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.

• intelliPATH Universal HRP Detection Kit, REF: IPK5011G80, containing DAB Buffer, Catalog Number: IPBF5009G20
  FDA Device · Class II · 2024-11-13 · Biocare Medical
• Hillrom Welch Allyn HScribe Holter System
  FDA Device · Class II · 2024-11-13 · Baxter Healthcare
• iotaSOFT Plus Drive Unit, REF IM-05
  FDA Device · Class III · 2024-11-13 · Iotamotion
• GE Healthcare Centricity Universal Viewer Zero Footprint, Model Numbers: 1) 2089507-083, GDZH-JINWAN-Centricity 2) 2089507-093, 10510-3-Cen…
  FDA Device · Class II · 2024-11-13 · Ge Healthcare
• DeRoyal CHILDREN'S LAPTRACEPACK, 89-9362.06
  FDA Device · Class II · 2024-11-13 · Deroyal Industries
• The FLUOROspeed is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic studies
  FDA Device · Class II · 2024-11-13 · Shimadzu Medical Systems Division
• Coated VICRYL Polyglactin 910 Suture VIO 36IN(90CM) USP0(M3.5) S/A CT, Product Number J358H
  FDA Device · Class II · 2024-11-13 · Ethicon
• Saphena Medical Venapax XL- Endoscopic Vessel Harvesting System for use in minimally invasive surgery allowing access for vessel harvesting…
  FDA Device · Class II · 2024-11-13 · Zimmer
• Medtronic DLP Aortic Root Cannula with Flow-Guard, REF 11012
  FDA Device · Class II · 2024-11-13 · Medtronic Perfusion Systems
• Hillrom Welch Allyn Diagnostic Cardiology Suite (formerly Connex Cardio)
  FDA Device · Class II · 2024-11-13 · Baxter Healthcare
• DeRoyal C-SECTION TRACEPACK, REF 89-9338-06
  FDA Device · Class II · 2024-11-13 · Deroyal Industries
• epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System, SMN 10736515
  FDA Device · Class II · 2024-11-13 · Siemens Healthcare Diagnostics
• DeRoyal CHILDREN'S ORTHOPEDIC TRACEPACK, 89-9349-06
  FDA Device · Class II · 2024-11-13 · Deroyal Industries
• Americot 20-01S (1/4" x 1/4") or 6mm x 6mm: Neurological sponges for use in the protection of neural tissue during surgery
  FDA Device · Class II · 2024-11-13 · American Surgical
• Tandem Intl Bipolar Cocr Shell/UHMWPE Liner, TI-6AL-4V Retaining Ring, 28MM I.D. 46 MM O.D., REF 71324046, sterile, femoral head bipolar co…
  FDA Device · Class II · 2024-11-13 · Smith And Nephew
• Hillrom Welch Allyn RScribe 12-Lead Electrocardiograph System
  FDA Device · Class II · 2024-11-13 · Baxter Healthcare
• Hillrom Welch Allyn XScribe Cardiac Stress Testing System
  FDA Device · Class II · 2024-11-13 · Baxter Healthcare
• DeRoyal CHILDREN'S GENERAL TRACEPACK, REF 89-9342-06
  FDA Device · Class II · 2024-11-13 · Deroyal Industries
• Hillrom Welch Allyn Q-Stress Cardiac Stress Testing System
  FDA Device · Class II · 2024-11-13 · Baxter Healthcare
• MEGA 7.5Fr. 40cc Intra-Aortic Balloon with Accessories, Model Number 0684-00- 0295-01
  FDA Device · Class II · 2024-11-13 · Datascope
• Cartesion Prime, Digital PET-CT, Model: PCD-1000A/3D.004, PCD-1000A/3D, is a diagnostic imaging system that combines Positron Emission Tomo…
  FDA Device · Class II · 2024-11-13 · Canon Medical System Usa
• smith&nephew LEIGON OXINIUM CONSTRAINED NONPOROUS FEMORAL COMPONENT, SIZE 3 LEFT, REF 71421163
  FDA Device · Class II · 2024-11-06 · Smith And Nephew
• Abbott Alinity m HPV AMP Kit, used with the Alinity m System, product codes: a) REF 09N15-095
  FDA Device · Class II · 2024-11-06 · Abbott Molecular
• KLS Martin Battery Pack, REF: KLS BP2 001, and KLS BP2 040 (bulk case of 40), used in conjunction with the KLS Martin MaxDriver 2.0 surgica…
  FDA Device · Class II · 2024-11-06 · Pro Dex
• Osom Ultra hCG Combo Test- IVD immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in serum or urine for the ea…
