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.
- BiPAP A30 Ventilator, Part Number 1111143 (US and OUS) OUS Only: Part Numbers 1111144 1111145 1111147 1111148 1111149 1111150 1111154 11111…
FDA Device · Class I · 2024-05-29 · Philips Respironics - Brand Name: MEDLINE Product Name: SYR 20ML L/L RED Model/Catalog Number: 91835 Product Description: NON-Sterile syringes without needles fo…
FDA Device · Class II · 2024-05-29 · Jiangsu Shenli Medical Production - Brand Name: MEDLINE Product Name: SYR 20ML/L WHITE HEP FLUSH Model/Catalog Number: 91862 Product Description: NON-Sterile syringes without…
FDA Device · Class II · 2024-05-29 · Jiangsu Shenli Medical Production - Ingenia Elition X- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device
FDA Device · Class II · 2024-05-29 · Philips North America - Ingenia 1.5T S Model Number (REF): 781347
FDA Device · Class II · 2024-05-29 · Philips North America - SmartPath to Ingenia Elition X - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device
FDA Device · Class II · 2024-05-29 · Philips North America - Brand Name: GMAX Product Name: SYR 10ML/LL syringe Model/Catalog Number: TS2210L-M Product Description: NON-Sterile syringes without needle…
FDA Device · Class II · 2024-05-29 · Jiangsu Shenli Medical Production - Brand Name: MEDLINE Product Name: SYR 3ML L/S Model/Catalog Number: 83083 Product Description: NON-Sterile syringes without needles for sin…
FDA Device · Class II · 2024-05-29 · Jiangsu Shenli Medical Production - Brand Name: MEDLINE Product Name: SYR 5ML L/L RED Model/Catalog Number: 91825 Product Description: NON-Sterile syringes without needles for…
FDA Device · Class II · 2024-05-29 · Jiangsu Shenli Medical Production - Achieva 3.0T Model Number (REF): (1) 781345
FDA Device · Class II · 2024-05-29 · Philips North America - Brand Name: MEDLINE Product Name: SYR 10ML L/L RED HEPARIN Model/Catalog Number: 91851 Product Description: NON-Sterile syringes without ne…
FDA Device · Class II · 2024-05-29 · Jiangsu Shenli Medical Production - Upgrade dStream - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device Model Number (REF…
FDA Device · Class II · 2024-05-29 · Philips North America - Brand Name: Wolf Medical - WOLF-PAK Product Name: DISPOSABLE SYRINGE 1 mL (cc) Luer Lock STERILE LATEX FREE NON PYROGENIC Model/Catalog Num…
FDA Device · Class II · 2024-05-29 · Jiangsu Shenli Medical Production - Brand Name: MEDLINE Product Name: SYR 10ML L/L YELLOW LIDO Model/Catalog Number: 91854 Product Description: NON-Sterile syringes without ne…
FDA Device · Class II · 2024-05-29 · Jiangsu Shenli Medical Production - OmniLab Advanced + Ventilator Product Numbers 1111122 1111123 1111124 1111125 1111126 1111127 1111138 1111141 1111142 KR1111127 R1111122 R1…
FDA Device · Class I · 2024-05-29 · Philips Respironics - Brand Name: Wolf Medical Product Name: 6 mL (cc) Luer Lock STERILE LATEX FREE NON PYROGENIC Model/Catalog Number: SYR06L Product Descriptio…
FDA Device · Class II · 2024-05-29 · Jiangsu Shenli Medical Production - Brand Name: MEDLINE Product Name: SYR 20ML L/L YELLOW Model/Catalog Number: 91839 Product Description: NON-Sterile syringes without needles…
FDA Device · Class II · 2024-05-29 · Jiangsu Shenli Medical Production - IMMULITE 2000 Anti-TG Ab Catalog # L2KTG6 (600 Tests), SMN 10381655, System, Test, Thyroid Autoantibody
FDA Device · Class II · 2024-05-29 · Siemens Healthcare Diagnostics - 2008T BlueStar Hemodialysis Machine, Model 191128 with Component: Blood Pump Rotor, Model Number: F40015481 Rev A
FDA Device · Class II · 2024-05-29 · Fresenius Medical Care Holdings - SURGIFOAM" Absorbable Gelatin Powder Kit, Product Code 1979
