Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 71909

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
August 04, 2015
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Salter Labs

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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.

Z-2781-2015
Recall number
Z-2781-2015
Initiated
August 04, 2015
Classification
Class II
Status
Terminated
Recalling firm
Salter Labs
Quantity
8,975

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Inspiratory valve cap on the nebulizer reservoir tower may be loose and may detach before or during treatment.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Lot Numbers 042015 through 070615A Series 8660, 8960, 8961, 8966, 8984. Nebulizers (part numbers 8660-7, 8960-7, 8960TG-7, 8967-7, 8982-7, 8984-7), Inspiratory valve cap (part number 600116).

Distribution pattern

Worldwide Distribution - US Nationwide and in the countries of Greece, UK, Belgium, Australia, and Switerzland.