  FDA Device · Class II · 2024-11-06 · Princeton Biomeditech
• SURG STRP 1/4X6 Model/Catalog Number: 801450
  FDA Device · Class II · 2024-11-06 · Integra Lifesciences
• 17-OH Progesterone ELISA 96 well kit- An enzyme immunoassay for the quantitative in vitro diagnostic measurement of 17-OH Progesterone (17-…
  FDA Device · Class III · 2024-11-06 · Drg International
• SURG PAT XRAY 1/2X1/2 Model/Catalog Number: 801400
  FDA Device · Class II · 2024-11-06 · Integra Lifesciences
• CADD-Solis Li-ion Rechargeable Battery Packs, REF 21-2160-XX, which are also sold as a component of the following CADD Solis Ambulatory Inf…
  FDA Device · Class I · 2024-11-06 · Smiths Medical Asd
• a. Hillrom Centrella Smart+ Medical-Surgical Hospital Bed, Product codes: P7900B000001, P7900B100010, P7900B100024, P7900B100208, P7900B100…
  FDA Device · Class II · 2024-11-06 · Baxter Healthcare
• Ambu¿ VivaSight 2 DLT Endobronchial tube, 35 FR (Catalog Number 412351000), 37 Fr (Catalog Number 412371000), 39 Fr (Catalog Number 4123910…
  FDA Device · Class II · 2024-11-06 · Ambu
• SURG PAT XRAY 1/2X3 Model/Catalog Number: 801407
  FDA Device · Class II · 2024-11-06 · Integra Lifesciences
• Chameleon PTA Balloon Catheter with Injection Port 5mm x 40mm x 75cm (CFN CH05-40-75US), 6mm x 40mm x 75cm (CFN CH06-40-75US), 7mm x 40mm x…
  FDA Device · Class II · 2024-11-06 · Covidien
• Nihon Kohden Adult Ear Clip SpO2 Sensor, 1.5 meter Model 809030007 Reusable SpO2 Ear Clip, each
  FDA Device · Class II · 2024-11-06 · Nihon Kohden America
• ClariTEE Probe- Miniature transesophageal echo ultrasound probe for use with ImaCor ultrasound diagnostic platforms
  FDA Device · Class II · 2024-11-06 · Imacor
• KING LTSD,SIZE 2.5, W/SUCTION PORT NON-STERILE KIT-Inserted into a patient s pharynx through the mouth to provide patent airway
  FDA Device · Class II · 2024-11-06 · King Systems
• SURG STRP 2X6 Model/Catalog Number: 801455
  FDA Device · Class II · 2024-11-06 · Integra Lifesciences
• smith&nephew GENESIS II NONPOROUS POSTERIOR STABILIZED FEMORAL COMPONENT, SIZE 5 LEFT, REF 71421015
  FDA Device · Class II · 2024-11-06 · Smith And Nephew
• SURG STRP 1/2X6 Model/Catalog Number: 801451
  FDA Device · Class II · 2024-11-06 · Integra Lifesciences
• VasoView HemoPro Endoscopic Vessel Harvesting System, Product Codes VH-3000-W and VH-3500
  FDA Device · Class I · 2024-11-06 · Maquet Cardiovascular
• KING LTSD,SIZE 2,W/SUCTION PORT STERILE-Inserted into a patient s pharynx through the mouth to provide patent airway
  FDA Device · Class II · 2024-11-06 · King Systems
• SURG STRP 1/8X6 Model/Catalog Number: 801449
  FDA Device · Class II · 2024-11-06 · Integra Lifesciences
• Nihon Kohden Adult/Pediatric Forehead Disposable SpO2 Sensor, 0.9m Model 809030006 Disp
  FDA Device · Class II · 2024-11-06 · Nihon Kohden America
• SURG PAT XRAY 3X3 Model/Catalog Number: 801409
  FDA Device · Class II · 2024-11-06 · Integra Lifesciences
• Duraform Dural Graft Implant, Size 3x3 , Model Number 80-1477US Lot CT007694
  FDA Device · Class II · 2024-11-06 · Integra Lifesciences
• SURG PAT XRAY 1/4X3 Model/Catalog Number: 801398
  FDA Device · Class II · 2024-11-06 · Integra Lifesciences
• KING LTSD,SIZE 2, W/SUCTION PORT NON-STERILE KIT-Inserted into a patient s pharynx through the mouth to provide patent airway
  FDA Device · Class II · 2024-11-06 · King Systems
• Brand Name: Vial2Bag Advanced¿ Product Name: Vial2Bag Advanced¿ 20mm Admixture Device Model/Catalog Number: 6070030 Software Version: Not a…
  FDA Device · Class II · 2024-11-06 · West Pharmaceutical Services Az
• smith&nephew LEGION OXINIUM POSTERIOR STABILIZED NONPOROUS FEMORAL COMPONENT, SIZE 5N, RIGHT, NARROW, REF 71421275