FDA Device · Class II · 2024-05-29 · Ethicon - Noblus AC Adapter used with the Noblus Ultrasound Imaging System Model : AHM250PS24
FDA Device · Class II · 2024-05-29 · Fujifilm Healthcare Americas - Brand Name: MEDLINE Product Name: SYR CNTRL 10ML L/L BLUE Model/Catalog Number: 91880 Product Description: NON-Sterile syringes without nee…
FDA Device · Class II · 2024-05-29 · Jiangsu Shenli Medical Production - Brand Name: MEDLINE Product Name: SYR 10ML L/L WHITE Model/Catalog Number: 91833 Product Description: NON-Sterile syringes without needles…
FDA Device · Class II · 2024-05-29 · Jiangsu Shenli Medical Production - Brand Name: MEDLINE Product Name: SYR 5ML L/L YELLOW NITRO Model/Catalog Number: 91852 Product Description: NON-Sterile syringes without ne…
FDA Device · Class II · 2024-05-29 · Jiangsu Shenli Medical Production - Brand Name: MEDLINE Product Name: SYR 3ML L/L RED Model/Catalog Number: 91820 Product Description: NON-Sterile syringes without needles for…
FDA Device · Class II · 2024-05-29 · Jiangsu Shenli Medical Production - Brand Name: MEDLINE Product Name: SYR 10ML L/L YELLOW HEP/SALINE Model/Catalog Number: 91855 Product Description: NON-Sterile syringes with…
FDA Device · Class II · 2024-05-29 · Jiangsu Shenli Medical Production - Brand Name: MEDLINE Product Name: SYR 20ML/L PURPLE Model/Catalog Number: 91843 Product Description: NON-Sterile syringes without needles f…
FDA Device · Class II · 2024-05-29 · Jiangsu Shenli Medical Production - Brand Name: MEDLINE Product Name: SYR CNTRL 10ML L/L GREEN Model/Catalog Number: 91879 Product Description: NON-Sterile syringes without ne…
FDA Device · Class II · 2024-05-29 · Jiangsu Shenli Medical Production - Brand Name: MEDLINE Product Name: SYR 5ML L/L PURPLE Model/Catalog Number: 91841 Product Description: NON-Sterile syringes without needles…
FDA Device · Class II · 2024-05-29 · Jiangsu Shenli Medical Production - Brand Name: GMAX Product Name: SYR 12ML/LL syringe Model/Catalog Number: TS2212L-M Product Description: NON-Sterile syringes without needle…
FDA Device · Class II · 2024-05-29 · Jiangsu Shenli Medical Production - Achieva 3.0T for PET -Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device Model Number…
FDA Device · Class II · 2024-05-29 · Philips North America - Evolution upgrade 3.0T Model Number (REF): (1)782117
FDA Device · Class II · 2024-05-29 · Philips North America - 2008T BlueStar Hemodialysis Machine, Model 191126 with Component: Blood Pump Rotor, Model Number: F40015481 Rev A
FDA Device · Class II · 2024-05-29 · Fresenius Medical Care Holdings - Ingenia 1.5T CX - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device
FDA Device · Class II · 2024-05-29 · Philips North America - Brand Name: MEDLINE Product Name: SYR 20ML L/L GREEN Model/Catalog Number: 91836 Product Description: NON-Sterile syringes without needles…
FDA Device · Class II · 2024-05-29 · Jiangsu Shenli Medical Production - Brand Name: MEDLINE Product Name: SYR 20ML L/S Model/Catalog Number: 83087 Product Description: NON-Sterile syringes without needles for si…
FDA Device · Class II · 2024-05-29 · Jiangsu Shenli Medical Production - Brand Name: MEDLINE Product Name: SYR 60ML L/L Model/Catalog Number: 83080 Product Description: NON-Sterile syringes without needles for si…
FDA Device · Class II · 2024-05-29 · Jiangsu Shenli Medical Production - Ingenia Ambition X- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device Model Number (R…
FDA Device · Class II · 2024-05-29 · Philips North America - SmartPath to dStream for 1.5T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device
