Chiu Technical Corp Transilluminator, Model BFO-150, a Fiber Optic Light Source (Illuminator), available in 2 voltages: 115v for USA users & 220v for foreign countries. --- Chiu Technical Corporation, 252 Indian Head Road, Kings Park, NY 11754. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Transilluminator, Model BFO-150, a Fiber Optic Light Source (Illuminator), available in 2 voltages: 115v for USA users & 220v for foreign countries. --- Chiu Technical Corporation, 252 Indian Head Road, Kings Park, NY 11754.
Brand
Chiu Technical Corp
Lot Codes / Batch Numbers
All Serial Numbers on the market
Products Sold
All Serial Numbers on the market
Chiu Technical Corp is recalling Transilluminator, Model BFO-150, a Fiber Optic Light Source (Illuminator), available in 2 voltages: due to Device was marketed without a 510(k).. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Device was marketed without a 510(k).
Recommended Action
Per FDA guidance
On 11/09/07, the recalling firm started faxing the Recall Letter and response form to its customers, informing them of the recall of the unapproved device to the user level.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026