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Terminated

eSuction Small Cavity, Model ET2005

FDA Recall Z-0270-2023 · Posted 2022-11-18

Recalling FirmEndo-Therapeutics, Inc.
Recall StatusTerminated
Product CodeFGX
Date Initiated2022-10-24
Date Terminated2024-01-24
Product Quantity28 devices

Reason for Recall

Improper device regulatory classification

Firm Action

Endo-Therapeutics, Inc. notified consignees via FedEx Overnight letter sent on 10/24/2022. The letter instructed consignees to cease further distribution of the affected devices immediately, notification to accounts if further distribution, return affected devices and complete and return the response form.

Root Cause

Other

Distribution Pattern

US distribution to Florida and Pennsylvania

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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