Category

Medical Devices Recalls

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

15,654 recalls
High RiskFDA
Zimmer Biomet, Inc.
Lineum 4.35mm x 28mm Translation Screw, Model No. 14-524728 The Lineum OCT Spine System is intended to provide immobilization and stab...
Medical Devices·64 affected·Nov 14, 2018
High RiskFDA
Biomerieux, Inc.
VITEK¿ 2 Systems Software Version 9.01 Update Kit.
Medical Devices·5 affected·Nov 13, 2018
CriticalFDA
Rvo 2.0, Inc
Raindrop Near Vision Inlay, REF: RD1-1, Sterile, Rx Only, Manufacturer ReVision Optics, Inc.
Medical Devices·2,869 affected·Nov 13, 2018
High RiskFDA
Raysearch Laboratories Ab
RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6, RayStation 7 and RayStation 8A
Medical Devices·69 affected·Nov 12, 2018
High RiskFDA
Bracco Injeneering S.a.
Empower FastLoad CT Syringe Pack -sterile disposable syringe kit for use with the EmpowerCT¿, EmpowerCTA¿ and EmpowerCTA¿+ Injector Syste...
Medical Devices·33,350 affected·Nov 12, 2018
High RiskFDA
Ge Healthcare, Llc
Centricity Universal Viewer Zero Footprint Client, Model Number 2090258-001, Software Versions 6.0 SP7, SP7.0.1, SP7.0.2, SP7.0.3, SP8, S...
Medical Devices·508 affected·Nov 9, 2018
High RiskFDA
Tekia, Inc.
TEKIA Model 872 Single Piece Hydrophilic Acrylic Intraocular Lenses, Diopter 15.0, Sterile. The firm name on the label is TEKIA, INC., I...
Medical Devices·81 affected·Nov 9, 2018
High RiskFDA
Icu Medical Inc
SAPPHIRE Epidural Set Yellow-Striped Microbore, 0.2 Micron Filter, PAV, 123 Inch, List Number 16373-02 Sapphire Epidural Sets are indi...
Medical Devices·31,050 affected·Nov 8, 2018
High RiskFDA
Hager & Meisinger Gmbh
Singles carbides by Meisinger, US-No: 245, Sterile R, cylinder round end; US-No 245; Reference: HMUN245-009; Shank: FG/314; Head Size 1/1...
Medical Devices·2,500 affected·Nov 7, 2018
High RiskFDA
The Binding Site Group, Ltd.
Binding Site Human IgM Kit (for SPAPLUS), REF: NK012.S The device consists of reaction buffer, sheep anti-IgM antiserum, six calibrato...
Medical Devices·60 affected·Nov 6, 2018
High RiskFDA
Capintec Inc
Captus 700 Thyroid Uptake System, Model # 5430-3137 and 5430-3138
Medical Devices·65 affected·Nov 5, 2018
High RiskFDA
Fresenius Medical Care Renal Therapies Group, Llc
Optiflux F160NR Capillary High Flux Dialyzer Single Use Only, Product Code 0500316E
Medical Devices·9,097 affected·Nov 5, 2018
High RiskFDA
Civco Medical Instruments Co., Inc.
SonoSite FUJIFILM Needle Guide Bracket, REF number P06013-08, Reusable non-sterile bracket for use with SonoSite L25 series transducers. ...
Medical Devices·115 affected·Nov 2, 2018
High RiskFDA
Civco Medical Instruments Co., Inc.
CIVCO Sales Demo Kit, REF DEMOGPGUIDE, for use by CIVCO and customer sales representatives.
Medical Devices·135 affected·Nov 2, 2018
High RiskFDA
Civco Medical Instruments Co., Inc.
CIVCO Biopsy Bracket, REF P03122-07, Reusable non-sterile single-angle bracket for use with SonoSite L25 series transducers.
Medical Devices·73 affected·Nov 2, 2018
High RiskFDA
Civco Medical Instruments Co., Inc.
SonoSite Needle Guide Bracket, REF numbers P06013-06 and P06013-07, Reusable non-sterile bracket for use with SonoSite L25 series transdu...
