Sterile Oxymetry Oligon Catheter Kit — Class II medical device recall Z-2007-2020
Terminated recall by Edwards Lifesciences, LLC, reported 2020-05-20, distributed in AZ, CA, FL, GA, IA, IL, IN, KY…. Sterile catheter kit packaging compromised.
| Recall number | Z-2007-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Edwards Lifesciences, LLC, Irvine, CA, United States |
| Recall initiated | 2020-03-27 |
| Classified | 2020-05-14 |
| Reported by FDA | 2020-05-20 |
| Terminated | 2021-04-27 |
| Distributed | AZ, CA, FL, GA, IA, IL, IN, KY, MA, MD, MO, SC, TN, TX, VA |
| Quantity | 597 units |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 00690103197181 |
| Lot numbers | 62132722, 62157774, 62563142, 62625932, 62749306 |
| Model numbers | XA3816SFKT |
Product
Sterile Oxymetry Oligon Catheter Kit. Pressure injectable. REF/UDI:XA3816SAFKT/ (01)00690103197181
Reason for recall
Sterile catheter kit packaging compromised.
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-2007-2020. 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.