Category

Medical Devices Recalls

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

15,654 recalls
High RiskFDA
Bard Medical Division
Bard Midstream Urine Collector with Rigid Funnel and Iodophor Prep Pads. Product Packaging: Three (3) PVP-I prep pads are packed into ea...
Medical Devices·131,950 affected·Mar 21, 2018
High RiskFDA
Madison Polymeric Engineering
First Step Endoscopic Cleaning Pad, 100ml, Flexible Endoscope Bedside Pre-Clean Kit, Catalogue Number EP-3
Medical Devices·115 affected·Mar 21, 2018
High RiskFDA
Madison Polymeric Engineering
Travel Kit, First Step EP-4 Kit (200 mL) and 1 Soiled Scope Bag (White), Flexible Endoscope Bedside Pre-Clean Kit, Catalogue Number TK-20...
Medical Devices·23 affected·Mar 21, 2018
High RiskFDA
Madison Polymeric Engineering
First Step Endoscopic Cleaning Pad, 200ml, Flexible Endoscope Bedside Pre-Clean Kit, Catalogue Number EP-4
Medical Devices·1,422 affected·Mar 21, 2018
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension Vista¿ MULTI 2 SDIL, KD694, SMN# 10483586
Medical Devices·1,195 affected·Mar 21, 2018
High RiskFDA
Madison Polymeric Engineering
First Step Endoscopic Cleaning Pad, 500ml, Flexible Endoscope Bedside Pre-Clean Kit, Catalogue Number EP-6
Medical Devices·359 affected·Mar 21, 2018
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension Vista¿ MULTI 1 SDIL, KD693, SMN# 10469971
Medical Devices·197 affected·Mar 21, 2018
High RiskFDA
Becton Dickinson & Company
BD Vacutainer¿ Ultra TouchTM Push Button Blood Collection Set 0.6 x 19 mm x 305 mm 23G x ¿ x 12. Catalog no 367364
Medical Devices·0 affected·Mar 20, 2018
High RiskFDA
Epic Extremity, Llc
Epic Extremity Plate System,10x10 Plate Caddy, Part 2111-1010 with 2.7 and 3.5mm Non-Locking Screw (2001-27XX-N & 2001-35XX-N)
Medical Devices·9 affected·Mar 20, 2018
High RiskFDA
Epic Extremity, Llc
Epic Extremity Plate System, Midfoot/Flatfoot Insert, Part 2111-0005 with Extended Butterfly Plate (2000-5002)
Medical Devices·6 affected·Mar 20, 2018
High RiskFDA
Becton Dickinson & Company
BD Vacutainer¿ Push Button Blood Collection Set 0.8 x 19 mm x 305 mm 21G x ¿ x 12 Catalog 367344
Medical Devices·0 affected·Mar 20, 2018
High RiskFDA
Teleflex Medical Europe Ltd
Teleflex MEDICAL LMA(TM) MADgic(TM) LARYNGO-TRACHEAL MUCOSAL ATOMIZATION DEVICE, MAD700, QTY: 1 Intended for the application of topical a...
Medical Devices·25 affected·Mar 19, 2018
High RiskFDA
Terumo Cardiovascular Systems Corporation
Sarns TCM II, Catalog Numbers: 4415; 4416;164925; 164930;164935;164940 UDI 00886799000014 The Sarns TCM is indicated for controlling a...
Medical Devices·2,393 affected·Mar 16, 2018
High RiskFDA
Ge Medical Systems Ultrasound & Primary Care Diagnostics, Ll
GE Healthcare Lunar: a) DPX NT, Model Numbers: LU8230, LU40338, LU42357, LU42369 b) DPX MD+, Model Numbers: LU8230, LU40338, LU40352 ...
Medical Devices·43 affected·Mar 16, 2018
High RiskFDA
Teleflex Medical Europe Ltd
Simplastic Suprapubic Puncture Instruments: Product Code Equivalent Code (a) 650704100 551310 (b) 650704120 551312 ...
