🔍 RecallPedia

All Recalls

95,094 total recalls in our database

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28,983
Food
 💊
17,685
Drugs
 🏥
38,779
Medical Devices
 🏠
9,647
Consumer Products

FrameLink. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipping purposes. Product Usage: The StealthStation System is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The StealthStation System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure such as the skull, a long bod, or vertebra can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.

Medtronic Navigation

🏥 Medical Devices Class I - Dangerous

Medtronic Navigation, Inc. announces a voluntary field action for the Medtronic Navigation StealthStation Software applications affected by Neurologica BodyTom/CereTom floor-based scanners.

Jul 18, 2016 Implants & Prosthetics Nationwide View Details →

ONLINE TDM Vancomycin 100 tests; ONLINE TDM Vancomycin 200 tests; Hitachi Vancomycin (Modular P); Hitachi Vancomycin (917, MOD P) The ONLINE TDM Vancomycin assay is for the quantitative determination of Vancomycin in human serum or plasma on Roche automated clinical chemistry analyzers.

Roche Diagnostics Operations

🏥 Medical Devices Class I - Dangerous

Roche Diagnostics Operations, Inc. has issued a voluntary recall for the Online TDM Vancomycin assay on the cobas c 311/501/502 analyzers and the Modular Analytics P module due method sheets that state an incorrect method comparison against the COBAS INTEGRA 800 analyzer.

May 26, 2016 Diagnostic Equipment Nationwide View Details →

Synergy Cranial S7. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipping purposes. Product Usage: The StealthStation System is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The StealthStation System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure such as the skull, a long bod, or vertebra can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.

Medtronic Navigation

🏥 Medical Devices Class I - Dangerous

Medtronic Navigation, Inc. announces a voluntary field action for the Medtronic Navigation StealthStation Software applications affected by Neurologica BodyTom/CereTom floor-based scanners.

Jul 18, 2016 Implants & Prosthetics Nationwide View Details →

Zimmer¿ Air Dermatome II Handpiece w/o Hose, item number 00-8851-001-01. The Zimmer Air Dermatome II handpiece and width plates are packaged inside of a padded-foam corrugate box. An operating manual is packed with the handpiece between the top foam pad and box lid. A product label is applied to the lid of the box. The width plates, when sold individually, are placed in a labeled poly zipper bag, which is then placed into a corrugated shipper carton or padded envelope. The Zimmer Air Dermatome II is a skin grafting instrument that is intended to provide variable graft thickness and width capabilities.

Zimmer Surgical

🏥 Medical Devices Class I - Dangerous

The surface coating applied to the device is blistering, peeling and discoloring after usage over time

Jul 4, 2016 Implants & Prosthetics Nationwide View Details →

Merge HEMO software.

Merge Healthcare

🏥 Medical Devices Class I - Dangerous

The International Normalized Ratio (INR) value displayed in the study report does not match the value that is imported on the pre-procedure labs screen from HL7

Jul 2, 2012 Other Medical Devices Nationwide View Details →

Zimmer¿ Air Dermatome II Width Plate, 1.5 inch. Part #00-8851-215-00. Width plate is packaged inside of a padded-foam corrugate box. A product label is applied to the lid of the box. The width plates, when sold individually, are placed in a labeled poly zipper bag, which is then placed into a corrugated shipper carton or padded envelope. The Zimmer Air Dermatome II is a skin grafting instrument that is intended to provide variable graft thickness and width capabilities.

Zimmer Surgical

🏥 Medical Devices Class I - Dangerous

The surface coating applied to the device is blistering, peeling and discoloring after usage over time

Jul 4, 2016 Implants & Prosthetics Nationwide View Details →

Zimmer¿ Air Dermatome II Width Plate, 3 inch. Part #00-8851-203-00. Width plate is packaged inside of a padded-foam corrugate box. A product label is applied to the lid of the box. The width plates, when sold individually, are placed in a labeled poly zipper bag, which is then placed into a corrugated shipper carton or padded envelope. The Zimmer Air Dermatome II is a skin grafting instrument that is intended to provide variable graft thickness and width capabilities.

