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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 97620

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

Open FDA event record

Event summary

Timeline bucket
September 04, 2025
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Lutronic Corporation

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

XERF EFFECTOR 60. Electrosurgical unit.

Z-0146-2026
Recall number
Z-0146-2026
Initiated
September 04, 2025
Classification
Class II
Status
Ongoing
Recalling firm
Lutronic Corporation
Quantity
7,490 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Manufacturing defects in devices manufactured from 4/1/25 to 8/20/25 can on rare occasions result in adverse events for patients.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Manufacturing defects in devices manufactured from 4/1/25 to 8/20/25 can on rare occasions result in adverse events for patients.

Code information

Model/Catalog Number: 1101210000, 1101210100, 1101210200; UDI: 08809447657752, SERIAL/LOT: MP60J25C02, MP60J25G05, MP60J25G06, MP60J25H03, and MP60J25H01. Devices manufactured from 04/01/25 to 08/20/25.

Distribution pattern

Worldwide - US Nationwide distribution in the states of CA, IL, MA, NJ, NY, PA, TX, and UT. The countries of Canada, South Korea, Hong Kong, Japan, Singapore, Vietnam, Myanmar, Philippines, Taiwan, and Thailand.