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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 88146

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

Open FDA event record

Event summary

Timeline bucket
April 14, 2021
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Dutch Ophthalmic USA, 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

Illuminated Stepped Laser Probe Curved-for use in combination with 23G vitrectomy system Product Code: 7510.ALC

Z-2097-2021
Recall number
Z-2097-2021
Initiated
April 14, 2021
Classification
Class II
Status
Ongoing
Quantity
13 Boxes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Barcode label extended expiration date. Barcode located at the short side of the outer box shows 2025-10-27 when scanned, while the correct expiry date is 2024-10-01

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Barcode label extended expiration date. Barcode located at the short side of the outer box shows 2025-10-27 when scanned, while the correct expiry date is 2024-10-01

Code information

Lot Number(s) 039406 Unique Device Identifier (UDI) 08717872016122

Distribution pattern

Nationwide Distribution in the states of CA, FL, MA, and UT.