Complete FDA and NHTSA recall records dated in August 2019.
These records include useful source details for the selected month.
The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter…
Capiox NX19 Oxygenator may contain a non-functioning arterial thermistor component
The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter…
The pressure gauge (manometer) may dislodge from the threaded insertion/mount, creating a leak.
Updated instructions for use: Ultra-Flex MYO/WIRE Monopolar pacing wire looped electrode (M-21 Series) to be consistent between electrode IFU and instructions for M-21 loop.
The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter…
Potential slippage of the biopsy positioner when the gantry is rotated during a biopsy procedure.
When creating 3D plans using either MU or Dose weighting modes, if the user changes the number of fractions, rescales the plan and then changes the wedge angle, the Monitor Units are scaled…
The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter…
The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter…
Kit lots contain a small percentage of damaged Filter-Tips that are leaking when being used with the QIAsymphony SP/AS Instruments (REF 9001297 and 9001301)
Potential for increased rate of false positive results and/or increased rate of random non-repeatable false positive results.
The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter…
Manufacturing error, the drill bit shaft is unable to properly capture the drill bit pin. Failure of the drill bit shaft to capture the drill bit pin could result in the drill bit coming…
The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter…
Potential slippage of the biopsy positioner when the gantry is rotated during a biopsy procedure.
The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter…
The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter…
The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter…
The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter…
Capiox NX19 Oxygenator may contain a non-functioning arterial thermistor component
The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter…
The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter…
The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter…
Use this page to compare the recalls reported during the month, then open an individual record for the exact reason, classification, company, remedy or distribution information available from the official source. Monthly counts are descriptive, not a safety rating.
