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All product recalls affecting Maine.
Includes nationwide recalls (tagged “Nationwide”) and recalls with Maine in the distribution area.
Honda (America Honda Motor Co) is recalling certain 2020-2024 Ridgeline vehicles. The rearview camera (RVC) tailgate wire harness may fatigue and break, which can prevent the rearview camera image from displaying.
Simultaneous ECG measurements with multiple devices, including a manual defibrillator, on the same patient may cause electrical noise or interference, which may lead to distortions of the ECG signal; distortions may lead to no or ineffective pacing, or no or inappropriate defibrillation pulse.
Products in distribution were found by FDA to be to be substantially different from the current cleared 510(k)s with a major change or modification to the device s intended use.
Potential for the bolt that secures the positioning arm to the gas spring to come loose and fall onto patient.
Some of the devices may function incorrectly resulting in no temperature display or erratic temperatures being displayed on the temperature monitoring devices.
Oliver Travel Trailers, INC. (OTT) is recalling certain 2009-2024 Elite II trailers. The towing coupler may be under rated for the Gross Vehicle Weight Rating (GVWR) of the trailer.
This recall involves Koriemfa multi-purpose bike helmets for teens and adults in size Medium (M), fitting a head circumference of about 21-1/2 to 22-1/2 inches. The helmets are sold in the color blue, with black padding, black straps, and a black and red buckle. The helmets have a black plastic knob at the back of the helmet for adjusting the fitting. The model "W-001", the serial number "LDW202103", and Manufacture Date "03/2021" are printed on a white label on the inside of the helmet. "KORIMEFA" is printed on the front of the helmet.
This recall involves Zegoo-branded 100% cotton children's nightgowns sold in light pink, pink, and blue. The nightgowns are short-sleeved, and have a double-lace layer at the collar with a small ribbon bow. A side-seam label lists the size, "100% Cotton," and "MADE IN CHINA."
This recall involves model years 2022 and 2023 Prowler Pro, Prowler Pro Crew, Tracker 800SX, and Tracker 800SX Crew utility vehicles. They were sold in various colors, including green, gray, red, fossil, and timber. "Prowler" or "Tracker" is stamped on the side of the cargo box. The 10th digit of the vehicle identification number (VIN), which is printed on the operator side of the frame under the cargo box, includes an "N" for model year 2022 and a "P" for model year 2023.
The results generated by the VITROS Immunodiagnostic Products Vitamin B12 Range Verifier Lot# 1200 RV Level 2 may cause range verification failure. The issue is detectable by the user when the product fails to meet the required range during processing of RV Level 2 of this lot. There is a potential for a delay in patient test results should the user have a need to switch to an alternate method of range verification including use of an alternate lot. As this issue affects the upper limit range verification, there is no impact to VITROS Immunodiagnostic Products Vitamin B12 assay performance. Were the assay to not perform as expected, the failure would be detectable by Quality Control. Past patient sample results are unaffected, and no review of reported results is required.
Reports of patient burns.
There is a potential for the top cover of the hospital bed mattress to delaminate as a result of improper cleaning and lack of adequate details on the appropriate use of cleaning agents containing bleach.
System monitor screen may display atypical behavior: Overlapping screens/buttons, Frozen screen, Distorted text, blanks, or zeroes in place of values, Unresponsive buttons where the user is unable to initiate a command, which may lead to anxiety /inconvenience, hemodynamic compromise, extended surgical time, and Pump Stop command may be selected
Due to a manufacturing defect from the battery supplier, affected batteries may experience a loss of capacity earlier in the battery lifecycle than expected and overall battery runtime may decrease earlier in the battery lifecycle than expected.
Winnebago Industries, Inc. (Winnebago) is recalling certain 2017-2025 Revel, 2020-2025 Navion, Porto, View, Vita, 2022-2023 Adventure Van, and 2024-2025 Ekko motorhomes. Supplemental Restraint System (SRS) wires can be caught in the seat mechanism when the driver or passenger seats are adjusted.
Defect in the external sterile packaging (pouch) leading to a gap or/and weakness of the seal may compromise the product sterility.
Defect in the external sterile packaging (pouch) leading to a gap or/and weakness of the seal may compromise the product sterility.
Potential for an incomplete seal on the packaging tray.
Potential for an incomplete seal on the packaging tray.
Defect in the external sterile packaging (pouch) leading to a gap or/and weakness of the seal that may compromise the product sterility.