Class I - Dangerous
Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile during their shelf-life.
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Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
38,779 Total Recalls
Arrow EPIDURAL NEEDLE KIT SL-05500
Arrow International
Class I - Dangerous
Product lidstock contains the incorrect expiration date for the product
Class I - Dangerous
Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile during their shelf-life.
Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
Class I - Dangerous
Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile during their shelf-life.
Class I - Dangerous
Siemens became aware of an issue of incorrect use of the bypass key overriding the built-in collision control creating risk of collision with obstacles or persons when the operator uses the override function.
Implant Retrieval Kit - Product Usage: The kit itself does not have a specific intended Use, but included devices have specific intended use as shown above.
Nobel Biocare Usa
Class I - Dangerous
Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile during their shelf-life.
UST-2265-2 Probe, Part Number: UST-2265-2 - Product Usage: The UST-2265-2 probe is intended to be used for diagnostic ultrasound imaging or fluid flow analysis of the human body as Continuous-wave Doppler (CWD) for Cardiac Adult, Cardiac Pediatric, and Peripheral Vessel.
Hitachi Medical Systems America
Class I - Dangerous
These 18 probes may have mis-wiring in the inner cables, causing decreased sensitivity and thus resulting in lower peak velocity readings.
Class I - Dangerous
Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
Presource Procedure Packs containing AAMI Level 3 surgical gowns, Multiple Catalog Numbers Produced Between September 1, 2018 and January 15, 2020
Cardinal Health 200
Class I - Dangerous
The kits contained recalled surgical gowns. The gowns were manufactured at locations that did not maintain proper environmental conditions. There is no assurance that the surgical gowns are sterile. An inadequately sterilized surgical gown could compromise a sterile field and increase the risk of a surgical site infection.
Arrow EPIDURAL CATHETERIZATION KIT JH-05500
Arrow International
Class I - Dangerous
Product lidstock contains the incorrect expiration date for the product
Class I - Dangerous
There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.
ADVIA Chemistry Enzymatic Creatinine (ECRE_2) reagent, SMN 10335869
Siemens Healthcare Diagnostics
Class I - Dangerous
There is a potential for falsely depressed creatinine results for patients on phenindione therapy when using the enzymatic methodology. Interference has not been observed with the creatinine Jaffe methodology.
Arrow¿ EPIDURAL CATHETERIZATION KIT AK-05000
Arrow International
Class I - Dangerous
Product lidstock contains the incorrect expiration date for the product
Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile during their shelf-life.
Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
Class I - Dangerous
Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile during their shelf-life.
Class I - Dangerous
Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile during their shelf-life.
Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
Arrow EPIDURAL NEEDLE COMPONENT AN-05505
Arrow International
Class I - Dangerous
Product lidstock contains the incorrect expiration date for the product