Data Foundry

Medical device recalls 2019

Brand Name Burn Navigator¿ Model Numbers: Catalog 1120 — Class II medical device recall Z-2295-2019

Terminated recall by Arcos, Inc, reported 2019-08-28, distributed in AZ, LA, MD, OR, TX, WA. Battery packs may heat up abnormally and ignite in rare instance.

Recall numberZ-2295-2019
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmArcos, Inc, Missouri City, TX, United States
Recall initiated2015-03-16
Classified2019-08-21
Reported by FDA2019-08-28
Terminated2022-02-09
DistributedAZ, LA, MD, OR, TX, WA
Quantity28
Model numbers1120, 1125, CF-H2, CF-VZSU53AQ, CF-VZSU53AR, CF-VZSU53AW, CMP-1523

Product

Brand Name Burn Navigator¿ Model Numbers: Catalog 1120, Burn Navigator¿ H2 Catalog 1125, Burn Navigator¿ H2 Transport Package Burn Navigator User Manual Manual-1120 Burn Navigator User's Manual, Rev. F Battery: Panasonic Model CF-H2 Part Number CMP-1523

Reason for recall

Battery packs may heat up abnormally and ignite in rare instance.

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-2295-2019. 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.