Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported April 22, 2026
Gentuity HF-OCT Imaging System Model G10-01; Software version 23.2.13;
The potential for repeated frames during HF-OCT pullback when using the Gentuity HF-OCT Console (software version 21.11 to 23.3.13) with the Vis-Rx and Vis-Rx Prime catheters. Thi…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Gentuity, LLC recalled Gentuity HF-OCT Imaging System Model G10-01; Software version 23.2.13; - a moderate-severity action.
Gentuity HF-OCT Imaging System Model G10-01; Software version 23.2.13; was recalled by Gentuity, LLC in April 22, 2026. Reason: The potential for repeated frames during HF-OCT pullback when using the Gentuity HF-OCT Console (software ver…. Check the official notice for the remedy. Verify recall #Z-1823-2026 with the FDA Devices before acting.
The recall
Gentuity, LLC issued this moderate-severity FDA Devices recall-The potential for repeated frames during HF-OCT pullback when using the Gentuity HF-OCT Console (software ver….
- Moderate
- severity level
- 184 units
- affected scope
- Class II
- classification
- April 22, 2026
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1823-2026 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1823-2026) was formally reported on April 22, 2026, with the manufacturer initiating the action on March 23, 2026. It is classified under Moderate severity (Class II), with a current status of Ongoing. Gentuity, LLC is listed as the recalling firm, operating out of Sudbury, MA. Federal records list the affected scope as 184 units (28 US, 156 OUS).
The documented reason for this recall is: The potential for repeated frames during HF-OCT pullback when using the Gentuity HF-OCT Console (software version 21.11 to 23.3.13) with the Vis-Rx and Vis-Rx Prime catheters. This correction is intended to ensure that … Distribution data in the federal record shows the product reached: Domestic - US Nationwide distribution in the states of CA, FL, GA, IL, MA, MN, NJ, NY, OH, PA, TX; International: United Arab Emirates, Belgium, Switzerland, Cyprus, Denmark, Spain, Finland, France, Greece, Italy, Japa…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
184 units (28 US, 156 OUS)
Related Recalls
6
3 from same agency
Product description
Gentuity HF-OCT Imaging System Model G10-01; Software version 23.2.13;
Reason for recall
The potential for repeated frames during HF-OCT pullback when using the Gentuity HF-OCT Console (software version 21.11 to 23.3.13) with the Vis-Rx and Vis-Rx Prime catheters. This correction is intended to ensure that users are fully informed of how to recognize, avoid, and mitigate this condition to maintain accurate longitudinal (length) measurements during OCT imaging.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-1823-2026 |
| Date reported | April 22, 2026 |
| Date initiated | March 23, 2026 |
| Recalling firm | Gentuity, LLC |
| Firm location | Sudbury, MA |
| Affected scope | 184 units (28 US, 156 OUS) |
| Distribution | Domestic - US Nationwide distribution in the states of CA, FL, GA, IL, MA, MN, NJ, NY, OH, PA, TX; International: United Arab Emirates, Belgium, Switzerland, Cyprus, Denmark, Spain, Finland, France, Greece, Italy, Japan, Kuwait, Latvia, P… |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1823-2026) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
Gentuity HF-OCT Imaging System Model G10-01; Software version 23.2.13;. Recalled by Gentuity, LLC. Units affected: 184 units (28 US, 156 OUS).
Why was this product recalled? ▼
The potential for repeated frames during HF-OCT pullback when using the Gentuity HF-OCT Console (software version 21.11 to 23.3.13) with the Vis-Rx and Vis-Rx Prime catheters. This correction is intended to ensure that users are fully informed of how to recognize, avoid, and mitigate this condition to maintain accurate longitudinal (length) measurements during OCT imaging.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 22, 2026. Severity: Moderate. Recall number: Z-1823-2026.
Where was the recalled product distributed? ▼
Distribution: Domestic - US Nationwide distribution in the states of CA, FL, GA, IL, MA, MN, NJ, NY, OH, PA, TX; International: United Arab Emirates, Belgium, Switzerland, Cyprus, Denmark, Spain, Finland, France, Greece, Italy, Japan, Kuwait, Latvia, Poland, Saudi Arabia, Slovakia;.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1823-2026) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported April 22, 2026. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.