MedWatch Safety Alerts

Update: Recommendations for Certain O&M Halyard Surgical N95 Respirators, Surgical Masks, and Pediatric Face Masks: FDA Safety Communication

Certain surgical respirators, surgical masks, and pediatric face masks by O&M Halyard do not meet quality and performance expectations

2023 Safety Communications

Listing of Medical Device 2023 Safety Communications

SCYNEXIS Issues a Voluntary Nationwide Recall of BREXAFEMME® (ibrexafungerp tablets) Due to Potential for Cross Contamination with a Non-Antibacterial ßlactam Drug Substance

SCYNEXIS, Inc. is conducting a voluntary nationwide recall of 2 lots of BREXAFEMME® (ibrexafungerp tablets) to the consumer level in the US market due to potential cross

Universal Meditech Inc. Expands Nationwide Recall to All Products Manufactured between March 2021 and November 2022

Universal Meditech Inc. initiated a nationwide recall of products it manufactured between March 2021 and November 2022. The recall is due to the reasons that: i. The company is

Hamilton Medical Inc. Recalls HAMILTON-C1, C2, C3, T1 Ventilators for Software Issues that May Cause Ventilators to Stop Without Notice

Hamilton Medical Inc. recalls HAMILTON-C1, C2, C3, T1 Ventilators for software issues that may cause ventilators to stop without notice after approximately 91 days of cumulative

VistaPharm LLC Issues Voluntary Nationwide Recall of Sucralfate Oral Suspension, 1g/10mL Due to Microbial Contamination Identified as Bacillus Cereus

September 22, 2023 – Largo, Florida, VistaPharm LLC is voluntarily recalling one (1) lot of Sucralfate Oral Suspension, 1g/10mL, to the consumer level, due to Bacillus cereus

2023 Medical Device Recalls

2023 Medical Device Recalls

Medline Industries Recalls Hudson RCI Addipak Unit Dose Vial, 0.9% Full Normal Saline Solution Due to Being Non-Sterile

Medline Industries recalled Hudson RCI Addipak Unit Dose Vial, 0.9% Full Normal Saline Solution, which is used for inhalation and irrigation therapy. The saline solution was found

Abbott Medical Recalls Proclaim and Infinity IPGs for Inability to Exit Magnetic Resonance Imaging (MRI) Mode

The Abbott Proclaim and Infinity neurostimulation systems deliver low-intensity electrical impulses to nerve structures. The device may be unable to exit MRI mode and resume

Bone Matrix Product: FDA Safety Communication - Important Information for Human Cell, Tissue and Cellular and Tissue-based Product (HCT/P) Establishments Regarding Tuberculosis Outbreaks

FDA is working closely with the CDC to investigate recent reports of a TB outbreak caused by Mycobacterium tuberculosis (Mtb) that appears to be linked to a bone matrix product

Mallinckrodt Manufacturing, LLC Recalls One-Way Valve, 22F x 22M for Not Opening Properly

The One-Way Valve, 22F x 22M is a single-use device accessory used to prevent backward flow of nitric oxide gas into the airways

2023 Letters to Health Care Providers

The FDA posts letters to health care providers about the safe use of medical devices

Novartis Issues Voluntary Nationwide Recall of One Lot of Sandimmune® Oral Solution (Cyclosporine Oral Solution, USP), 100 mg/mL Due to Crystallization

Novartis is conducting a voluntary nationwide recall at the consumer level of one lot of its Sandimmune® Oral Solution (cyclosporine oral solution, USP), 100 mg/mL in the US due to

Church & Dwight Issues Voluntary Nationwide Recall of One Specific Lot of TheraBreath Strawberry Splash for Kids 16oz Sold Exclusively on Amazon Between May 31 and September 02, 2023, Due to Microbial Contamination Identified as Yeast (Candida Parapsilosis)

FOR IMMEDIATE RELEASE – September 13, 2023 – EWING, N.J – Church & Dwight Co., Inc. (NYSE:CHD) today initiated a voluntary recall of one specific lot of TheraBreath Strawberry

Hua Da Trading Inc dba Wefun Inc Issues Voluntary Nationwide Recall of WEFUN Capsules Due to Presence of Undeclared Sildenafil

Brooklyn, New York, WEFUN Inc is voluntarily recalling 300 Boxes of WEFUN Capsules to the consumer level. FDA analysis has found the product to be tainted with sildenafil

Getinge/Maquet/Datascope Recalls Cardiosave Hybrid and Rescue Intra-aortic Balloon Pumps (IABPs) for System Over Temperature Alarms Causing Pump Stops

The Cardiosave IABP may stop unexpectedly when internal temperatures exceed 176 degrees Fahrenheit

Getinge/Maquet/Datascope Recalls Cardiosave Hybrid and Rescue Intra-aortic Balloon Pumps (IABPs) for Autofill Failure Alarms Resulting in Pump Stops

Cardiosave IABPs are used to inflate and deflate intra-aortic balloons. The device may stop unexpectedly due to Autofill Failure Alarms and will be put in standby mode

Datascope/Maquet/Getinge Recalls Cardiosave Hybrid and Rescue Intra-aortic Balloon Pumps (IABPs) for Unexpected Shutdowns

Datascope/Maquet/Getinge recalls Cardiosave Hybrid and Rescue Intra-aortic Balloon Pumps (IABPs) for unexpected electrical shutdowns

Getinge/Maquet/Datascope Recalls Cardiosave Hybrid and Rescue Intra-aortic Balloon Pumps (IABPs) for Power Failures When Device is Unseated from Cart

Cardiosave IABPs are used to inflate and deflate intra-aortic balloons. If they become unseated from the hospital cart, they can shut down without warning

Universal Meditech Inc. Issues Nationwide Recall of All Products Manufactured Between March 2021 and November 2022

On July 1, 2023, Universal Meditech Inc. initiated a nationwide recall of products it manufactured between March 2021 and November 2022. The recall is due to the reasons that: i.