This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it.  Affected Product Product Names: Adult Manual Resuscitator with Medium Adult Mask, Bag Reservoir, Filter, Manometer and 7…

This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program. The FDA has become aware of a potentially high-risk issue. The FDA will keep the public informed and update this web page as significant new information becomes available.  Affected Product The FDA is aware that B. Braun Medical Inc. has…

This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program. The FDA has become aware of a potentially high-risk device issue. The FDA will keep the public informed and update this web page as significant new information becomes available. Affected Product The FDA is aware that BD and their subsidiary…

Summary Company Announcement Date: July 11, 2025 FDA Publish Date: July 14, 2025 Product Type: Drugs Reason for Announcement: Recall Reason Description Company closure and discontinuation of quality activities. Company Name: Nostrum Laboratories, Inc. Brand Name: Brand Name(s) Nostrum Laboratories Product Description: Product Description Sucralfate Tablets USP 1 gram Company Announcement NEW YORK, DC, UNITED…

This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it. Affected Product What to Do On May 15, AirLife sent all affected customers a letter recommending the…

This recall involves updating instructions for using devices and does not involve removing them from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it without following the updated instructions.   Affected Product Product…

This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it. Affected Product Image A: Adaptors provided in the accessory bag of the AirLife Infant Heated Wire Circuit….

AUDIENCE: Patient, Health Care Professional, Pharmacy, Pediatrics ISSUE: The FDA is revising the labeling of all extended-release stimulants indicated to treat attention-deficit/hyperactivity disorder (ADHD) – including certain formulations of amphetamine and methylphenidate – to warn about the risk of weight loss and other adverse reactions (side effects) in patients younger than 6 years taking these…

This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program. The FDA has become aware of a potentially high-risk issue. The FDA will keep the public informed and update this web page as significant new information becomes available.  Affected Product The FDA is aware that Abiomed has issued a letter…

This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program. The FDA has become aware of a potentially high-risk issue. The FDA will keep the public informed and update this web page as significant new information becomes available.  Affected Product  Spectrum V6 infusion pump startup screen Spectrum V8 infusion pump…