May 8, 2024 The U.S. Food and Drug Administration (FDA) is alerting health care providers and facilities about our continued safety and quality concerns with the following Getinge/Maquet cardiovascular medical devices: Getinge/Maquet/Datascope Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pump (IABP) devices and Getinge/Maquet Cardiohelp system and HLS Sets. The FDA recommends that health care facilities…
MEGADYNE™ Initiates Global Discontinuation and Voluntary Recall of MEGA SOFT™ Pediatric Patient Return Electrode
Summary Company Announcement Date: May 10, 2024 FDA Publish Date: May 10, 2024 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Reports of patient burn injuries Company Name: Megadyne Medical Products Inc. Brand Name: Brand Name(s) Ethicon Megadyne Product Description: Product Description Mega Soft Pediatric Patient Return Electrode Company Announcement Cincinnati, OH –…
Route 92 Medical Inc. Recalls Catheter due to Distal Tip Separation at the Proximal Marker Band
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: Product Codes: QJP, DQY, NRY Model Numbers: K190431 Route 92 Medical Delivery Catheter (DQY), also known as Tenzing 7 and sold separately. K203043 Route 92…
Tandem Diabetes Care, Inc. Recalls Version 2.7 of the Apple iOS t:connect Mobile App Used in Conjunction with t:slim X2 Insulin Pump with Control-IQ Technology Prompted by a Software Problem Leading to Pump Battery Depletion
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…