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FDAMarch 1, 2023device

Step Bladeless Trocars, 10 mm cannula and dilator with radially expandable sleeve and 5 - 10 mm reducer, Product Number S101010

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Medtronic was made aware of a supplier calibration issue during the contract sterilization process that may lead to unsterile product. Use of affected product may lead to an unspecified infection or, in the case of sutures used in the eye, pose a loss of vision risk.

What to do

FDA enforcement status: Ongoing

Brands named

covidien lpcovidiencovidien lp

UPCs

10884521090767

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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