Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Laser distance measurers

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall Laser distance measurers see related information
Date Initiated by Firm November 21, 2019
Create Date December 30, 2019
Recall Status1 Open3, Classified
Recall Number Z-0681-2020
Recall Event ID 84499
Product Classification Alignment laser product - Product Code RER
Product The products involved are DeWALT laser distance measurers, model numbers DW0165, DW0165S, DW0330S and Stanley Fatmax FMHT77506. These products were produced for DeWALT and Stanley by a contract manufacturer.
Code Information The products involved are DeWALT laser distance measurers, model numbers DWO 165, DWO 1 65S, DW0330S and Stanley Fat Max FMHT77506 TLM 165. These products were produced for DeWALT and Stanley by a contract manufacturer.. 
Recalling Firm/
Manufacturer		 STANLEY BLACK & DECKER INC.
400 Executive Blvd
Southington CT 06489-1096
Manufacturer Reason
for Recall		 The products are labeled as Class II lasers. However, the level of laser radiation emitted by the distributed products may exceed the limit (1 mW) established for Class II lasers. These products would be more appropriately classified into laser Class IIIa (IEC Laser Class IIIR).
FDA Determined
Cause 2		 Radiation Control for Health and Safety Act
Action The products are labeled as Class II lasers. However, the level of laser radiation emitted by the distributed products may exceed the limit ( I mnW) established for Class 11 lasers. These products would be more appropriately categorized in Class Ilia (IFEC Laser Class 3R).
Quantity in Commerce 13917
Distribution Nationwide
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
-
-