Department of JusticeU.S. Attorney’s OfficeDistrict of Connecticut FOR IMMEDIATE RELEASETuesday, April 30, 2024 Vanessa Roberts Avery, United States Attorney for the District of Connecticut; Fernando P. McMillan, Special Agent in Charge of the FDA Office of Criminal Investigations, New York Field Office; and Stephen Belleau, Acting Special Agent in Charge of the Drug Enforcement Administration…
Gibson Farms Voluntarily Recalls Organic Light Halves and Pieces Shelled Walnuts Because of Possible Health Risk
Summary Company Announcement Date: April 30, 2024 FDA Publish Date: April 30, 2024 Product Type: Food & Beverages Foodborne Illness Reason for Announcement: Recall Reason Description Due to potential Escherichia coli 0157:H7 (E. coli) contamination Company Name: Gibson Farms Brand Name: Brand Name(s) Gibson Farms Product Description: Product Description California Shelled Walnuts, Organic Light Halves…
BioMérieux Inc. Recalls VITEK 2 AST Kit due to Incorrect Ceftriaxone Concentrations
Please be aware, this recall is a correction, not a product removal. 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: VITEK 2 AST kit Product Codes: LON Model Numbers: See table below Distribution…
H-E-B Issues Voluntary Recall for 3-Ounce Cups of Creamy Creations Ice Cream in Select Flavors
Summary Company Announcement Date: April 27, 2024 FDA Publish Date: April 29, 2024 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Potential presence of metal fragments Company Name: H-E-B Brand Name: Brand Name(s) Product Description: Product Description Creamy Creations ice cream Company Announcement The ice cream is being voluntarily recalled for potential…
SonarMed Inc. Recalls Airway Acoustic Sensors Due to a Restricted Inner Diameter of Airway Causing Suction Catheter Passage Difficulty
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: SonarMed Airway acoustic sensors Product Codes: OQU Model Numbers: AW-S025, AW-S030, AW-S035 Distribution Dates: October 12, 2022 to August 11, 2023 Devices Recalled in the…
Anesthesiologist Pleads Guilty to Taking Fentanyl from Hospital
Department of JusticeU.S. Attorney’s OfficeWestern District of Missouri FOR IMMEDIATE RELEASEThursday, April 25, 2024 KANSAS CITY, Mo. – An anesthesiologist at a Lee’s Summit, Mo., hospital pleaded guilty in federal court today to illegally taking fentanyl from the hospital. Roman Peplinski, 37, of Kansas City, Mo., waived his right to a grand jury and pleaded…
Outset Medical, Inc. Recalls Certain Tablo Hemodialysis Systems for Risk of Patient Exposure to Higher Than Allowable Levels of Toxic Compound NDL-PCBAs
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 Name: Tablo Hemodialysis Device Product Codes: See Recall Database Entry Devices Recalled in the U.S.: 879 Dates Distributed: August 25, 2018 to December 4, 2023 Date…
InfuTronix, LLC Recalls Nimbus and Nimbus II Infusion Pump Systems for Multiple Device Failures That May Cause Severe Injury and Death
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: Nimbus: Administration Set, Flex, PainPro, also known as the Halo Ambulatory Infusion System Nimbus II: PainPRO, Flex, Plus, EpiD, and EMS Product Codes: See Recall…
Fresenius Medical Care Recalls Stay-Safe Catheter Extension Sets and Stay-Safe/Luer Lock Adapter for Risk of Patient Exposure to Higher Than Allowable Levels of Toxic Compound NDL-PCBA
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 Name: Stay-Safe Catheter Extension Sets, Stay-Safe/Luer Lock Adapter Product Codes: See Recall Database Entries: Devices Recalled in the U.S.: 2,192,535 Dates Distributed: March 5, 2003 to…
Tama Corporation Recalls Product Because of Possible Health Risk
Summary Company Announcement Date: April 25, 2024 FDA Publish Date: April 26, 2024 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Potential to be contaminated with Listeria monocytogenes Company Name: TAMA Corporation Brand Name: Brand Name(s) Product Description: Product Description Queso de Mano PAISA Company Announcement Tama Corporation of Doral FL is…