Category

Medical Devices Recalls

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

15,654 recalls
High RiskFDA
Icu Medical De Mexico, S.a. De C.v.
216 cm (85") PVC/PUR Smallbore Bifuse Ext Set w/3-Port NanoClave Manifold, Check Valve, NanoClave, MicroClave Clear, Clamp, Rotating Luer.
Medical Devices·50 affected·Mar 1, 2018
High RiskFDA
Icu Medical De Mexico, S.a. De C.v.
61 cm (24") Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, MicroClave Clear, 1.2 Micron Filter, 3 Gang 4-Way NanoClave Stopc...
Medical Devices·100 affected·Mar 1, 2018
High RiskFDA
Icu Medical De Mexico, S.a. De C.v.
43 cm (17") Smallbore Ext Set w/3-Port NanoClave Manifold, Check Valve, NanoClave, 0.2 Micron Filter, 2 BCV-Clave, Rotating Luer.
Medical Devices·100 affected·Mar 1, 2018
High RiskFDA
Icu Medical De Mexico, S.a. De C.v.
10" Smallbore Ext Set w/6-Port NanoClave Manifold (Orange, Red, Blue, Purple, Yellow, Green Rings), NanoClave (Light Blue Ring), Check Va...
Medical Devices·150 affected·Mar 1, 2018
High RiskFDA
Icu Medical De Mexico, S.a. De C.v.
30 cm (12") PUR Bifuse Ext Set w/3-Port NanoClave Manifold, Check Valve, 2 NanoClave, Rotating Luer a single use, sterile, non-pyrogenic ...
Medical Devices·100 affected·Mar 1, 2018
High RiskFDA
Icu Medical De Mexico, S.a. De C.v.
PROXIMALE - 28 cm (11") Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, NanoClave (Red Rings), Rotating Luer.
Medical Devices·532 affected·Mar 1, 2018
High RiskFDA
Zimmer Gmbh
Avenir Muller Stem; Item Number: 01.06010.104, Lot Number: 2905496, UDI: (01)00889024479500 (17)220430 (10)2905496
Medical Devices·0 affected·Feb 28, 2018
High RiskFDA
Vygon U.s.a.
PICC Tray, Product Code: AMS-9093CP Convenience kit for the insertion of PICCs into the vascular system.
Medical Devices·16,520 affected·Feb 28, 2018
High RiskFDA
Vygon U.s.a.
PICC Insertion Tray, Product Code: AMS-7192CS-4 Convenience kit for the insertion of PICCs into the vascular system.
Medical Devices·16,520 affected·Feb 28, 2018
High RiskFDA
Zimmer Gmbh
Avenir Muller Stem; Item Number: 01.06010.003, Lot Number: 2904368, UDI: (01) 00889024479494 (17) 220331 (10) 2904368
Medical Devices·0 affected·Feb 28, 2018
High RiskFDA
Vygon U.s.a.
Maximum Barrier Insertion Tray, Product Code: AMS-9152CP Convenience kit for the insertion of PICCs into the vascular system.
Medical Devices·16,520 affected·Feb 28, 2018
High RiskFDA
Vygon U.s.a.
Maximum Barrier Tray, Product Code: AMS-9018CP Convenience kit for the insertion of PICCs into the vascular system.
Medical Devices·16,520 affected·Feb 28, 2018
High RiskFDA
Vygon U.s.a.
Maximum Barrier Tray, Product Code: MCITX-1 Convenience kit for the insertion of PICCs into the vascular system.
Medical Devices·16,520 affected·Feb 28, 2018
High RiskFDA
Vygon U.s.a.
PICC Insertion Tray, Product Code: AMS-7192CS-3 Convenience kit for the insertion of PICCs into the vascular system.
Medical Devices·16,520 affected·Feb 28, 2018
High RiskFDA
Radiometer Medical Aps
AQURE, Software version 2.3.0 and 2.3.1 Product Usage: The AQURE system is intended to let allow the management of analytical devices...
