Sakar International, Inc. Maximo Concepts Alcohol Breath Tester, Model Number: MAX91721, Sakar International, Inc., Edison, NJ (LED 3 Step Alcohol Breath Tester) Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Maximo Concepts Alcohol Breath Tester, Model Number: MAX91721, Sakar International, Inc., Edison, NJ (LED 3 Step Alcohol Breath Tester)
Brand
Sakar International, Inc.
Lot Codes / Batch Numbers
Item Codes: MAX91721, MAX91721CL, MAX91721B, MAX91721-6, MAX91721CL-16, MAX91721CL-FR, MAC91721CL-PDQ and MAX91721B-DW. The device does not contain any serial or control/lot numbers.
Products Sold
Item Codes: MAX91721, MAX91721CL, MAX91721B, MAX91721-6, MAX91721CL-16, MAX91721CL-FR, MAC91721CL-PDQ and MAX91721B-DW. The device does not contain any serial or control/lot numbers.
Sakar International, Inc. is recalling Maximo Concepts Alcohol Breath Tester, Model Number: MAX91721, Sakar International, Inc., Edison, NJ due to Marketed without a 510(k). Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Marketed without a 510(k)
Recommended Action
Per FDA guidance
Recall notification letters , Urgent Device Recall, were sent by first class mail on 11/30/2007 requesting return of product and notification of accounts sold product.
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