Category

Medical Devices Recalls

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

15,654 recalls
High RiskFDA
Carefusion 303, Inc.
Trifurcated Extension Set, model no. ME 1224. Trifurcated Extension Set, model no. MP 9230.
Medical Devices·9,550 affected·Jan 16, 2014
High RiskFDA
Philips Healthcare
InnerCool RTx Endovascular System, Model Numbers: 861470 (120V), 861472 (240V). Product Usage: The InnerCool RTx device is a thermal ...
Medical Devices·50 affected·Jan 13, 2014
High RiskFDA
Accuray Incorporated
Accuray CyberKnife Robotic Radiosurgery System; Accuray Incorporated Sunnyvale, CA. Indicated for treatment planning and image guided ...
Medical Devices·302 affected·Jan 13, 2014
High RiskFDA
Smith & Nephew Inc.
Smith & Nephew RENASYS-AB Abdominal Dressing Kit with Soft Port REF #'s: 66800980 (The RENASYS Soft Port Dressing Kits are used in conj...
Medical Devices·28,250 affected·Jan 9, 2014
High RiskFDA
Smith & Nephew Inc.
Smith & Nephew RENASYS Soft Port REF: 66800799 (The RENASYS Soft Port Dressing Kits are used in conjunction with negative pressure woun...
Medical Devices·162,629 affected·Jan 9, 2014
High RiskFDA
Smith & Nephew Inc.
Smith & Nephew RENASYS-F Foam Dressing Kit with Soft Port REF #'s: 66800794, 66800795, and 66800796 (The RENASYS Soft Port Dressing Kit...
Medical Devices·1,710,773 affected·Jan 9, 2014
High RiskFDA
Smith & Nephew Inc.
Smith & Nephew RENASYS-G Sterile, Gauze Dressing Kit with Soft Port REF #'s: 66800961 (The RENASYS Soft Port Dressing Kits are used in ...
Medical Devices·7,353 affected·Jan 9, 2014
High RiskFDA
Smith & Nephew Inc.
Smith & Nephew RENASYS-Gauze with Soft Port Kit REF #'s: 66800933, 66800934, 66800935, and 66800936 (The RENASYS Soft Port Dressing Ki...
Medical Devices·498,980 affected·Jan 9, 2014
High RiskFDA
Mindray Ds Usa, Inc. Dba Mindray North America
Panaroma Central Station Product Usage: This device can view real time, store, print, graph, and trend patient clinical and demogra...
Medical Devices·732 affected·Jan 8, 2014
High RiskFDA
Agfa Corp.
IMPAX RIS QDOC 5.8
Medical Devices·14 affected·Jan 8, 2014
High RiskFDA
Synthes, Inc.
Synthes Driving Cap/Threaded Both parts are intended for use in the Tibia system, LFN and RAFN systems. Their function is to insert a ...
Medical Devices·143 affected·Jan 7, 2014
CriticalFDA
Teleflex Medical
ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 7.5, Rx only, Product Usage: A tracheal tube is a device inser...
Medical Devices·190,871 affected·Jan 6, 2014
CriticalFDA
Teleflex Medical
ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port and Preloaded Stylet, 6.5, Rx only, Product Usage: A tracheal t...
Medical Devices·190,871 affected·Jan 6, 2014
CriticalFDA
Teleflex Medical
ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 6.5, Rx only, Product Usage: A tracheal tube is a device inserte...
Medical Devices·190,871 affected·Jan 6, 2014
CriticalFDA
Teleflex Medical
ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 8.5, Rx only, Product Usage: A tracheal tube is a device inser...
Medical Devices·190,871 affected·Jan 6, 2014
CriticalFDA
Teleflex Medical
ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 7.0, Rx only, Product Usage: A tracheal tube is a device insert...
Medical Devices·190,871 affected·Jan 6, 2014
CriticalFDA
Teleflex Medical
ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port and Preloaded Stylet, 7.5, Rx only, Product Usage: A tracheal t...
Medical Devices·190,871 affected·Jan 6, 2014
CriticalFDA
Teleflex Medical
ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port and Preloaded Stylet, 9.0, Rx only, Product Usage: A tracheal t...
Medical Devices·190,871 affected·Jan 6, 2014
CriticalFDA
Teleflex Medical
ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port and Preloaded Stylet, 8.0, Rx only, Product Usage: A tracheal t...
