Food, drugs, devices › Riverpoint Medical, LLC
Device recall: RP RIVERPOINT MEDICAL 18G Brachy Grid B&K(TM) style, REF RPG-18 Product Usage: The Riverpoint Brachytherapy Grid is used
FDA enforcement event 81935 is a device recall by Riverpoint Medical, LLC of Portland, OR, initiated 9 Jan 2018 and classified Class III, with 1 product record.
FDA defines Class III as a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences. 4% of the 1,074 device enforcement events initiated in 2018 carry the same class.
Status: Terminated, terminated 15 Apr 2019. Initiation: voluntary: firm initiated. Riverpoint Medical, LLC has 7 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Riverpoint Medical, LLC, Portland, OR.
Reason for recall
"Product is labeled with "CE", but is not yet approved in the European Union."
Distribution
"US Nationwide Distribution in the states of IL, WA, and FL"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0777-2019 | 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… | 443 devices | Class III | Terminated | 6 Feb 2019 |
Context
Other enforcement events for Riverpoint Medical, LLC
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 25 Oct 2023 | Iconix Knotless 1.4mm Anchor with XBraid S (Blue/Black) REF 3911-714-520 Iconix Knotless 1.4mm Anchor with XBraid S (Bla | Device | Class II | 1 |
| 9 Dec 2020 | Covidien CV-9590 Velosorb Fast Braided Fast absorbable Suture 14 Metric 36" 90 cm, GS-24 Taper 1/2 40 mm, undyed, UDI: 1 | Device | Class II | 1 |
| 3 Aug 2020 | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 6/0 Undyed 18" P-10 Cutting, Product Number: SV9913, UDI: 208 | Device | Class II | 40 |
| 8 Feb 2019 | Riverpoint Medical 18G Brachy Grid, B&K style, REF RPG-18, Sterile, Rx. The firm name on the label is Riverpoint Medical | Device | Class II | 1 |
| 5 Aug 2016 | Nylon Surgical Suture for human use and vet use, sold under brand name Riverlon, Securolon, Weblon. Product is sterile. | Device | Class II | 2 |
| 13 Dec 2012 | Polyglycolic-Lactic Acid Absorbable Surgical Suture Label reads in part "Coated VILET *** (Polyglacin 910) Suture UNDYED | Device | Class II | 1 |
All 7 events for Riverpoint Medical, LLC
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Product is labeled with "CE", but is not yet approved in the European Union."
What does Class III mean?
FDA classifies recalls by relative degree of health hazard. Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
Where was the product distributed?
FDA's distribution pattern field reads: "US Nationwide Distribution in the states of IL, WA, and FL"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 15 Apr 2019. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.