W. L. Gore & Associates Inc.: Medical Device Recall in 2020 - (Recall #: Z-1962-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

Gore DrySeal Flex Introducer Sheath, Catalog #DSF1433, 33cm 14FR, Sterile. The responsible firm on the label is W. L. Gore & Associates, Inc., Flagstaff, AZ.

Product Classification:

Class II

Date Initiated: November 18, 2019

Date Posted: May 20, 2020

Recall Number: Z-1962-2020

Event ID: 85379

Reason for Recall:

The devices were mislabeled with the incorrect product size resulting in 16Fr devices being labeled as 14Fr devices.

Status: Terminated

Product Quantity: 141 devices

Code Information:

Serial numbers 21077298, 21077364, 21077365, 21077366, 21077631, 21077350, 21077351, 21077414, 21060888, 21077339, 21077340, 21077341, 21077417, 21077418, 21061626, 21077286, 21077336, 21077337, 21077211, 21077304, 21077305, 21077307, 21077308, 21077309, 21077640, 21077559, 21077563, 21077564, 21077183, 21077346, 21077347, 21077616, 21077617, 21077618, 21077619, 21077419, 21077596, 21077345, 21077620, 21077635, 21077322, 21077602, 21077362, 21077622, 21077623, 21077624, 21077625, 21077626, 21077627, 21077628, 21077348, 21077349, 21077633, 21077644, 21077363, 21077352, 21077634, 21077621, 21077318, 21077319, 21061622, 21077590, 21077591, 21077629, 21077632, 21060886, 21077593, 21077594, 21077274, 21077282, 21077338, 21077636, 21077637, 21077638, 21077639, 21077642, 21077643, 21061625, 21061627, 21077601, 21077608, 21077284, 21077303, 21077320, 21077321, 21077316, 21077415, 21077416, 21077299, 21077300, 21077301, 21077302, 21077369, 21077342, 21077599, 21077600, 21077197, 21077595, 21061623, 21077641, 21077597, 21061624, 21077285, 21077184, 21077185, 21077609, 21077436, 21077437, 21077592, 21077190, 21077191, 21077192, 21077193, 21077194, 21077195, 21077196, 21077206, 21077207, 21077208, 21077561, 21077562, 21077367, 21077368, 21077188, 21077630, 21077186, 21077187, 21077189, 21077310, 21077317, 21077334, 21077353, 21077605, 21077343, 21077344, 21077177, 21077178, 21077179, 21077180, 21077181, and 21077598.

Distribution Pattern:

All distribution is foreign to the following countries: Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Japan, Norway, Spain, Sweden, Switzerland, and the UK.

Voluntary or Mandated:

Voluntary: Firm initiated