Use caution Medical device recall · FDA · Published May 6, 2022

Getinge VOLISTA StandOP Surgical Light Recall: Paint Particles May Cause Infection During

Getinge recalls VOLISTA StandOP Surgical Lights with certain product codes due to risk of paint particles detaching during surgery, potentially causing infection or tissue reactions. Affected units include specific model numbers and serial ranges.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1308-2022Medical device Getinge ›

Use caution until it’s fixed

Paint particles may detach and fall in the operating field. In the worst case scenario, infection, organ irritation, hypersensitivity reaction, and tissue granuloma may result if paint particles fall during surgical operation into the patient body or in the operating field.

Take action

Contact the company

Recalling firmGetinge Usa Sales Inc1 Geoffrey Way · Wayne, NJ 07470-2035

✎ GovInfoNow plain-language explainer

Getinge is recalling certain VOLISTA StandOP Surgical Lights because paint particles may detach and fall into the operating field during surgery. If these particles enter the patient, they could cause infection, organ irritation, or other serious reactions. Read more at govinfonow.com/recall/60723-getinge-volista-standop-surgical-light-recall-paint-particles-may-cause.

Source Summary by GovInfoNow · govinfonow.com/recall/60723-getinge-volista-standop-surgical-light-recall-paint-particles-may-cause · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1308-2022

Cite this page

“Getinge VOLISTA StandOP Surgical Light Recall: Paint Particles May Cause Infection During.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/60723-getinge-volista-standop-surgical-light-recall-paint-particles-may-cause. Based on FDA recall #Z-1308-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1308-2022%22&limit=1).

The FDA announced on May 6, 2022, that Getinge Usa Sales Inc is recalling VOLISTA StandOP Surgical Lights due to the risk of paint particles detaching and falling into the operating field. The agency said this defect could cause infection or tissue granuloma if particles enter a patient's body during surgery.

How to tell if you have it

Brand: Getinge
Product: VOLISTA StandOP Surgical Light
Part Numbers: ARD568811901 VLT600SF AIM STP, ARD568811911 VLT600SF AIM STP, ARD568811961 VLT600DF AIM STP, ARDVST229000A VST60SF AIM, ARDVST229001A VST60DF AIM, ARDVST229002A VST66SF AIM, ARDVST229003A VST66DF AIM, ARDVST229034A VST60SF, ARDVST229036A VST66SF, ARDVST229037A VST66DF
Units affected: 337 in the US

The hazard

According to the FDA, paint particles may detach and fall in the operating field. In the worst case scenario, infection, organ irritation, hypersensitivity reaction, and tissue granuloma may result if paint particles fall during surgical operation into the patient body or in the operating field.

Context

GovInfoNow's records show Getinge Usa Sales Inc has 16 other recalls on record since 2021-12-09. Other recent recalls of similar products include Getinge Vaporizer Sevoflurane Recall (2025-01-15), Getinge MEERA CL Mobile Operating Table Recall (2024-10-03), and Getinge ALPHAMAXX Mobile Operating Table Charger Recall (2024-05-29). Other recent recalls of similar products include Medline recalls eye surgery kits with high endotoxin levels in neuro sponges (2026-03-19), Steris ALYON Surgical Lighting System Recall (2026-05-15), and Vortex Surgical 25GA Subretinal Injection Cannula Recall (2025-12-16).

How to tell if you have this one

Check for product codes ARD568811901, ARD568811911, ARD568811961, ARDVST229000A, ARDVST229001A, ARDVST229002A, ARDVST229003A, ARDVST229034A, ARDVST229036A, or ARDVST229037A. Also check serial numbers listed in the recall notice.

Brand
Getinge
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Codes
Review the product codes listed in the recall notice to confirm if your surgical light is affected.
Contact Getinge
Reach out to Getinge directly for assistance with the recall process or to confirm if your unit is affected.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 24 states.

FDA distribution: “Worldwide distribution - US Nationwide distribution in the states of AR, AZ, CA, CO, CT, GA, IA, ID, KS, KY, LA, MA, MD, ME, MO, NE, NY, OH, OR, TN, TX, UT, VA, WA.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Arizona, Arkansas, California, Colorado, Connecticut, Georgia, Idaho, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Missouri, Nebraska, New York, Ohio, Oregon, Tennessee, Texas, Utah, Virginia, Washington.

Recall timeline

FDA published this recall 2 months after the firm started it.

May 6, 2022Firm started the recall
Jun 30, 2022FDA classified it Class II
Jul 6, 2022Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

How can I tell if my surgical light is in the recall?

Check the product code or serial number on your light against the list provided in the recall notice.

What should I do if I have a recalled surgical light?

Contact Getinge directly to confirm if your unit is affected and to receive guidance on next steps.

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Link to this recall

<a href="https://govinfonow.com/recall/60723-getinge-volista-standop-surgical-light-recall-paint-particles-may-cause">Getinge VOLISTA StandOP Surgical Light Recall: Paint Particles May Cause Infection During (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-1308-2022 (May 6, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1308-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.