Device recall: Neoprobe GDS Control Unit, Model Number NPCU3
Class III FDA enforcement event 86228. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
It was discovered during a documentation review that China has the software version as v5.01 approved for use in China. The current software version on devices distributed in China since 2011 is v6.01.
Class III, in the words of FDA
a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences
Devicor Medical Products Inc started this device recall on 7 Sep 2020. The firm address in the FDA record is in Cincinnati, OH. FDA put the recall in Class III. FDA event 86228 has 1 product record. The first FDA enforcement report date is 14 Oct 2020. The record gives the status Terminated, with the termination date 9 May 2023.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
The products were distributed only to China.
Recalling firm
Devicor Medical Products Inc, Cincinnati, OH.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
1 product record in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0070-2021 | Neoprobe GDS Control Unit, Model Number NPCU3 | 49 | Class III | Terminated | 14 Oct 2020 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class III: The lowest of the three FDA recall classes.
The event in context
- Device events that started in 2020
- 916
- Share of these events in Class III
- 3%
- Product records in this event
- 1Median of the firm: 1
- Events of the firm on the register
- 5
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 24 Apr 2026 | HydroMARK Breast Biopsy Site Marker, Model Number: 4010-02-15-T3 | Device | Class II | 1 |
| 30 Mar 2022 | HydroMARK Breast Biopsy Marker, Model No. 4010-05-08-T4 | Device | Class II | 1 |
| 28 Feb 2017 | Mammotome Revolve Dual Vacuum Assist Biopsy System The device is used to sample breast tissue that has been identified a | Device | Class II | 1 |
| 19 May 2016 | Mammotome Revolve Dual Vacuum Assist Biopsy System Model number: MST1009 & MST0815. Each disposable probe is packaged wi | Device | Class II | 1 |
Official channels
- FDA enforcement report Z-0070-2021The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 86228. https://recallregister.com/fda/iii/86228/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
The products were distributed only to China.
- What quantity of product is in FDA event 86228?
- The FDA record gives this quantity:
49
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2020 have the same class?
- 3% of the 916 device events that started in 2020 are in Class III.