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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 86045

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
July 14, 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

2 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 2

Smart Stapes Protheses Piston 0.4mm X 5.25 mm- Partial Ossicular Replacement Catalog Number: 70142168

Z-2813-2020
Recall number
Z-2813-2020
Initiated
July 14, 2020
Classification
Class II
Status
Terminated
Quantity
16 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
Mislabeled

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Mislabeled outer carton: packaged with the outer carton label stating the contents were the 70143662 Smart Piston but the inside package contents was the 70142158 Stapes Piston; see image below

Code information

Lot number: PR898678

Distribution pattern

CA , FL , GA , PA Foreign: New Zealand , Switzerland

device · product 2 of 2

Smart Stapes Protheses Piston 0.6mm X 4.25 mm- Partial Ossicular Replacement Catalog Number: 70143662

Z-2814-2020
Recall number
Z-2814-2020
Initiated
July 14, 2020
Classification
Class II
Status
Terminated
Quantity
21 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
Mislabeled

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Mislabeled outer carton: packaged with the outer carton label stating the contents were the 70143662 Smart Piston but the inside package contents was the 70142158 Stapes Piston; see image below

Code information

Lot number: PR911937

Distribution pattern

CA , FL , GA , PA Foreign: New Zealand , Switzerland

Field note

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