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All product recalls affecting Maine.
Includes nationwide recalls (tagged “Nationwide”) and recalls with Maine in the distribution area.
The MSOT Acuity Echo does not include an adequate instruction for safe operation of the device. The previous version of the user manuals contained a wrong value for the Nominal Ocular Hazard Distance (NOHD).
Labeling update to include a contraindication statement against the use of medicine cabinets in procedure and operating rooms.
Labeling update to include a contraindication statement against the use of medicine cabinets in procedure and operating rooms.
Labeling update to include a contraindication statement against the use of medicine cabinets in procedure and operating rooms.
Software issues could potentially result in: 1) delays in accessing dispensing software application, 2) wrong therapy (dose, item, timing, etc.), or 3) unauthorized access and/or compliance related issues
Labeling is insufficient regarding delays in access to medication. The firm is strengthening the label as an additional risk mitigation.
This recall involves SIG SAUER ROMEO5 Red Dot Sights, Models SOR52001 and 7400579, which is a part included with Model SORJ53101. They are labeled with the SIG SAUER logo and ROMEO5 name on one side of the product. The model number can be found on the product packaging. The recalled dot sights contain either the letter K or M as the last digit of the serial number printed on the bottom of the sight. Sig Sauer will provide instructions on how to access the serial number. The optic sights come in the color black and with one packaged CR2032 button cell battery.
Precision Thin blade attachments have a potential to be out of measurement specifications, preventing them from securely fitting into the compatible handpiece.
This recall involves Wemfg's children's multi-purpose bike helmets. The helmets were sold in size small (S), fitting a head circumference of about 19-1/2 to 21-1/4 inches; and in the following multiple color combinations: blue/pink, green/blue, green/blue/purple, pink/blue/green, pink/purple/pink, pink/yellow/green, purple/pink/blue and purple/pink/yellow. All helmets have black padding, black straps and a black and red buckle. The helmets have a black and red plastic knob at the back of the helmet for adjusting the fitting. The model "MD-710-S" is printed on a white label on the inside of the helmet.
Blue Bird Body Company (Blue Bird) is recalling certain 2024-2025 All American school buses. Due to incorrect wiring, the high and low beams are reversed, causing the high beam indicator to illuminate incorrectly. As such, these vehicles fail to comply with the requirements of Federal Motor Vehicle Safety Standard number 108, "Lamps, Reflective Devices, and Associated Equipment."
Blue Bird Body Company (Blue Bird) is recalling one 2025 All American transit bus. Due to incorrect wiring, the high and low beams are reversed, causing the high beam indicator to illuminate incorrectly. As such, these vehicles fail to comply with the requirements of Federal Motor Vehicle Safety Standard number 108, "Lamps, Reflective Devices, and Associated Equipment."
Failed stability specifications: during routine stability monitoring quality concerns were identified. Physical separation for ingredients was observed.
Three lots of Rapid fFN Specimen Collection kit (901164, 901165, and 904850) contain Rapid fFN Specimen Collection Tubes which may be empty, underfilled, or overfilled with extraction buffer. The transport tubes are used with the Fetal Fibronectin Enzyme Immunoassay and Rapid fFN for the TLiIQ System which aids in assessing the risk of preterm delivery. The use of empty transport tubes or transport tubes containing insufficient extraction buffer volume may result in invalid results and/or delays in obtaining results. Additionally, the use of underfilled tubes may result in false positive results and the use of overfilled tubes may result in false negative results.
Labeling update to include a contraindication statement against the use of medicine cabinets in procedure and operating rooms.
Presence of Foreign Tablets/Capsules
Tesla, Inc. (Tesla) is recalling certain 2024-2025 Model 3, Model S, 2023-2025 Model X, and Model Y vehicles. The computer circuit board may short, resulting in the loss of the rearview camera image. As such, these vehicles fail to comply with the requirements of Federal Motor Vehicle Safety Standard (FMVSS) number 111, "Rear Visibility."
It was identified internally that two commingle events occurred where the metal support post within the polyethylene articular surface was assembled incorrectly for three units within the scope.
Sysmex was made aware of a report of false results due to carry-over caused by the sporadic omission of the probe wash step during antibody pipetting on the PS-10 Sample Preparation System.
Certain implants in the Irix-A Lumbar Fusion System were distributed while labeled with an incorrect expiration date.
Their is a potential that implanted pulse generators may stop delivering therapy due to an internal component issue.