Category

Medical Devices Recalls

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

15,654 recalls
High RiskFDA
Zimmer Biomet, Inc.
Zimmer Segmental System, ZSS Distal Femur. Sizes as follows: a. Size B-LT (Item No. 00585001201); b. Size B-RT (Item No. 005850012...
Medical Devices·3,350 affected·Aug 1, 2017
High RiskFDA
Icu Medical, Inc.
140" (356 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, Remv 4-Way Stopcock, Clave¿, Rotating Luer, 2 Ext, Sterile The blood tu...
Medical Devices·160,016 affected·Jul 31, 2017
High RiskFDA
Icu Medical, Inc.
88" (224 cm) 20 Drop Y-Type Blood Set w/200 Micron Filter, Hand Pump, Clave¿, Rotating Luer w/Filter Cap, Sterile The blood tubing acc...
Medical Devices·160,016 affected·Jul 31, 2017
High RiskFDA
Icu Medical, Inc.
120" (305 cm) 10 Drop Primary Set w/2 MicroClave¿, Hand Pump, Remv 2 Gang 4-Way Stopcock, Y-Connector, Rotating Luer, 1 Ext, Sterile T...
Medical Devices·160,016 affected·Jul 31, 2017
High RiskFDA
Icu Medical, Inc.
Lopez Valve¿ w/Red Cap, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intende...
Medical Devices·160,016 affected·Jul 31, 2017
High RiskFDA
Icu Medical, Inc.
132" (335 cm) Y-Type Admin Set w/170 Micron Blood Filter, Pump, 2 Clave¿, Remv 2 Gang 4-Way Stopcocks, Luer Lock, 2 Ext, Sterile The blo...
Medical Devices·160,016 affected·Jul 31, 2017
High RiskFDA
Icu Medical, Inc.
99" (251 cm) 20 Drop Y-Type Blood Set w/200 Micron Filter, Hand Pump, 2 Clave¿, Rotating Luer, Sterile The blood tubing accessory with...
Medical Devices·160,016 affected·Jul 31, 2017
High RiskFDA
Icu Medical, Inc.
98" (249 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 2 Gang 4-Way Stopcocks, Clave¿, Rotating Luer, 1 Ext, Sterile The blood ...
Medical Devices·160,016 affected·Jul 31, 2017
High RiskFDA
Icu Medical, Inc.
164" (417 cm) 20 Drop Y-Type Blood Admin Set w/200 Micron Filter, Hand Pump, Remv 4 Gang 4-Way Stopcocks w/Baseplate, 4 MicroClave¿ Clear...
Medical Devices·160,016 affected·Jul 31, 2017
High RiskFDA
Icu Medical, Inc.
99" (251 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 2 Clave¿, Rotating Luer, Sterile The blood tubing accessory with CLAVE C...
Medical Devices·160,016 affected·Jul 31, 2017
High RiskFDA
Icu Medical, Inc.
125" (318 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 3 Clave¿, Remv 3 Gang 4-Way Stopcock w/Baseplate, Rotating Luer, 3 Ext, St...
Medical Devices·160,016 affected·Jul 31, 2017
High RiskFDA
Icu Medical, Inc.
143" (363 cm) 20 Drop Y-Type Blood Set w/200 Micron Filter, Hand Pump, 2 Clave¿, Drop-In Ext w/3 Gang 4 Way Stopcocks, MicroClave¿, Luer ...
Medical Devices·160,016 affected·Jul 31, 2017
High RiskFDA
Icu Medical, Inc.
115" (292 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 3 Prepierced Ports¿, T-Connector w/Pre-Pierced Port, Luer Slip, 2 Ext, Ste...
Medical Devices·160,016 affected·Jul 31, 2017
High RiskFDA
Icu Medical, Inc.
112" (284 cm) 20 Drop Y-Type Blood Set w/200 Micron Filter, Hand Pump, 3 Clave¿, Rotating Luer, Sterile The blood tubing accessory wit...
Medical Devices·160,016 affected·Jul 31, 2017
High RiskFDA
Icu Medical, Inc.
116" (295 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 3 MicroClave¿, 2 Ext, Rotating Luer, Sterile The blood tubing accessory...
Medical Devices·160,016 affected·Jul 31, 2017
High RiskFDA
Icu Medical, Inc.
