Category

Medical Devices Recalls

15,654 medical devices recalls on record from CPSC, FDA, and USDA.

15,654 recalls
High RiskFDA
Coltene Whaledent Inc
SciCan STATIS SL S10001 Dental Handpieces-Intended for the removal of carious material, reducing hard tooth structure, cavity preparation...
Medical Devices·3,896 affected·Jan 20, 2023
High RiskFDA
Linet Spol. S.r.o.
Sprint 200 wheeled stretcher, Item numbers 1ES200-7, 1ES210-1, and 1ES211-1.
Medical Devices·335 affected·Jan 18, 2023
High RiskFDA
Hologic, Inc.
Hologic 3Dimensions/Selenia Dimensions Models: RM-SDM-00001-3D SDM-00001-2D SDM-00001-3D SDM-05000-3D3 SDM-05000-2DC SDM-00001-M3...
Medical Devices·797 affected·Jan 16, 2023
High RiskFDA
Fujifilm Irvine Scientific, Inc.
Irvine Scientific Oil for Embryo Culture (Light Mineral Oil) REF Catalog # 9305
Medical Devices·15,131 affected·Jan 16, 2023
High RiskFDA
Siemens Medical Solutions Usa, Inc.
SIEMENS Biograph mCT: a) Flow 64-4R Seismic, b) S(40)-3R Seismic, c) S(64)-3R Seismic, d) S(40)-4R Seismic, e) S(64)-4R Seismic, f) S(20...
Medical Devices·6 affected·Jan 16, 2023
High RiskFDA
Siemens Medical Solutions Usa, Inc.
SIEMENS Biograph Vision: a) 450, b) 600, c) 600 Edge
Medical Devices·4 affected·Jan 16, 2023
High RiskFDA
Summit Medical, Llc
Summit Medical Nasal Septal Button, Medium, 5cm, REF SP-78105, sterile.
Medical Devices·30 affected·Jan 13, 2023
High RiskFDA
Wishbone Medical, Inc.
WishBone Medical Smart Correction Dual Joint Express Struts, external skeleton fixation device Type Part Number XXS ...
Medical Devices·195 affected·Jan 4, 2023
RecallFDA
Owens & Minor Distribution, Inc.
FLUIDSHIELD 3 Fog-Free Procedure Mask with SO SOFT Lining and SO SOFT Earloops, Orange, WrapAround Visor Product Code 47147
Medical Devices·73 affected·Jan 3, 2023
High RiskFDA
Medline Industries, Lp - Northfield
(1) Medline Sterile Hand Pack, Item DYNJ63380A, 3 kits per case, contains BD Chloraprep Hi-Lite Orange, 26 mL Applicator, Vendor PN: 9308...
Medical Devices·1,689 affected·Dec 27, 2022
High RiskFDA
Medline Industries, Lp - Northfield
Medline Sterile Oncology Port Access Tray, Item #DYNDC2239, 20 sterile kits per case, containing Ethicon Biopatch Protective Disk with CH...
Medical Devices·4,360 affected·Dec 27, 2022
High RiskFDA
Medline Industries, Lp - Northfield
(1) Medline Sterile Maximum Barrier Pack-LF, Item DYNJ0248546C, 6 kits per case, contains BD Chloraprep Hi-Lite Orange, 10.5 mL Applicato...
Medical Devices·720 affected·Dec 27, 2022
High RiskFDA
Quest Medical, Inc.
Precision Delivery Set with Filter, REF: PD06F; and Precision Delivery Set with Trifurcated Luer, REF: PDT05CV2
Medical Devices·13,900 affected·Dec 23, 2022
High RiskFDA
Philips Healthcare (suzhou) Co., Ltd.
Incisive CT, model 728143 & 728144 running Software Version 5.0.0.
Medical Devices·828 affected·Dec 23, 2022
High RiskFDA
Access Vascular, Inc
HydroMID 4Fr Single Lumen Maximal Barrier Kit- Indicated for short term access (<30days) to the peripheral venous access system for int...
