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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 80497

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

Open FDA event record

Event summary

Timeline bucket
June 25, 2018
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Leica Microsystems, 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

Leica M530 OHX Microscope System Supplied with 100 - 120 Vac.

Z-2659-2018
Recall number
Z-2659-2018
Initiated
June 25, 2018
Classification
Class II
Status
Terminated
Recalling firm
Leica Microsystems, Inc.
Quantity
123 devices total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Recall is due to a design weakness of the power insert module.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Recall is due to a design weakness of the power insert module.

Code information

US: 90116001, 30118001, 51215001, 201117001, 30916001, 270216001, 100917001, 31117001, 00817001, 0316001, 31217001, 180118001, 200218001, 151217001, 21217001, 21214001, 80218001, 170118001, 01017002, 101017001, 170915001, 150117001, 150217001, 291117001, 260517001, 300915001, 0318001, 30318001, 100915001, 310717001, 140716001, 50516001, 281116001, 300517001, 0316001, 30115001, 200617001, 190117001, 170117001, 241217001, 261217001, 271217001, 90118001, 0617001, 250118001, 280115001, 191015001, 81117001, 150617001, 120417001, 140917001, 10318001, 140417001, 250717001, 80518001, 160616001, 170417001, 150417001, 11116001, 91017001, 81117002, 281117001, 20218001, 300118001, 131015001, 140318001, 110516001, 00318001, 160118001, 30518001, 200316001, 120917001, 210118001, 310717001, 30218001, 1217001, 190617001, 130617001, 280817001, 80317001, 310817001, 10917001, 60317001, 60218001, 80917001 230318001, 170318001; Puerto Rico: 241216001, 261216001; JAPAN: 140717001,171017001, 211117001, 291217001, 290118001, 210218001, 280218001, 020318001, 120318001, 160318001; BRAZIL: 120416001, 220917001, 311017001, 70118001, 70318001; COLOMBIA: 60517001; ECUADOR: 170316001, 231216001, 190917001; MEXICO: 31215001, 130117001, 91217001; TAIWAN: 190815001, 220317001, 190317001, 40517001, 210717001, 210717002, 211217001

Distribution pattern

United States distribution: AR, AZ, CA, CO, CT, DE, FL, IL, IN, KS, KY, LA, MO, NJ, NY, NV, OH, OR, PA, TX, UT, PR. International distribution to Japan, Brazil, Columbia, Ecuador, Mexico, Taiwan