Recall: Encision voluntarily pulls surgical tips | On Call

October 17, 2011 by MassDevice staff

Encision Inc. recalls its surgical electrode tips over concerns that they may break during "aggressive cleaning."

MassDevice On Call

MASSDEVICE ON CALL — Encision Inc. (PINK:ECIA) voluntarily recalled electrode tips used with its AEM surgical systems over concerns that the tips could break off as a result of "aggressive cleaning."

The Boulder, Colo.-based laparoscopic device maker said that a replacement instrument has been designed and is undergoing FDA review.

In the mean time, Encision is replacing existing tips with the prior model at no charge to customers, according to a press release.

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In connection with the recall, Encision announced that it recorded a one-time charge of $430,000 for the quarter ended September 30, 2011. That included non-cash charges of $105,000 for removal of affected tips already in inventory and for increasing warranty accruals.

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