PlainRecalls

Optovue, Inc.

Compiled from official public sources by the publisher.

6 recalls on record · Latest: Sep 6, 2017

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Agency notice ledger

Federal filing book Optovue, Inc. LIGHT-BOOK · SINGLE-AGENCY

#2,241 of 14,151 · 6 notices · 0.006% archive

  • BOOK 6 notices
  • RANK #2,241 of 14,151
  • SHARE 0.006% archive
  • AGENCY FDA Devices (6)
  • CAT medical devices
  • CATS 1 category
  • LATEST Sep 6, 2017
  • PHOTO 1908 Brands

Nearest notice-volume peer: 1908 Brands (0 notice gap)

Optovue, Inc. accounts for about 0.006% of the 104,423-notice archive on 6 distinct filings — a mid share signal beside absolute volume. FDA · CPSC · USDA FSIS · NHTSA notice stamps for this firm. Read with this firm → · Dominant category → · Similar-volume firm →

Optovue, Inc.'s standing among 14,151 recalling firms

Optovue, Inc. ranks 2,241st of 14,151 tracked firms by distinct recall-event count. Archive size reflects filing volume, not inherent product danger.

Optovue, Inc. vs all firms by recall-notice count

Where this firm's archive sits among every tracked recalling manufacturer

6 2241st of 14151 higher than 11,804 of 14,151 firms

Firms, banded by distinct federal recall-event inventory

Each bar is a band; taller bars hold more firms. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source FDA · CPSC · USDA FSIS · NHTSA federal recall filings · 2026-09-13

Optovue, Inc. in the notice-volume neighbourhood

Distinct federal recall events among this firm and nearest nationwide peers

notices

What this shows Optovue, Inc. holds about 0.006% of archive notices alongside 6 distinct filings.

Source FDA · CPSC · USDA FSIS · NHTSA filings aggregated by PlainRecalls As of September 2026
FDA Devices Moderate Sep 6, 2017

iFusion, Device Listing Number D203271. Product Usage: The iCam is a non-contact, high resolution digital imaging device which is suitable for photographing, displaying and storing images of the retina and external areas of the eye to be evaluated under non-mydriatic conditions. The iCam takes digital images of the posterior and external structures of the eye without the use of a mydriatic agent and is intended for use as an aid to clinicians in the evaluation, diagnosis and documentation o
FDA Devices Moderate Sep 6, 2017

iVue with Normative Database, Device Listing Number D185549. Product Usage: The iVue (K121739) is a non-contact, high resolution tomographic imaging device. It is intended for in vivo imaging, axial cross-sectional, and three dimensional imaging and measurement of anterior and posterior ocular structures, including retina, retinal nerve fiber layer, ganglion cell complex (GCC), optic disc, cornea, and anterior chamber of the eye. The iVue with Normative Database is a quantitative tool for t
FDA Devices Moderate Sep 6, 2017

iVue 500 with iScan, D216606. Product non-contact, high resolution tomographic imaging device. It is intended for in vivo imaging, axial cross-sectional and three-dimensional imaging and measurement of anterior and posterior ocular structures, including retina, retinal nerve fiber layer, ganglion cell complex (GCC), optic disc, cornea, and anterior chamber of the eye. The iVue 500 with normative database is a quantitative tool for the comparison of retina, retinal nerve fiber layer, ganglion
FDA Devices Moderate Apr 27, 2016

iVue and iVue 500 (now called iScan) OCT systems with software version 2016.0.0.127 (USA only) and 2016.1.0.127 (out of US) Opthalmic: iVue is a non-contact, high resolution tomographic imaging device. It is intended for in vivo imaging, axial cross-sectional and three-dimensional imaging and measurement of anterior and posterior ocular structures, including retina, retinal nerve fiber layer, ganglion cell complex (GCC), optic disc, cornea, and anterior chamber the eye.
FDA Devices Low Jun 12, 2013

Optovue iVue with Normative Database (NDB) with Software Version 3.0 and 3.1. Intended for in vivo imaging.
FDA Devices Moderate Oct 31, 2012

Reference materials "RETINAL OCT Analysis and Interpretation Method" shipped with iVue System (K091404) and the "Retina Poster" shipped with iVue System (K091404) and RTVue Systems (K101505); Models: iVue-100, RTVue-100; The physical Product is manufactured and distributed by Optovue, Inc. Fremont, CA The product is an optical coherence tomography system indicated for the in vivo imaging and measurement of the retina, retinal nerve fiber layer, optic disk, and for cornea and anterior eye sc

Optovue, Inc. holds a measurable archive slice

Drug and device firms outside this manufacturer and state, matched by notice volume and category footprint.

Similar recall count

Nearest multi-notice firms by distinct-event totals (6 here).

1908 Brands 6 Abbott Molecular 6 Advance Medical Designs, Inc. 6 Air Stream Corp. 6 Aire-Master of America Inc 6

Similar medical devices volume

Nearest multi-notice firms in the same narrow category lane.

Abbott Molecular 6 Advance Medical Designs, Inc. 6 American Medical Systems, Inc. 6 Animas Corporation 6

Frequently Asked Questions

How many federal recall notices name Optovue, Inc.? ▼
PlainRecalls indexes 6 distinct federal recall events naming Optovue, Inc., aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (archive as of September 2026). That count is an issuance inventory, not a hazard score.
Where does Optovue, Inc. sit among other recalling firms? ▼
Optovue, Inc. ranks #2,241 of 14,151 by distinct recall-event count among 14,151 firms in this archive (83rd percentile of firms with fewer notices). Rank tracks filing frequency, not product danger.
Which agency issues most of Optovue, Inc.'s notices? ▼
FDA Devices accounts for 6 of this firm's 6 indexed notices.
What product category dominates Optovue, Inc.'s filing book? ▼
Filings for Optovue, Inc. span 1 product category, led by medical devices. Browse that category archive for peer firms and related notices.
Is a higher notice count more dangerous? ▼
No. Archive size reflects how often federal agencies publish recalls naming the firm — reporting volume, coverage, and product range all move the number. Always verify the individual notice with the issuing agency before acting on a specific product.
Optovue, Inc.: 6 federal recall notices aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (lead agency FDA Devices). Verify individual notices with FDA directly before acting on a specific recall.

Firm-level totals aggregate distinct federal recall events naming Optovue, Inc.; individual notices remain authoritative on each linked recall page.

Methodology · Corrections · FDA · CPSC · USDA FSIS · NHTSA · Archive as of September 2026