Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM instead of 'specially controlled medical device"
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Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
38,779 Total Recalls
Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM instead of 'specially controlled medical device"
Class I - Dangerous
Flow sensors could have damaged tubes in the form of small punctures or cuts.
Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM instead of 'specially controlled medical device"
Class I - Dangerous
5F Micro-Introducer Kits may not contain the correct device, packaged with a 4F Sheath/Dilator component
3M Red Dot Monitoring Electrode with 4mm Adapter - Product Usage: intended to be used by healthcare professionals for ECG monitoring. 10 electrodes per card; 4 cards per pouch; 20 pouches per shipper box (800 electrodes total).
3M Company - Health Care Business
Class I - Dangerous
Corrosion could cause performance failures in the product.
Class I - Dangerous
Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions.
5.5MM Arthrogarde Hip Access Cannula
Smith & Nephew
Class I - Dangerous
The J Lock feature on the cannula body was manufactured incorrectly, preventing the cannula from locking into an irrigation extender or arthroscope in the correct orientation.
The wall charger may not properly charge the infusion pump battery.
Class I - Dangerous
Masks processed at one site were not maintained at levels of condensation during a portion of the decontamination cycle.
Bard 3F SL PowerMidline Full Kit CE-indicated for short term access to the peripheral venous system for selected intravenous therapies, blood sampling, and power injection of contrast media Ref: P6153208
Becton Dickinson & Company
Class I - Dangerous
Kits do not contain the stylet/T-lock assembly indicated as a component on the label, may lead to a procedural delay and possibly discard of the kit.
Class I - Dangerous
The periodic Paddle Checks recommended in the Instructions for Use for Sterilizable Defibrillator Paddles may not detect one failure mode for the Switched Internal Defibrillator Paddles. Philips has created an addendum to the IFU, that includes a test for the switched paddles only, which will detect this failure mode.
Merge LIS
Merge Healthcare
Class I - Dangerous
A defect in the software resulted in medications that are not associated with the patient (i.e., medications that the patient is not currently taking) appearing on their report.
9372HD Digital Capture (ver. 1.1.0 + w/ 9263 endoPortal),
Pentax of America
Class I - Dangerous
There is an intermittent software issue that could affect the systems, in which an exam video for one patient (Patient A) might be copied to another patient (Patient B). This does not occur at the time the user performs and initially reviews an exam; it is not evident until a follow-up review occurs.
KWIK-STIK 6 Pack Klebsiella pneumoniae derived from NCTC 13443 (Catalog# 01145K) should contain the NDM-1 positive strain, but was confirmed to be NDM-1 negative.
The Streamline Navigation System taps have experienced binding with other devices.
Class I - Dangerous
One da Vinci Xi Endoscope Controller in the field was improperly calibrated during servicing. The result of this improper calibration may result in the tip of the endoscope may reach higher temperature causing the potential for thermal tissue injury and/or overly bright images.
Class I - Dangerous
There is a potential for a smudge artifact that could be suspect for pathology in some images due to incorrect settings.
Class I - Dangerous
The Streamline Navigation System taps have experienced binding with other devices.
Class I - Dangerous
The device may be incorrectly laser marked as a right stem, when it should have been laser marked as a left stem.