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

Cap, Product Number Cap, Part Numbers CAP1, CAP2 recalled

Burlington Medical is recalling Cap, Product Number Cap, Part Numbers CAP1, CAP2, 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: 389083 423885 413884 417509 384253 378507 378503 378505 418959 418960 423897 423899 423893 423895 414395 419567 417515 417514 420508 385648 414155 420509 415418 420507 420501 409316 409320 409330 403879 403880 403882 403881 409310 404000 441028 441030 441022 441031 441027 442251 443572 441025 441024 443579 443574 431256 443575 431517 443573

Quantity recalled49

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-2127-2019
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

Cap, Product Number Cap, Part Numbers CAP1, CAP2 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: 389083 423885 413884 417509 384253 378507 378503 378505 418959 418960 423897 423899 423893 423895 414395 419567 417515 417514 420508 385648 414155 420509 415418 420507 420501 409316 409320 409330 403879 403880 403882 403881 409310 404000 441028 441030 441022 441031 441027 442251 443572 441025 441024 443579 443574 431256 443575 431517 443573

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	Thyroid Collar, Magnetic Closure, Product Number TS5 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	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

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19 Aug 2026Device	CLASS II	Philips Azurion recalled by Philips Medical Systems	Philips Medical Systems Nederl	Potency & Assay