Zimmer Surgical

🏥 Medical Devices Class I - Dangerous

The surface coating applied to the device is blistering, peeling and discoloring after usage over time

Jul 4, 2016 Implants & Prosthetics Nationwide View Details →

IntelliVue Patient Monitor Product Usage: The monitors are indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. The monitors are intended to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates. The monitors are intended for use by trained healthcare professionals in a hospital environment.

Philips Electronics North America

🏥 Medical Devices Class I - Dangerous

If an affected Patient Monitor has been powered on continuously for several months, any displayed waveforms will contain outdated data and therefore fail to reflect the patients current condition.

Jul 26, 2016 Diagnostic Equipment Nationwide View Details →

AU5800 Chemistry Analyzers, Reference No. A98352 The AU series are automated, clinical chemistry analyzers that measure analytes in patient samples (serum, plasma, urine, CSF) in combination with appropriate reagents, calibrators, quality, control (QC) materials, and other accessories.

Beckman Coulter

🏥 Medical Devices Class I - Dangerous

Beckman coulter has received complaints regarding leaking and cracked C cups. When the cup cracks, coolant can leak onto the connectors of the Printed Circuit Boards (PCB) in the analyzer, resulting in a short-circuit causing the instrument to go into a stop mode.

Jul 30, 2015 Other Medical Devices Nationwide View Details →

Spirit Plus Bed, A-C Powered Hospital Bed

CHG Hospital Beds

🏥 Medical Devices Class I - Dangerous

Stryker Medical is initiating a voluntary recall of the Spirit Select and Spirit Plus A-C powered hospital beds due to reports of hi-lo actuators broken at the mount ends, which could cause the bed to unexpectedly lower resulting in patient injury.

Jun 28, 2016 Other Medical Devices Nationwide View Details →

AU480 Chemistry Analyzers, Reference No. B28624 The AU series are automated, clinical chemistry analyzers that measure analytes in patient samples (serum, plasma, urine, CSF) in combination with appropriate reagents, calibrators, quality, control (QC) materials, and other accessories.

Beckman Coulter

🏥 Medical Devices Class I - Dangerous

Beckman coulter has received complaints regarding leaking and cracked C cups. When the cup cracks, coolant can leak onto the connectors of the Printed Circuit Boards (PCB) in the analyzer, resulting in a short-circuit causing the instrument to go into a stop mode.

Jul 30, 2015 Other Medical Devices Nationwide View Details →

Zimmer¿ Air Dermatome II Handpiece, item number 00-8851-001-00. The Zimmer Air Dermatome II handpiece and width plates are packaged inside of a padded-foam corrugate box. An operating manual is packed with the handpiece between the top foam pad and box lid. A product label is applied to the lid of the box. The width plates, when sold individually, are placed in a labeled poly zipper bag, which is then placed into a corrugated shipper carton or padded envelope. The Zimmer Air Dermatome II is a skin grafting instrument that is intended to provide variable graft thickness and width capabilities.

Zimmer Surgical

🏥 Medical Devices Class I - Dangerous

The surface coating applied to the device is blistering, peeling and discoloring after usage over time

Jul 4, 2016 Implants & Prosthetics Nationwide View Details →

Zimmer¿ Air Dermatome II Width Plate, 4 inch. Part #00-8851-204-00. Width plate is packaged inside of a padded-foam corrugate box. A product label is applied to the lid of the box. The width plates, when sold individually, are placed in a labeled poly zipper bag, which is then placed into a corrugated shipper carton or padded envelope. The Zimmer Air Dermatome II is a skin grafting instrument that is intended to provide variable graft thickness and width capabilities.

Zimmer Surgical

🏥 Medical Devices Class I - Dangerous

The surface coating applied to the device is blistering, peeling and discoloring after usage over time

Jul 4, 2016 Implants & Prosthetics Nationwide View Details →

Fusion ENT Application. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipping purposes. Product Usage: The StealthStation System is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The StealthStation System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure such as the skull, a long bod, or vertebra can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.

Medtronic Navigation

🏥 Medical Devices Class I - Dangerous

Medtronic Navigation, Inc. announces a voluntary field action for the Medtronic Navigation StealthStation Software applications affected by Neurologica BodyTom/CereTom floor-based scanners.

Jul 18, 2016 Implants & Prosthetics Nationwide View Details →