C.R. Bard, Inc.: Medical Device Recall in 2016 - (Recall #: Z-0406-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

Totalis, RIGID and Totalis"I Flex ENDO KIT, Manufacturer: C.R. Bard, Inc., Covington, GA 30014.

Product Classification:

Class II

Date Initiated: October 13, 2016

Date Posted: November 23, 2016

Recall Number: Z-0406-2017

Event ID: 75492

Reason for Recall:

Labeling: Statement was added to the Warnings/Precautions section requesting end users to consider the presence of a knot if significant resistance is encountered during attempts at removal.

Status: Terminated

Product Quantity: 75,089 units

Code Information:

Product Codes: REK32N and FEK32HW.

Distribution Pattern:

U.S. Nationwide.

Voluntary or Mandated:

Voluntary: Firm initiated