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All product recalls affecting North Dakota.
Includes nationwide recalls (tagged “Nationwide”) and recalls with North Dakota in the distribution area.
A single batch of ISO-100 IsoLoc Gas-Release Endorectal Balloons is mislabeled. The affected ISO-100 balloon catheter has a nominal fill volume of 100cc/ml but the inner pouch identifies the product as an ISO-60 (fill volume of 60cc/ml).
VITROS Chemistry Products FS Diluent Pack 3, Lot 01-1645 may cause results to be negatively biased when used to dilute patient samples tested with VITROS Chemistry Products CRP Slides.
Vermeer Manufacturing Company (Vermeer) is recalling certain 2015-2022 BC900XL brush chipper trailers. The service and maintenance manuals list the incorrect lug nut torque value.
Firm is marketing and distributing the Pink Luminous Breast device without premarket approval
FR Conversions is recalling certain 2023-2024 Ram Promaster vehicles, equipped with certain GO-ES Space Saver Foldaway Seats. The recliner mechanism may not engage when the seat back is fully reclined. As such, these vehicles fail to comply with the requirements of Federal Motor Vehicle Safety Standard number 210, "Seat Belt Assembly Anchorages."
Lack of Assurance of Sterility-The potential for incomplete crimp seals.
Lack of Assurance of Sterility-The potential for incomplete crimp seals.
Aluminum Trailer Company (ATC) is recalling certain 2021-2024 Toy Hauler 5th wheel trailers. The LED backlight circuit board in the cooktop range may fail, causing the board to overheat.
Potential for there to be a fluid ingress into the handle of the harvesting tool, which may lead to the device not providing cautery or providing cautery when not intended.
Siemens Healthineers has identified an issue with the RAPIDPoint500e system software version 5.3. This issue affects how the sample source is identified at the LIS when using the capillary mode. With this software version, samples run in the capillary mode are incorrectly labeled as arterial when displayed on the LIS, leading to the potential for results to be flagged according to an established arterial range. Capillary sample results are correctly identified as capillary on both the RAPIDPoint 500e system display and the instrument printouts. The issue only affects the new software version 5.3 and only capillary sample mode is impacted. The inability to distinguish specimen sources for blood gas may lead to incorrect diagnoses and management decisions.
The devices are labeled "not made with DEHP" or the DEHP free symbol; however, the glue used contains traces of DEHP.
The devices are labeled "not made with DEHP" or the DEHP free symbol; however, the glue used contains traces of DEHP.
Forest River, Inc. (Forest River) is recalling certain 2024 Aurora and Catalina travel trailers. The furnace may have been installed directly on top of vinyl linoleum floor, which can allow the floor to overheat.
The devices are labeled "not made with DEHP" or the DEHP free symbol; however, the glue used contains traces of DEHP.
The Braun Corporation (Braun) is recalling certain 2023-2024 Chrysler Voyager vehicles, equipped with certain GO-ES Space Saver Foldaway Seats. The recliner mechanism may not engage when the seat back is fully reclined. As such, these vehicles fail to comply with the requirements of Federal Motor Vehicle Safety Standard number 210, "Seat Belt Assembly Anchorages."
Potential for there to be a fluid ingress into the handle of the harvesting tool, which may lead to the device not providing cautery or providing cautery when not intended.
Cranial Caudal Blades manufactured incorrectly could result in fracture and/or damage to the bone structure
The devices are labeled "not made with DEHP" or the DEHP free symbol; however, the glue used contains traces of DEHP.
Forest River, Inc. (Forest River) is recalling certain 2024-2025 Solera, 2023-2025 Forester, and Sunseeker motorhomes. The Liquid Propane (LP) line may not be properly secured, which can cause the line to become damaged and leak.
41 mm acetabular outer heads were potentially assembled with a 42 mm locking ring, may lead to joint instability leading requiring surgical intervention