V.A.C. Ulta Therapy Unit REF CAPULTDEV01 & ULTDEV01 The 3M” V.A.C.¿ Ulta Negative Pressure Wound Therapy…
Medical device recall Z-0507-2025. Published in FDA’s Enforcement Report on Dec 4, 2024.
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 Dec 4, 2024. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word, and 51 states named
- 83,721 devices 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?
Due to potential system error alarm and the inability to initiate therapy as a result of broken occlusion sensors.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
V.A.C. Ulta Therapy Unit REF CAPULTDEV01 & ULTDEV01 The 3M” V.A.C.¿ Ulta Negative Pressure Wound Therapy System is an integrated wound management system that provides Negative Pressure Wound Therapy with an instillation option.
83,721 devices, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Model Number: CAPULTDEV01/BR.S UDI-DI codes: 00849554000636 00849554000636 00849554001084 Serial Numbers: GAAC06245 GAAC06246 GAAC06247 GAAC06248 GAAC06249 GAAC06250 GAAC06251 GAAC06252 GAAC06253 GAAC06254 GAAC06255 GAAC06256 GAAC06257…
Every code shown here, 1,996 characters
Model Number: CAPULTDEV01/BR.S UDI-DI codes: 00849554000636 00849554000636 00849554001084 Serial Numbers: GAAC06245 GAAC06246 GAAC06247 GAAC06248 GAAC06249 GAAC06250 GAAC06251 GAAC06252 GAAC06253 GAAC06254 GAAC06255 GAAC06256 GAAC06257 GAAC06258 GAAC06259 GAAC06260 GAAC06261 GAAC06262 GAAC06263 GAAC06264 GAAC06265 GAAC06266 GAAC06267 GAAC06268 GAAC06269 GAAC06270 GAAC06271 GAAC06272 GAAC06273 GAAC06274 GAAC06275 GAAC06276 GAAC06277 GAAC06278 GAAC06279 GAAC06280 GAAC06281 GAAC06282 GAAC06283 GAAC06284 GAAC06285 GAAC06286 GAAC06287 GAAC06288 GAAC06289 GAAC06290 GAAC06291 GAAC06292 GAAC06293 GAAC06294 GAAC06295 GAAC06296 GAAC06297 GAAC06298 GAAC06299 GAAC06300 GAAC06301 GAAC06302 GAAC06303 GAAC06304 GAAC06305 GAAC06306 GAAC06307 GAAC06308 GAAC06309 GAAC06310 GAAC06311 GAAC06312 GAAC06313 GAAC06314 GAAC06315 GAAC06316 GAAC06317 GAAC06318 GAAC06319 GAAC06320 GAAC06321 GAAC06322 GAAC06323 GAAC06324 GAAC06863 GAAC06864 GAAC06865 GAAC06866 GAAC06867 GAAC06868 GAAC06869 GAAC06870 GAAC06871 GAAC06872 GAAC06873 GAAC06874 GAAC06875 GAAC06876 GAAC06877 GAAC06878 GAAC06879 GAAC06880 GAAC06881 GAAC06882 GAAC06883 GAAC06884 GAAC06885 GAAC06886 GAAC06887 GAAC06888 GAAC06889 GAAC06890 GAAC06891 GAAC06892 GAAC06893 GAAC06894 GAAC06895 GAAC06896 GAAC06897 GAAC06898 GAAC06899 GAAC06900 GAAC06901 GAAC06902 GAAC06903 GAAC06904 GAAC06905 GAAC06906 GAAC06907 GAAC06908 GAAC06909 GAAC06910 GAAC06911 GAAC06912 GAAC06913 GAAC06914 GAAC06915 GAAC06916 GAAC06917 GAAC06918 GAAC06919 GAAC06920 GAAC06921 GAAC06922 GAAC06923 GAAC06924 GAAC06925 GAAC06926 GAAC06927 GAAC06928 GAAC06929 GAAC06930 GAAC06931 GAAC06932 GAAC06933 GAAC06934 GAAC06935 GAAC06936 GAAC06937 GAAC06938 GAAC06939 GAAC06940 GAAC06941 GAAC06942 GAAC06943 GAAC06944 GAAC06945 GAAC06946 GAAC06947 GAAC06948 GAAC06949 GAAC06950 GAAC06951 GAAC06952 GAAC06953 GAAC06954 GAAC06955 GAAC06956 GAAC06957 GAAC06958 GAAC11856 GAAC11857 GAAC11858 GAAC11859 GAAC11860 GAAC11861 GAAC11862 GAAC11863 GAAC11864 GAAC11865 GAAC11866 GAAC11867 GAAC11868…
FDA’s list runs to 911,786 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: U.S.(nationwide): AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MP, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY O.U.S.(foreign) countries to: Australia, Estonia, Italy, Norway, Spain, Austria, Finland, Japan, Oman, Sweden, Bahrain, France, Jordan, Philippines, Switzerland, Brazil, Germany, Kuwait, Poland, Thailand, Canada, Greece, Malaysia, Qatar, Tunisia, Chile, Hong Kong, Malta, Romania, Turkey, China, India, Mexico, Saudi, Arabia, United Arab Emirates, Colombia, Indonesia, Morocco, Singapore, United Kingdom, Cyprus, Ireland, Netherlands, Slovenia, Czechia, Israel, New Zealand, South Africa, Vietnam, and Denmark
The states and territories these words name
51 states and territories.
Every one of them
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- District of Columbia
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Northern Mariana Islands
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
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 Nov 5, 2024.
- FDA classified it on Nov 22, 2024.
- FDA’s Enforcement Report published it on Dec 4, 2024.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- KCI USA, INC., of San Antonio, TX.
- 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 911,786 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.