SPS Sterilization, Inc: Medical Device Recall in 2018 - (Recall #: Z-3038-2018)

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:

Boston Scientific Wallstent Enteral Endoprosthesis Colonic/Duodenal Stent, 22MM X 90MM, resterilized.

Product Classification:

Class II

Date Initiated: March 7, 2018

Date Posted: September 19, 2018

Recall Number: Z-3038-2018

Event ID: 80317

Reason for Recall:

The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process used does not have adequate support for the extended shelf life.

Status: Terminated

Product Quantity: 2 units total

Code Information:

Code Number 6559-R; Lot Number 17252887 (Serial Number 16211282016-02); Lot Number 17465176 (Serial Numbers 97403172017-16, 97403172017-40)

Distribution Pattern:

US distribution to AZ, CA, FL, OH, PA, TX, VA, WV

Voluntary or Mandated:

Voluntary: Firm initiated