Thyroid Collar, Velcro Closure, Product Number TS2
Medical device recall Z-2121-2019. 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
- 2190 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, Velcro Closure, Product Number TS2, Part Numbers RBTS2-R, RETS2-R, RLTS2PED, RLTS2-R, RLTS2-SEP, RLTS2-T2T, SBTS2-R, SETS2-R, SLTS2-R, UETS2-R, UETS2-SEP, ULTS2-R, ULTS2-SEP 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.
2190, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial Numbers: 408295 388081 419292 419288 418098 418451 441111 441126 418276 414683 433375 418402 419210 376932 419356 424063 414941 418090 420827 420829 420824 418406 420882 422416 415855 408485 441114 441112 419019 378626 378642 419081…
Every code shown here, 1,997 characters
Serial Numbers: 408295 388081 419292 419288 418098 418451 441111 441126 418276 414683 433375 418402 419210 376932 419356 424063 414941 418090 420827 420829 420824 418406 420882 422416 415855 408485 441114 441112 419019 378626 378642 419081 419342 419344 419345 406104 383177 383182 409423 408465 408432 408461 378560 414902 443732 433389 433390 433392 433326 433320 433324 433391 433377 433321 433318 443669 443728 443729 419064 418395 376802 378694 443934 440968 440887 388190 383019 383020 388027 409498 414539 414548 418201 418203 414938 420897 441203 414742 414686 414682 414681 414688 418295 386771 419253 420444 420446 420480 385447 419110 414981 419156 419115 419112 419157 385452 383166 383096 383097 383098 414748 388142 388146 388147 388150 417737 417736 418087 420316 409473 383106 383134 383135 418292 388059 422336 384664 384734 384733 384740 384679 383379 383152 383146 407620 408327 408328 428304 419338 388124 383150 387990 420289 383163 408388 408440 409495 414942 414943 420405 443738 414549 414553 378600 378603 378596 378606 378604 378598 378597 378599 378605 388039 418495 440830 414614 414615 414613 414620 414621 414619 414616 414622 414618 414617 440885 376801 376796 408382 407623 378639 424045 378264 378569 379216 378584 388051 384514 384513 378683 379217 384530 378682 378685 383011 379218 378678 378687 383009 384529 388049 378686 378679 378680 414808 440894 419012 419070 388035 378627 378635 378532 424006 385446 440853 414899 376858 419231 414879 383307 420305 414821 443878 441205 419399 455153 455155 433382 414906 419312 424072 408325 433352 441164 433385 419422 419418 385502 419421 418100 433269 441116 441190 441207 414798 388152 419096 419013 419089 440848 388189 419126 414501 383056 383058 383059 383057 441097 414998 419385 379231 378692 378700 383366 383356 383380 383370 441064 443957 441060 443962 414824 383406 414819 420363 376929 379238 379236 408352 408347 378585 378614 419425 408419 408372 378528 408350 441040 414696 415933 433384 414967 414986…
FDA’s list runs to 15,344 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 15,344 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.