Data Foundry

Medical device recalls 2015

NebuTech Nebulizer — Class II medical device recall Z-2781-2015

Terminated recall by Salter Labs, reported 2015-09-23, distributed nationwide. The Inspiratory valve cap on the nebulizer reservoir tower may be loose and may detach before or during treatm

Recall numberZ-2781-2015
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmSalter Labs, Carlsbad, CA, United States
Recall initiated2015-08-04
Classified2015-09-17
Reported by FDA2015-09-23
Terminated2016-05-06
DistributedNationwide (US)
Countries outside the USAU, BE, GB, GR
Quantity8,975
Reason classesdevice malfunction
Lot numbers042015
Model numbers600116, 8660-7, 8960-7, 8960TG-7, 8967-7, 8982-7, 8984-7

Product

NebuTech Nebulizer, Model number: Series 8660, 8960, 8961, 8966, 8984. Nebulizer used to generate aerosols delivered directly to the patient for breathing. Designed to be used in either a hospital or homecare environment.

Reason for recall

The Inspiratory valve cap on the nebulizer reservoir tower may be loose and may detach before or during treatment.

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-2781-2015. 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.