FDA Medical Device Recalls (openFDA)
Burlington Medical, LLC: 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.
- Recall number
- Z-2127-2019
- 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.
- Status
- Terminated
- Initiated
- 2019-06-07
- Posted
- 2019-07-30
- Terminated
- 2023-04-28
- Reason
- 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
- 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
- 49
- Distribution
- US Nationwide distribution. The products were distributed to the following foreign countries: Korea, Thailand.
- Lot, serial or model codes
- 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
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- EAJ
- Firm FEI
- 1000120804
- Firm city
- Newport News
- Firm state
- VA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28