As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.
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Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
38,779 Total Recalls
Incorrect cannula of the sheath introducer (smaller than intended).
Class I - Dangerous
As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.
As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.
As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.
As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.
As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.
As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.
NuOSS Cancellous Intended for use in dental surgery.
Collagen Matrix
Class I - Dangerous
On 8/25/2015, Collagen Matrix, Inc discovered that one of the 171 units of NuOss Cancellous product shipped to a distributor may have included an incorrect size.
As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.
As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.
Pilling Modular Verres Body/Obturator, Product Code 140880
Teleflex Medical
Class I - Dangerous
Packaging error in which customers who ordered product code 140880 (Verres cannula for use with a separately available needle tip) were incorrectly provided with product code 140878 (Verres cannula with integral needle tip).
Stockert Heater-Cooler 3T; Item Number 16-02-8, H3T/240V/60Hz ; 16-02-82, H3T208V/60Hz ; 16-02-85, H3T/120V/60Hz. Device Listing E572259
Sorin Group USA
Class I - Dangerous
On August 15, 2012, Sorin informed consignees via letter of changes made to create Version 12 of the Heater-Cooler 3T IFU. The revised IFU included enhancements to achieve water quality that meets the standard for German drinking water.
Class I - Dangerous
The firm discovered that one of the hysteroscope models listed for processing in four existing Quick Connects has one inlet port rather than two inlet ports as indicated in the Quick Connect processing instructions.
As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.
As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.
Class I - Dangerous
As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.
As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.
Class I - Dangerous
The sterile battery may contain particulates within the sterile package.
As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.