Medical Devices·297 affected·Nov 2, 2018
High RiskFDA
Civco Medical Instruments Co., Inc.
CIVCO Needle Guide Bracket, REF 674-057, Reusable non-sterile bracket for use with SonoSite L25 series tranducers, Rx.
Medical Devices·49 affected·Nov 2, 2018
High RiskFDA
Civco Medical Instruments Co., Inc.
CIVCO Needle Guide Starter Kit, REF 674-039, Reusable non-sterile bracket with sterile needle guides (1cm, 1.5cm, 2cm depths) with (10.2 ...
Medical Devices·20 affected·Nov 2, 2018
High RiskFDA
Ascom (us) Inc.
Ascom Telligence Nurse Call System
Medical Devices·57 affected·Nov 2, 2018
High RiskFDA
Civco Medical Instruments Co., Inc.
CIVCO Needle Guide Starter Kit, REF numbers P12922-01 and P12922-02, Reusable non-sterile bracket with sterile (1cm, 1.5cm, 2cm depths) n...
Medical Devices·234 affected·Nov 2, 2018
High RiskFDA
Civco Medical Instruments Co., Inc.
SonoSite L25 Bracket Kit containing 1 Reusable non-sterile bracket, REF numbers P03122-01, P03122-02, P03122-03, P03122-04, and P03122-...
Medical Devices·1,375 affected·Nov 2, 2018
High RiskFDA
Civco Medical Instruments Co., Inc.
CIVCO Needle Guide Starter Kit, REF 674-037, Reusable non-sterile bracket with sterile needle guides (1.5cm, 2.5cm, 3.5cm, 4.5 depths) wi...
Medical Devices·468 affected·Nov 2, 2018
High RiskFDA
Foundation Medicine, Inc.
FoundationOne CDx Test Results
Medical Devices·800 affected·Oct 31, 2018
RecallFDA
Collagen Matrix Inc
Porcine Anorganic Bone Mineral 4.0cc
Medical Devices·136 affected·Oct 30, 2018
High RiskFDA
Merit Medical Systems, Inc.
Custom Procedure Kit, Custom Kit, REF/Product Code: K12T-03688, single use, RX Only, Sterile EO, LATEX FREE, UDI: (01)00884450389409
Medical Devices·88 affected·Oct 26, 2018
High RiskFDA
Intuitive Surgical, Inc.
da Vinci SP Instrument Arm Drape. REF 430013-12 QTY 1 Pouch
Medical Devices·1,818 affected·Oct 25, 2018
RecallFDA
Neomed Inc
NEOCONNECT, Enteral Extension with ENFit connector, REF EXT-60NC The NeoMed NeoConnect Enteral Only Extension Set is intended for use...
Medical Devices·654 affected·Oct 24, 2018
High RiskFDA
Zimmer Biomet, Inc.
Vanguard Knee System -PS Open Box Femoral Left, 62.5 mm Item Number: 183126
Medical Devices·8 affected·Oct 22, 2018
CriticalFDA
Arjohuntleigh Polska Sp. Z.o.o.
ARJOHUNTLEIGH GETINGE GROUP Flites Passive Clip Sling - Product Usage: The Arjo Passive Clip Sling is a product intended for assisted t...
Medical Devices·10 affected·Oct 22, 2018
High RiskFDA
Zimmer Biomet, Inc.
Vanguard Knee System -PS Open Box Femoral Right, 65 mm Item Number:183108
Medical Devices·8 affected·Oct 22, 2018
High RiskFDA
Becton Dickinson & Co.
BD BBL Trypticase Soy Agar with 5% Sheep Blood, Catalog No. 221261, (non-selective, non-differential)
Medical Devices·54,300 affected·Oct 22, 2018
High RiskFDA
Biomerieux, Inc.
VITEK 2 Antimicrobial Susceptibility Testing (AST) using one or more of these susceptibility products: Catalog # 410028, VITEK 2 AST-ST0...