Medical Devices·4,220 affected·Mar 15, 2018
High RiskFDA
Zimmer Gmbh
Normed Charcot Osteotome Chisel (Various sizes)
Medical Devices·0 affected·Mar 15, 2018
High RiskFDA
Teleflex Medical Europe Ltd
Baker Jejunostomy Tubes: Product Code Equivalent Code (a) 655300160 655316 (b) 655500200 655520
Medical Devices·200 affected·Mar 15, 2018
High RiskFDA
Micro-tech (nanjing) Co., Ltd.
Trident Endoscopic Ultrasonic Biopsy Needle (FNB)
Medical Devices·40 affected·Mar 12, 2018
High RiskFDA
Stryker Gmbh
Hinge Coupling Hoffmann LRF Catalog # 4933-0-800 Intended for fixation of fractures, joint contractures, fusions, limb lengthening, de...
Medical Devices·18 affected·Mar 12, 2018
High RiskFDA
Micro-tech (nanjing) Co., Ltd.
Trident Endoscopic Ultrasonic Aspiration Needle (FNA)
Medical Devices·40 affected·Mar 12, 2018
High RiskFDA
Mckesson Israel Ltd.
McKesson Cardiology Hemo, Release SW version 13.0. Used for physiological monitoring, image and data processing. McKesson Cardiology...
Medical Devices·31 affected·Mar 12, 2018
High RiskFDA
Richard Wolf Gmbh
RICHARD WOLF TUBE SET FOR TEM, REF 4170.801. Used for the transanal endoscopic microsurgery.
Medical Devices·1,710 affected·Mar 11, 2018
High RiskFDA
The Binding Site Group, Ltd.
Binding Site Optilite Beta-2-Microglobulin Urine Kit, Ref LK043.L.OPT.A, IVD. The firm name on the label is The Binding Site Group Ltd.,...
Medical Devices·20 affected·Mar 9, 2018
High RiskFDA
Stryker Medical Division Of Stryker Corporation
6381 M-1 Cot Fastener, catalog no. 6381000000
Medical Devices·3 affected·Mar 9, 2018
High RiskFDA
Ethicon, Inc.
Evicel Accessory Device - 45 cm Flexible Tip (SET OF 3), Product Code EVT45. Accessory Tips for use only with EVICEL Fibrin Sealant (Hum...
Medical Devices·738 affected·Mar 7, 2018
High RiskFDA
Sps Sterilization, Inc
Edwards Lifesciences Avid Dual Stage Venous Drainage Cannula, 29/37F (9.6/12.3MM) X 37CM (14.5"), resterilized.
Medical Devices·5 affected·Mar 7, 2018
High RiskFDA
Sps Sterilization, Inc
Edwards Lifesciences Thin-Flex Single Stage Venous Drainage Cannula, 34F (11.3MM) X 40CM (16"), resterilized.
Medical Devices·5 affected·Mar 7, 2018
High RiskFDA
Smith & Nephew, Inc.
D-RAD Self-Tapping Locking Screw intended for the fixation of fractures involving the distal radius. smith&nephew D-RAD 2.4MM X 10MM S-T ...
Medical Devices·59 affected·Mar 7, 2018
High RiskFDA
Sps Sterilization, Inc
Edwards Lifesciences Thin-Flex Single Stage Venous Drainage Cannula, 38FRX40CM, resterilized.
Medical Devices·10 affected·Mar 7, 2018
High RiskFDA
Autochair
Product: Milford Smartbase Model # 9934105 Pride SmartBase Pride product codes: LSMPLCG A & LSMPLCG B
Medical Devices·0 affected·Mar 7, 2018
High RiskFDA
Integra Lifesciences Corp.
Manuka Honey Wound Gel Catalogue No: 716597 Product Usage: Helps maintain a moist wound environment which has shown to be conducive ...
Medical Devices·766 affected·Mar 6, 2018
High RiskFDA
Synthes (usa) Products Llc
Part no. 690.379, Graphic Case F/6.5mm Cannulated Screw Set
Medical Devices·4 affected·Mar 5, 2018
High RiskFDA
Synthes, Inc.
