Thyroid Collar, Magnetic Closure, Product Number TS5
Medical device recall Z-2119-2019. 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
- 210 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, Magnetic Closure, Product Number TS5, Part Numbers RBTS5-R, RBTS5-T2T, RLTS5-R, RLTS5-T2T, SLTS5-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.
210, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial Numbers: 419121 443916 408275 419300 419026 418172 418354 418174 418350 418362 418357 414627 418364 418363 418176 418358 418353 418352 418351 418349 418355 418359 418171 418175 418356 379202 418360 383132 414631 419298 408499 408495…
Every code shown here, 1,485 characters
Serial Numbers: 419121 443916 408275 419300 419026 418172 418354 418174 418350 418362 418357 414627 418364 418363 418176 418358 418353 418352 418351 418349 418355 418359 418171 418175 418356 379202 418360 383132 414631 419298 408499 408495 429803 408423 408355 383130 424076 378575 378519 427547 419022 419028 419021 383160 414632 408413 408277 419024 383332 376923 378521 378520 383131 379205 419116 415973 409388 409389 408429 408418 422377 379201 379207 409387 409390 379199 414630 414629 418345 418361 418344 418438 418431 418177 443920 440828 433315 379161 379213 414834 441233 443685 407663 408415 408426 408425 408424 433368 441226 408496 418346 443682 433337 418407 383348 383347 414625 422460 414624 414635 383158 419379 419120 408416 418405 419377 383349 419375 383129 383126 419380 414831 414626 424075 383263 414634 383062 414633 379162 379227 379224 408278 441210 418410 383157 419299 408500 409998 418182 419378 388168 419025 420496 379203 379200 440827 441231 409999 383155 383156 383128 383127 419111 388169 378522 383133 383125 383350 419056 419027 433360 383161 414835 388171 440824 433311 441125 427541 443683 443674 441198 441055 415974 431461 408279 408276 418452 418448 441197 418180 424963 419374 433312 408422 379225 419118 419297 414832 408280 379206 441232 443676 418181 383162 414833 422374 418178 443675 441227 443677 443678 433316 443671 408383 418348 418347 383061 443684 419023 419376 419117 379226 379214 418450 440880 407618 378574 378577 378576 415000
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.”
- 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.