FDA Issues Warning to Evenflo After Reports of Electrical Shock from Breast Pump Use

David Mittleman

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Several women who used the Evenflo breast pump were shocked while expressing their breast milk—literally. Recently, the Food and Drug Administration issued a warning to the Evenflo Company for failing to properly investigate the complaints of several women who reported receiving electrical shocks while using the company’s breast pump.

In an August 25^th letter that was released on Tuesday, the FDA said it found manufacturing violations at two Ohio Evenflo plants. Inspections at the two facilities revealed that Evenflo wasn’t in compliance with the federal manufacturing rules that make it mandatory for companies to review and evaluate all complaints. In fact, Evenflo received a total of 55 various complaints and only reviewed 37 of those. The 18 other complaints were left uninvestigated, with at least three of those complaints specifically relating to reports of electrical shock from using the breast pumps.

Moreover, according to federal regulations, companies are required to report issues with medical devices to the FDA. However, Evenflo did not follow through on these requirements, and the FDA reports that the company has still failed to address these concerns. Lindsay Harris, Evenflo’s vice president of quality and product integrity, maintains that the company is “working cooperatively with the FDA” to address the agency’s concerns.