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
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
Siemens' conducting a recall due to a potential issue when using the measurement package of the VA10 version of syngo Dynamics.
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.
Prime Series Stretchers (Fifth Wheel, Big Wheel and Zoom) Powered stretcher
Stryker Medical Division of Stryker
Class I - Dangerous
The hydraulic jack assemblies (PN: 0753-002-101, 0753-002-070, 0753-002-001, and 0753-002-001) were manufactured using the incorrect oil. The oil used does not contain the same wear resistance additives as the specified oils and therefore its use increases the potential for wear which may cause a leak event or jack drift. Testing was done to evaluate the jacks with incorrect oil and leak events we
During the 36 month real time shelf life testing of NuOss XC Sinus (BMCU-Umbrella) to verify the 3 year shelf life designated for the device, 3 of 13 products did not pass the recovery test, which requires that the compressed product fully expand within 1 minute of hydration time.
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.
Product 72 consists of all product code: JDI and same usage: Item no: 805002202 ZIMTRON HEAD 12/14 0X22 MM For use in total or hemi hip arthroplasty
Zimmer Manufacturing B.V.
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.
Percutaneous Insertion Tray; Product Code: IAK-06845 The Arrow¿ IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation, during systole increases blood supply to the heart muscle and decreases work of the left ventricle.
Arrow International, Inc., Division of Teleflex Medical
Class I - Dangerous
The sheath body may become separated from the sheath hub. If the separation occurs, there is a potential for bleeding from the device.
Class I - Dangerous
Increased U90-382 or 6LU condition codes generated by VITROS 250, 350, 5,1 FS, 4600 and 5600 Chemistry Systems when using Calibrator Kit 9, Lot 954. A trend of complaints regarding customers actions following U90-382 or 6LU condition codes was noted (See RES 72289 - VITROS Calibrator Kit 9, lot 954 recall).
Abbott Vascular has recently received reports of cases on Clip Delivery System devices that contain the One-Way Actuator Knob where a user attempted implanting a MitraClip, but the Clip could not be detached from the delivery system due to a mandrel fracture.
GE Healthcare has updated the Service Manuals for a number of CT and PET CT Scanners to update an incorrect torque value.
Class I - Dangerous
Zimmer Biomet initiated a lot-specific voluntary recall on 02/11/2016, of the M/L Taper Hip Prosthesis. single manufacturing lot of Size 12.5, Extended Offset, M/L Taper hip stems was incorrectly etched. The device was etched as STD, rather than EXT. The product packaging is labeled correctly as Extended. Offset, and the device is an extended offset stem.
Milex Arcing Diaphragm Size 95; Model Number: MXWS95
CooperSurgical
Class I - Dangerous
The products have been identified to contain an incorrect size Diaphragm.
Class I - Dangerous
Customers have reported that the pinch clamp on the RP Bag was missing. Ascetic fluid from the abdominal cavity may splash User if bag is not clamped prior to removal.
Ultra 8 IAB: 8Fr 40cc; Product Code: IAB-05840-U The Arrow¿ IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation, during systole increases blood supply to the heart muscle and decreases work of the left ventricle.
Arrow International, Inc., Division of Teleflex Medical
Class I - Dangerous
The sheath body may become separated from the sheath hub. If the separation occurs, there is a potential for bleeding from the device.
GE Healthcare has updated the Service Manuals for a number of CT and PET CT Scanners to update an incorrect torque value.
GE Healthcare has updated the Service Manuals for a number of CT and PET CT Scanners to update an incorrect torque value.
Increased U90-382 or 6LU condition codes generated by VITROS 250, 350, 5,1 FS, 4600 and 5600 Chemistry Systems when using Calibrator Kit 9, Lot 954. A trend of complaints regarding customers actions following U90-382 or 6LU condition codes was noted (See RES 72289 - VITROS Calibrator Kit 9, lot 954 recall).