CT3Plus (a.k.a
Medical device recall Z-2914-2016. Published in FDA’s Enforcement Report on Oct 12, 2016.
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 Oct 12, 2016. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Not named no state, in where it went
- 44 systems CT3Plus; 47 systems CT3PZ 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?
FDA inspection found that customers who had received devices with promotional material with outside use indications were not notified when labeling was revised to remove these indications.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
CT3Plus (a.k.a. CT3PZ); Catalog number: 7300-0038/ 7300-0038-1. Dermatology: For use in dermatology for incision, excision, ablation, and vaporization with hemostasis of soft tissue; For treatment of fine lines and wrinkles; For mild to moderate inflammatory acne vulgaris; For back acne and atrophic scarring, and; For podiatry, (incision, excision, and coagulation of soft tissue), including. matrixectomy, periungal and subungal warts, plantar warts, radical nail excision, and neuromas
44 systems CT3Plus; 47 systems CT3PZ, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial numbers CT3Plus: 4009 4023 ABB0271 4030 4016 ABB0900 ABC0363 BBC1457 ABB0862 ABD0757 ABD1363 ABE0101 ABE1258 BBE1875 ABC1193 BBG1209 ABH1818 ABC1067 ABK2803 ABM0371 ABM1206 ABP1160 ABS1067 ACA1652 ACA1790 ACA2139 ACC1485 ACD0843…
Every code shown here, 714 characters
Serial numbers CT3Plus: 4009 4023 ABB0271 4030 4016 ABB0900 ABC0363 BBC1457 ABB0862 ABD0757 ABD1363 ABE0101 ABE1258 BBE1875 ABC1193 BBG1209 ABH1818 ABC1067 ABK2803 ABM0371 ABM1206 ABP1160 ABS1067 ACA1652 ACA1790 ACA2139 ACC1485 ACD0843 ACC1158 ACA1333 ABB0388 SEM02 SEM07 ABB0423 ABE1663 4014 UHG01 UHM02 ABS1761 ABC0921 ABF0613 3045 ABM1410 ABC1252. Serial numbers CT3PZ: ACA1011 ABD0501 UKH01-Z ADMS01 ADMS02 ADMS03 ADPA01 ADPA02 ABS1353-Z ADPD02 ADPD03 ADPD04 ADPD05 ADPD06 ADPE01 ADPE02 ABM1999 ADPE06 ADPE05 ADPG01 ABP1509 ADPH01 ADPH02 ADPH04 ADPH05 ADPH06 ADPH07 ADPE04 ADPK01 ADPK04 ADPK05 ADPK07 ADPM03 ADPP02 ADSB01 3023 4004 ACD1006 4002-Z ACD1621-Z ADSP01 UHK01-Z ADSS04 ADTE01 ADTG01 ABS1171-Z ADUE01.
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.
US distribution only.
These words name no state.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, 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 Sep 19, 2016.
- FDA classified it on Sep 30, 2016.
- FDA’s Enforcement Report published it on Oct 12, 2016.
- FDA terminated it on Dec 13, 2016.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- New Star Lasers, Inc., of Roseville, CA.
- 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.”
- 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.