The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Recalled Product Product Names: HAMILTON-C1 with SW version <2.2.10 and neonatal option installed HAMILTON-C2 with SW version <2.2.5 and neonatal option installed HAMILTON-C3 with SW version <2.0.9 and neonatal…
Dr. Berne’s Whole Health Products Issues Voluntary Nationwide Recall of Dr. Berne’s MSM Drops 5% and 15% Solution Eye Drops Due to Bacterial and Fungal Contamination
Summary Company Announcement Date: August 26, 2023 FDA Publish Date: August 26, 2023 Product Type: Drugs Reason for Announcement: Recall Reason Description Bacterial and Fungal Contamination Company Name: Dr. Berne’s Whole Health Products Brand Name: Brand Name(s) Dr. Berne’s Product Description: Product Description MSM 5% Solution Eye Drops, MSM 15% Solution Eye Drops, Castor Oil…
Draeger Recalls Carina Sub-Acute Care Ventilators for Contaminants in Airpath
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Please be aware, this recall is a voluntary correction, not a product removal.Draeger will be updating affected devices to address this issue. Clinicians may continue to use the devices…
Inmar Supply Chain Solutions, LLC, Issues a Voluntary Recall of Product Stored at its Arlington, Texas Facility Due to Conditions at the Facility
Summary Company Announcement Date: August 23, 2023 FDA Publish Date: August 23, 2023 Product Type: Animal & VeterinaryDrugsFood & BeveragesMedical Devices Foodborne Illness Reason for Announcement: Recall Reason Description Potential Salmonella contamination and presence of rodent activity at the distribution center & temperature abuse Company Name: Inmar Supply Chain Solutions Brand Name: Brand Name(s) Numerous…
Datascope/Maquet/Getinge Recalls Cardiosave Hybrid and Rescue Intra-aortic Balloon Pumps (IABPs) for PCBA Failures Affecting the Ability to Charge the Batteries Leading to Unexpected Shutdowns
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Recalled Product Product Names: Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP) and Cardiosave Rescue Intra-Aortic Balloon Pump (IABP) Product Models: Distribution Dates: March 6, 2012 to May 19, 2023 Devices…
Abiomed Recalls the Labeling for Impella RP Flex with SmartAssist for Risk of Blood Clots
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Please be aware, this recall is a voluntary correction, not a product removal. Recalled Product Product Names: Impella RP Flex with SmartAssist Product Codes: See Recall Database Entry Model…
Philips Respironics Recalls Trilogy Evo, Evo O2, EV300, and Evo Universal Ventilators After Finding Dust and Dirt in Air Path That Can Reduce Air Flow to Patients
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Recalled Product Product Name: Philips Respironics Trilogy Evo, Trilogy Evo O2, Trilogy EV300, Trilogy Evo Universal Product Models and Serial Numbers: See Medical Device Recall Database Distribution Dates: March…
Do Not Use Tests Manufactured by Universal Meditech, Inc.: FDA Safety Communication
Date Issued: August 11, 2023 The U.S. Food and Drug Administration (FDA) is warning consumers and patients to not use the following tests manufactured by Universal Meditech, Inc. (UMI): One Step Pregnancy Test DiagnosUS One Step Ovulation Test HealthyWiser UriTest 10 Parameter Reagent Test Strips for Urinalysis HealthyWiser UriTest UTI Test Strips HealthyWiser KetoFast Ketone…
Datascope/Maquet/Getinge Recalls Cardiosave Hybrid and Rescue Intra-aortic Balloon Pumps (IABPs) for Unexpected Shutdowns
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Recalled Product Recalled Product: Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP) and Cardiosave Rescue Intra-Aortic Balloon Pump (IABP) Product Models: Distribution Dates: March 6, 2012 to May 19, 2023 Devices…
Dräger Issues Worldwide Voluntary Recall Notification for Carina Sub-Acute Care Ventilators to Address Possible Contamination of the Breathing Gas with 1,3-Dichloropropan-2-ol
Summary Company Announcement Date: August 01, 2023 FDA Publish Date: August 04, 2023 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Product Safety/Potential Foreign Material Company Name: Drägerwerk AG & Co. KGaA Brand Name: Brand Name(s) Product Description: Product Description Carina Sub-Acute Care Ventilators Company Announcement Drägerwerk AG & Co. KGaA initiated a…