Summary Company Announcement Date: September 08, 2023 FDA Publish Date: September 08, 2023 Product Type: Drugs Reason for Announcement: Recall Reason Description Device & Drug Safety/Microbial Contamination Company Name: Church & Dwight Co., Inc. Brand Name: Brand Name(s) TheraBreath Product Description: Product Description TheraBreath Kids Strawberry Splash Oral Rinse Company Announcement FOR IMMEDIATE RELEASE –…
Hua Da Trading Inc dba Wefun Inc Issues Voluntary Nationwide Recall of WEFUN Capsules Due to Presence of Undeclared Sildenafil
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: Hua Da Trading Inc dba Wefun Inc Brand Name: Brand Name(s) Product Description: Product Description Dietary Supplement with undeclared Sildenafil Company Announcement FOR IMMEDIATE RELEASE – 08/25/2023…
Getinge/Maquet/Datascope Recalls Cardiosave Hybrid and Rescue Intra-aortic Balloon Pumps (IABPs) for System Over Temperature Alarms Causing 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…
UPDATE: Risk of Device Failures for Getinge’s Maquet/Datascope Cardiosave Intra-Aortic Balloon Pump (IABP) – Letter to Health Care Providers
August 31, 2023 The U.S. Food and Drug Administration (FDA) is providing an update about device failures for Getinge/Maquet/Datascope Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pump (IABP) devices. The FDA is issuing this letter to help ensure health care providers are aware of the latest recalls and recommendations to users. Since June 2023, Getinge/Maquet/Datascope initiated…
WEFUN Inc Issues Voluntary Nationwide Recall of WEFUN Capsules Due to Presence of Undeclared Sildenafil
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…