Severity
Low
LowClass IIITerminated
FDA Devices recall · Reported February 6, 2019
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.
Product is labeled with "CE", but is not yet approved in the European Union.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Riverpoint Medical, LLC recalled RP RIVERPOINT MEDICAL 18G Brachy Grid B&K(TM) style, REF RPG-18 Product Usage: The Ri… - a low-severity action.
RP RIVERPOINT MEDICAL 18G Brachy Grid B&K(TM) style, REF RPG-18 Product Usage: The Ri… was recalled by Riverpoint Medical, LLC in February 6, 2019. Reason: Product is labeled with "CE", but is not yet approved in the European Union.. Check the official notice for the remedy. Verify recall #Z-0777-2019 with the FDA Devices before acting.
The recall
Riverpoint Medical, LLC issued this low-severity FDA Devices recall-Product is labeled with "CE", but is not yet approved in the European Union..
- Low
- severity level
- 443 units
- affected scope
- Class III
- classification
- February 6, 2019
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0777-2019 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0777-2019) was formally reported on February 6, 2019, with the manufacturer initiating the action on January 9, 2018. It is classified under Low severity (Class III), with a current status of Terminated. Riverpoint Medical, LLC is listed as the recalling firm, operating out of Portland, OR. Federal records list the affected scope as 443 devices.
The documented reason for this recall is: Product is labeled with "CE", but is not yet approved in the European Union. Distribution data in the federal record shows the product reached: US Nationwide Distribution in the states of IL, WA, and FL. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified low severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
443 devices
Related Recalls
6
3 from same agency
Product description
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Low (Class III) |
| Status | Terminated |
| Recall number | Z-0777-2019 |
| Date reported | February 6, 2019 |
| Date initiated | January 9, 2018 |
| Recalling firm | Riverpoint Medical, LLC |
| Firm location | Portland, OR |
| Affected scope | 443 devices |
| Distribution | US Nationwide Distribution in the states of IL, WA, and FL |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0777-2019) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Riverpoint Medical, LLC. Units affected: 443 devices.
Why was this product recalled? ▼
Product is labeled with "CE", but is not yet approved in the European Union.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 6, 2019. Severity: Low. Recall number: Z-0777-2019.
Where was the recalled product distributed? ▼
Distribution: US Nationwide Distribution in the states of IL, WA, and FL.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0777-2019) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported February 6, 2019. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.