CLASS III Device recall · Reported 14 Oct 2020 · FDA Enforcement Report

Neoprobe GDS Control Unit recalled by Devicor Medical Products

Devicor Medical Products is recalling Neoprobe GDS Control Unit. The recall was initiated on 7 Sep 2020 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codesUDI: 00841911100317; Serial Numbers: 122066557 122066558 122066559 122066560 122066561 122666652 123066667 123066668 123066669 123366695 123366696 123366697 123366698 123366699 123366700 123366701 123366702 123266693 123266694 134467282 143367591 144867780 145067796 150367828 150367829 150367840 150467866 150467867 150367830 150367831 150367832 150967913 150967914 151067915 151067916 151067917 151267970 151267971 151267972 151267973 151267974 185269399 185269403 190269421 190469433 190469430 190469428 150467871 150467869

Quantity recalled49

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0070-2021
FDA event ID: 86228
Recalling firm: Devicor Medical Products, Cincinnati, OH
Classification: Class III
Status: Terminated
Recall initiated: 7 Sep 2020
FDA classified: 8 Oct 2020
Reported: 14 Oct 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

7 Sep 2020	Recall initiated by company
8 Oct 2020	Classified by FDA	+31 days
14 Oct 2020	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

Neoprobe GDS Control Unit, Model Number NPCU3

Where it was distributed

The products were distributed only to China.

Questions about this recall

Is Neoprobe GDS Control Unit recalled?

Yes. Devicor Medical Products recalled Neoprobe GDS Control Unit on 7 Sep 2020. The recall is Class III and its status is Terminated. Recall number Z-0070-2021.

Why was it recalled?

Which lots are affected?

UDI: 00841911100317; Serial Numbers: 122066557 122066558 122066559 122066560 122066561 122666652 123066667 123066668 123066669 123366695 123366696 123366697 123366698 123366699 123366700 123366701 123366702 123266693 123266694 134467282 143367591 144867780 145067796 150367828 150367829 150367840 150467866 150467867 150367830 150367831 150367832 150967913 150967914 151067915 151067916 151067917 151267970 151267971 151267972 151267973 151267974 185269399 185269403 190269421 190469433 190469430 190469428 150467871 150467869

Where was it sold?

The products were distributed only to China.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class III mean?

Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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