99" (251 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 2 Clave¿, Rotating Luer, Sterile The blood tubing accessory with CLAVE Con...
Medical Devices·160,016 affected·Jul 31, 2017
High RiskFDA
Icu Medical, Inc.
162" Y-Type Blood Set w/170 Micron Filter, Bulb Hand Pump, 3 Pre-Pierced Ports, 4 Gang 4-Way Stopcocks w/Baseplate, 3 Remv Ext, Rotating ...
Medical Devices·160,016 affected·Jul 31, 2017
High RiskFDA
Icu Medical, Inc.
168 cm (66") 20 Drop Blood Set w/200 Micron Filter, Rotating Luer, Sterile The blood tubing accessory with CLAVE Connector is a single...
Medical Devices·160,016 affected·Jul 31, 2017
High RiskFDA
Icu Medical, Inc.
100" (254 cm) 20 Drop Y-Type Blood Admin Set w/200 Micron Filter, Hand Pump, 2 Clave¿, Rotating Luer w/Filter Cap, Sterile The blood t...
Medical Devices·160,016 affected·Jul 31, 2017
High RiskFDA
Icu Medical, Inc.
105" (267 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, Pre-Slit Port, MicroClave¿ Clear, Rotating Luer, 1 Ext, Approx Priming Vol...
Medical Devices·160,016 affected·Jul 31, 2017
High RiskFDA
Icu Medical, Inc.
107" (272 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 2 Clave¿, Remv 2 Gang 4-Way Stopcocks, Rotating Luer, 2 Ext, Sterile Th...
Medical Devices·160,016 affected·Jul 31, 2017
High RiskFDA
Icu Medical, Inc.
218 cm (86") Appx 16.4 ml, 20 Drop Blood Set w/200 Micron Filter, 2 MicroClave¿, Check Valve, Y-Connector, Rotating Luer, Sterile The ...
Medical Devices·160,016 affected·Jul 31, 2017
High RiskFDA
Icu Medical, Inc.
139" (353 cm) Y-Type Blood Set w/ 170 Micron Filter, Hand Pump, BCV, 3-Gang w/2 4-Way Stopcocks w/Baseplate, 1o2¿ Valve, 2 Clave¿, Pre-Pi...
Medical Devices·160,016 affected·Jul 31, 2017
High RiskFDA
Icu Medical, Inc.
112" Y-Type Blood Set w/170 Micron Filter, Hand Pump, Pre-Slit Port, Rotating Luer, Sterile The blood tubing accessory with CLAVE Conn...
Medical Devices·160,016 affected·Jul 31, 2017
High RiskFDA
Icu Medical, Inc.
94" (239 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, MicroClave¿ Clear, Rotating Luer, Approx Priming Volume: 57.2 mL, Sterile ...
Medical Devices·160,016 affected·Jul 31, 2017
High RiskFDA
Oakworks Inc
Foot Controls impacted for the following devices: OAKWORKS¿ Medical CFPM 300 Imaging Table OAKWORKS¿ Medical CFPM 301 Imaging Table ...
Medical Devices·1,104 affected·Jul 31, 2017
High RiskFDA
Icu Medical, Inc.
94" (239 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, Rotating Luer, Sterile The blood tubing accessory with CLAVE Connector i...
Medical Devices·160,016 affected·Jul 31, 2017
High RiskFDA
Icu Medical, Inc.
132" (335 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, Clave¿, 4-Way Stopcock, Rotating Luer, 1 Ext, Sterile The blood tubing ...
Medical Devices·160,016 affected·Jul 31, 2017
High RiskFDA
Icu Medical, Inc.
32" (81 cm) Appx 4.4 mL Blood Set w/20 Drop 200 Micron Filter, Rotating Luer, Sterile The blood tubing accessory with CLAVE Connector ...
Medical Devices·160,016 affected·Jul 31, 2017
High RiskFDA
Icu Medical, Inc.
134" (340 cm) Y-Type Admin Set w/170 Micron Blood Filter, Pump, Clave¿, 2 Gang 4-Way Stopcocks, Rotating Luer w/Filter Cap, 2 Ext, Steril...
Medical Devices·160,016 affected·Jul 31, 2017
High RiskFDA
Icu Medical, Inc.
121" (307 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 3 Clave¿, Remv 4-Way Stopcock, T-Connector w/Pre-Slit Port, Rotating Luer,...