Medical Devices·2 affected·Feb 27, 2018
High RiskFDA
Beaver-visitec International Inc.
Wet-Field Hemostatic Eraser Bipolar 25G, fine tip, straight, 5/SP; Part Number 221267; UDI: 30886158010549
Medical Devices·1,025 affected·Feb 26, 2018
High RiskFDA
Beaver-visitec International Inc.
WET-FIELD OSHER THERMODOT MARKER, 25GA FINE TIP, CURVED; Part number 221270. Designed to create an ink-free, fine dot on the eye that ...
Medical Devices·110 affected·Feb 26, 2018
High RiskFDA
Preservation Solutions, Inc.
Cold Storage Solution, 2L, labeled as Waters IGL Cold Storage Solution, Catalog No. CSS/2000/US; and, Belzer UW Cold Storage Solution, Ca...
Medical Devices·31,104 affected·Feb 26, 2018
High RiskFDA
Stryker Instruments Div. Of Stryker Corporation
T4 Zipper Toga (S/M); Catalog Number: 0400-810-000 Sterile personal protection garment
Medical Devices·34,570 affected·Feb 23, 2018
High RiskFDA
Deerfield Imaging, Inc.
IMRIS ORT300, Removable Operating Room Table, Part Numbers: (a) 114093-000 (b) 114093-600
Medical Devices·13 affected·Feb 23, 2018
High RiskFDA
Stryker Instruments Div. Of Stryker Corporation
T4 Zipper Toga, X-Large; Catalog number: 0400-850-000 Sterile personal protection garment
Medical Devices·34,570 affected·Feb 23, 2018
High RiskFDA
Orthofix, Inc
ORTHOFIX, Connector System, SMALL SET SCREW, REF 79-2003
Medical Devices·397 affected·Feb 23, 2018
High RiskFDA
Stryker Instruments Div. Of Stryker Corporation
T5 Zipper Toga with Peel-Away Face Shield, (XL/T); Catalog number: 0400-850-100 Sterile personal protection garment
Medical Devices·34,570 affected·Feb 23, 2018
High RiskFDA
Stryker Instruments Div. Of Stryker Corporation
T4 Pullover Toga, L/XL; Catalog Number: 0400-720-000 Sterile personal protection garment
Medical Devices·34,570 affected·Feb 23, 2018
High RiskFDA
Stryker Instruments Div. Of Stryker Corporation
T4 Zipper Toga, Regular; Catalog number: 0400-830-000 Sterile personal protection garment
Medical Devices·34,570 affected·Feb 23, 2018
High RiskFDA
Deerfield Imaging, Inc.
IMRIS ORT200, Removable Operating Room Table, Part Numbers: (a) 113821-000 (b) 113821-600 (c) 114148-000 (d) 114148-600
Medical Devices·17 affected·Feb 23, 2018
High RiskFDA
Medical Components, Inc Dba Medcomp
REPAIR KIT, REF RPK-01, UDI 884908039856 Product Usage: The Medcomp Repair Kit is indicated for use in replacing damaged female her c...
Medical Devices·1,575 affected·Feb 23, 2018
High RiskFDA
Stryker Instruments Div. Of Stryker Corporation
T4 Zipper Toga, (L/XL); Catalog Number: 0400-820-000 Sterile personal protection garment
Medical Devices·34,570 affected·Feb 23, 2018
High RiskFDA
Medical Components, Inc Dba Medcomp
TWO PART ADAPTER, REF MCTLA2000, UDI 884908027310 Product Usage: The Medcomp Repair Kit is indicated for use in replacing damaged fem...
