Boston Scientific Wallstent Enteral Endoprosthesis Colonic/Duodenal… — Class II medical device recall Z-3038-2018
Terminated recall by SPS Sterilization, Inc, reported 2018-09-19, distributed in AZ, CA, FL, OH, PA, TX, VA, WV. The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization p
| Recall number | Z-3038-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | SPS Sterilization, Inc, Nixa, MO, United States |
| Recall initiated | 2018-03-07 |
| Classified | 2018-09-13 |
| Reported by FDA | 2018-09-19 |
| Terminated | 2018-11-27 |
| Distributed | AZ, CA, FL, OH, PA, TX, VA, WV |
| Quantity | 2 units |
| Reason classes | labeling |
| Lot numbers | 17252887, 17465176 |
| Serial numbers | 16211282016-02, 97403172017-16, 97403172017-40 |
Product
Boston Scientific Wallstent Enteral Endoprosthesis Colonic/Duodenal Stent, 22MM X 90MM, resterilized.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-3038-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.