Medical Devices·184,374 affected·Oct 22, 2018
High RiskFDA
Ortho-clinical Diagnostics
VITROS 5,1 FS Chemistry System, Version 3.0 & below For use in the in vitro quantitative measurement of a variety of analytes of clin...
Medical Devices·1,105 affected·Oct 19, 2018
High RiskFDA
Beckman Coulter Inc.
iChem VELOCITY Urine Chemistry Strips, REF 800-7212, 100 test strips/vial. The firm name on the label is Beckman Coulter Ireland, Inc., ...
Medical Devices·956,798 affected·Oct 18, 2018
High RiskFDA
Philips Medical Systems (cleveland) Inc
Brilliance 6 Slice (Air), Model 728256 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of...
Medical Devices·6,343 affected·Oct 18, 2018
High RiskFDA
Philips Medical Systems (cleveland) Inc
Brilliance 40, Model 728235 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body b...
Medical Devices·6,343 affected·Oct 18, 2018
High RiskFDA
Philips Medical Systems (cleveland) Inc
Brilliance 16 Slice (Power), Model 728240 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images...
Medical Devices·6,343 affected·Oct 18, 2018
High RiskFDA
Philips Medical Systems (cleveland) Inc
Brilliance 64, Model 728231 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body ...
Medical Devices·6,343 affected·Oct 18, 2018
High RiskFDA
Nxstage Medical, Inc.
NxStage PureFlow B Solution-RFP-402, Premixed Dialysate for Hemodialysis NxStage PureFlow B Solution is indicated for use with renal ...
Medical Devices·21,071 affected·Oct 17, 2018
High RiskFDA
Nxstage Medical, Inc.
NxStage PureFlow B Solution-RFP-400, Premixed Dialysate for Hemodialysis. NxStage PureFlow B Solution is indicated for use with ren...
Medical Devices·59,100 affected·Oct 17, 2018
High RiskFDA
Nxstage Medical, Inc.
NxStage PureFlow B Solution-RFP-RFP-456, Premixed Dialysate for Hemodialysis NxStage PureFlow B Solution is indicated for use with re...
Medical Devices·15,880 affected·Oct 17, 2018
High RiskFDA
Nxstage Medical, Inc.
NxStage PureFlow B Solution-RFP-401, Premixed Dialysate for Hemodialysis NxStage PureFlow B Solution is indicated for use with renal ...
Medical Devices·186,476 affected·Oct 17, 2018
High RiskFDA
Nxstage Medical, Inc.
NxStage PureFlow B Solution-RFP-RFP-454, Premixed Dialysate for Hemodialysis NxStage PureFlow B Solution is indicated for use with re...
Medical Devices·7,275 affected·Oct 17, 2018
High RiskFDA
Argon Medical Devices, Inc
(1) Argon Medical Devices Vascuclamp, Radiopaque Vascular Clamp, Small Straight, REF 046-1-200, 2 clamps/package, 5 packages/box, 10 boxe...
Medical Devices·49,130 affected·Oct 16, 2018
High RiskFDA
Argon Medical Devices, Inc
Argon Medical Devices TRI-JECT, 3 Way IV Administration Organizer without Stopcock, REF 041230001A, 25/box, Sterile, Rx. The firm name o...
Medical Devices·49,130 affected·Oct 16, 2018
High RiskFDA
Canon Medical System, Usa, Inc.
Radrex-i X-Ray System (DRAD-3000E) TFP-4336W (Wireless FPD) Software version: v5.00ER005 Product Usage: The RADREX-I is a general pu...
Medical Devices·46 affected·Oct 16, 2018
High RiskFDA
Carl Zeiss Meditec, Inc.
The PLEX Elite 9000, a Swept-Source OCT [SS-OCT] - Product Usage: The PLEX Elite 9000 Swept-Source OCT [SS-OCT] is a non- contact, high ...
Medical Devices·151 affected·Oct 16, 2018
High RiskFDA
Argon Medical Devices, Inc
(1) Argon Medical Devices Double Female LL Adapter, Special Adapter to Convert a Male Fitting to Female LL, REF 040183000A, 25/box, Steri...
Medical Devices·49,130 affected·Oct 16, 2018