Medical Devices·160,016 affected·Jul 31, 2017
High RiskFDA
Icu Medical, Inc.
147" (373 cm) Bifuse Blood Set w/170 Micron Filter, Hand Pump, 2 Clave¿ w/Remv 3 Gang 1o2¿ Manifold (Blue, Yellow, Red), Check Valve Rota...
Medical Devices·160,016 affected·Jul 31, 2017
High RiskFDA
Icu Medical, Inc.
140" (356 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 3 Clave¿, Remv 4-Way Stopcock, Rotating Luer, 2 Ext, Sterile The blood ...
Medical Devices·160,016 affected·Jul 31, 2017
High RiskFDA
Icu Medical, Inc.
Lopez Valve¿, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use ...
Medical Devices·160,016 affected·Jul 31, 2017
High RiskFDA
Icu Medical, Inc.
117" (297 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 2 Clave¿, Remv 3 Gang 4-Way Stopcocks, Rotating Luer, 1 Ext, Sterile Th...
Medical Devices·160,016 affected·Jul 31, 2017
High RiskFDA
Icu Medical, Inc.
126" (320 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, Remv 2 Gang 4-Way Stopcock, Clave¿, Rotating Luer, 1 Ext, Sterile The b...
Medical Devices·160,016 affected·Jul 31, 2017
High RiskFDA
Icu Medical, Inc.
135" (343 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 2 Clave¿, Remv 4-Way Stopcock, Rotating Luer, 2 Ext, Sterile The blood ...
Medical Devices·160,016 affected·Jul 31, 2017
High RiskFDA
Brainlab Ag
AIRO Mobile CT System, Model Number: MobiCT-32 Product Usage: The AIRO is intended to be used for X-ray computed tomography applicati...
Medical Devices·102 affected·Jul 28, 2017
High RiskFDA
Roche Diagnostics Corporation
Cobas 8000 Modular Series system; Software Version 05-02 and 06-03; UDI: 05641446001
Medical Devices·399 affected·Jul 28, 2017
High RiskFDA
Nxthera
Rezum System, Vapor BPH Ablation System, Model Number D2201-003. NxThera Inc. 7351 Kirkwood Lane Suite 138 Maple Grove, MN 55369 USA. ...
Medical Devices·113 affected·Jul 28, 2017
High RiskFDA
Baxter Healthcare Corporation
Empty IntraVia Container with Non-DEHP Fluid Path, 500mL Containers are intended for use in the preparation and administration of drug...
Medical Devices·29,088 affected·Jul 27, 2017
High RiskFDA
Optovue, Inc.
iVue with Normative Database, Device Listing Number D185549. Product Usage: The iVue (K121739) is a non-contact, high resolution tomo...
Medical Devices·326 affected·Jul 27, 2017
High RiskFDA
Depuy Orthopaedics, Inc.
Concorde Lift Torque Limiting Handle. Must be used with supplemental internal spinal fixation systems that have been cleared for use...
Medical Devices·130 affected·Jul 26, 2017
High RiskFDA
Synthes (usa) Products Llc
2.5 mm Reaming Rod, Ball tip, 950 mm, sterile, Part Number: 351.706S Reaming Rods are intended for guiding of reamers during orthoped...
Medical Devices·6,257 affected·Jul 26, 2017
High RiskFDA
Synthes (usa) Products Llc
Light Clip for Oracle Retractor, sterile, Part Number: 03.809.925S Reaming Rods are intended for guiding of reamers during orthopedic ...
Medical Devices·6 affected·Jul 26, 2017
High RiskFDA
Depuy Orthopaedics, Inc.
Concorde Lift Driver Shaft AO. Used with supplemental internal spinal fixation systems that have been cleared for use in the lumbar sp...
Medical Devices·130 affected·Jul 26, 2017
High RiskFDA
Synthes (usa) Products Llc
2.5 mm Reaming Rod, Ball tip, 1150 mm, sterile, Part Number: 351.708S Reaming Rods are intended for guiding of reamers during orthoped...
Medical Devices·1,144 affected·Jul 26, 2017
High RiskFDA
Siemens Medical Solutions Usa, Inc.
Syngo Imaging version V31 (model # 10014063) is a Picture Archiving and Communication System (PACS) intended to display, process, read, r...
Medical Devices·36 affected·Jul 25, 2017