Data Foundry

Medical device recalls 2020

The products involved are DeWALT laser distance measurers — Class II medical device recall Z-0681-2020

Ongoing recall by STANLEY BLACK & DECKER INC., reported 2020-01-08, distributed nationwide. The products are labeled as Class II lasers. However, the level of laser radiation emitted by the distributed

Recall numberZ-0681-2020
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedFDA mandated
Recalling firmSTANLEY BLACK & DECKER INC., Southington, CT, United States
Recall initiated2019-11-21
Classified2019-12-30
Reported by FDA2020-01-08
DistributedNationwide (US)
Quantity13,917
Reason classeslabeling
Model numbers165, 65S, DW0165, DW0165S, DW0330S

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 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).

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0681-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.