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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 85558

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

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Event summary

Timeline bucket
April 23, 2020
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Olympus Corporation of the Americas

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

OLYMPUS ShockPulse-SE Lithotripsy System, Model SPL-T Transducer

Z-2197-2020
Recall number
Z-2197-2020
Initiated
April 23, 2020
Classification
Class II
Status
Terminated
Quantity
18

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
A component of the Olympus ShockPulse Transducer was manufactured with non-conforming material that could allow water ingress during autoclaving sterilization.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

A component of the Olympus ShockPulse Transducer was manufactured with non-conforming material that could allow water ingress during autoclaving sterilization.

Code information

Serial numbers: 1910PW30607705, 1910PW30607712, 1910PW30607601, 1910PW30607708, 1910PW30607709, 1910PW30607701, 1910PW30607814, 1910PW30607906, 1910PW30607603, 1910PW30607706, 1910PW30607802, 1910PW30607808, 1910PW30607809, 1910PW30607804, 1910PW30607713, 1910PW30607803 Lot Numbers: CG2003, CG2010, CG2011, CG2026, CG2027, CG2033, CG2035, CG2000, CG2025, CG2001, CG2019, CG2022, CG2029, CG2021, CG2008, CG2036, CG2037, CG2006, CG2004, CG2007, CG2012, CG2013, CG2015

Distribution pattern

Distribution US nationwide to states of: Texas, Ohio, New Mexico, California, Oklahoma, Michigan, Connecticut, North Carolina, Nebraska, and Pennsylvania; and Canada.