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15,654 recalls
High RiskFDA
Young Dental Manufacturing I, Llc
Darby Prophylaxis Paste with 1.23% Fluoride Ion, Mint Coarse
Medical Devices·534 affected·May 13, 2024
High RiskFDA
Ethicon, Inc.
PDS Plus Antibacterial (polydioxanone) Suture - Intended for use in general soft tissue approximation, including use in paediatric cardio...
Medical Devices·45,828 affected·May 10, 2024
High RiskFDA
Ethicon, Inc.
MONOCRYL (poliglecaprone 25) Suture - Intended for use in general soft tissue approximation and/or ligation where an absorbable material ...
Medical Devices·306,000 affected·May 10, 2024
High RiskFDA
Ethicon, Inc.
VICRYL (polyglactin 910) Suture - Indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic sur...
Medical Devices·341,532 affected·May 10, 2024
CriticalFDA
Canon Medical System, Usa, Inc.
MRI systems: Vantage Orian MRT-1550 (MEXL-1550), Vantage Elan MRT-2020 (MEXL-1520), Vantage Titan MRT-1504 (MEXL-1504), Vantage Titan 3T ...
Medical Devices·153 affected·May 10, 2024
High RiskFDA
Ethicon, Inc.
PDS II (polydioxanone) Suture - Intended for use in general soft tissue approximation, including use in paediatric cardiovascular tissue,...
Medical Devices·56,952 affected·May 10, 2024
High RiskFDA
Ion Beam Applications S.a.
IBA Proton Therapy System - PROTEUS 235 - Designed to produce and deliver a proton beam for the treatment of patients with localized tumo...
Medical Devices·2 affected·May 10, 2024
High RiskFDA
Ethicon, Inc.
VICRYL Plus Antibacterial (polyglactin 910) Suture - Indicated for use in general soft tissue approximation and/or ligation, except for o...
Medical Devices·55,296 affected·May 10, 2024
High RiskFDA
Beaver Visitec International, Inc.
Xstar Safety Slit Knife, 2.75 mm 45¿ Bevel Up, Model Number 378227
Medical Devices·1,300 affected·May 10, 2024
High RiskFDA
Sol-millennium Medical Inc.
Syringes with Eccentric Tips labeled as: 1) SOL-M 10ml Eccentric Tip Syringe w/o Needle, Model No. P180010ET, UPC 81001809551; 2) SO...
Medical Devices·0 affected·May 9, 2024
High RiskFDA
Sol-millennium Medical Inc.
Syringes with Luer Slip Tips labeled as: 1) SOL-M 1ml Slip Tip Syringe w/o Needle, Model No. 180011, UPC 8183923010138; 2) SOL-M 1ml...
Medical Devices·0 affected·May 9, 2024
High RiskFDA
Sol-millennium Medical Inc.
Syringes with Low Dead Space labeled as: a) SOL-M 1ml Slip Tip Syringe w/o needle (low dead space), Model No. 180011LDS, UPC 840368511...
Medical Devices·0 affected·May 9, 2024
High RiskFDA
Stryker Gmbh
Stryker Hoffman LRF Wire Tensioner REF 4933-9-100, a component of the Hoffmann LRF System.
Medical Devices·39 affected·May 9, 2024
High RiskFDA
Sol-millennium Medical Inc.
Syringes with exchangeable needles labeled as: SOL-CARE: 1) SOL-CARE 10ml Luer Lock Syringe w/Safety Needle 21G*1 1/2 (needle asid...
Medical Devices·0 affected·May 9, 2024
High RiskFDA
First Source Inc
First Source Vision M. Portable cart and platform that supports an X-ray system and laptop computer.
Medical Devices·680 affected·May 9, 2024
High RiskFDA
Baxter Healthcare Corporation
Centrella Max - The Centrella Smart+ Bed is intended for use in healthcare environments as a patient support system to prevent and/or tre...
Medical Devices·38,136 affected·May 8, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Medline ReNewal Reprocessed Covidien LigaSure Maryland Jaw Sealer/Divider, Nano-Coated, Compatible w/ FT10 37 cm FT10 SW Version 4.0.1.15...
Medical Devices·2,860 affected·May 7, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Medline ReNewal Reprocessed Covidien LigaSure Blunt Tip, Sealer/Divider, Nano-Coated, Compatible w/ FT10 37cm FT10 SW Version 4.0.1.15 or...
Medical Devices·3,618 affected·May 7, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Medline ReNewal Reprocessed Covidien LigaSure Impact, Sealer/Divider, Nano-Coated, Compatible w/ FT10 18cm FT10 SW Version 4.0.1.15 or lo...
Medical Devices·230 affected·May 7, 2024
CriticalFDA
Icu Medical Inc
Replacement Battery List Number SUB0000594 and SUB0000864 found in Plum A+ & Plum A+3 Infusion Systems, Pump List Numbers: 11005, 11971, ...
Medical Devices·14,744 affected·May 7, 2024
High RiskFDA
Blue Belt Technologies, Inc
CORI Starter Kit, Real Intelligence CORI, CORI STARTER KIT - UNIVERSAL.Intended to assist the surgeon in providing software-defined spati...
