Burlington Medical — Class II medical device recall Z-1756-2026
Ongoing recall by Burlington Medical, LLC, reported 2026-04-08, distributed nationwide. Potential for attenuation degradation over time, decreasing the lifespan.
| Recall number | Z-1756-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Burlington Medical, LLC, Newport News, VA, United States |
| Recall initiated | 2026-02-11 |
| Classified | 2026-04-02 |
| Reported by FDA | 2026-04-08 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BD, CA, CL, HK, IN, MX, MY, PA, SG, TH, TW, UY, VN |
| Quantity | 14,323 |
| Reason classes | specification failure |
| UPC / GTIN / UDI-DI | 00197513001270, 00197513001287, 00840331258400, 00840331258417, 00840331258448, 00840331258455, 00840331258462, 00840331258479, 00840331258486, 00840331258493, 00840331258509, 00840331258516, 00840331258523, 00840331258578, 00840331258608, 00840331258615, 00840331258622, 00840331258639, 00840331258646, 00840331258653, 00840331258660, 00840331258677, 00840331258684, 00840331258691, 00840331258707 and 121 more |
| Model numbers | C8F17, R8601, R8A10, R8F01, R8F17, R8P500, S8601, S8A10, S8F01, S8F17, U8601, U8A10, U8F01, U8F17 |
Product
Burlington Medical, Frontal Aprons
Reason for recall
Potential for attenuation degradation over time, decreasing the lifespan.
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-1756-2026. 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.