FDA Device · Class II · 2024-05-29 · Philips North America - Brand Name: GMAX Product Name: SYR 5ML/LL syringe Model/Catalog Number: TS2205L-M Product Description: NON-Sterile syringes without needles…
FDA Device · Class II · 2024-05-29 · Jiangsu Shenli Medical Production - Brand Name: GMAX Product Name: SYR 20ML/LL syringe Model/Catalog Number: TS2220L-M Product Description: NON-Sterile syringes without needle…
FDA Device · Class II · 2024-05-29 · Jiangsu Shenli Medical Production - Brand Name: MEDLINE Product Name: SYR 5ML L/L RED NITRO Model/Catalog Number: 91866 Product Description: NON-Sterile syringes without needl…
FDA Device · Class II · 2024-05-29 · Jiangsu Shenli Medical Production - Brand Name: MEDLINE Product Name: SYR 10ML L/L YELLOW Model/Catalog Number: 91834 Product Description: NON-Sterile syringes without needles…
FDA Device · Class II · 2024-05-29 · Jiangsu Shenli Medical Production - Brand Name: MEDLINE Product Name: SYR 3ML L/L BLUE Model/Catalog Number: 91822 Product Description: NON-Sterile syringes without needles fo…
FDA Device · Class II · 2024-05-29 · Jiangsu Shenli Medical Production - Brand Name: GMAX Product Name: SYR 60ML/LL syringe Model/Catalog Number: TS2260L-M Product Description: NON-Sterile syringes without needle…
FDA Device · Class II · 2024-05-29 · Jiangsu Shenli Medical Production - Brand Name: MEDLINE Product Name: SYR 10ML L/L BLUE LIDO Model/Catalog Number: 91847 Product Description: NON-Sterile syringes without need…
FDA Device · Class II · 2024-05-29 · Jiangsu Shenli Medical Production - Brand Name: MEDLINE Product Name: SYR 60ML L/S Model/Catalog Number: 83079 Product Description: NON-Sterile syringes without needles for si…
FDA Device · Class II · 2024-05-29 · Jiangsu Shenli Medical Production - Brand Name: MEDLINE Product Name: SYR 5ML L/L BLUE HEPARIN Model/Catalog Number: 91867 Product Description: NON-Sterile syringes without ne…
FDA Device · Class II · 2024-05-29 · Jiangsu Shenli Medical Production - Optical Inspection System, YSi series, YRi series
FDA Device · Class II · 2024-05-29 · Yamaha Motor - Ingenia 3.0T CX Model Number (REF): (1) 782105 (2) 781271
FDA Device · Class II · 2024-05-29 · Philips North America - Prelude Guide Sheath Roadster, REF PG6F45S018, 6F 0.087" (2.2 mm), 45 cm, STERILE EO, RX ONLY
FDA Device · Class II · 2024-05-29 · Merit Medical Systems - Brand Name: MEDLINE Product Name: SYR 3ML L/L PURPLE Model/Catalog Number: 91840 Product Description: NON-Sterile syringes without needles…
FDA Device · Class II · 2024-05-29 · Jiangsu Shenli Medical Production - Brand Name: MEDLINE Product Name: SYR 20ML L/L WHITE Model/Catalog Number: 91838 Product Description: NON-Sterile syringes without needles…
FDA Device · Class II · 2024-05-29 · Jiangsu Shenli Medical Production - Cascade IOMAX Cortical Module, REF: 190296-200
FDA Device · Class II · 2024-05-29 · Cadwell Industries - Brand Name: MEDLINE Product Name: SYR 10ML L/L PURPLE Model/Catalog Number: 91842 Product Description: NON-Sterile syringes without needles…
FDA Device · Class II · 2024-05-29 · Jiangsu Shenli Medical Production - Brand Name: MEDLINE Product Name: SYR 5ML L/L GREEN Model/Catalog Number: 91826 Product Description: NON-Sterile syringes without needles f…
FDA Device · Class II · 2024-05-29 · Jiangsu Shenli Medical Production - MR RT - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device
FDA Device · Class II · 2024-05-29 · Philips North America - Integra¿ Cranial access kit (without Prep solutions) Bit and Guard- Used during a ventriculostomy procedure
