FDA Warning & Recall Information

On December 12, 2022, Smith’s Medical sent out an Urgent Medical Device Correction Letter to customers after identifying two potential problems with its CADD Infusion System Infusion Sets, according to the FDA. Designed for use with CADD pumps (“multi-therapy infusion pumps for ambulatory medication delivery,” […]

On December 29, 2022, Sunsprout Enterprises voluntarily recalled four lots of raw alfalfa sprouts due to potential salmonella contamination. The action comes on the heels of a preliminary investigation conducted by the State of Nebraska and the CDC in response to an outbreak of illness […]

A June 27, 2022, recall of Hamilton Medical AG’s Hamilton-C6 Intensive Care Ventilator has since been labeled Class I by the FDA due to risks of major injuries or death. Designed to provide “breathing support for infants (neonatal), children (pediatric) and adult patients,” the Hamilton-C6 […]

Due to an ongoing shortage of Philips Invivo MRI breast biopsy grid plates and other Philips Invivo MRI disposables, the FDA recommends that healthcare providers talk to patients about other options for Magnetic Resonance Imaging (MRI)-guided breast biopsy procedures. Product codes linked to the MRI […]

After receiving a report of a product mix-up, Accord Healthcare Inc. has voluntarily recalled a single lot of Daptomycin for Injection 500 mg/vial and Daptomycin for Injection 350 mg/vial to the consumer level. According to a company announcement published on the FDA site on December […]

The FDA is calling to attention a voluntary recall of one lot of Hospira, Inc.’s Vancomycin Hydrochloride Injection, USP 1.5g/vial Single Dose Fliptop Vial. On December 22, 2022, the company initiated the action on lot 33045BA to the user level after two glass particulates were […]

On December 23, 2022, GFA Production (Xiamen) Co., Ltd. initiated a voluntary nationwide recall of one lot of its Easy Care first aid AfterBurn cream after an FDA analysis found the product contaminated with the microbes Bacillus licheniformis and Bacillus sonorensis. A risk statement published […]

On December 22, 2022, the FDA issued new information concerning a number of Philips Respironics (Philips) Trilogy 100 and Trilogy 200 ventilators it had recalled in June 2021.  The ventilators, which include BiPAP and CPAP machines, were initially recalled due to potential health risks found […]

Due to a spike in reports of false negative test results, the manufacturer ALK-Abelló, Inc. has voluntarily withdrawn four lots of Allergenic Extract – Peanut (Arachis hypogaea) – For Diagnostic Use Only, the FDA announced on December 20, 2022.  The move was made after a […]

A recall of Baxter Healthcare Corporation’s Clearlink Basic Solution Set with Duovent, initiated by the firm on August 9, 2022, has been labeled by the FDA as Class I, the most serious type. This designation indicates that use of the product may lead to serious […]

An October 17, 2022 recall of the Arrow AutoCAT 2 and AC3 Intra-Aortic Balloon Pumps by Arrow International, LLC (a subsidiary of Teleflex) has been identified by the FDA as Class I, the most serious category.  The action affects products sold under 12 different names, […]

Due to a risk of serious injuries or death, the FDA has identified a Class I recall of the Arrow MAC Two-Lumen Central Venous Access Kits and the Pressure Injectable Arrowg+ard Blue Plus Three Lumen Central Venous Catheter (CVC) Kits by Teleflex and Arrow International, […]