There is a possibility that the Set Screw (p/n 90-2923) sub-component of the Parallel Rod Connector Assembly (p/n 52-6800) & Axial Rod Connector (p/n 52-6700) may crack during final tightening. Orthofix Inc received six (6) customer complaints related to set screw cracking between November 15, 2010 and December 2012.
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Other Medical Devices
🏥 Medical Devices • 15,809 recalls
Liko/Hill-Rom to date has received two reports from facilities alleging that the overhead rail system has failed to the extent that the overhead rails have fallen down while in use in high humidity (swimming pool) areas. Analysis of the incidents suggest that the components (hardware) used to secure the rail to the ceiling had corroded and may be unsuitable for environments with an atmosphere con
VACUETTE Safety Blood Collection Set + Luer Adapter, 23x12" Safety Blood Collect LA Product, Item number 450096. Usage: The Safety Blood Collection Set is used in routine venipuncture procedures.
Greiner Bio-One North America
Class I - Dangerous
The VACUETTE Safety Blood Collection Set + Luer Adapter may display leaking (small droplets) during use due to a crack on the luer connector piece.
Class I - Dangerous
The beam is displayed at the "gantry" angle, but the dose is calculated at the "rotation_start" angle.
Maquet ELS Cannula 15 FR. Used for extracorporeal membrane oxygenation (ECMO) for the treatment of respiratory insufficiency in infants.
Maquet Cardiovascular Us Sales
Class I - Dangerous
ELS 15 Fr Cannula could potentially contain an occluded arterial lumen.
Varian Eclipse Treatment Planning System for Radiotherapy; Model Number: H48. In addition, the Eclipse Proton Eye algorithm is specifically indicated for planning proton treatment of neoplasms of the eye.
Varian Medical Systems, Inc. Oncology Systems
Class I - Dangerous
The calculation of dose dynamic plans containing different energy fields is incorrect when the Pencil Beam Convolution 11.0 algorithm (PBC 11.0) is used.
Electrode Socket Terminal pulling away from the electrode lead wire when the electrical stim lead wire was removed.
Ultradent Products, Chromaclone PVS, Regular Set heavy body, Bubble Gum Flavor, 50 ml, Impression Material, Part No. 5012, Lot No. B7PPC. Used in prosthodontics.
Ultradent Products
Class I - Dangerous
Incorrect packaging of regular set and fast set cartridges.
Class I - Dangerous
The product may contain low level microbial contamination which could result in incorrect results.
Electrode Socket Terminal pulling away from the electrode lead wire when the electrical stim lead wire was removed.
Lockheed Martin Gyrocam Systems ( LMGS) LMGS 15" camera systems. Laser pointer and illuminator used for law enforcement surveillance from aircraft. Models DNV, TS and DS
Lockheed Martin Gyrocam Systems
Class I - Dangerous
These camera systems were manufactured by LMGS and found to fail to comply with the FDA laser performance standard during an FDA inspection. These camera systems incorporate Class IIIb surveying, leveling, and alignment lasers and were entered into US commerce without a variance. Additionally, the manufacturer did not submit a product report to FDA for the camera system.
Class I - Dangerous
Possible instability of Orthopedic Table Top. If the epoxy bond fails, the aluminum plug may migrate out of the carbon fiber tube. If this occurs, the Orthopedic Table Spar may need to be replaced to ensure stability of the Orthopedic Table Top.
Ultradent Products, Chromaclone PVS, Fast Set heavy body, Bubble Gum Flavor, 50 ml, Impression Material, Part No. 5013, Lot No. B7DS3, Used in prosthodontics.
Ultradent Products
Class I - Dangerous
Incorrect packaging of regular set and fast set cartridges.
Class I - Dangerous
The recall was initiated because Breg has determined that some Sterile Polar Pads products manufactured from January 2010 to October 2012 may have sustained damage to the product packaging which may compromise product sterility assurance.
Electrode Socket Terminal pulling away from the electrode lead wire when the electrical stim lead wire was removed.
Class I - Dangerous
The firm is recalling the product because the cartridges may contain discs that have an insufficient dose of antibiotic.
Electrode Socket Terminal pulling away from the electrode lead wire when the electrical stim lead wire was removed.
Fresenius Liberty Cycler Set Single Conn. Ext. DL. Part Number: 050-87216. Acute and chronic peritoneal dialysis.
Fresenius Medical Care Holdings
Class I - Dangerous
There is a small risk of a leak in Cycler Sets and if the Cycler Set is punctured, the dialysate may become contaminated potentially resulting in peritonitis.
Class I - Dangerous
The recall was initiated because Breg has determined that some Sterile Polar Pads products manufactured from January 2010 to October 2012 may have sustained damage to the product packaging which may compromise product sterility assurance.
Class I - Dangerous
Contact between the bur and bur guard could generate metal fragments that may or may not be visible to the surgeon and can potentially remain in the surgical site. The materials used to fabricate the bur guard are not traceable, design validation did not effectively evaluate adequate protection of adjacent tissue and inspection results for each of these bur guards were not documented.