Medical Devices·916 affected·May 7, 2024
High RiskFDA
Novasignal Corp.
NovaGuide 2 Traditional Ultrasound , REF: NSC-TCDNG2
Medical Devices·28 affected·May 6, 2024
High RiskFDA
Novasignal Corp.
NovaGuide 2 Intelligent Ultrasound, REFs: NSC-NVGSYS2 & NSC-NVGSYS2-CA
Medical Devices·45 affected·May 6, 2024
High RiskFDA
American Contract Systems, Inc.
American Contract Systems Spine Pack convenience kit
Medical Devices·3 affected·May 6, 2024
High RiskFDA
American Contract Systems, Inc.
American Contract Systems Hand Pack convenience kit
Medical Devices·90 affected·May 6, 2024
High RiskFDA
American Contract Systems, Inc.
American Contract Systems Biopsy Drape Pack convenience kit
Medical Devices·224 affected·May 6, 2024
High RiskFDA
Atrium Medical Corporation
ADVANTA VXT, 6X80, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft
Medical Devices·53,308 affected·May 3, 2024
CriticalFDA
Philips North America Llc
Achieva 3.0T Model Number (REF): (1) 781345; (2) 781344; (3) 781278; (4) 781277; (5) 781177
Medical Devices·386 affected·May 3, 2024
High RiskFDA
Philips North America Llc
HA FlexTrak II-Patient transport functionality to transport the patient from the preparation area to the MR system, Product Number: 9897...
Medical Devices·590 affected·May 3, 2024
High RiskFDA
Atrium Medical Corporation
ADVANTA VXT, 6X70, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft
Medical Devices·53,308 affected·May 3, 2024
High RiskFDA
Atrium Medical Corporation
ADVANTA VXT, 7X70, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft
Medical Devices·53,308 affected·May 3, 2024
CriticalFDA
Philips North America Llc
Ingenia Ambition S Model Number (REF): (1) 782139; (2) 782133; (3) 782108; (4) 781359
Medical Devices·328 affected·May 3, 2024
High RiskFDA
Atrium Medical Corporation
ADVANTA VXT, 5X50, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft
Medical Devices·53,308 affected·May 3, 2024
High RiskFDA
Atrium Medical Corporation
FLIXENE, 4-6X35, 2GDS, GWT-GW. Double-Ended Slider GDS. Vascular graft
Medical Devices·53,308 affected·May 3, 2024
High RiskFDA
Atrium Medical Corporation
ADVANTA VXT, 7X70, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft
Medical Devices·53,308 affected·May 3, 2024
CriticalFDA
Philips North America Llc
SmartPath to dStream for 3.0T Model Number (REF): 782145
Medical Devices·3 affected·May 3, 2024
High RiskFDA
Atrium Medical Corporation
ADVANTA VXT, 7X70, 1GDS, NH, STR-TW. Single-Ended Slider GDS. Vascular graft
Medical Devices·53,308 affected·May 3, 2024
CriticalFDA
Philips North America Llc
Evolution upgrade 3.0T Model Number (REF): (1)782117; (2) 782143
Medical Devices·0 affected·May 3, 2024
High RiskFDA
Atrium Medical Corporation
FLIXENE, 6X50, 1GDS, STR. Single-Ended Slider GDS. Vascular graft
Medical Devices·53,308 affected·May 3, 2024
High RiskFDA
Atrium Medical Corporation
FLIXENE, 4-6X45, 2GDS, GWT-GW. Double-Ended Slider GDS. Vascular graft
Medical Devices·53,308 affected·May 3, 2024
High RiskFDA
Atrium Medical Corporation
ADVANTA VXT, 6X70, 1GDS, NH, STR-TW. Single-Ended Slider GDS. Vascular graft
Medical Devices·53,308 affected·May 3, 2024
High RiskFDA
Atrium Medical Corporation
FLIXENE, 4-7X45, 2GDS, GWT-GW. Double-Ended Slider GDS. Vascular graft
Medical Devices·53,308 affected·May 3, 2024
High RiskFDA
Atrium Medical Corporation
FLIXENE, 7X50, 1GDS, STR. Single-Ended Slider GDS. Vascular graft
Medical Devices·53,308 affected·May 3, 2024
High RiskFDA
Philips North America Llc
HA FlexTrak-Patient transport functionality to transport the patient from the preparation area to the MR system, Product Number: 9897100...
Medical Devices·100 affected·May 3, 2024
High RiskFDA
Atrium Medical Corporation
FLIXENE, 4-6X45, 2GDS, GWT. Double-Ended Slider GDS. Vascular graft
Medical Devices·53,308 affected·May 3, 2024
High RiskFDA
Atrium Medical Corporation
ADVANTA VXT, 8X70, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft
Medical Devices·53,308 affected·May 3, 2024
High RiskFDA
Atrium Medical Corporation
FLIXENE, 7X80, 1GDS, GW. Single-Ended Slider GDS. Vascular graft
Medical Devices·53,308 affected·May 3, 2024
High RiskFDA
Atrium Medical Corporation
FLIXENE, 7X40, 1GDS, GW. Single-Ended Slider GDS. Vascular graft
Medical Devices·53,308 affected·May 3, 2024