Terumo Advanced Perfusion System 1-Level Sensor II Gel Pads Product… — Class II medical device recall Z-1459-2017
Terminated recall by Terumo Cardiovascular Systems Corporation, reported 2017-03-22, distributed nationwide. Terumo CVS initiated a voluntary recall for the Level Sensor II Pads and Level Sensor Gel Pads due to non-comp
| Recall number | Z-1459-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Terumo Cardiovascular Systems Corporation, Ann Arbor, MI, United States |
| Recall initiated | 2017-02-20 |
| Classified | 2017-03-13 |
| Reported by FDA | 2017-03-22 |
| Terminated | 2017-06-01 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AU, BE, CA, CL, CN, CO, ID, IN, JP, MX, MY, SG, TH, TW, VN |
| Quantity | 3,794 |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00886799000519 |
| Model numbers | 217390 |
Product
Terumo Advanced Perfusion System 1-Level Sensor II Gel Pads Product Usage: Level sensor pads are used to attach the level sensors to a hard shell reservoir. includes coupling gel.
Reason for recall
Terumo CVS initiated a voluntary recall for the Level Sensor II Pads and Level Sensor Gel Pads due to non-compliant labeling because the product expiration date is displayed in a format that may not be recognizable to all users.
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-1459-2017. 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.