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Johnson & Johnson (NYSE:JNJ) has suffered another manufacturing quality snafu that has forced the company to issue a recall of over 157,000 surgical stapler devices and accessories that could pose serious health risks.
The U.S. Food and Drug Administration (FDA) has said that use of the faulty surgical products could cause serious negative health consequences, including possibly death, and the agency last week elevated the recalled devices to a Class 1 rating, the FDA’s most serious classification.
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The products being recalled are the Proximate PPH hemorrhoidal circular stapler and accessories, the Proximate HCS hemorrhoidal circular stapler and accessories, and the Transtar circular stapler procedure set. All are used in hemorrhoid treatment procedures and have been recalled due to “difficulty firing the device which may result in incomplete firing stroke that may result in an incomplete staple formation.”
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According to the FDA website, the misfiring of the stapler devices can cause all sorts of problems, including severe pain, sepsis, bleeding, dysfunction, and occlusion of the rectal canal.
The defective products were manufactured and distributed between April 2011 and July 2012, according to the FDA, and Johnson & Johnson has attributed the issues to a “lubrication process change” made back in April 2011. Customers and distributors alike have been encouraged to cease use of any recalled products immediately and contact the company.
Johnson & Johnson could surely do without this most recent piece of negative publicity. The company has wrestled numerous recalls and supply disturbances due to product quality concerns in the past three years. Investors might view this latest mishap as a sign that the company still has not righted the ship and could see its stock price hurt as a result.
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