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: NOxBOXi Nitric Oxide Delivery System Product Serial Numbers: See Recall Database Entry Distribution Dates: May 21, 2021 to February 27, 2023 Devices Recalled in the…
Draeger Medical Recalls Oxylog 3000 Plus Emergency and Transport Ventilators for Risk of Unexpected Depleted Battery and Ventilator Stop
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: Oxylog 3000 Plus Emergency and Transport Ventilator Part Numbers: 5704811 and 5704813 Product Material Numbers: See Recall Database Entry Distribution Dates: April 30, 2012 to…
Megadyne Recalls MEGA 2000 and MEGA Soft Reusable Patient Return Electrodes for Risk of Serious Burn Injuries to Patients
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 and Codes: Devices Recalled in the U.S.: 21,200 Dates Distributed: March 11, 2021 – May 9, 2023 Date Initiated by Firm: June 1, 2023 Device…
UPDATE: Paclitaxel-Coated Devices to Treat Peripheral Arterial Disease Unlikely to Increase Risk of Mortality – Letter to Health Care Providers
July 11, 2023 The U.S. Food and Drug Administration (FDA) is informing health care providers about updated information associated with paclitaxel-coated devices used to treat peripheral arterial disease (PAD). Based on the FDA’s review of the totality of the available data and analyses, we have determined that the data does not support an excess mortality…
Cipla Issues Voluntary Nationwide Recall of Six Batches of Albuterol Sulfate Inhalation Aerosol, 90 mcg (200 Metered Inhalation) Due to Container Defect
Summary Company Announcement Date: July 06, 2023 FDA Publish Date: July 07, 2023 Product Type: Drugs Reason for Announcement: Recall Reason Description Failure to deliver the recommended dose Company Name: Cipla Brand Name: Brand Name(s) Product Description: Product Description Albuterol Sulfate Inhalation Aerosol, 90 mcg (200 Metered Inhalation) Company Announcement FOR IMMEDIATE RELEASE – Mumbai,…
UPDATE: NuVasive Specialized Orthopedics’ Precice Devices – Letter to Health Care Providers
June 28, 2023 The U.S. Food and Drug Administration (FDA) is providing an update to information and recommendations for the NuVasive Specialized Orthopedics’ (NuVasive) Precice Intra-medullary Limb Lengthening (IMLL) system, which includes Precice Short. In March 2023, NuVasive received FDA 510(k) clearance for the expanded use of the Precice IMLL system (including Precice Short) for…
Teleflex, and Arrow International, Recall ARROW Endurance Extended Dwell Peripheral Catheter System for Risk of Catheter Separation and Leakage
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: ARROW Endurance Extended Dwell Peripheral Catheter System Product Codes: See Recall Database Entry Devices Recalled in the U.S.: 262,016 Dates Distributed: October 26, 2018 to…
The Harvard Drug Group, LLC Issues Voluntary Nationwide Recall of Dronabinol Capsules, USP, 2.5 mg and Ziprasidone Hydrochloride Capsules, 20 mg Due to Label Mix-up
Summary Company Announcement Date: June 13, 2023 FDA Publish Date: June 14, 2023 Product Type: Drugs Reason for Announcement: Recall Reason Description Packaging may contain incorrect product due to labeling mix-up Company Name: The Harvard Drug Group, LLC d/b/a Major Pharmaceutical and Rugby Laboratories Brand Name: Brand Name(s) Major Pharmaceuticals Product Description: Product Description Dronabinol…
BearCare, Inc. Recalls Rechargeable Walnut Wearable Smart Thermometers for Risks of Serious Injury, including Burns During Use
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: Walnut Wearable Smart Thermometer Product Model Number: WT20 Product Lot Number: 20221115W002 Devices Recalled in the U.S.: 979 Dates Distributed: December 1, 2022 – April…
Oxygenator Devices Used for Extracorporeal Circulation – Letter to Health Care Providers
June 9, 2023 The U.S. Food and Drug Administration (FDA) is providing information to health care providers and facilities on the use of oxygenators in extracorporeal circulation. On May 18, 2023, Getinge/Maquet issued an Urgent Medical Device Removal notice to inform users to not use all Quadrox Oxygenators and certain Getinge/Maquet Venous Hardshell Cardiotomy…