Reported Jun 4, 2025 · Ongoing

DORO¿ Easy-Connect Navigation Adaptor; BRAINLAB (item No. 1204.002)

Pro-Med Instruments GmbH

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Pro-Med Instruments Gmbh · BOETZINGER STRASSE 86 · Freiburg Im Breisgau, N/A · N/A

Is this the product you have?

  • DORO¿ Easy-Connect Navigation Adaptor; BRAINLAB (item No. 1204.002)
Lot codes and dates
  • Model/Item No1204.002
  • UDI-DI04250435506738
  • Serial numbers

    222 of 222 codes

    • 1102010
    • 1201002
    • 1201004
    • 1201005
    • 1201006
    • 1201008
    • 1201009
    • 1201011
    • 1206012
    • 1206013
    • 1206014
    • 1206015
    • 1206016
    • 1206018
    • 1310001
    • 1310002
    • 1310003
    • 1312001
    • 1312002
    • 1312003
    • 1312004
    • 1312005
    • 1312006
    • 1312007
    • 1312008
    • 1312009
    • 1312010
    • 1407011
    • 1407012
    • 1407013
    • 1407014
    • 1407015
    • 1407016
    • 1407017
    • 1407018
    • 1407019
    • 1407020
    • 1501026
    • 1501027
    • 1501028
    • 1501029
    • 1501030
    • 1503031
    • 1503032
    • 1503033
    • 1503034
    • 1503035
    • 1503035
    • 1503036
    • 1503037
    • 1503038
    • 1503039
    • 1503040
    • 1505041
    • 1505042
    • 1505043
    • 1505044
    • 1505045
    • 1505046
    • 1505047
Amount recalled
217 units

Where it was sold

Why it was recalled

Potential of compromised compatibility resulting in influence on the positioning of the reference array and an influence of the function of the navigation system cannot be excluded.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 5:40 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.