Reprocessed Agilis Steerable Introducer: indicated for introducing… — Class II medical device recall Z-0090-2019
Terminated recall by Sterilmed, Inc., reported 2018-10-17, distributed nationwide. Reprocessed Agilis Steerable Introducers may not meet endotoxin requirements per product specification for bio
| Recall number | Z-0090-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Sterilmed, Inc., Plymouth, MN, United States |
| Recall initiated | 2018-09-17 |
| Classified | 2018-10-09 |
| Reported by FDA | 2018-10-17 |
| Terminated | 2020-08-04 |
| Distributed | Nationwide (US) |
| Quantity | 218 units |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 10888551044912, 10888551044929, 10888551044950 |
Product
Reprocessed Agilis Steerable Introducer: indicated for introducing various cardiovascular catheters into the heart. (a) small curl (16.8mm curve type/71 cm length), Product Code STJ408309; (b) medium curl (22.4 mm curve type/71 cm length), Product Code STJ408310; (c) large curl (50 mm curve type/71 cm length), Product Code STJ408324
Reason for recall
Reprocessed Agilis Steerable Introducers may not meet endotoxin requirements per product specification for biological residues determined by LAL testing.
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-0090-2019. 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.