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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 85858

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

Open FDA event record

Event summary

Timeline bucket
November 18, 2019
Product types
Device
Classifications
Class III
Statuses
Terminated
Recalling firm wording
LivaNova USA Inc.

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

LivaNova USA Sterile Disposable Connector,1/2x1/2, 20 units per case

Z-2642-2020
Recall number
Z-2642-2020
Initiated
November 18, 2019
Classification
Class III
Status
Terminated
Recalling firm
LivaNova USA Inc.
Quantity
140 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Some packages of sterile disposable connectors contained a 3/8x1/4 reducer instead of the specified 1/2x1/2 connector. No significant risk to health is expected as the issue is easily detectable and the different shape would prevent use of the connector.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Some packages of sterile disposable connectors contained a 3/8x1/4 reducer instead of the specified 1/2x1/2 connector. No significant risk to health is expected as the issue is easily detectable and the different shape would prevent use of the connector.

Code information

Item# EC2135S, Lot No. 1923900091

Distribution pattern

Distributed to medical facilities in 5 states including: Minnesota, Kansas, Missouri, Utah and Washington.