  FDA Device · Class II · 2024-11-06 · Smith And Nephew
• SURG STRP 1-1/2X6 Model/Catalog Number: 801454
  FDA Device · Class II · 2024-11-06 · Integra Lifesciences
• SURG PAT XRAY 1X3 Model/Catalog Number: 801408
  FDA Device · Class II · 2024-11-06 · Integra Lifesciences
• Access Thyroglobulin Antibody II, REF A32898, containing Instructions for Use, IFU REF B14994, B63978, and A38168
  FDA Device · Class II · 2024-11-06 · Beckman Coulter
• GE Healthcare Giraffe Incubator Carestation CS1, Infant Incubator
  FDA Device · Class I · 2024-11-06 · Datex Ohmeda
• SURG PAT XRAY 3/4X3/4 Model/Catalog Number: 801401
  FDA Device · Class II · 2024-11-06 · Integra Lifesciences
• Abbott Alinity m STI AMP Kit, used with the Alinity m System, product codes: a) REF 09N17-095
  FDA Device · Class II · 2024-11-06 · Abbott Molecular
• LIFEPAK 15 (LP15) Model/Catalog Numbers: o 97577-000101 o 99577-000046 o 99577-000055 o 99577-000061 o 99577-000076 o 99577-001250 o 99577-…
  FDA Device · Class II · 2024-11-06 · Physio Control
• Olympus Electrosurgical Generator, Model Number ESG-410 (SEP) Version WA91327U
  FDA Device · Class II · 2024-11-06 · Olympus
• Product Name: Insight Base Flex - 8, Ref 608-3TX
  FDA Device · Class III · 2024-11-06 · Trackx Technology
• SURG STRP 3/4X6 Model/Catalog Number: 801452
  FDA Device · Class II · 2024-11-06 · Integra Lifesciences
• Phasitron5 Breathing Circuit (P5-10, P5-HC, P5-UC-10). component of Intrapulmonary Percussive Ventilation, used to provide airway clearance…
  FDA Device · Class I · 2024-11-06 · Percussionaire
• SURG PAT XRAY 1/4X1-1/2 Model/Catalog Number: 801397
  FDA Device · Class II · 2024-11-06 · Integra Lifesciences
• SURG PAT XRAY 1/4X1/4 Model/Catalog Number: 801399
  FDA Device · Class II · 2024-11-06 · Integra Lifesciences
• SURG PAT XRAY 1X1 Model/Catalog Number: 801403
  FDA Device · Class II · 2024-11-06 · Integra Lifesciences
• SURG STRP 3X6 Model/Catalog Number: 801456
  FDA Device · Class II · 2024-11-06 · Integra Lifesciences
• AVOXimeter 1000E, Product Number: AVOX1000E. The AVOXimeter 1000E is a battery-operated bedside whole blood oximeter
  FDA Device · Class II · 2024-11-06 · Accriva Diagnostics
• 1) Flex Extenders, 5.2" x 15mm OD x 15mm ID REF S6411P 2) Flex Extender, 5.2" x 15mm OD x 22/15mm ID REF 7 5132 The Westmed Flex Extenders…
  FDA Device · Class II · 2024-11-06 · Westmed
• MICR PATIE RND Model/Catalog Number: 801396
  FDA Device · Class II · 2024-11-06 · Integra Lifesciences
• SURG PAT XRAY 1/2X1 Model/Catalog Number: 801402
  FDA Device · Class II · 2024-11-06 · Integra Lifesciences
• Olympus Endoscopic Flushing Pump, Model/Catalog Number: OFP-2 (K10001141)
  FDA Device · Class II · 2024-11-06 · Olympus
• remel BactiDrop Acridine Orange, REF 21502, 50 per package
  FDA Device · Class II · 2024-11-06 · Remel
• Quest Spectrum 3 Fluorescent Imaging System Model/Catalog Number: ART-SYS-0029, ART-SYS-0030 The Quest Spectrum3 is a fluorescent imaging s…
  FDA Device · Class II · 2024-11-06 · Olympus
• SURG STRP 1X6-200 Model/Catalog Number: 801453
  FDA Device · Class II · 2024-11-06 · Integra Lifesciences
• KING LTSD,SIZE 0, W/SUCTION PORT NON-STERILE KIT-Inserted into a patient s pharynx through the mouth to provide patent airway
  FDA Device · Class II · 2024-11-06 · King Systems
• GE Healthcare Giraffe Omnibed Carestation CS1, combination infant incubator and infant warmer
  FDA Device · Class I · 2024-11-06 · Datex Ohmeda
• SURG STRP 3-1/2X6 Model/Catalog Number:801457
  FDA Device · Class II · 2024-11-06 · Integra Lifesciences