FDA Device · Class II · 2024-05-29 · Integra Lifesciences - Achieva 3.0T TX for PET Model Number (REF): 781479
FDA Device · Class II · 2024-05-29 · Philips North America - Brand Name: GMAX Product Name: SYR 3ML/LL syringe Model/Catalog Number: TS2203L-M Product Description: NON-Sterile syringes without needles…
FDA Device · Class II · 2024-05-29 · Jiangsu Shenli Medical Production - Brand Name: MEDLINE Product Name: SYR 3ML L/L Model/Catalog Number: 83084 Product Description: NON-Sterile syringes without needles for sin…
FDA Device · Class II · 2024-05-29 · Jiangsu Shenli Medical Production - Brand Name: GMAX Product Name: SYR 35ML/LL syringe Model/Catalog Number: TS2235L-M Product Description: NON-Sterile syringes without needle…
FDA Device · Class II · 2024-05-29 · Jiangsu Shenli Medical Production - Brand Name: Wolf Medical Product Name: 35 mL (cc) Luer Lock STERILE LATEX FREE NON PYROGENIC Model/Catalog Number: SYR35L Product Descripti…
FDA Device · Class II · 2024-05-29 · Jiangsu Shenli Medical Production - Brand Name: MEDLINE Product Name: SYR 20ML L/L BLUE SALINE Model/Catalog Number: 91845 Product Description: NON-Sterile syringes without ne…
FDA Device · Class II · 2024-05-29 · Jiangsu Shenli Medical Production - Brand Name: GMAX Product Name: SYR 10ML/LS syringe Model/Catalog Number: TS2210S-M Product Description: NON-Sterile syringes without needle…
FDA Device · Class II · 2024-05-29 · Jiangsu Shenli Medical Production - Optum Nimbus II Plus, Model number AAA-00170
FDA Device · Class I · 2024-05-29 · Optumhealth Care Solutions - Panorama HFO- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device
FDA Device · Class II · 2024-05-29 · Philips North America - MR system 1.5T Marlin- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device
FDA Device · Class II · 2024-05-29 · Philips North America - MR RT Upgrades- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device
FDA Device · Class II · 2024-05-29 · Philips North America - Blood Pump Rotor, Model Number: F40015481 Rev A
FDA Device · Class II · 2024-05-29 · Fresenius Medical Care Holdings - Brand Name: GMAX Product Name: SYR 10ML/LL Blue syringe Model/Catalog Number: TS2210B-M Product Description: NON-Sterile syringes without n…
FDA Device · Class II · 2024-05-29 · Jiangsu Shenli Medical Production - Brand Name: GMAX Product Name: SYR 12ML/LS syringe Model/Catalog Number: TS2212S-M Product Description: NON-Sterile syringes without needle…
FDA Device · Class II · 2024-05-29 · Jiangsu Shenli Medical Production - Brand Name: MEDLINE Product Name: SYR 30ML/LS Model/Catalog Number: 83077 Product Description: NON-Sterile syringes without needles for sin…
FDA Device · Class II · 2024-05-29 · Jiangsu Shenli Medical Production - Achieva 1.5T Conversion- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device Model Numb…
FDA Device · Class II · 2024-05-29 · Philips North America - BiPAP A40 Ventilators: BiPAP A40, Part Numbers 1111169 (US and OUS) and (OUS ONLY)1111170 1111171 1111173 1111174 1111175 1111177 1116156 1…
FDA Device · Class I · 2024-05-29 · Philips Respironics - Incisive CT - Computed Tomography X-Ray System intended to produce cross-sectional images of the body
FDA Device · Class II · 2024-05-29 · Philips North America - Brand Name: MEDLINE Product Name: SYR CNTR 10ML L/L YELLOW Model/Catalog Number: 91876 Product Description: NON-Sterile syringes without ne…
FDA Device · Class II · 2024-05-29 · Jiangsu Shenli Medical Production - Brand Name: MEDLINE Product Name: SYR 10ML L/L GREEN CONT Model/Catalog Number: 91857 Product Description: NON-Sterile syringes without nee…
