Z-2127-2019Class II

Cap, Product Number Cap, Part Numbers CAP1, CAP2

Name: Z-2127-2019 Cap, Product Number Cap, Part Numbers CAP1, CAP2
Creator: Burlington Medical, LLC
Published: 2019-06-07
License: https://open.fda.gov/license/

Burlington Medical LLC / initiated 2019-06-07 / Terminated / root cause: manufacturing process

FDA source

Burlington Medical, LLC began a recall of Cap, Product Number Cap, Part Numbers CAP1, CAP2 Product Usage: Products are designed to protect healthcare workers against scatter (secondary) radiation while... on 2019-06-07. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2127-2019
Classification: Class II
Status: Terminated
Initiated: 2019-06-07
Posted: 2019-07-30
Terminated: 2023-04-28
Recalling firm: Burlington Medical LLC
Product: 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.
Product code: EAJ Apron, Leaded
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.
Root cause tag: manufacturing process
FDA root cause: Under Investigation by firm
Action: Urgent Medical Device Recall notification letters were sent to customers on 6/7/19. Please take the following actions: Cease using recalled products immediately, quarantine the products, and prepare the products for return shipment to Burlington Medical. Contact Burlington Medical at (800) 221-3466 for specific return instructions. Note that Burlington Medical Customer Care will work with you to facilitate the return of recalled products, including by issuing you a Recall Tracking number. Burlington Medical will replace all recalled products at no cost to you. The replacement product will be the same size and model as the recalled product; if the same size and model is not available or has been discontinued, then Burlington Medical will replace the recalled product with a Burlington Medical product that is similar to the recalled product. Our Customer Care team will arrange for free shipment of the replacement product. If you have any questions, please call your Burlington Medical representative or Burlington Medical Customer Care at (800) 221-3466. The recall was expanded an additional Urgent Medical Device Recall notification letters were sent to customers on 7/3/19.
Quantity in commerce: 49
Distribution: US Nationwide distribution. The products were distributed to the following foreign countries: Korea, Thailand.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2127-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2107-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-07	2019-07-30
Z-2108-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-07	2019-07-30
Z-2109-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-07	2019-07-30
Z-2110-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-07	2019-07-30
Z-2111-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-07	2019-07-30
Z-2112-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-07	2019-07-30
Z-2113-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-07	2019-07-30
Z-2114-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-07	2019-07-30
Z-2115-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-07	2019-07-30
Z-2116-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-07	2019-07-30
Z-2117-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-07	2019-07-30
Z-2118-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-07	2019-07-30
Z-2119-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-07	2019-07-30
Z-2120-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-07	2019-07-30
Z-2121-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-07	2019-07-30
Z-2122-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-07	2019-07-30
Z-2123-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-07	2019-07-30
Z-2124-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-07	2019-07-30
Z-2125-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-07	2019-07-30
Z-2126-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-07	2019-07-30
Z-2127-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-07	2019-07-30
Z-2128-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-07	2019-07-30
Z-2129-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-07	2019-07-30
Z-2130-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-07	2019-07-30

Product code EAJ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)