• KING LTSD,SIZE 2.5, W/SUCTION PORT STERILE-Inserted into a patient s pharynx through the mouth to provide patent airway
  FDA Device · Class II · 2024-11-06 · King Systems
• AMBU / KING LTSD, SIZE 0,1 W/SUCTION PORT, STERILE- Inserted into a patient s pharynx through the mouth to provide patent airway
  FDA Device · Class II · 2024-11-06 · King Systems
• smith&nephew LEIGON OXINIUM CONSTRAINED NONPOROUS FEMORAL COMPONENT, SIZE 4 LEFT, REF 71421164
  FDA Device · Class II · 2024-11-06 · Smith And Nephew
• SURG PAT XRAY 1/2X2 Model/Catalog Number: 801406
  FDA Device · Class II · 2024-11-06 · Integra Lifesciences
• KING LTSD,SIZE 1,W/SUCTION PORT STERILE-Inserted into a patient s pharynx through the mouth to provide patent airway
  FDA Device · Class II · 2024-11-06 · King Systems
• SURG PAT XRAY 1/2X1-1/2 Model/Catalog Number: 801404
  FDA Device · Class II · 2024-11-06 · Integra Lifesciences
• KING LTSD,SIZE 1, W/SUCTION PORT NON-STERILE KIT-Inserted into a patient s pharynx through the mouth to provide patent airway
  FDA Device · Class II · 2024-11-06 · King Systems
• Baxter Operating Table TruSystem 7000 (MBW), Product code REF 1841048
  FDA Device · Class II · 2024-10-30 · Baxter Healthcare
• Medline EYE PACK, REF LYN036EPESB
  FDA Device · Class II · 2024-10-30 · Medline Industries Northfield
• CADD Medication Cassette Reservoir, 100mL, FS, YELLOW, Product Code 21-7300-24
  FDA Device · Class II · 2024-10-30 · Smiths Medical Asd
• AD-TECH Spencer Probe Depth Electrode, REF SD08R-AP58X-000 8-Contact 1.12mm (A style) Depth Electrode
  FDA Device · Class II · 2024-10-30 · Ad Tech Medical Instrument
• medex Arterial Kit 1/EA, Product Code REF MX7827
  FDA Device · Class II · 2024-10-30 · Smiths Medical Asd
• CADD Medication Cassette Reservoir, 50mL, FS, Product Code 21-7301-24JP
  FDA Device · Class II · 2024-10-30 · Smiths Medical Asd
• STERILIZABLE INTERNAL DEFIBRILLATION PADDLES REF LP20 STERILIZABLE INTERNAL DEFIBRILLATION PADDLES REF LP15 Defibrillation is indicated for…
  FDA Device · Class II · 2024-10-30 · Physio Control
• medex TranStar KIDS KIT 34IN. CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA, Product Code REF MX9545
  FDA Device · Class II · 2024-10-30 · Smiths Medical Asd
• Medline PEDIATRIC DRAPE PK, REF DYNJ81297
  FDA Device · Class II · 2024-10-30 · Medline Industries Northfield
• Medline brand, medical procedure convenience kits, labeled as: a) SET UP PACK, REF DYNJ36320A
  FDA Device · Class II · 2024-10-30 · Medline Industries Northfield
• medex TranStar KIDS KIT 7INCH CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA, Product Code REF MX9547
  FDA Device · Class II · 2024-10-30 · Smiths Medical Asd
• medex TRANSTAR MONITORING KIT 1/EA, Product Code REF MX20103R1
  FDA Device · Class II · 2024-10-30 · Smiths Medical Asd
• Medline IV TEAM PICC, REF DYNJ48222
  FDA Device · Class II · 2024-10-30 · Medline Industries Northfield
• CADD Medication Cassette Reservoir, 50mL, FS, Product Code 21-7301-24
  FDA Device · Class II · 2024-10-30 · Smiths Medical Asd
• EZDilate Wire Guided Balloon- Indicated for use in adult and adolescent (> 12 years) populations to endoscopically dilate strictures of the…
  FDA Device · Class II · 2024-10-30 · Olympus
• CADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24
  FDA Device · Class II · 2024-10-30 · Smiths Medical Asd
• Medline brand medical procedure convenience kits, labeled as: a) KIT LINE INSERTION, REF CVI4730A
  FDA Device · Class II · 2024-10-30 · Medline Industries Northfield
• CADD Medication Cassette Reservoir, 100mL, Product Code 21-7002-24
  FDA Device · Class II · 2024-10-30 · Smiths Medical Asd

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)