CLASS II Device recall · Reported 7 Aug 2019 · FDA Enforcement Report

Thyroid Collar, Magnetic Closure, Product Number TS5 recalled

Burlington Medical is recalling Thyroid Collar, Magnetic Closure, Product Number TS5, Part Numbers RBTS5-R, RBTS5-T2T, distributed nationwide in the US. The recall was initiated on 7 Jun 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSerial 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

Quantity recalled210

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2119-2019
FDA event ID: 83144
Recalling firm: Burlington Medical, Newport News, VA
Classification: Class II
Status: Terminated
Recall initiated: 7 Jun 2019
FDA classified: 30 Jul 2019
Reported: 7 Aug 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Imaging Equipment

Timeline

7 Jun 2019	Recall initiated by company
30 Jul 2019	Classified by FDA	+53 days
7 Aug 2019	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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.

Product as listed by the FDA

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.

Where it was distributed

US Nationwide distribution. The products were distributed to the following foreign countries: Korea, Thailand.

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

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

Where was it sold?

US Nationwide distribution. The products were distributed to the following foreign countries: Korea, Thailand.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

23 other products · FDA event 83144

This product is part of a recall event; the main page for the event is Frontal Apron with Quick Drop Velcro Closure (no elastic) recalled.

Reported	Class	Recall	Company	Reason	Where
7 Aug 2019	CLASS II	Frontal Apron with Quick Drop Velcro Closure (no elastic) recalled	Burlington Medical	Other	Nationwide
7 Aug 2019	CLASS II	Hood, Product Number Hood, Part Numbers HOOD1, HOOD2 recalled	Burlington Medical	Other	Nationwide
7 Aug 2019	CLASS II	Frontal Apron Velcro Closure, Product Number F recalled	Burlington Medical	Other	Nationwide
7 Aug 2019	CLASS II	Frontal Support Belt Apron, Product Number F recalled	Burlington Medical	Other	Nationwide
7 Aug 2019	CLASS II	Overlap Vest, Single recalled by Burlington Medical	Burlington Medical	Other	Nationwide
7 Aug 2019	CLASS II	Vest, Single recalled by Burlington Medical	Burlington Medical	Other	Nationwide
7 Aug 2019	CLASS II	2 pc Full Overlap Vest & Kilt, Single recalled by Burlington Medical	Burlington Medical	Other	Nationwide
7 Aug 2019	CLASS II	Front/Back Apron with Stretch Velcro Closure recalled	Burlington Medical	Other	Nationwide
7 Aug 2019	CLASS II	2 pc Full Wrap Vest & Kilt, Product Number VK recalled	Burlington Medical	Other	Nationwide
7 Aug 2019	CLASS II	Kilt, Single recalled by Burlington Medical	Burlington Medical	Other	Nationwide
7 Aug 2019	CLASS II	Sleeve, Product Number Sleeve, Part Numbers Resl, SL recalled	Burlington Medical	Other	Nationwide
7 Aug 2019	CLASS II	Thyroid Collar, Buckle Closure, Product Number TS4 recalled	Burlington Medical	Other	Nationwide
7 Aug 2019	CLASS II	Thyroid Collar Oversize, Product Number TS3 recalled	Burlington Medical	Other	Nationwide
7 Aug 2019	CLASS II	2 pc Full Wrap Vest & Kilt Back-Saver , Product Number Pvk recalled	Burlington Medical	Other	Nationwide
7 Aug 2019	CLASS II	Porta Shield, Product Number Porta Shield recalled by Burlington Medical	Burlington Medical	Other	Nationwide
7 Aug 2019	CLASS II	Frontal Quick Drop OR Apron, Product Number recalled	Burlington Medical	Other	Nationwide
7 Aug 2019	CLASS II	Half Apron, Product Number Half Apron, Part Numbers Rehalf*, REHALF3 recalled	Burlington Medical	Other	Nationwide
7 Aug 2019	CLASS II	Cap, Product Number Cap, Part Numbers CAP1, CAP2 recalled	Burlington Medical	Other	Nationwide
7 Aug 2019	CLASS II	Peak Vest, Single recalled by Burlington Medical	Burlington Medical	Other	Nationwide
7 Aug 2019	CLASS II	1 pc Full Wrap Support Belt Apron, Product Number F111 recalled	Burlington Medical	Other	Nationwide
7 Aug 2019	CLASS II	Thyroid Collar, Velcro Closure, Product Number TS2 recalled	Burlington Medical	Other	Nationwide
7 Aug 2019	CLASS II	Frontal Stretch Buckle Closure Apron, Product Number recalled	Burlington Medical	Other	Nationwide
7 Aug 2019	CLASS II	1 pc Full Wrap Back Relief Apron recalled by Burlington Medical	Burlington Medical	Other	Nationwide

More recalls from Burlington Medical

All 37

Reported	Class	Recall	Company	Reason	Where
8 Apr 2026Device	CLASS II	BAT (Breast, Axilla and Thyroid) Coverage recalled by Burlington Medical	Burlington Medical	Potency & Assay	Nationwide
8 Apr 2026Device	CLASS II	Burlington Medical, Kilt recalled	Burlington Medical	Potency & Assay	Nationwide
8 Apr 2026Device	CLASS II	Burlington Medical, Caps recalled	Burlington Medical	Potency & Assay	Nationwide
8 Apr 2026Device	CLASS II	Thyroid Shield recalled by Burlington Medical	Burlington Medical	Potency & Assay	Nationwide
8 Apr 2026Device	CLASS II	Burlington Medical, Blockers recalled	Burlington Medical	Potency & Assay	Nationwide

Other Imaging Equipment recalls

All 2,336

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Device	CLASS II	Medline Convenience Kits containing BD ChloraPrep Clear recalled	Medline Industries	Packaging Defects	Nationwide
9 Sep 2026Device	CLASS II	Medline Convenience Kits: Ultrasound Breast Pack recalled	Medline Industries	Sterility	Nationwide
2 Sep 2026Device	CLASS II	Alphenix Models Infx-8000C Infx-8000F Infx-8000V This device recalled	Canon Medical System USA	Other	Nationwide
2 Sep 2026Device	CLASS II	Merge PACS and Merge OrthoPACS recalled by Merge Healthcare	Merge Healthcare	Labeling Errors	Nationwide
19 Aug 2026Device	CLASS II	Philips Azurion recalled by Philips Medical Systems	Philips Medical Systems Nederl	Potency & Assay