Class I - Dangerous
A&D may have shipped blood pressure monitors that were not labeled for use with small cuff.
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Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
38,779 Total Recalls
Zenostar MT Color A2 60ml, art. no. 681051. Product Usage: For coloring dental porcelain
Ivoclar Vivadent
Class I - Dangerous
The primary packaging of these products may show leaks in individual cases. As a consequence, the liquid may escape inadvertently and direct contact with this liquid may lead to skin irritation.
Zenostar MT Color A1 60ml, art. no. 681050, Product Usage: For coloring dental porcelain
Ivoclar Vivadent
Class I - Dangerous
The primary packaging of these products may show leaks in individual cases. As a consequence, the liquid may escape inadvertently and direct contact with this liquid may lead to skin irritation.
Three complaints describing TruSystem tables unexpectedly descending approximately 20 centimeters.
Zenostar MT Color Impulse orange, art. no. 681168. Product Usage: For coloring dental porcelain
Ivoclar Vivadent
Class I - Dangerous
The primary packaging of these products may show leaks in individual cases. As a consequence, the liquid may escape inadvertently and direct contact with this liquid may lead to skin irritation.
Three complaints describing TruSystem tables unexpectedly descending approximately 20 centimeters.
Class I - Dangerous
The infant performance test did not meet the test specification for the Infant Head Uniformity test with High Resolution. As a result, when the user performs High Resolution head scans, the reconstructed images may exhibit degraded image quality manifested as non-uniformity of the image, CT number shift greater than 5 Hounsfield units, and reduction in gray/white matter differentiation. The issue is most sever in the High Resolution mode, and the factory reference pediatric scan protocols are set to High Resolution default. Adults head scans have a factory reference protocol that defaults to standard resolution which doesn't experience the issue.
Zenostar MT Color D3 60ml, art. no. 681064. Product Usage: For coloring dental porcelain
Ivoclar Vivadent
Class I - Dangerous
The primary packaging of these products may show leaks in individual cases. As a consequence, the liquid may escape inadvertently and direct contact with this liquid may lead to skin irritation.
Siemens became aware of a potential issue with the patient table for Ysio Max and Multix Fusion systems. There is an unlikely risk that an internal part of the table may detach causing the table top to tilt to the left side which could result in an injury to a patient on the table.
FDA inspection found that customers who had received devices with promotional material with outside use indications were not notified when labeling was revised to remove these indications.
Three complaints describing TruSystem tables unexpectedly descending approximately 20 centimeters.
Zenostar MT Color C2 60ml art. no. 681060. Product Usage: For coloring dental porcelain
Ivoclar Vivadent
Class I - Dangerous
The primary packaging of these products may show leaks in individual cases. As a consequence, the liquid may escape inadvertently and direct contact with this liquid may lead to skin irritation.
During final sampling inspection, one of the lots was discovered with a total incomplete packaging seal of the sterile product.
Toshiba America Medical Systems, Inc . Aquilion RXL TSX-101 A/R, U CT Scanner Diagnostic imaging systems indicated to acquire and display cross sectional volumes of the whole body, to include the head.
Toshiba American Medical Systems
Class I - Dangerous
It has been found that if the scan range extends beyond the maximum Field of View (FOV), a reconstruction operation error may occur. As a result, scanning may be interrupted and rebooting of the system may be necessary. Please note that this issue has not occurred in the U.S.
Arthrex Suture Washer
Arthrex
Class I - Dangerous
The device was assembled incorrectly. Suture and washer were not assembled; components were placed loose in the package.
Class I - Dangerous
During final sampling inspection, one of the lots was discovered with a total incomplete packaging seal of the sterile product.
FDA inspection found that customers who had received devices with promotional material with outside use indications were not notified when labeling was revised to remove these indications.
Merit Inflation Syringe Kit. Catalog Number KOS-02857
Merit Medical Systems
Class I - Dangerous
Merit Medical Systems, Inc. announces a voluntary field action for Merit Inflation Syring Kit due to unit labels missing required device labeling information.
Walrus Arterial Embolectomy Catheter The arterial embolectomy catheter is intended for use in removing arterial emboli.
Arrow International
Class I - Dangerous
Arrow is recalling due to incorrect labeling of products.
Zenostar MT Color A3.5 60ml, art. no. 681053. Product Usage: For coloring dental porcelain
Ivoclar Vivadent
Class I - Dangerous
The primary packaging of these products may show leaks in individual cases. As a consequence, the liquid may escape inadvertently and direct contact with this liquid may lead to skin irritation.