FDA Medical Devices
U.S. Food and Drug Administration — Medical device recalls
26,000 recalls · Page 74 of 520
Moderate May 29, 2024
Brand Name: GMAX Product Name: SYR 6ML/LL syringe Model/Catalog Number: TS2206L-M Product Description: NON-Sterile syringes without needles for si…
Jiangsu Shenli Medical Production Co., Ltd.
Moderate May 29, 2024
Brand Name: MEDLINE Product Name: SYR 3ML L/L Model/Catalog Number: 83084 Product Description: NON-Sterile syringes without needles for single use…
Jiangsu Shenli Medical Production Co., Ltd.
Moderate May 29, 2024
Intera 1.5T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 781295
Philips North America Llc
Moderate May 29, 2024
Brand Name: MEDLINE Product Name: SYR 10ML L/L BLUE LIDO Model/Catalog Number: 91847 Product Description: NON-Sterile syringes without needles for…
Jiangsu Shenli Medical Production Co., Ltd.
Moderate May 29, 2024
Achieva 1.5T Initial system Model Number (REF): 781178
Philips North America Llc
Moderate May 29, 2024
Brand Name: GMAX Product Name: SYR 30ML/LL syringe Model/Catalog Number: TS2230L-M Product Description: NON-Sterile syringes without needles for s…
Jiangsu Shenli Medical Production Co., Ltd.
Moderate May 29, 2024
Brand Name: MEDLINE Product Name: SYR 5ML L/L PURPLE Model/Catalog Number: 91841 Product Description: NON-Sterile syringes without needles for sin…
Jiangsu Shenli Medical Production Co., Ltd.
Moderate May 29, 2024
MR RT - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 781439
Philips North America Llc
Moderate May 29, 2024
8000-021-002, Scopis¿ ENT Software with TGS¿ with Sofware Version: NOVA 3.6.0 RC16. Scopis is a next-generation solution for navigating functional en…
Stryker Leibinger GmbH & Co. KG
Moderate May 29, 2024
Brand Name: GMAX Product Name: SYR 10ML/LS syringe Model/Catalog Number: TS2210S-M Product Description: NON-Sterile syringes without needles for s…
Jiangsu Shenli Medical Production Co., Ltd.
Moderate May 29, 2024
Brand Name: Wolf Medical Product Name: 20 mL (cc) Luer Lock STERILE LATEX FREE NON PYROGENIC Model/Catalog Number: SYR20L Product Description: NON…
Jiangsu Shenli Medical Production Co., Ltd.
Moderate May 29, 2024
Brand Name: MEDLINE Product Name: SYR 5ML L/S Model/Catalog Number: 83085 Product Description: NON-Sterile syringes without needles for single use…
Jiangsu Shenli Medical Production Co., Ltd.
Moderate May 29, 2024
Brand Name: MEDLINE Product Name: SYR 5ML L/L GREEN Model/Catalog Number: 91826 Product Description: NON-Sterile syringes without needles for sing…
Jiangsu Shenli Medical Production Co., Ltd.
Moderate May 29, 2024
Ingenia Elition X- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 781…
Philips North America Llc
Critical May 29, 2024
OmniLab Advanced + Ventilator Product Numbers 1111122 1111123 1111124 1111125 1111126 1111127 1111138 1111141 1111142 KR1111127 R1111122 R111112…
Philips Respironics, Inc.
Moderate May 29, 2024
Brand Name: GMAX Product Name: SYR 60ML/LL syringe Model/Catalog Number: TS2260L-M Product Description: NON-Sterile syringes without needles for s…
Jiangsu Shenli Medical Production Co., Ltd.
Moderate May 29, 2024
Brand Name: MEDLINE Product Name: SYR 10ML L/L WHITE Model/Catalog Number: 91833 Product Description: NON-Sterile syringes without needles for sin…
Jiangsu Shenli Medical Production Co., Ltd.
Moderate May 29, 2024
Brand Name: Wolf Medical Product Name: 3 mL (cc) Luer Lock STERILE LATEX FREE NON PYROGENIC Model/Catalog Number: SYR03L Product Description: NON-…
Jiangsu Shenli Medical Production Co., Ltd.
Critical May 29, 2024
BiPAP A30 Ventilator, Part Number 1111143 (US and OUS) OUS Only: Part Numbers 1111144 1111145 1111147 1111148 1111149 1111150 1111154 1111…
Philips Respironics, Inc.
Moderate May 29, 2024
Brand Name: GMAX Product Name: SYR 12ML/LS syringe Model/Catalog Number: TS2212S-M Product Description: NON-Sterile syringes without needles for s…
Jiangsu Shenli Medical Production Co., Ltd.
Moderate May 29, 2024
Brand Name: Wolf Medical Product Name: 60 mL (cc) Luer Lock STERILE LATEX FREE NON PYROGENIC Model/Catalog Number: SYR60L Product Description: NON…
Jiangsu Shenli Medical Production Co., Ltd.
Moderate May 29, 2024
2008T BlueStar Hemodialysis Machine, Model 191130 with Component: Blood Pump Rotor, Model Number: F40015481 Rev A
Fresenius Medical Care Holdings, Inc.
