Z-0681-2020Class II

The products involved are DeWALT laser distance measurers, model numbers DW0165, DW0165S, DW0330S and Stanley...

Name: Z-0681-2020 The products involved are DeWALT laser distance measurers, model numbers DW0165, DW0165S, DW0330S and Stanley...
Creator: Stanley Black & Decker Inc.
Published: 2019-11-21
License: https://open.fda.gov/license/

Stanley Black & Decker Inc. / initiated 2019-11-21 / Open, Classified / root cause: labeling and UDI

FDA source

STANLEY BLACK & DECKER INC. began a recall of The products involved are DeWALT laser distance measurers, model numbers DW0165, DW0165S, DW0330S and Stanley Fatmax FMHT77506. These products were produced... on 2019-11-21. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0681-2020
Classification: Class II
Status: Open, Classified
Initiated: 2019-11-21
Posted: 2019-12-30
Recalling firm: Stanley Black & Decker Inc.
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.
Product code: RER Alignment Laser Product
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).
Root cause tag: labeling and UDI
FDA root cause: 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
Product codes and lots: 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..

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0681-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0681-2020	Class II	Ongoing	FDA Mandated	2020-01-08	2019-12-30

Product code RER

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)