Covidien ($COV) is recalling its Roticulator staplers around the world, citing a packaging issue that might have rendered some products non-sterile, MassDevice reports.
The company disclosed the recall in a release from its Hong Kong division, but told MassDevice it had not planned to issue a press release on the issue because it's "not material." Covidien warned that use of the impacted devices could lead to an increased risk of infection for patients, and the company has asked providers to quarantine and return the affected staplers.
The recall applies to two models of the Roticulator 55 and three of the Roticulator 30, which are medical staplers used in abdominal, gastric and pediatric surgeries. Covidien discovered the issue in a routine audit of products, a spokesperson told MassDevice, and is working with the FDA to move forward with the recall.
It's Covidien's second recall in recent months, although this one is less serious than the last: In January, the company recalled its Duet tissue-reinforcement system after reports of 13 serious injuries and three deaths tied to the device.
- read the MassDevice report