Fujifilm recalls duodenoscopes over infection risk

Fujifilm Medical Systems U.S.A. on July 21 issued a nationwide recall of its duodenoscope model ED-530XT over concerns its design could hinder proper reprocessing of the device and spread infection.

The company issued the recall after receiving regulatory approval for an updated design and device label intended to reduce infection risk. The updated design requires several replacement parts — including a new distal end cap and forceps elevator mechanism — along with a new operations manual.

Fujifilm will contact all customers using the recalled device and send instructions for how to receive the replacement parts by October.

In January, the FDA issued a safety alert stating Fujifilm Medical Systems planned to remove four duodenoscope legacy models from clinical use. The retired models were set to be replaced with the ED-530XT.

To learn more about the recall, click here.

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