Cap — Class II medical device recall Z-2127-2019
Terminated recall by Burlington Medical, LLC, reported 2019-08-07, distributed nationwide. The protective material used in the manufacture of the products could potentially provide inadequate protectio
| Recall number | Z-2127-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Burlington Medical, LLC, Newport News, VA, United States |
| Recall initiated | 2019-06-07 |
| Classified | 2019-07-30 |
| Reported by FDA | 2019-08-07 |
| Terminated | 2023-04-28 |
| Distributed | Nationwide (US) |
| Countries outside the US | KR, TH |
| Quantity | 49 |
| Serial numbers | 378503, 378505, 378507, 384253, 385648, 389083, 403879, 403880, 403881, 403882, 404000, 409310, 409316, 409320, 409330, 413884, 414155, 414395, 415418, 417509, 417514, 417515, 418959, 418960, 419567 and 24 more |
| Model numbers | CAP1, CAP2 |
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2127-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.