RecallRadar

FDA Device recall Z-2642-2020

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

On 2020-07-29 the FDA classified a Class III recall of LivaNova USA Sterile Disposable Connector,1/2x1/2, 20 units per case by Livanova Usa, citing 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 ea….

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-2642-2020
ClassificationClass III
Statusterminated
Initiated2019-11-18
Published2020-07-29
Last updated2026-09-13 11:55 UTC
CompanyLivanova Usa
DistributionKS, MN, MO, UT, WA

Product

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

Reason

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.

Identifiers

code_infoItem# EC2135S, Lot No. 1923900091

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2642-2020%22

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