Thyroid Collar, Buckle Closure, Product Number TS4
Medical device recall Z-2122-2019. Published in FDA’s Enforcement Report on Aug 7, 2019.
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 Aug 7, 2019. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 807 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?
The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter radiation of varying degrees depending on many different variables (e.g., distance, shielding, position, time, kV, etc.). Long-term exposure to scatter radiation may increase the risk of cancer, infertility, or other health-related conditions.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Thyroid Collar, Buckle Closure, Product Number TS4, Part Numbers RBTS4-R, RBTS4-T2T, RETS4-R, RLTS4-R, RLTS4-SEP, RLTS4-T2T, SBTS4-R, SETS4-T2T, SLTS4-R, UETS4-R Product Usage: Products are designed to protect healthcare workers against scatter (secondary) radiation while performing fluoroscopic and radiographic procedures by reducing the amount of radiation reaching the user.
807, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial Numbers: 443646 419128 418103 418484 388010 376800 376806 419076 441180 441183 441186 441113 441181 441139 441136 441130 441131 441135 443748 423654 414987 420870 420877 443626 419123 388250 388245 383021 383032 381507 388123 381663…
Every code shown here, 1,997 characters
Serial Numbers: 443646 419128 418103 418484 388010 376800 376806 419076 441180 441183 441186 441113 441181 441139 441136 441130 441131 441135 443748 423654 414987 420870 420877 443626 419123 388250 388245 383021 383032 381507 388123 381663 381508 376803 440957 440956 440966 433273 433267 440958 433270 414813 414814 414836 414837 414838 384534 388075 378637 414934 418310 418308 418302 418307 418303 383136 420902 424097 418102 418336 378749 409409 409435 381660 419139 383147 383145 419275 419274 418368 433348 408393 408010 408390 408316 409467 383081 388121 419246 424109 414884 408307 408322 408317 408313 408344 408330 408377 388248 378630 378638 378581 440846 433424 440842 441224 408308 408305 409448 408320 408310 408311 408323 408303 408312 408315 408306 408309 408340 408314 419043 383023 419074 431097 414823 424013 443695 443660 440979 443666 443651 443652 443648 443735 414896 419060 415987 415968 415965 415958 409372 415957 409430 409380 383259 414690 420357 378617 378618 383354 388056 378579 376925 388048 383359 384533 388048 376928 383184 419271 388034 419055 388009 414691 414697 414695 420900 420315 420933 385437 376926 376930 378616 440960 419198 419370 419426 417741 418254 419371 433400 433429 433438 441196 433427 441236 443665 433401 431374 443670 433441 433266 433500 429814 378586 384521 388074 422318 383048 420251 419194 378608 431162 443739 433485 418248 418249 383368 419401 420976 383044 383046 378612 419424 419412 414875 383051 422420 441039 414698 419269 419037 379180 419383 440845 417689 417690 441067 441069 443961 443953 441066 443958 441063 441068 414506 417709 417743 424060 415865 427558 440849 417695 419207 419264 384503 419335 419286 383291 383300 383305 383301 383273 383296 420852 420832 420853 420830 420855 418198 420846 420856 420840 420837 418225 420839 408493 408857 408405 408856 443725 419212 384610 419245 419433 388141 388184 388178 388241 388228 378538 383298 383266 383270 383294 383295 388018 388072 383293 383292 383256 383272 378541…
FDA’s list runs to 5,664 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.
US Nationwide distribution. The products were distributed to the following foreign countries: Korea, Thailand.
These words name no state.
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?
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 Jun 7, 2019.
- FDA classified it on Jul 30, 2019.
- FDA’s Enforcement Report published it on Aug 7, 2019.
- FDA terminated it on Apr 28, 2023.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Burlington Medical, LLC, of Newport News, VA.
- 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 5,664 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
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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.