30-12-2020
This update to the February 2020 safety communication provides information on the final guidance, Product Labeling for Laparoscopic Power...
The snaps can break or detach from the rompers, posing a choking, laceration and pinching hazards to children.
The snaps can break or detach from the suits, posing choking and laceration hazards to children.
29-12-2020
The FDA posts Medical Device Safety Communications to describe the FDA's current analysis of an issue and contain specific regulatory approaches and...
09-05-2018
FDA Investigates Multistate Outbreak of B. cepacia Complex Linked to Medline Remedy Essentials No-Rinse Cleansing Foam (FDA Announcement)
Dräger Medical is recalling the Fabius Anesthesia machines due to excessive oil that was not removed at the time of production. Such excess oil may...
The driveside crankarm can disengage and cause the rider to lose control, posing fall and injury hazards.
The women’s scarves fail to meet the federal flammability standard for clothing textiles, posing a risk of burn injuries to consumers.
08-05-2018
The FDA has received reports associated with the use of these devices in the treatment of unruptured brain aneurysms that suggest some events of...
Ampicillin and Sulbactam for Injection USP, 3 g/Single-Dose Vials by AuroMedics Pharma: Recall - Exposure to particulate may result in local site...
Piperacillin and Tazobactam for Injection, USP 3.375 g by AuroMedics Pharma: Recall: Exposure to particulate matter may result in local...
The steering wheel on the go-kart can detach, break or crack while in use, posing a laceration and/or collision hazard to young children.
07-05-2018
East Windsor, New Jersey, AuroMedics Pharma LLC is voluntarily recalling two lots of Piperacillin and Tazobactam for injection, USP 3.375 g...
AuroMedics Pharma LLC is voluntarily recalling two lots of Ampicillin and Sulbactam for Injection USP, 3 grams*/ Single-Dose vial, to the...