Medical Devices·155 affected·Dec 22, 2022
High RiskFDA
Sunmed Holdings, Llc
Air-Q3 AirQ3 Standard ILA with Manual Cuff Inflation and GA Size REF Number 0.0 50005 0.5 50055 1.0 ...
Medical Devices·43,290 affected·Dec 22, 2022
CriticalFDA
Getinge Usa Sales Inc
Getinge Flow-e Anesthesia System, Part No. 6887900
Medical Devices·8 affected·Dec 22, 2022
High RiskFDA
Medline Industries, Lp - Northfield
MEDLINE UNITE FOOT & ANKLE DRILL BIT, 1.3MM Solid Core, REF MPN10013
Medical Devices·190 affected·Dec 22, 2022
CriticalFDA
Getinge Usa Sales Inc
Getinge Flow-c Anesthesia System, Part No. 6887700
Medical Devices·8 affected·Dec 22, 2022
High RiskFDA
Trimed Inc.
RipCord Syndesmosis Button, REF: STA001K
Medical Devices·76 affected·Dec 22, 2022
CriticalFDA
Getinge Usa Sales Inc
Getinge Flow-i Anesthesia Systems Flow-i C20, Part no. 6677200 Flow-i C30, Part no. 6677300 Flow-i C40, Part no. 6677400
Medical Devices·8,016 affected·Dec 22, 2022
High RiskFDA
Access Vascular, Inc
HydroMID 4Fr Single Lumen Maximal Barrier Kit-indicated for short term access (<30days) to the peripheral venous access system for intr...
Medical Devices·445 affected·Dec 22, 2022
High RiskFDA
Maquet Cardiovascular, Llc
Vasoshield Syringe Packs, Model VH-5001
Medical Devices·530 affected·Dec 22, 2022
High RiskFDA
Maquet Cardiovascular, Llc
Hemopro 2 with Vasoshield, Model VH-4001
Medical Devices·9,817 affected·Dec 22, 2022
High RiskFDA
Siemens Medical Solutions Usa, Inc
Software : myNeedle Guide 2D license, myNeedle Guide 2D AWP only Workflow license, or myNeedle Guide 3D license. Used on the followin...
Medical Devices·29 affected·Dec 22, 2022
High RiskFDA
Roche Molecular Systems, Inc.
cobas SARS-CoV-2 & Influenza A/B Qualitative nucleic acid test for use on the cobas 5800/6800/8800 Systems; Material Number 09446125190
Medical Devices·9,948 affected·Dec 21, 2022
High RiskFDA
Olympus Corporation Of The Americas
EVIS EXERA III Colonovideoscope-For endoscopy and endoscopic surgery within the lower digestive tract (including the anus, rectum, sigmoi...
Medical Devices·1 affected·Dec 21, 2022
High RiskFDA
Beaver Visitec International, Inc.
Ultracell Wick with 80cc Collection Bag, 20/box
Medical Devices·4,640 affected·Dec 20, 2022
CriticalFDA
Ge Medical Systems Israel, Functional Imaging
GE Nuclear Medicine 600/800 series systems, specifically: a) BRIVO B615 3/8 inch DHP BJG NR, b) BRIVO 615 3/8 inch, c) BRIVO B615 3/8...
Medical Devices·7 affected·Dec 19, 2022
CriticalFDA
Ge Medical Systems Israel, Functional Imaging
GE Nuclear Medicine 600/800 series systems, specifically: a) 830, b) 830 / Dismount, c) 830 /, d) 830 / 5842894-20, e) 830 / Dismou...
Medical Devices·748 affected·Dec 19, 2022
CriticalFDA
Ge Medical Systems Israel, Functional Imaging
GE Nuclear Medicine 600/800 series systems, specifically: a) 870 CZT O540+ Gantry 7.25mm, b) D670 CZT Gantry 7.25mm, c) DISCOV NM/CT 8...
