RP RIVERPOINT MEDICAL 18G Brachy Grid B&K — Class III medical device recall Z-0777-2019
Terminated recall by Riverpoint Medical, LLC, reported 2019-02-06, distributed nationwide. Product is labeled with "CE", but is not yet approved in the European Union.
| Recall number | Z-0777-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Riverpoint Medical, LLC, Portland, OR, United States |
| Recall initiated | 2018-01-09 |
| Classified | 2019-01-28 |
| Reported by FDA | 2019-02-06 |
| Terminated | 2019-04-15 |
| Distributed | Nationwide (US) |
| Quantity | 443 devices |
| Reason classes | labeling |
| Lot numbers | 18061816, 18101521 |
| Model numbers | RPG-18 |
Product
RP RIVERPOINT MEDICAL 18G Brachy Grid B&K(TM) style, REF RPG-18 Product Usage: The Riverpoint Brachytherapy Grid is used during Brachytherapy procedures to assist with the precise insertion of the needle or other probes. The Riverpoint Brachytherapy Grid is placed against the skin of the patient to help the user place the needles in a grid pattern. The letters and numbers can also correspond with computerized grids to aid in placement.
Reason for recall
Product is labeled with "CE", but is not yet approved in the European Union.
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-0777-2019. 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.