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: Version 2.7 of the Apple iOS t:connect mobile app used in conjunction with…
STOP CLOPEZ CORP Issues Voluntary Worldwide Recall of Schwinnng Capsules Due to the Presence of Undeclared Nortadalafil
Summary Company Announcement Date: April 22, 2024 FDA Publish Date: April 23, 2024 Product Type: Drugs Reason for Announcement: Recall Reason Description Product is tainted with Nortadalafil Company Name: STOP CLOPEZ CORP Brand Name: Brand Name(s) Product Description: Product Description Herbal Dietary Supplement Company Announcement FOR IMMEDIATE RELEASE – 04/22/2024– Hollywood, FL, US, STOP CLOPEZ…
SonarMed Inc. Recalls Airway Monitors Due to a Software Anomaly Resulting in Failure to Detect a Partial Obstruction in 2.5mm Sensors and Up To 3mm Distal to the Sensor Tip
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 monitors Product Codes: OQU Model Numbers: AW-M0001 Distribution Dates: October 13, 2022 to October 6, 2023 Devices Recalled in the U.S.: 145 Date…
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…
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…
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…
FDA D.I.S.C.O. Burst Edition: FDA approval of Enhertu (fam-trastuzumab deruxtecan-nxki) for unresectable or metastatic HER2-positive solid tumors
Podcast Welcome back to the D.I.S.C.O., FDA’s Drug Information Soundcast in Clinical Oncology, Burst Edition, brought to you by FDA’s Division of Drug Information in partnership with FDA’s Oncology Center of Excellence. Today we’ll provide a quick update on a recent FDA cancer drug approval. On April 5, 2024, the FDA granted accelerated approval to…
Elekta Instrument AB Recalls Disposable Biopsy Needle Kit for Leksell Stereotactic System for Possibly Containing Microscopic Stainless Steel Debris on the Inside of the Biopsy Needle
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: Disposable Biopsy Needles (911933) Product Codes: HAW Lot Number: 837838839 Distribution Dates: August 29, 2023 to January 5, 2024 Devices Recalled in the U.S.: 10…