Summary Company Announcement Date: August 25, 2023 FDA Publish Date: September 05, 2023 Product Type: Dietary SupplementsDrugs Reason for Announcement: Recall Reason Description Undeclared drug, Sildenafil Company Name: WEFUN Inc. Brand Name: Brand Name(s) Product Description: Product Description Dietary Supplement with undeclared Sildenafil Company Announcement FOR IMMEDIATE RELEASE – 08/25/2023 – Brooklyn, New York, WEFUN…
Marlex Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Digoxin Tablets USP, 0.125mg and Digoxin Tablets USP, 0.25mg Due to Label Mix-Up
Summary Company Announcement Date: August 30, 2023 FDA Publish Date: August 31, 2023 Product Type: Drugs Reason for Announcement: Recall Reason Description Label Mix-Up Company Name: Marlex Pharmaceuticals, Inc. Brand Name: Brand Name(s) Marlex Pharmaceuticals, Inc. Product Description: Product Description Digoxin Tablets USP, 0.125mg and 0.25mg Company Announcement FOR IMMEDIATE RELEASE – August 30, 2023…
Getinge/Maquet/Datascope Recalls Cardiosave Hybrid and Rescue Intra-aortic Balloon Pumps (IABPs) for Gas Loss and Gas Gain Failures
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 Codes and Models: Distribution Dates: March 6, 2012 to May 19,…
Getinge/Maquet/Datascope Recalls Cardiosave Hybrid and Rescue Intra-aortic Balloon Pumps (IABPs) for Power Failures When Device is Unseated from Cart
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…
Universal Meditech Inc. Issues Nationwide Recall of All Products Manufactured Between March 2021 and November 2022
Summary Company Announcement Date: August 28, 2023 FDA Publish Date: August 31, 2023 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Due to lack of appropriate premarket clearance or approval which potentially could result in inaccurate test results Company Name: Universal Meditech Inc. Brand Name: Brand Name(s) Healthy Wiser and more Product Description:…
Getinge/Maquet/Datascope Recalls Cardiosave Hybrid and Rescue Intra-aortic Balloon Pumps (IABPs) for Autofill Failure Alarms Resulting in Pump Stops
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…
Hamilton Medical Inc. Recalls HAMILTON-C1, C2, C3, T1 Ventilators for Software Issues that May Cause Ventilators to Stop Without Notice
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…