Class I - Dangerous
Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
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Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
38,779 Total Recalls
Custom Tubing Packs Custom tubing pack for oxygenators
Maquet Cardiovascular Us Sales
Class I - Dangerous
Maquet Cardiopulmonary (MCP) is conducting a voluntary recall based on the potential risk of exposure to endotoxin for various products.
Class I - Dangerous
Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
GE Healthcare, Aisys Carestation.
GE Medical Systems
Class I - Dangerous
GE Healthcare has recently become aware of a potential safety issue involving a momentary, self-correcting anesthetic agent bolus when using 21% oxygen on all Aisys CS2 and upgraded Aisys anesthesia devices.
Reports of the bolts connecting the stretcher to the hydraulic piston and the stretcher tilting mechanism becoming loose.
Class I - Dangerous
Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Class I - Dangerous
ICU Medical Inc. has received a report of compounded volumes not meeting the accuracy specification by the Diana Compounding System when mixing volumes under 5ml.
Class I - Dangerous
Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Class I - Dangerous
Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Class I - Dangerous
Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Class I - Dangerous
Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Class I - Dangerous
Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Customers may not receive an intended audible alarm or alert if relying on hearing the alarm or alert.
Class I - Dangerous
Labeling error: Catalog contains Instructions for Use (IFU) error; incorrect inflation volume.
Class I - Dangerous
Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Class I - Dangerous
Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Class I - Dangerous
Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Class I - Dangerous
ICU Medical Inc. has received a report of compounded volumes not meeting the accuracy specification by the Diana Compounding System when mixing volumes under 5ml.
Class I - Dangerous
Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Class I - Dangerous
ICU Medical Inc. has received a report of compounded volumes not meeting the accuracy specification by the Diana Compounding System when mixing volumes under 5ml.