Medical Devices·35 affected·Feb 23, 2018
High RiskFDA
Stryker Instruments Div. Of Stryker Corporation
T4 Pullover Toga, X-Large; Catalog Number: 0400-770-000 Sterile personal protection garment
Medical Devices·34,570 affected·Feb 23, 2018
High RiskFDA
Sofradim Production
Versatex Monofilament Mesh 50 x 50cm, Product No. VTX5050M The device is made out of a macroporous three-dimensional monofilament poly...
Medical Devices·703 affected·Feb 23, 2018
High RiskFDA
Deerfield Imaging, Inc.
IMRIS T2X Table, Part Numbers: (a) 108000-000 (b) 108000-600 (c) 109682-000 (d) 109682-600
Medical Devices·14 affected·Feb 23, 2018
High RiskFDA
Ge Healthcare
GE Healthcare Centricity PACS-IW, Model Numbers: (a) 2052831-00X (b) 2049588-008 Product Usage: Centricity PACS-IW by GE Healthcare...
Medical Devices·569 affected·Feb 23, 2018
RecallFDA
Coopervision Inc.
clariti 1 day (-1.25) 90 pack, UV Blocking, 90 silicone hydrogel, daily disposable contact lenses The Clariti 1 Day (somofilcon A) So...
Medical Devices·32 affected·Feb 21, 2018
High RiskFDA
Philips Medical Systems (cleveland) Inc
Brilliance 64 with 4.1.7 XX026 software version model number 728231 Product Usage: Computed Tomography X-ray systems intended to prod...
Medical Devices·291 affected·Feb 21, 2018
High RiskFDA
Siemens Medical Solutions Usa, Inc.
Biograph Horizon, PET/CT System using VJ10A, VJ10B, VJ20A scanners that provide registration and fusion of high resolution physiologic an...
Medical Devices·14 affected·Feb 21, 2018
High RiskFDA
Siemens Medical Solutions Usa, Inc
Syngo.plaza software VB10A model numbers: 10863171, 10863172, 10863173 Syngo.Plaza is a Picture Archiving and Communication System (PA...
Medical Devices·92 affected·Feb 20, 2018
High RiskFDA
Siemens Medical Solutions Usa, Inc
Syngo.plaza software Syngo.Plaza is a Picture Archiving and Communication System (PACS) intended to display, process, read, report,...
Medical Devices·92 affected·Feb 20, 2018
High RiskFDA
Deerfield Imaging, Inc.
IMRIS T2X Table, Part Number 109682-600
Medical Devices·16 affected·Feb 20, 2018
RecallFDA
Aesculap Implant Systems Llc
Strauss Penis Clamp 130MM/General Instruments
Medical Devices·0 affected·Feb 16, 2018
RecallFDA
Aesculap Implant Systems Llc
Doyen-Collin Mouth Gag 120MM/ General Instruments
Medical Devices·0 affected·Feb 16, 2018
High RiskFDA
Siemens Medical Solutions Usa, Inc
SOMATOM Spirit Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.
Medical Devices·1,301 affected·Feb 15, 2018
High RiskFDA
Siemens Medical Solutions Usa, Inc
SOMATOM Sensation Open Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.
Medical Devices·1,301 affected·Feb 15, 2018
High RiskFDA
Siemens Medical Solutions Usa, Inc
SOMATOM Scope Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.
Medical Devices·1,301 affected·Feb 15, 2018
High RiskFDA
Siemens Medical Solutions Usa, Inc
SOMATOM Sensation 64 Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.
Medical Devices·1,301 affected·Feb 15, 2018
High RiskFDA
Siemens Medical Solutions Usa, Inc
SOMATOM Emotion (2003) Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.
Medical Devices·1,301 affected·Feb 15, 2018
High RiskFDA
Siemens Medical Solutions Usa, Inc
SOMATOM Perspective Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.
Medical Devices·1,301 affected·Feb 15, 2018
High RiskFDA
Teleflex Medical
Teleflex MEDICAL WECK Visistat 35. Used for the external skin closure of lacerations.
Medical Devices·12 affected·Feb 15, 2018