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
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
- Device type
- Other Medical Devices
Timeline
| 25 Jul 2013 | Recall initiated by company | |
| 21 Aug 2013 | Classified by FDA | +27 days |
| 28 Aug 2013 | Published 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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