UDENYCA recall — FDA D-0353-2026
Temperature Abuse. 116 cartons with specific serial numbers of Lot 2199821, were stored incorrectly in a controlled room temperature environment instead of the required refrigerated…
Complete FDA and NHTSA recall records dated in 2026, organized for browsing by month, category and recalling company.
Select a month to review the recall records reported during that period.
Records are ordered by the best available source date.
Temperature Abuse. 116 cartons with specific serial numbers of Lot 2199821, were stored incorrectly in a controlled room temperature environment instead of the required refrigerated…
General Motors, LLC (GM) is recalling certain 2022 Chevrolet Tahoe, Chevrolet Suburban, GMC Yukon, GMC Yukon XL, Cadillac Escalade, and Cadillac Escalade ESV vehicles equipped with 10 Speed…
Nissan North America, Inc. (Nissan) is recalling certain 2024-2025 Rogue vehicles equipped with 3-cylinder 1.5L variable compression turbo (VC-Turbo) engines. The gears in the electronic…
Nissan North America, Inc. (Nissan) is recalling certain 2023-2025 Rogue vehicles equipped with 3-cylinder 1.5L variable compression turbo (VC-Turbo) engines. Increased temperatures can…
General Motors, LLC is recalling certain 2020 Chevrolet Silverado 2500, 3500, GMC Sierra 2500, 3500, and 2020-2022 Chevrolet Silverado 1500 and GMC Sierra 1500 vehicles that may have been…
Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or…
There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which…
Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or…
Due to a software implementation error that allowed instruments arms failing an important diagnostic test to remain in clinical use. This test was supposed to be used to detect Universal…
Customers may experience inaccurate test results by observing a higher frequency of classification in the indeterminate and positive zone and/or low specificity when compared back to…
A customer experienced that during assembly and load testing of the device, the bolt for mounting the lifting bar broke. Upon further investigation of this customer complaint, it became…
Devices which did not undergo thermoforming could deform and lose performance.
942-01-40G acetabular system package was found to contain 942-01-36H acetabular system; and several other acetabular system and knee insert devices may also have a packaging discrepancy,…
There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which…
To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.
A customer experienced that during assembly and load testing of the device, the bolt for mounting the lifting bar broke. Upon further investigation of this customer complaint, it became…
There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which…
Internal investigations have identified an issue with the durability of the connecting cable near the connection to the Venous Bubble Sensor. Excessive bending of the connecting cable can…
Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or…
Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is prolongation of the procedure to…
Devices which did not undergo thermoforming could deform and lose performance.
Devices which did not undergo thermoforming could deform and lose performance.
Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is prolongation of the procedure to…
Devices which did not undergo thermoforming could deform and lose performance.
This archive groups records by their reported or recall date. It does not imply that every recall was initiated, announced and resolved during the same calendar year. Open the individual record for the exact dates and source details supplied by FDA or NHTSA.