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.
the anti-toggle ring of the hex driver may separate from the driver shaft. If this occurs during surgery, the anti-toggle ring can be pressed into the pedicle screw head and cause…
In these units, the brake is usually released by gripping the drive handle and applied by letting go of the handle. However, for systems within a specified manufacture period, we have…
When the Millipore Water Purification Module Progard Pretreatment Packs are used with Dimension Vista Triglyceride assay, patient and QC triglyceride results may be erroneously elevated as…
FUJIFILM Medical Systems U.S.A., Inc., Modality Systems became aware of the possibility that the braking mechanism might not be engaged in all cases when the driving handle has been…
Updates to the Instructions for Use.
Due to an inhomogeneous coating solution, pinholes can become visible in even dark images. Visibility of the pinholes varies as material from this coating run shows pinholes in different…
When the Millipore Water Purification Module Progard Pretreatment Packs are used with Dimension Vista Triglyceride assay, patient and QC triglyceride results may be erroneously elevated as…
An internal assessment of packaging confirmed the potential for a breach in the sterile barrier.
Potential for the sterile packaging to be compromised
The firm is conducting a Device Modification for Fructosamine Calibrator, Fructosamine Control 1 and Control 3 for the lots specified. The assigned value of Fructosamine in this calibrator…
Updates to the Instructions for Use.
There is the potential for the Lambotte chisel to break at the welded piece parts of the chisel body and knocking plate.
The firm is conducting a Device Modification for Fructosamine Calibrator, Fructosamine Control 1 and Control 3 for the lots specified. The assigned value of Fructosamine in this calibrator…
Updates to the Instructions for Use.
An internal assessment of packaging confirmed the potential for a breach in the sterile barrier.
The devices were released from a lot for which one sample failed to meet the company' s tensile strength specification for lot release.
The firm is conducting a Device Modification for Fructosamine Calibrator, Fructosamine Control 1 and Control 3 for the lots specified. The assigned value of Fructosamine in this calibrator…
Complaints were received indicating that the outer label incorrectly identified the product as size "1" instead of "-1". The product contained within the package is size "-1"
the anti-toggle ring of the hex driver may separate from the driver shaft. If this occurs during surgery, the anti-toggle ring can be pressed into the pedicle screw head and cause…
An internal assessment of packaging confirmed the potential for a breach in the sterile barrier.
The devices were released from a lot for which one sample failed to meet the company' s tensile strength specification for lot release.
Complaints were received indicating that the outer label incorrectly identified the product as size "1" instead of "-1". The product contained within the package is size "-1"
Updates to the Instructions for Use.
Updates to the Instructions for Use.
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.
