VOLISTA StandOP Surgical Light
Medical device recall Z-1308-2022. Published in FDA’s Enforcement Report on Jul 6, 2022.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Jul 6, 2022. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word, and 24 states named
- 337 (US); 8594 (OUS) how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
VOLISTA StandOP Surgical Light, Product Code/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
337 (US); 8594 (OUS), in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Product Code UDI Product Description ARD568811901 N/A VLT600SF AIM STP ARD568811911 N/A VLT600SF AIM STP ARD568811951 N/A VLT600DF AIM STP ARD568811961 N/A VLT600DF AIM STP ARD568812951 N/A VLT400DF AIM STP ARD568821911 N/A VLT600SF AIM…
Every code shown here, 1,997 characters
Product Code UDI Product Description ARD568811901 N/A VLT600SF AIM STP ARD568811911 N/A VLT600SF AIM STP ARD568811951 N/A VLT600DF AIM STP ARD568811961 N/A VLT600DF AIM STP ARD568812951 N/A VLT400DF AIM STP ARD568821911 N/A VLT600SF AIM STP QL ARD568821961 N/A VLT600DF AIM STP QL ARD568831961 N/A VLT600DF AIM STP ARDROL309018A 3700712400873 VST60 AIM ROL ARDROL309022A 3700712400866 VST40 TK AIM ROL B ARDROL309023A 3700712400903 VST60 TK AIM ROL B ARDVST229000A 3700712401603 VST60SF AIM ARDVST229001A 3700712401566 VST60DF AIM ARDVST229002A 3700712401764 VST66SF AIM ARDVST229003A 3700712401726 VST66DF AIM ARDVST229034A 3700712401597 VST60SF ARDVST229035A 3700712401559 VST60DF ARDVST229036A 3700712401757 VST66SF ARDVST229037A 3700712401719 VST66DF Serial Numbers: AR500002 AR500005 500000 500005 568811961AR031047 568811961AR031052 00002 00005 00006 00007 500005 510001 510002 510003 510004 510005 500029 500030 38009 38026 00125 00126 AR038016 AR038013 00113 500046 500069 AR038019 AR038018 AR038020 AR038021 AR038022 AR038023 AR038025 AR038024 500007 500008 568811911AR035028 568811911AR035025 500000 500001 500003 500004 AR038015 AR038012 AR035028 AR035025 00003 00114 500001 500004 500006 500007 510018 510019 510026 510028 568811961AR031053 AR031053 00001 500004 500027 510011 510012 510013 510014 510015 510017 510020 510021 510022 510023 510024 510062 510063 510064 510057 510058 510059 500026 AR031048 AR031054 31030 AR021001 AR021002 00004 568811911AR035024 AR035024 35024 00110 AR035015 AR035014 AR035013 DEL_AR035012 568811911AR035015 568811911AR035014 568811911AR035013 568811911AR035012 AR035012 35013 35014 35015 00001 00002 510017 500028 500033 568811911AR035027 568811911AR035017 AR035017 AR035027 00108 00109 AR031003 AR031022 AR031026 AR031012 AR031002 AR031001 AR031006 AR031024 AR031025 AR031019 AR031020 AR031009 AR031010 AR03001 AR031000 AR031008 31003 AR031000 510027 AR031051 AR031050 AR031047 AR031052 31050 31051 AR031009 38025 38026 38027 38028 AR031046 AR031044…
FDA’s list runs to 3,678 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
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.
The states and territories these words name
24 states and territories.
Every one of them
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Georgia
- Iowa
- Idaho
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Missouri
- Nebraska
- New York
- Ohio
- Oregon
- Tennessee
- Texas
- Utah
- Virginia
- Washington
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on May 6, 2022.
- FDA classified it on Jun 30, 2022.
- FDA’s Enforcement Report published it on Jul 6, 2022.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Getinge Usa Sales Inc, of Wayne, NJ.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 3,678 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
-
U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.