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All product recalls affecting New York.
Includes nationwide recalls (tagged “Nationwide”) and recalls with New York in the distribution area.
Rivian Automotive, LLC. (Rivian) is recalling certain 2024 R1T and R1S vehicles. The dashboard air bag warning label may be missing. As such, these vehicles fail to comply with the requirements of Federal Motor Vehicle Safety Standard number 208, "Occupant Crash Protection."
This recall involves Spin Swivel Chairs. The upholstered swivel chairs have gold-colored stainless steel swivel legs and were sold in ivory, gray, orange, and blue upholstery. The swivel chairs measure approximately 32.5 inches tall, 32 inches deep, and 30.5 inches wide.
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.
The adjustment ring on the device may become loose resulting in the wire tension not being able to be set correctly.
Potential for the bolt that secures the positioning arm to the gas spring to come loose and fall onto patient.
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.
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.
General Motors, LLC (GM) is recalling certain 2024 Cadillac Lyriq, Chevrolet Blazer EV, Chevrolet Silverado EV, GMC Hummer EV SUV, and GMC Sierra EV vehicles. The electric motors in the rear drive units may have insufficiently insulated wires that can contact each other, resulting in a loss of drive power.
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.
Multitest with compromised raw material used to assess immune system status may result in flow cytometry plot with unusual staining pattern, nonspecific aggregates, high background, double positive event increase on CD3+CD4+vsCD3+CD8+ and/or CD3-CD16+CD56+vsCD3-CD19+, contaminated antibodies, may lead to erroneous or delayed results, additional patient sample, might impact healthcare decisions
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