FDA Medical Device Recalls (openFDA)
Burlington Medical, LLC: Sleeve, Product Number Sleeve, Part Numbers RESL, SL 3 L, SL 3 M, SL 3 S, L 3 X, SL 3 XS, UESL 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-2123-2019
- Recalling firm
- Burlington Medical, LLC
- Product
- Sleeve, Product Number Sleeve, Part Numbers RESL, SL 3 L, SL 3 M, SL 3 S, L 3 X, SL 3 XS, UESL 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
- 39
- Distribution
- US Nationwide distribution. The products were distributed to the following foreign countries: Korea, Thailand.
- Lot, serial or model codes
- Serial Numbers: 444749 418756 418757 408712 388138 388139 407957 339006 419340 391212 381909 381862 391205 414767 419574 419561 419562 419190 419189 391214 443199 418796 350481 407814 407813 443198 443200 443201 443197 391203 381803 379683 419191 419192 419107 383262 383261 387157 387158
- 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