🏥 Medical Devices • 7,015 recalls
The plastic film used to manufacture these Angiography Drape and Cesarean Birth Drape products is causing the drapes to stick, which may prevent the products from being unfolded and applied properly. Sold in single sterile and bulk non-sterile configurations.
The plastic film used to manufacture these Angiography Drape and Cesarean Birth Drape products is causing the drapes to stick, which may prevent the products from being unfolded and applied properly. Sold in single sterile and bulk non-sterile configurations.
Medtronic Heart Valves Division
Due to reports of actuator separation for various delivery catheter systems. Affected products were manufactured before July 11, 2020.
The plastic film used to manufacture these Angiography Drape and Cesarean Birth Drape products is causing the drapes to stick, which may prevent the products from being unfolded and applied properly. Sold in single sterile and bulk non-sterile configurations.
The plastic film used to manufacture these Angiography Drape and Cesarean Birth Drape products is causing the drapes to stick, which may prevent the products from being unfolded and applied properly. Sold in single sterile and bulk non-sterile configurations.
Medtronic Heart Valves Division
Due to reports of actuator separation for various delivery catheter systems. Affected products were manufactured before July 11, 2020.
The plastic film used to manufacture these Angiography Drape and Cesarean Birth Drape products is causing the drapes to stick, which may prevent the products from being unfolded and applied properly. Sold in single sterile and bulk non-sterile configurations.
Medtronic Heart Valves Division
Due to reports of actuator separation for various delivery catheter systems. Affected products were manufactured before July 11, 2020.
Bard Access Systems
Catheter convenience kits contain the incorrect guidewire. Kits were labeled with 70cm guidewires, but contained a 50cm guidewire.
Bard Access Systems
Catheter kits contained the incorrect micro-introducers.
A portion of a validation lot was inadvertently released to the US Market. The product did not meet the validation testing criteria regarding leakage.
Medical Action Industries, Inc. 306
There is a potential for flaking metal and/or brown spots on the hemostats sold as individual units or packaged in the kits
Medical Action Industries, Inc. 306
There is a potential for flaking metal and/or brown spots on the hemostats sold as individual units or packaged in the kits
Medical Action Industries, Inc. 306
There is a potential for flaking metal and/or brown spots on the hemostats sold as individual units or packaged in the kits
The product may have a yellowish-brown/greenish-brown residue present at the tip of the cannula.
Angio tubing included within Custom Convenience kits may contain insufficient or incomplete weld
Angio tubing included within Custom Convenience kits may contain insufficient or incomplete weld
(1) Updated IFU for the LX Illumination Packs: Warning - Avoid contact between the distal opening of the delivery sleeve and tissue/debris within the surgical.field to prevent complete occlusion. Some surgical approaches (e.g., endonasal) may increase this potential. {f unintended reduction in light output occurs and/or occlusion of the sleeve is suspected, both the delivery sleeve and the fiber should be replaced (2) Removal for the LX Light Source potential for the distal tip of the sleeve/fiber assembly potential to burn healthy tissue resulting in minor to moderate injury to the patient or end user.
The devices may not meet the minimum required sterility assurance level.
Normand-Info S.A.S.U.
Instructions For Use for software versions 1.5 to 1.9 did not provide sufficient instructions regarding the proper programming and testing of rules. Therefore, rules written by users that were not validated or incorrectly validated may lead to erroneous results.