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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 88229

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

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Event summary

Timeline bucket
June 30, 2021
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

Soltive Premium Super Pulsed Laser System (TFL-PLS) & Pro Super Pulsed Laser System (TFL-SLS). Intended for incision, excision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue, with or without an endoscope, in urology, lithotripsy, gastroenterological surgery and gynecological surgery

Z-2294-2021
Recall number
Z-2294-2021
Initiated
June 30, 2021
Classification
Class II
Status
Terminated
Quantity
408 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Thermal injury following dusting and fragmenting treatment of ureteral stones when user exceeded the 20W standard presets

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Thermal injury following dusting and fragmenting treatment of ureteral stones when user exceeded the 20W standard presets

Code information

Software Version 2.0 (all serial numbers)

Distribution pattern

US Nationwide Distribution Foreign: Canada Australia Japan Hong Kong Europe Singapore