Moderate May 29, 2024
Brand Name: GMAX Product Name: SYR 20ML/LS syringe Model/Catalog Number: TS2220S-M Product Description: NON-Sterile syringes without needles for s…
Jiangsu Shenli Medical Production Co., Ltd.
Moderate May 29, 2024
Achieva 1.5T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device Model Number (REF): (1) 7812…
Philips North America Llc
Moderate May 29, 2024
Brand Name: MEDLINE Product Name: SYR 5ML L/L YELLOW Model/Catalog Number: 91829 Product Description: NON-Sterile syringes without needles for sin…
Jiangsu Shenli Medical Production Co., Ltd.
Moderate May 29, 2024
Brand Name: MEDLINE Product Name: SYR 5ML L/L RED NITRO Model/Catalog Number: 91866 Product Description: NON-Sterile syringes without needles for …
Jiangsu Shenli Medical Production Co., Ltd.
Moderate May 29, 2024
Brand Name: GMAX Product Name: SYR 20ML/LL syringe Model/Catalog Number: TS2220L-M Product Description: NON-Sterile syringes without needles for s…
Jiangsu Shenli Medical Production Co., Ltd.
Moderate May 29, 2024
Brand Name: MEDLINE Product Name: SYR 10ML L/S BLUE Model/Catalog Number: 91872 Product Description: NON-Sterile syringes without needles for sing…
Jiangsu Shenli Medical Production Co., Ltd.
Moderate May 29, 2024
Panorama HFO- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 781350
Philips North America Llc
Moderate May 29, 2024
Brand Name: Wolf Medical Product Name: 35 mL (cc) Luer Lock STERILE LATEX FREE NON PYROGENIC Model/Catalog Number: SYR35L Product Description: NON…
Jiangsu Shenli Medical Production Co., Ltd.
Moderate May 29, 2024
Ingenia 3.0T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): (1) 782…
Philips North America Llc
Moderate May 29, 2024
Brand Name: Cerene Cryotherapy Device Product Name: DEVICE, THERMAL ABLATION, ENDOMETRIAL Model/Catalog Number: FGS-7000 Product Description: The …
Channel Medsystems, Inc.
Moderate May 22, 2024
CARDIOHELP-i System. Blood oxygenation and carbon dioxide removal system.
Maquet Medical Systems USA
Moderate May 22, 2024
Medtronic Disposable Pressure Display Sets: a) DLP¿ 114.3 cm (45 in), Model Number 61000; b) DLP¿ 114.3 cm (45 in), Model Number 62000
Medtronic Perfusion Systems
Critical May 22, 2024
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK (5PKX3), REF H749085263002; cardiac catheter
Boston Scientific Corporation
Moderate May 22, 2024
Ingenia 1.5T with Evolution Upgrade 1.5T - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device R…
Philips North America Llc
Moderate May 22, 2024
Medtronic Vessel Cannulae: a) DLP¿ 2 mm Vessel Cannula Blunt Tip, Model Number 30004; b) DLP¿ 3 mm Vessel Cannula Blunt Tip, Model Number 300…
Medtronic Perfusion Systems
Critical May 22, 2024
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR6 (5PK), REF H74908526042; cardiac catheter
Boston Scientific Corporation
Moderate May 22, 2024
The Sophysa Pressio¿ Ventricular Intracranial Pressure Monitoring Kit monitoring is intended for monitoring intracranial ventricular pressure and tem…
Sophysa S.A.
Critical May 22, 2024
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AR1 (5PK), REF H74908526842; cardiac catheter
Boston Scientific Corporation
Moderate May 22, 2024
Patient Information Center iX and Patient Information Center iX Expand, Software Version 4.x.
Philips North America Llc
Moderate May 22, 2024
Medtronic Intracoronary Shunts: a) ClearView¿ 1.00 mm Intracoronary Shunt, Model Numbers: 31100; b) ClearView¿ 1.25 mm Intracoronary Shunt, Mod…
Medtronic Perfusion Systems
Moderate May 22, 2024
Medtronic Left Heart Vent Catheters: a) DLP¿ Intracardiac Sump 20 Fr, Model Number 12012, b) DLP¿ Left Heart Vent Catheter 10 Fr., Model Number …
Medtronic Perfusion Systems
Moderate May 22, 2024
RKN130002, RHEO KNEE 2 YR WARRANTY, MD, CE, External lower limb prosthetic component
Ossur H / F
Moderate May 22, 2024
Namic FLUID DELIVERY SET, REF 91300040
MEDLINE INDUSTRIES, LP - Northfield
Moderate May 22, 2024
Novalung sensor box is a component of the Novalung Console (F30000162)-Indicated for long-term (> 6 hours) respiratory/ cardiopulmonary support that …
Fresenius Medical Care Holdings, Inc.
Critical May 22, 2024
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR4 (5PK), REF H74908526022; cardiac catheter
Boston Scientific Corporation
Critical May 22, 2024
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO IM (5PK), REF H749085262012; cardiac catheter
Boston Scientific Corporation
Moderate May 22, 2024
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) Press…
Medtronic Perfusion Systems
Critical May 22, 2024
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL5 125CM (5PK), REF H749085262352; cardiac catheter
Boston Scientific Corporation