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All product recalls affecting Alaska.
Includes nationwide recalls (tagged “Nationwide”) and recalls with Alaska in the distribution area.
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.
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.
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.
Assays may produce false negative results due to decreased activity of the enzyme utilized in manufacturing.
CORI Surgical System with Real Intelligence Software exhibits an increased Marker Registration Error (MRE) which may cause tracker arrays to flicker on screen of the CORI Surgical System during use, and may cause surgical delay
Presence of foreign substance: plastic-like substance.
Failed Stability Specifications - at 12 months 2-8 degrees C followed by 6 weeks at 25 degrees C.