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.
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…
Devices which did not undergo thermoforming could deform and lose performance.
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 deterioration of the cutting knife, including overheating and burning, can contribute to tip breakage during use.
Devices which did not undergo thermoforming could deform and lose performance.
Devices which did not undergo thermoforming could deform and lose performance.
A deterioration of the cutting knife, including overheating and burning, can contribute to tip breakage during use.
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…
To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.
Devices which did not undergo thermoforming could deform and lose performance.
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…
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,…
To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.
Devices which did not undergo thermoforming could deform and lose performance.
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…
Devices which did not undergo thermoforming could deform and lose performance.
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…
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.
It was found that the contacts of the electromagnetic contactors used inside the cabinet of the X-ray high-voltage generator were welded, and the current might continue to be supplied to…
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…
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.
