Neptune Plus — Class II medical device recall Z-0293-2016
Terminated recall by TZ Medical Inc., reported 2015-11-25, distributed nationwide. The IFU of the Neptune Plus Pads, does not match that submitted in the original 510k. Need to remove: for haem
| Recall number | Z-0293-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | TZ Medical Inc., Portland, OR, United States |
| Recall initiated | 2015-10-14 |
| Classified | 2015-11-18 |
| Reported by FDA | 2015-11-25 |
| Terminated | 2016-10-24 |
| Distributed | Nationwide (US) |
| Quantity | 32,170 units |
| Lot numbers | AGR554, AGR554/24, AGR570/43, AGR744124, AGR744137 |
| Model numbers | 8870-03 |
Product
Neptune Plus, HEMOSTASIS PAD WITH ANTIMICROBIAL BARRIER, For hemostasis following needle/sheath removal, Part number 8870-03
Reason for recall
The IFU of the Neptune Plus Pads, does not match that submitted in the original 510k. Need to remove: for haemostasis following needle/sheath removal
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-0293-2016. 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.