Z-0681-2020 Class II Ongoing
FDA device recall Z-0681-2020 was initiated by STANLEY BLACK & DECKER INC. on November 21, 2019 and is designated Class II. 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… The recall status is ongoing. Affected quantity: 13917.
Recall Details
- Product Type
- Devices
- Report Date
- January 8, 2020
- Initiation Date
- November 21, 2019
- Termination Date
- N/A
- Voluntary/Mandated
- FDA Mandated
- Product Quantity
- 13917
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).
Distribution Pattern
Nationwide
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..