Recall Z-0681-2020— STANLEY BLACK & DECKER INC.
Class II · Ongoing
Class II FDA medical device recall by STANLEY BLACK & DECKER INC., initiated 2019-11-21. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: 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)..
- Recalling firm
- STANLEY BLACK & DECKER INC.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2019-11-21
- Firm location
- Southington, CT, United States
Product description
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.
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).
Data sourced from openFDA. This site is unofficial and independent of the FDA.