FDA Device · Class II · 2024-05-29 · Jiangsu Shenli Medical Production - Brand Name: Wolf Medical Product Name: 20 mL (cc) Luer Lock STERILE LATEX FREE NON PYROGENIC Model/Catalog Number: SYR20L Product Descripti…
FDA Device · Class II · 2024-05-29 · Jiangsu Shenli Medical Production - Brand Name: Wolf Medical Product Name: 3 mL (cc) Luer Lock STERILE LATEX FREE NON PYROGENIC Model/Catalog Number: SYR03L Product Descriptio…
FDA Device · Class II · 2024-05-29 · Jiangsu Shenli Medical Production - Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK 145 (5PKX3), REF H749085265022
FDA Device · Class I · 2024-05-22 · Boston Scientific - VITROS Immunodiagnostic Products Free T3 Calibrators-IVD are for use with Free T3 Reagent Pack for the quantitative measurement of free tri…
FDA Device · Class II · 2024-05-22 · Quidelortho - Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO JIG3.5 (5PK), REF H749085262522
FDA Device · Class I · 2024-05-22 · Boston Scientific - Sterile CoFlex NL: Latex Free Flexible Cohesive Bandage, Tan, 4INx5YD (5400S)
FDA Device · Class II · 2024-05-22 · Andover Healthcare - Medtronic Left Heart Vent Catheters: a) DLP¿ Intracardiac Sump 20 Fr, Model Number 12012, b) DLP¿ Left Heart Vent Catheter 10 Fr., Model Nu…
FDA Device · Class II · 2024-05-22 · Medtronic Perfusion Systems - Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO LCB (5PK), REF H749085261952
FDA Device · Class I · 2024-05-22 · Boston Scientific - TriMed, Threaded IM Nail 3.6mm, 60mm, TI, Ref: IMN3.6-60 T, Non Sterile, MD, Rx Only TriMed, Threaded IM Nail 3.6mm, 65mm, TI, Ref: IMN3.6-…
FDA Device · Class II · 2024-05-22 · Trimed - Medtronic Cardioplegia Adapters: a) DLP¿ 1.8 m (6 ft) Pressure Monitoring Extension Line Adapter, Model Number 25009, b) DLP¿ 1.8 m (6 ft)…
FDA Device · Class II · 2024-05-22 · Medtronic Perfusion Systems - Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR5 125CM (5PK), REF H749085262302
FDA Device · Class I · 2024-05-22 · Boston Scientific - CardinalHealth Curity Flexible Adhesive Bandage X-Large 2 x 3.75 in. (5.1 x 9.5 cm), Model 44102, Sterile, Hypoallergenic
FDA Device · Class II · 2024-05-22 · Cardinal Health 200 - EchoTip¿ Ultra Endoscopic Ultrasound Access Needle, ECHO-19, G31520
FDA Device · Class II · 2024-05-22 · Cook Medical - Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO CLS3.5 (5PK), REF H74908526574A2
FDA Device · Class I · 2024-05-22 · Boston Scientific - Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL5 125CM (5PK), REF H749085262352
FDA Device · Class I · 2024-05-22 · Boston Scientific - Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO TIG4 (5PK), REF H749085262502
FDA Device · Class I · 2024-05-22 · Boston Scientific - Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL6 (5PK), REF H74908526252
FDA Device · Class I · 2024-05-22 · Boston Scientific - Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO WRP (SGL), REF H74908526511
FDA Device · Class I · 2024-05-22 · Boston Scientific - Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO CAS1 (5PK), REF H749085261712
FDA Device · Class I · 2024-05-22 · Boston Scientific - Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO IM (5PK), REF H749085262012
FDA Device · Class I · 2024-05-22 · Boston Scientific - Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AL3 (5PK), REF H749085261002
FDA Device · Class I · 2024-05-22 · Boston Scientific - Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO JIG4 (5PK), REF H749085262532
FDA Device · Class I · 2024-05-22 · Boston Scientific
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)