Medline Industries, Inc.: Medical Device Recall in 2018 - (Recall #: Z-2978-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

Laparoscopy CDS

Product Classification:

Class II

Date Initiated: April 12, 2017

Date Posted: September 12, 2018

Recall Number: Z-2978-2018

Event ID: 78411

Reason for Recall:

One manufacturing lot of a non-sterile pack was assembled with a non-sterile component labeled sterile (kit component #80532NS). The non-sterile component 80532NS was supposed to be placed inside the sterile portion of the pack where it would subsequently be exposed to the ethylene oxide sterilization process. However, the component was not placed in the sterile portion of the pack during assembly and was never exposed to the sterilization process. Component 80532NS was inadvertently released non-sterile. Component 80532NS is packaged by Medline and is an Anti-fog kit that contains 1 bottle of 6g Anti-Fog solution and an adhesive backed sponge.

Status: Terminated

Product Quantity: 15 kits

Code Information:

Model: CDS920114F. Lot: 17MB5499

Distribution Pattern:

CA, NM

Voluntary or Mandated:

Voluntary: Firm initiated