FDA recall, , Moderate risk
Terex Utilities Power Over Fiber Base Module
The Power Over Fiber Base Module is not certified and is improperly labeled.
Summary by Recall Canary from the FDA notice
What happened
Device not certified - no laser product report was filed with CDRH prior to distribution. Improperly labeled - omitted labels required under 21 CFR 1040.10 / IEC 60825-1 via LN#56. Missing certification and proper manufacturer's ID label.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Compare these details with yours, then check the recall notice to see which units are recalled.
Power Over Fiber Base Module
- Affected units
- Power Over Fiber Base Module Identification P/N 633232 P/N 622365 P/N 633383 P/N 633910 P/N 635731
Recall details
- Company began the recall
- Sold in
U.S. Nationwide Distribution and International Distribution
- Company
- Terex UtilitiesWatertown, South Dakota
- Hazard
- Unapproved product
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99382
- Recall number
- Z-2745-2026
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
