All Recalls

95,114 total recalls in our database

NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL REF: SAK-305 Lactate 45, Potassium 1, Sodium 140, Calcium 3, Magnesium 1 Chloride 100, Glucose (mg/dL) 100 Batch Size (liters) 40

NxStage Medical

🏥 Medical Devices Class I - Dangerous

SAK Dialysate Concentrate contain aluminum levels which exceed internal product specification

May 14, 2014 Other Medical Devices Nationwide View Details →

IF 8000; 1/F Interferential Electrical Stimulation Device; NMES (neuromuscular electrical stimulation) mode. Designed for use in physical therapy, rehabilitation, and pain relief applications.

Zynex Medical

🏥 Medical Devices Class I - Dangerous

Zynex notified customers that a malfunction in the IF 8000 can result in the device ceasing to operate, and in some instances,overheating and becoming hot to the touch.

Jan 25, 2009 Other Medical Devices Nationwide View Details →

ANSPACHREF 98-0016eMax 2 Modified Hand ControlRx Only This device is intended to be used with Anspach Systems

The Anspach Effort

🏥 Medical Devices Class I - Dangerous

The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.

Nov 28, 2012 Other Medical Devices View Details →

ANSPACHCustom QD11 Attachment with thinner nose tubeRx Only*** This device is intended to be used with Anspach Systems

The Anspach Effort

🏥 Medical Devices Class I - Dangerous

The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.

Nov 28, 2012 Other Medical Devices View Details →

HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating, Sterile. 0.035 OD, Standard Shaft, Straight Tip, 150 CM Length Manufactured for Covidien, Plymouth, MN; Manufactured by: NDC Inc., Fremont, CA. Manufactured in Costa Rica The HydroFinity Hydrophilic guidewire facilitates the introduction and placement of catheters and interventional devices to the desired anatomical location during diagnostic or interventional procedures.

Nitinol Devices and Components

🏥 Medical Devices Class I - Dangerous

Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guidewire.

May 28, 2014 Diagnostic Equipment Nationwide View Details →

Model RG3000 and RG4000 Series Valve Integrated Pressure Regulator (VIPR)

Western / Scott Fetzer Company

🏥 Medical Devices Class I - Dangerous

Separation events have occurred, including the VIPR separating from the Aluminum cylinder.

Apr 7, 2014 Other Medical Devices Nationwide View Details →

Shaver Handpiece Sterilization Tray. Model number 272-700-000. For sterilization of Stryker Endoscopy arthroscopic shaver.

Stryker Endoscopy

🏥 Medical Devices Class I - Dangerous

STERRAD 100S parameters provided in the Shaver Handpiece reprocessing guide (P10299 Revision A) did not fully consider all worst-case scenarios during validation testing.

May 19, 2014 Other Medical Devices View Details →

ANSPACHREF 98-0023Custom 5 cm Extension Bearing SleeveRx Only This device is intended to be used with Anspach Systems

The Anspach Effort

🏥 Medical Devices Class I - Dangerous

The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.

Nov 28, 2012 Other Medical Devices View Details →

Puritan Bennett 840 Ventilator (4-840120DIUU-XX) The PB840 Ventilator System is intended to provide invasive or non-invasive ventilatory support and monitoring for infant, pediatric, and adult patients with respiratory failure or respiratory insufficiency. It is used in hospitals and healthcare facilities.

Nellcor Puritan Bennett Inc. (dba Covidien LP)

🏥 Medical Devices Class I - Dangerous

Covidien is conducting a medical device field correction for specific Puritan Bennett 840 Ventilators due to customer reports of loss of graphical user interface (GUI) display information while the ventilator continues to provide breath support.

Jun 3, 2014 Diagnostic Equipment Nationwide View Details →

ANSPACHModified QD11 Attachment with Soft Tissue ProtectorRx Only*** This device is intended to be used with Anspach Systems

The Anspach Effort

🏥 Medical Devices Class I - Dangerous

The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.

