Complete FDA and NHTSA recall records dated in 2018, 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.
Leaky bottles due to a defect in the bottle cap compromising the sterility of the product
There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.
Reports of circulatory support system motor stopping. Motor stop can be attributed to a break of a wire or short circuit between wires within the electrical cable where the cable exits the…
Atellica Solution system software (SW) version 1.13 and lower, five (5) behavioral issues were identified: 1. Reagent Lock may not work as intended with Primary Reagent ReadyPacks and…
These catheters may have the following deficiencies: 1) barium sulfate omission, and 2) actual catheter tip length is one centimeter shorter than printed on the tip
Some of the Disposable Smooth Interior Tubing may pull apart when stretched.
There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.
Atellica Solution system software (SW) version 1.13 and lower, five (5) behavioral issues were identified: 1. Reagent Lock may not work as intended with Primary Reagent ReadyPacks and…
There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.
The firm has identified performance anomalies with the device caused when more than 64 TD60 telemetry transmitters have been connected to a central station. The anomaly causes some ECG…
There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.
There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.
There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.
There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.
There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.
These catheters may have the following deficiencies: 1) barium sulfate omission, and 2) actual catheter tip length is one centimeter shorter than printed on the tip
Calibration setting was incorrectly entered during manufacturing causing the optical coherence tomography (OCT) to obtain the incorrect two-dimensional images of ocular structures of the…
There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.
There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.
The conduit length and branch length of a SG Pulmonary Hemi-Artery were switched on the product labeling. The graft labeling indicates the conduit length is 1.0cm and the branch length is…
Leaky bottles due to a defect in the bottle cap compromising the sterility of the product
A potential bias was identified with certain kits compared to the internal standards.
There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.
There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.
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.
