · Siemens Healthcare Diagnostics
• Flexima Regular Kit Biliary Catheter System Kit, Material Numbers REF M001271650
  FDA Device · Class II · 2024-09-25 · Boston Scientific
• System Code Name: 722282 Azurion 7 M20 722281 Azurion 5 M20 722236 Azurion 7 B20 722235 Azurion 7 B12 722234 Azurion 7 M20 722233 Azurion 7…
  FDA Device · Class II · 2024-09-25 · Philips Medical Systems Nederland B V
• HAWK Advanced Hypothermia Management Set, Item Number: 59-320
  FDA Device · Class II · 2024-09-25 · Safeguard Us Operating
• stryker TORNIER PERFORM HUMERAL SYSTEM - STEMLESS US Anatomic Nucleus, REF DWM003A
  FDA Device · Class II · 2024-09-25 · Tornier
• STREAMLINE BLOODLINE SET FOR DIALOG DR-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodialysis
  FDA Device · Class II · 2024-09-25 · B Braun Medical
• 1. Tech Medical Services Inc
  FDA Device · Class II · 2024-09-25 · Unimax Medical Systems
• VTC Regular Kit Nephrostomy Catheter System Kit, Material Number REF M001245300
  FDA Device · Class II · 2024-09-25 · Boston Scientific
• STREAMLINE LONG-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodialysis
  FDA Device · Class II · 2024-09-25 · B Braun Medical
• Alaris Syringe Module Model 8110, a modular infusion pump and monitoring system
  FDA Device · Class II · 2024-09-25 · Carefusion 303
• Flexima Regular Kit Nephrostomy Catheter System Kit, Material Numbers REF M001271860
  FDA Device · Class II · 2024-09-25 · Boston Scientific
• STREAMLINE FRESENIUS FOR DAVITA-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodialysis
  FDA Device · Class II · 2024-09-25 · B Braun Medical
• Acceava Respiratory Strep A, CLIA Waived, Catalog Number 4580295008
  FDA Device · Class II · 2024-09-25 · Cypress Medical Products
• SL BLOODLINE FOR FMC 2008 SERIES-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodialysis
  FDA Device · Class II · 2024-09-25 · B Braun Medical
• Alaris PCA Module Model 8120, a modular infusion pump and monitoring system
  FDA Device · Class II · 2024-09-25 · Carefusion 303
• STREAMLINE FRESENIUS FOR DAVITA-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodialysis
  FDA Device · Class II · 2024-09-25 · B Braun Medical
• ViewPoint
  FDA Device · Class II · 2024-09-25 · Ge Healthcare
• vanSonnenberg Sump Locking Pigtail Regular Kit Sump Catheter System Kit, Material Number REF M001273090
  FDA Device · Class II · 2024-09-25 · Boston Scientific
• Baxter EXACTAMIX Inlet, Vented, Micro-Volume Inlet, REF H938175, for use in a pharmaceutical compounding device
  FDA Device · Class I · 2024-09-25 · Baxter Healthcare
• Baxter EXACTAMIX Inlet, Vented, High Volume Inlet, REF H938174, for use in a pharmaceutical compounding device
  FDA Device · Class I · 2024-09-25 · Baxter Healthcare
• System Name: 708038 MultiDiagnost Eleva with Flat Detector 708037 MultiDiagnost Eleva with Flat Detector 708036 MultiDiagnost Eleva 708034…
  FDA Device · Class II · 2024-09-25 · Philips Medical Systems Nederland B V
• Baxter EXACTAMIX Inlet, Non-Vented, High Volume Inlet, REF H938173, for use in a pharmaceutical compounding device
  FDA Device · Class I · 2024-09-25 · Baxter Healthcare
• STREAMLINE BLOODLINE SET FOR DIALOG-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodialysis
  FDA Device · Class II · 2024-09-25 · B Braun Medical
• System Name: 722044 INTEGRIS Allura 15-12 (biplane) 722030 Integris CV Cesar-Powerpack-Visub-Nicol 722021 INTEGRIS Allura 9 (biplane) 72201…
  FDA Device · Class II · 2024-09-25 · Philips Medical Systems Nederland B V
• Medline Convenience kits, labeled as: 1) DYNJ39451D , Pack Number HOOD PACK
  FDA Device · Class II · 2024-09-18 · Medline Industries Northfield
• Medline Convenience kits labeled as: 1) KIT GENERAL CLOSURE , Pack Number DYKMBNDL200A
  FDA Device · Class II · 2024-09-18 · Medline Industries Northfield
• 25-LHP-928, HeNe Laser System, 25 mW
  FDA Device · Class II · 2024-09-18 · Pacific Lasertech
• Medline Convenience kits, labeled as: 1) TRACH CDS-LF , Pack Number CDS983142B
  FDA Device · Class II · 2024-09-18 · Medline Industries Northfield
• Syringes with Luer Slip Tips labeled as: 1) SOL-M 1ml Slip Tip Syringe w/o Needle, Model No. 180011, UPC 8183923010138
  FDA Device · Class II · 2024-09-18 · Sol Millennium Medical
• Atellica IM CA 19-9 (250 Test - REF)-In vitro diagnostic use in the quantitative measurement of the CA 19-9 tumor-associated antigen in hum…
  FDA Device · Class II · 2024-09-18 · Siemens Healthcare Diagnostics
• Medline convenience kits containing semi-rigid suction liners labeled as follows: NICU ADMIT KIT, Pack Number DYKA1014G
  FDA Device · Class II · 2024-09-18 · Medline Industries Northfield
• Medline Convenience kits labeled as: 1) ADULT DRAWER 5, Pack Number ACC010647A
  FDA Device · Class II · 2024-09-18 · Medline Industries Northfield
• Medline Convenience kits labeled as: 1) OSTEOTOMY ORAL PROCEDURE, Pack Number CDS983010J
  FDA Device · Class II · 2024-09-18 · Medline Industries Northfield

Other years

2026 (2,024) · 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)