Medical Devices·86 affected·Dec 19, 2022
CriticalFDA
Datascope Corp.
Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-34, 099...
Medical Devices·11,906 affected·Dec 19, 2022
CriticalFDA
Ge Medical Systems Israel, Functional Imaging
GE Nuclear Medicine 600/800 series systems, specifically: a) 850, b) 850 / Dismount, c) 850 3/8 inch NM Gantry, d) 860 / Dismount, e)...
Medical Devices·380 affected·Dec 19, 2022
High RiskFDA
Siemens Medical Solutions Usa, Inc
ARTIS pheno, ARTIS icono biplane, and ARTIS icono floor
Medical Devices·550 affected·Dec 16, 2022
High RiskFDA
Access Vascular, Inc
HydroPICC 4Fr Single Lumen, 80cm Guidewire - Basic Kit, Model Number 80001002
Medical Devices·0 affected·Dec 16, 2022
High RiskFDA
Carbon Medical Technologies, Inc.
Mammotome MammoStar Biopsy Site Identified, REF STAR1401
Medical Devices·550 affected·Dec 16, 2022
High RiskFDA
Novasignal Corp.
NovaGuide Intelligent Ultrasound System, Model: NA-RBTSYS1. Comprised of NovaBot Automated Headset (AKA: NeuralBot, Model: NA-RBT1) and L...
Medical Devices·4 affected·Dec 16, 2022
High RiskFDA
Access Vascular, Inc
HydroMID 4Fr Single Lumen - Basic Kit, Model Number 80004002
Medical Devices·1,789 affected·Dec 16, 2022
High RiskFDA
Siemens Medical Solutions Usa, Inc
System Material # Artis zee floor 10094135 Artis zee ceiling 10094137 Artis zee multi-purpose 10094139 Artis zee biplane 10094141 ...
Medical Devices·609 affected·Dec 16, 2022
High RiskFDA
Stradis Healthcare
McCormick Medical Distribution PORT TRAY, 25 trays per case. Distributed by McCormick Medical Distribution.
Medical Devices·250 affected·Dec 15, 2022
High RiskFDA
Stradis Healthcare
HCT 12 CC SYRINGE KIT, 20/TRAY,5 TRAYS/BAG, 5 BAGS /CASE HCT. Distributed by Health Care Technology.
Medical Devices·112,675 affected·Dec 15, 2022
High RiskFDA
Stradis Healthcare
HCT 6 CC SYRINGE KIT, 25/TRAY, 4 TRAYS/BAG, 5 BAGS/CASE. Distributed by Health Care Technology.
Medical Devices·76,260 affected·Dec 15, 2022
High RiskFDA
Teknimed Sas
HIGH V+ Spinal Cement System REF T040321K
Medical Devices·236 affected·Dec 15, 2022
High RiskFDA
Meridian Bioscience Inc
Revogene SARS-CoV-2_IVD real-time RT-PCR test intended for the qualitative detection of RNA from SARSCoV-2 Catalog Number: 410700
Medical Devices·92 affected·Dec 15, 2022
High RiskFDA
Stradis Healthcare
Stradis Healthcare TCTR Convenience Kit. Manufactured by Stradis Healthcare.
Medical Devices·80 affected·Dec 15, 2022
High RiskFDA
Stradis Healthcare
HCT MAX BARRIER PICC INSERTION TRAY 12 per case. Distributed by Health Care Technology
Medical Devices·200 affected·Dec 15, 2022
High RiskFDA
Stradis Healthcare
Tacy Medical, Inc Syringe Convenience Pack, IML L/L, Sterile, 60 packs per bag, 5 bags per case. Manufactured for Tracy Medical, Inc.
Medical Devices·275 affected·Dec 15, 2022
High RiskFDA
Stradis Healthcare
Vital Care Products NEONATAL PICC TRAY, Sterile, QTY 20. Manufactured for Vital Care Products, Inc.
Medical Devices·200 affected·Dec 15, 2022