FDA Medical Device Recalls (openFDA)
Riverpoint Medical, LLC: 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.
- Recall number
- Z-0777-2019
- Recalling firm
- Riverpoint Medical, LLC
- 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.
- Status
- Terminated
- Initiated
- 2018-01-09
- Posted
- not on file
- Terminated
- 2019-04-15
- Reason
- Product is labeled with "CE", but is not yet approved in the European Union.
- Root cause
- Error in labeling
- Action
- The firm initiated the recall by telephone following with an email and letter on 01/09/02019 The firm requested the return of the recalled product.
- Quantity
- 443 devices
- Distribution
- US Nationwide Distribution in the states of IL, WA, and FL
- Lot, serial or model codes
- Lot Numbers: 18061816, 18101521
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- IWJ
- Firm FEI
- 3006981798
- Firm city
- Portland
- Firm state
- OR
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28