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All product recalls affecting Maryland.
Includes nationwide recalls (tagged “Nationwide”) and recalls with Maryland in the distribution area.
Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
CGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limit
Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
CGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limit
Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
Marketed without an approved NDA/ANDA. FDA analysis found the product to be tainted with Diclofenac and Dexamethasone.
Optical Sensors have been damaged due to physical interaction between the inlet and another device resulting in a Placement Signal Not Reliable (PSNR) alarm and loss of Central Venous (CV) Placement Signal, Pulmonary Artery (PA) Placement Signal & Pulmonary Artery Pulse Index (PAPi) metrics. Abiomed is reinforcing that there is a risk of potential interaction between the tip of guidewires, indwelling central venous lines or devices and inlet of the Impella pumps listed above during the insertion, manipulation, and removal of those devices. The interaction may result in optical sensor damage, temporary pump stop, or permanent pump stop.
A subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built before September 2018, have an increased potential to initiate Safety Mode during telemetry or other normal, higher-power operations due to latent high battery impedance.
Incorrect labeling for seven manufactured lots of certain models of Arterial Cannulae.
Product contains undeclared FD&C Yellow 5 and FD&C Yellow 6.
Gillig, LLC (Gillig) is recalling certain 2023 Low Floor diesel-hybrid transit buses. During vehicle operations in full electric vehicle (EV) mode, the odometer will not display accumulated mileage. As such, these vehicles fail to comply with the requirements of Federal Motor Vehicle Safety Standard (FMVSS) number 101, "Controls and Displays."
Spore test strip monitoring system, designed for routine monitoring of sterilization processes, may have a printing error on the return envelope that may cause spore test results to be reported to the incorrect customer's account.
Suzuki Motor USA, LLC (Suzuki) is recalling certain 2023-2025 Burgman 400 (AN400AM3-M5) scooters. The fuel supply hose assembly may contact the fuel vapor hose assembly, causing the fuel supply hose to become damaged and leak fuel.
Potential for Polytetrafluoethylene (PTFE) material encasing the stent loop may prevent the stent from being pushed out of the introducer.
Great Dane Trailers (Great Dane) is recalling certain 2025 Champion Dry Freight trailers. Missing kingpin welds may prevent the upper coupler from securely connecting the trailer.
Advanced Technology Products, Inc (ATP) is recalling certain OEC/Technidot black 1/4" DOT air brake tubing with part numbers DOTA04ABK, DOTA04CBK, and DOTA04DBK. Sunlight exposure may cause the air brake tubing to crack and burst under pressure. As such, this equipment fails to comply with the requirements of Federal Motor Vehicle Safety Standard (FMVSS) number 106, "Brake Hoses."
Due to the presence of Toxic yellow oleander
CGMP Deviations: N-Nitroso-Desmethyl Chlorpromazine impurity (NNDCI) were found to be failing per current FDA recommended limit.