Medical Devices·190,871 affected·Jan 6, 2014
CriticalFDA
Teleflex Medical
ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 9.0, Rx only, Product Usage: A tracheal tube is a device inser...
Medical Devices·190,871 affected·Jan 6, 2014
High RiskFDA
Stryker Medical Division Of Stryker Corporation
The Gaymar Medi-Therm device provides a means of regulating patient temperature by supplying temperature-controlled water through a conne...
Medical Devices·1,002 affected·Dec 27, 2013
High RiskFDA
Icu Medical, Inc.
7" (18 cm) Appx 0.31 ml, Smallbore Ext Set w/Remv MicroClave¿ Clear, NanoClave" T-Connector, Clamp, Rotating Luer, Part No. A1000, Item...
Medical Devices·4,000 affected·Dec 24, 2013
High RiskFDA
Icu Medical, Inc.
5" Smallbore Ext Set w/MicroClave¿ T-Connector, Clamp, Rotating Luer, Item # B33101-T, Lot # 2791358. The ICU Needleless Connector is...
Medical Devices·800 affected·Dec 24, 2013
High RiskFDA
Icu Medical, Inc.
5" Smallbore Ext Set w/MicroClave¿ T-Connector, Clamp, Luer Slip, Item # B3303-T, Lot # 2791243. The ICU Needleless Connector is a sin...
Medical Devices·50 affected·Dec 24, 2013
High RiskFDA
Icu Medical, Inc.
78" Ext Set w/2 BCV-Clave¿, Remv 2-Gang 4-Way Stopcocks, NanoClave" T-Connector, 4 Clamps, Rotating Luer, 3 Exts, Part No. A1000, Item ...
Medical Devices·500 affected·Dec 24, 2013
High RiskFDA
Icu Medical, Inc.
6" (15 cm) Appx 0.58 ml, Smallbore Trifuse Ext Set w/3 NanoClave¿, 3 Clamps, Rotating Luer, Part No. A1000, Item No. 011-A1029 The ICU ...
Medical Devices·500 affected·Dec 24, 2013
High RiskFDA
Icu Medical, Inc.
103" (262 cm) Appx 3.9 ml, Smallbore Bifuse Ext Set w/NanoClave", Anti-Siphon Valve, Check Valve, 2 Clamps, Luer Lock, Part No. A1000, ...
Medical Devices·50 affected·Dec 24, 2013
High RiskFDA
Icu Medical, Inc.
14" (36 cm ) Appx 0.50 ml, Smallbore Ext Set w/MicroClave¿ Clear, NanoClave¿, 2 Clamps, Rotating Luer, Part No. A1000, Item No. A1081 ...
Medical Devices·100 affected·Dec 24, 2013
High RiskFDA
Icu Medical, Inc.
183 cm (72") Smallbore Quadfuse Ext Set w/4 NanoClave¿ (Yellow, Green Rings), 4 Anti-Syphon Valves, 0.2 Micron Positive Filter, BCVClave...
Medical Devices·250 affected·Dec 24, 2013
High RiskFDA
Icu Medical, Inc.
6" (15 cm) Appx 0.37 ml, Smallbore Bifuse Ext Set w/2 NanoClave", 2 Clamps, Luer Lock, Part No. A1000, Item No. K7096-001 The ICU Needl...
Medical Devices·4,000 affected·Dec 24, 2013
High RiskFDA
Icu Medical, Inc.
NanoClave Stopcock, Part No. A1000, Item No. 011-AC100 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device inten...
Medical Devices·50 affected·Dec 24, 2013
High RiskFDA
Icu Medical, Inc.
10" Smallbore Pentafuse Ext Set w/5 NanoClave", 5 Clamps, Rotating Luer, Part No. A1000, Item No. A1071 The ICU Needleless Connector is...
Medical Devices·50 affected·Dec 24, 2013
High RiskFDA
Icu Medical, Inc.
31 cm (12") Smallbore Bifuse Ext Set w/2 NanoClave¿, Orange Ring, 2 Anti Syphon Valves, 0.2 Micron Postive Filter, Clamp, NanoClave¿ TCo...
Medical Devices·250 affected·Dec 24, 2013
High RiskFDA
Icu Medical, Inc.
106" (269 cm) Appx 7.8 ml, Transfer Set w/Check Valve, NanoClave" TConnector, Anti-Siphon Valve, 2 Clamps, Luer Lock, Part No. A1000, It...
Medical Devices·500 affected·Dec 24, 2013
High RiskFDA
Icu Medical, Inc.