Nov 28, 2012 Other Medical Devices View Details →

ANSPACHREF SP-4604-003mm Fluted Ball for Adjustable 25cm Mia AttachmentRx Only This device is intended to be used with Anspach Systems

The Anspach Effort

🏥 Medical Devices Class I - Dangerous

The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.

Nov 28, 2012 Other Medical Devices View Details →

Accell Evo3C Demineralized Bone Matrix, 5 cc, Model Number: 02-6000-050 , Lot Number: 132160. Product Usage: Accell Evo3c Demineralized Bone Matrix Putty is intended for filling voids and gaps in the skeletal system that are not intrinsic to the stability of the bony structure. Accell Evo3c is indicated for use as a bone graft extender in the spine, extremities and pelvis, or as a bone void filler in the extremities and pelvis. The voids or gaps may be surgically created defects or the result of traumatic injury to the bone.

Integra LifeSciences

🏥 Medical Devices Class I - Dangerous

This lot of Accell Evo3C Demineralized Bone Matrix, 5cc was incorrectly packaged in boxes that describe the product as Accell Evo3 Demineralized Bone Matrix. Evo3C is contraindicated for treatment of vertebral compression and not indicated for use in the posterolateral spine.

May 19, 2014 Surgical Instruments Nationwide View Details →

Glucose Hexokinase Liquid Reagent For the in vitro quantitative determination of Glucose in serum.

JAS Diagnostics

🏥 Medical Devices Class I - Dangerous

JAS Diagnostics, Inc. of Miami Lakes, FL is recalling their Glucose Hexokinase reagent due to certain lots not performing according to their specifications.

Apr 7, 2014 Infusion Pumps View Details →

Coulter DxH Cleaner 5L, Part No. 628022. For use on UniCel DxH Systems for components that come in contact with blood samples.

Beckman Coulter

🏥 Medical Devices Class I - Dangerous

Beckman Coulter is recalling the UniCel DxH800 and UniCel DxH600 Coulter Analysis Systems because the optical degradation may potentially cause a delay in reporting results for nucleated red blood cells (nRBC), automated white blood cell differential and the reticulocyte.

Nov 8, 2013 Other Medical Devices View Details →

ANSPACHREF SP-3012-0013 mm Drill with Depth Stop for Short Heavy Duty AttachmentRx Only This device is intended to be used with Anspach Systems

The Anspach Effort

🏥 Medical Devices Class I - Dangerous

The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.

Nov 28, 2012 Other Medical Devices View Details →

ANSPACHREF 98-00228 mm Coarse Headless Screw with DriverRx Only This device is intended to be used with Anspach Systems

The Anspach Effort

🏥 Medical Devices Class I - Dangerous

The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.

Nov 28, 2012 Infusion Pumps View Details →

ANSPACHREF 98-0042XMax Motor with Custom HoseRx Only This device is intended to be used with Anspach Systems

The Anspach Effort

🏥 Medical Devices Class I - Dangerous

The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.

Nov 28, 2012 Other Medical Devices View Details →

ANSPACHREF SP-5000-00Threaders, Arthroscopic Suture AnchorRx Only This device is intended to be used with Anspach Systems

The Anspach Effort

🏥 Medical Devices Class I - Dangerous

The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.

Nov 28, 2012 Other Medical Devices View Details →

Siemens StreamLAB(R) Analytical Workcell; Catalog number 746002.901. Designed to automate sample handling and processing in the clinical laboratory.

Siemens Healthcare Diagnostics

🏥 Medical Devices Class I - Dangerous

Firm has received reports from customers that the small pins at the bottom of the center door panel of the Input/Output Module, which protrude approximately 5/8 inch (16 mm), have contributed to trip and fall incidents. Customers are advised that when working in the area of the Input/Output Module to be aware of the two pins that protrude and use caution.

Oct 11, 2012 Other Medical Devices Nationwide View Details →

ANSPACHREF 98-0035Custom eMax 2 Plus Motor with microMax Disconnect SleeveRx Only This device is intended to be used with Anspach Systems

The Anspach Effort

🏥 Medical Devices Class I - Dangerous

The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.

Nov 28, 2012 Other Medical Devices View Details →