CLASS II Device recall · Reported 28 Aug 2013 · FDA Enforcement Report

Stryker Visum 300 Ceiling-mounted Exam Light recalled

Stryker Communications is recalling Stryker Visum 300 Ceiling-mounted Exam Light. The recall was initiated on 25 Jul 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesProduct sold under the following part numbers: 0682001410A, 0682001410B, 0682001410C, 0682001410D, 0682001410E, 0682001410F, 0682001410G, and 0682001410H and shipped prior to February 28, 2013.
Quantity recalled1,375 units

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-1992-2013
FDA event ID
65888
Recalling firm
Stryker Communications, Flower Mound, TX
Classification
Class II
Status
Terminated
Recall initiated
25 Jul 2013
FDA classified
21 Aug 2013
Reported
28 Aug 2013
Type
Voluntary: Firm initiated
Customers notified by
Letter
Reason category
Other Reasons

Timeline

25 Jul 2013Recall initiated by company
21 Aug 2013Classified by FDA+27 days
28 Aug 2013Published in enforcement report+7 days

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

Reason for recall

Potential incomplete final weld on the drop tube flange.

Product as listed by the FDA

Stryker Visum 300 Ceiling-mounted Exam Light.

Where it was distributed

Worldwide Distribution: US natiowide and to the country of Canada.

Questions about this recall

Is Stryker Visum 300 Ceiling-mounted Exam Light recalled?

Yes. Stryker Communications recalled Stryker Visum 300 Ceiling-mounted Exam Light on 25 Jul 2013. The recall is Class II and its status is Terminated. Recall number Z-1992-2013.

Why was it recalled?

Potential incomplete final weld on the drop tube flange.

Which lots are affected?

Product sold under the following part numbers: 0682001410A, 0682001410B, 0682001410C, 0682001410D, 0682001410E, 0682001410F, 0682001410G, and 0682001410H and shipped prior to February 28, 2013.

Where was it sold?

Worldwide Distribution: US natiowide and to the country of Canada.

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 II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

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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