13" Pentafuse Smallbore Ext Set w/NanoClave", 1.2 Micron Filter, 3 MicroClave¿ Clear (Yellow, Red, Green Rings), 6 Clamps, Rotating Luer...
Medical Devices·500 affected·Dec 24, 2013
High RiskFDA
Icu Medical, Inc.
28" (71 cm) Appx 1.0 ml, Smallbore Ext Set w/Anti-Siphon Valve, MicroClave¿ T-Connector, Clamp, Rotating Luer, Item # B33071-T, Lot # 27...
Medical Devices·50 affected·Dec 24, 2013
High RiskFDA
Icu Medical, Inc.
17 cm (7") Smallbore Trifuse Ext Set w/3 NanoClave¿ ( Light Blue, Lavender Rings), 3 Anti-Syphon Valves, Rotating Luer, Item #011-A1096,...
Medical Devices·100 affected·Dec 24, 2013
High RiskFDA
Icu Medical, Inc.
8" (20 cm) Appx 0.43 ml, Smallbore Bifuse Ext Set w/2 NanoClave", 2 Clamps, Luer Lock, Part No. A1000, Item No. K7107-001 The ICU Nee...
Medical Devices·500 affected·Dec 24, 2013
High RiskFDA
Icu Medical, Inc.
6" (15 cm) Appx 0.27 ml, Smallbore Ext Set w/Clamp, NanoClave" TConnector, Rotating Luer, Part No. A1000, Item No. K7084-001 The ICU N...
Medical Devices·4,000 affected·Dec 24, 2013
High RiskFDA
Icu Medical, Inc.
78" Ext Set w/Check Valve, CLAVE¿ Clear, Remv 2 Gang 4-Way Stopcocks, NanoClave¿, NanoClave¿ T-Connector, 4 Clamps, Rotating Luer, 3 Ex...
Medical Devices·1,300 affected·Dec 24, 2013
High RiskFDA
Icu Medical, Inc.
8" Ext Set w/NanoClave" Stopcock, Clamp, Rotating Luer, Part No. A1000, Item No. AC102 The ICU Needleless Connector is a single use, st...
Medical Devices·50 affected·Dec 24, 2013
High RiskFDA
Icu Medical, Inc.
6" (15 cm) Appx 0.27 ml, Smallbore Ext Set w/Clamp, NanoClave" TConnector w/Luer Slip, Part No. A1000, Item No. K7085-001 The ICU Need...
Medical Devices·4,000 affected·Dec 24, 2013
High RiskFDA
Icu Medical, Inc.
7" (18 cm) Appx 0.24 ml, Smallbore Ext Set w/NanoClave", Clamp, Luer Lock, Part No. A1000, Item No. K7095-001 The ICU Needleless Connec...
Medical Devices·500 affected·Dec 24, 2013
High RiskFDA
Icu Medical, Inc.
8" (20 cm) Appx 0.49 ml, Smallbore Bifuse Ext Set w/2 NanoClave", 2 Clamps, Luer Lock, Part No. A1000, Item No. A1069 The ICU Needleles...
Medical Devices·50 affected·Dec 24, 2013
High RiskFDA
Icu Medical, Inc.
6" (15 cm) Appx 0.56 ml, Smallbore Trifuse Ext Set w/3 NanoClave", 3 Clamps, Luer Lock, Part No. A1000, Item No. K7097-001 The ICU Need...
Medical Devices·4,000 affected·Dec 24, 2013
High RiskFDA
Icu Medical, Inc.
7" (18 cm) Appx 0.29 ml, Smallbore Ext Set w/MicroClave¿ Clear, NanoClave", Clamp, Rotating Luer, Part No. A1000, Item No. K7088-001 T...
Medical Devices·4,000 affected·Dec 24, 2013
High RiskFDA
Icu Medical, Inc.
6" (15 cm) Appx 0.26 ml, Smallbore Ext Set w/Clamp, NanoClave¿ TConnector, Rotating Luer, Part No. A1000, Item No. A1001 The ICU Needle...
Medical Devices·700 affected·Dec 24, 2013
High RiskFDA
Icu Medical, Inc.
11" Smallbore Bifuse Ext Set w/1.2 Micron Filter, NanoClave", 3 Clamps, Rotating Luer, Part No. A1000, Item No. K7105-001 The ICU Needl...
Medical Devices·500 affected·Dec 24, 2013