Flex Arm Product Usage: The Synthes Flex Arm is a component of the Synthes Minimally Invasive Support System, which provides secure t...
Medical Devices·84 affected·Mar 5, 2018
High RiskFDA
Synthes (usa) Products Llc
Part no. 690.380, Graphic Case F/7.3mm Cannulated Screw Set
Medical Devices·3 affected·Mar 5, 2018
High RiskFDA
Getinge Disinfection Ab
Getinge AGS, FSLC, FSUC, RC accessory to Washer- Disinfector 86 Series UDI Info: 86 Series Washer Disinfector 07340153700246, 073401537...
Medical Devices·170 affected·Mar 2, 2018
High RiskFDA
Beckman Coulter Inc.
BECKMAN COULTER iQ200 Series Urine Microscopy Analyzer, Catalog Numbers: 700-3345, C10684, 700-3375, C10683, 700-3325, 700-3347, 700-33...
Medical Devices·5,247 affected·Mar 2, 2018
High RiskFDA
Randox Laboratories Ltd.
Lipase, Catalog number: LI3837; GTIN: 05055273204230 and Catalog number: LI8361; GTIN: 05055273214284 Product Usage: For Professional...
Medical Devices·8 affected·Mar 2, 2018
High RiskFDA
Icu Medical De Mexico, S.a. De C.v.
38 cm (15") Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, MicroClave Clear, 3 Gang 4-Way NanoClave Stopcock (Glow, Blue, Re...
Medical Devices·350 affected·Mar 1, 2018
High RiskFDA
Icu Medical De Mexico, S.a. De C.v.
PROXIMALE - 18 cm (7") Appx 0.92 ml, PUR Smallbore Ext Set, 6-Port NanoClave Manifold w/NanoClave (Purple Rings), Check Valve, Rotating L...
Medical Devices·30 affected·Mar 1, 2018
High RiskFDA
Icu Medical De Mexico, S.a. De C.v.
40 cm (16") Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, NanoClave, 0.2 Micron Filter, 2 BCV-Clave, Rotating Luer.
Medical Devices·150 affected·Mar 1, 2018
High RiskFDA
Icu Medical De Mexico, S.a. De C.v.
191 cm (75") Appx 2.9 ml, PVC/PUR Smallbore Bifuse Ext Set w/6-Port NanoClave Manifold w/2 Red Rings, Check Valve, 2 MicroClave Clear, Cl...
Medical Devices·50 affected·Mar 1, 2018
High RiskFDA
Icu Medical De Mexico, S.a. De C.v.
20 cm (8") PUR Smallbore Ext Set w/3-Port NanoClave Manifold, Check Valve, NanoClave, Rotating Luer single use, sterile, non-pyrogenic de...
Medical Devices·81 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 Rings), Check Valve, Clamp, Rotating Luer.
Medical Devices·200 affected·Mar 1, 2018
High RiskFDA
Icu Medical De Mexico, S.a. De C.v.
10" Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, Clamp, Rotating Luer
Medical Devices·650 affected·Mar 1, 2018
High RiskFDA
Icu Medical De Mexico, S.a. De C.v.
DISTALE - 203 cm (80") Bifuse Ext Set w/6 Gang 1o2 Manifold, 8 MicroClave Clear (Green Rings), Back Check Valve, 3-Port NanoClave Manifol...
Medical Devices·122 affected·Mar 1, 2018
High RiskFDA
Icu Medical De Mexico, S.a. De C.v.
165 cm (65") PUR Smallbore Ext Set w/3-Port NanoClave Manifold, Check Valve, NanoClave, Rotating Luer a single use, sterile, non-pyrogeni...
Medical Devices·50 affected·Mar 1, 2018
High RiskFDA
Icu Medical De Mexico, S.a. De C.v.
18 cm (7") PUR Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, NanoClave, Rotating Luer.
Medical Devices·100 affected·Mar 1, 2018
High RiskFDA
Icu Medical De Mexico, S.a. De C.v.
Kit w/3 Ext Sets, 3 Drop-In MicroClave Clear
Medical Devices·302 affected·Mar 1, 2018