- by FDASeptember 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 contamination in the product.
- by FDAHamilton 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 use.
- by FDAUniversal 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 going out of business, hence would not be able to continue fulfilling any post-market responsibilities of these distributed
- by FDAMedline 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 to be non-sterile.
- by FDA2023 Medical Device Recalls
- by FDAThe 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 therapy.
- by FDAFDA 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.
- by FDAThe One-Way Valve, 22F x 22M is a single-use device accessory used to prevent backward flow of nitric oxide gas into the airways.
- by FDANovartis 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 crystal formation observed in some bottles, which could potentially result in incorrect dosing. No other Sandimmune for
- by FDAThe FDA posts letters to health care providers about the safe use of medical devices.
- by FDAFOR 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 Splash for Kids 16oz after the Company identified a microbial contamination due to the presence of yeast (Candida Parapsilo
- by FDACertain surgical respirators, surgical masks, and pediatric face masks by O&M Halyard do not meet quality and performance expectations.
- by FDABrooklyn, 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. Sildenafil is an ingredient known as a Phosphodiesterase Inhibitor (PDE-5) inhibitor found in FDA-approved products for the trea
- by FDAListing of Medical Device 2023 Safety Communications
- Getinge Maquet/Datascope Intra-Aortic Balloon Pump (IABP) Shortage – Letter to Health Care Providersby FDAThe FDA is alerting health care facilities and providers of a shortage of Getinge Maquet/Datascope Intra-Aortic Balloon Pump (IABP) devices, including limited supplies of IAB catheters, new Cardiosave IABPs, and Cardiosave IABP parts.
- by FDAOn 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.The company is going out of business, hence would not be able to continue fulfilling any post-market responsibilities of
- by FDACardiosave IABPs are used to inflate and deflate intra-aortic balloons. If they become unseated from the hospital cart, they can shut down without warning.
- by FDADatascope/Maquet/Getinge recalls Cardiosave Hybrid and Rescue Intra-aortic Balloon Pumps (IABPs) for unexpected electrical shutdowns.
- by FDACardiosave 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.
- by FDAThe Cardiosave IABP may stop unexpectedly when internal temperatures exceed 176 degrees Fahrenheit.