Complete FDA and NHTSA recall records dated in 2019, 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.
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
Certain Auriga consoles may exhibit faster than normal power degradation due to a potential issue in the mechanical cooling system that could lead to a low power error (1301) being…
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
Potential for an electrical short circuit leading to possible fire hazard due to liquid ingress into AC power outlets.
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
Potential for products to fail performance testing per the Instructions for Use (IFU) starting at 106 days after date of manufacturing. Expiration date is shortened from 9 months to 105…
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
Potential for products to fail performance testing per the Instructions for Use (IFU) starting at 57 days after date of manufacturing. Expiration date is shortened from 7 months to 56 days.
The firm has identified a complaint trend regarding breakage of the LimiTorr Transducer Mount stopcock and MoniTorr Panel Mount stopcock.
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
The firm has identified a complaint trend regarding breakage of the LimiTorr Transducer Mount stopcock and MoniTorr Panel Mount stopcock.
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
Some lots of test strips do not fit tightly into the optical block, and may fall out during analysis, which could lead to an incorrect result being di P832 Chemistry (Diagnostic) CHH 2…
Potential for products to fail performance testing per the Instructions for Use (IFU) starting at 57 days after date of manufacturing. Expiration date is shortened from 7 months to 56 days.
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
Complaints received of sporadic erroneously elevated platelet results without flags or system messages. Thrombocytopenia may go unrecognized.
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
The margin tool in Leksell GammaPlan 11.1 systematically overestimates margin in certain areas of the volume.
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.
