RelayPro Thoracic Stent-Graft System — Class I medical device recall Z-2160-2026
Ongoing recall by Bolton Medical Inc., reported 2026-06-03, distributed in PR. Labeling update concerning proximal clasp disconnection from the outer control tube which may prevent stent gr
| Recall number | Z-2160-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Bolton Medical Inc., Sunrise, FL, United States |
| Recall initiated | 2026-04-22 |
| Classified | 2026-05-22 |
| Reported by FDA | 2026-06-03 |
| Distributed | PR |
| Countries outside the US | AR, CA, CL, CO, GB, MX |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00843576150461, 00843576150478, 00843576150485, 00843576150492, 00843576150508, 00843576150515, 00843576150522, 00843576150539, 00843576150591, 00843576150607, 00843576150614, 00843576150621, 00843576150638, 00843576150645, 00843576150652, 00843576150669, 00843576150720, 00843576150737, 00843576150744, 00843576150751, 00843576150768, 00843576150775, 00843576150782, 00843576150799, 00843576150850 and 24 more |
Product
RelayPro Thoracic Stent-Graft System (various sizes) Reference numbers: 28-N4-32-104-32U 28-N4-32-164-28U 28-N4-32-164-32U 28-N4-32-209-28U 28-N4-32-209-32U 28-N4-32-259-32U 28-N4-34-109-34U 28-N4-34-154-30U 28-N4-34-154-34U 28-N4-34-209-30U 28-N4-34-209-34U 28-N4-34-259-34U 28-N4-36-109-36U 28-N4-36-154-32U 28-N4-36-154-36U 28-N4-36-199-32U 28-N4-36-199-36U 28-N4-36-259-36U 28-N4-38-109-38U 28-N4-38-154-34U 28-N4-38-154-38U 28-N4-38-199-34U 28-N4-38-199-38U 28-N4-38-259-38U 28-N4-40-114-40U 28-N4-40-154-36U 28-N4-40-154-40U 28-N4-40-204-36U 28-N4-40-204-40U 28-N4-40-259-40U 28-N4-42-114-42U 28-N4-42-159-38U 28-N4-42-159-42U 28-N4-42-204-38U 28-N4-42-204-42U 28-N4-42-259-42U 28-N4-44-114-44U 28-N4-44-164-40U 28-N4-44-164-44U 28-N4-44-209-40U 28-N4-44-209-44U 28-N4-44-259-40U 28-N4-44-259-44U 28-N4-46-114-46U 28-N4-46-164-42U 28-N4-46-164-46U 28-N4-46-209-42U 28-N4-46-209-46U 28-N4-46-259-42U
Reason for recall
Labeling update concerning proximal clasp disconnection from the outer control tube which may prevent stent graft from being released from the delivery system.
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-2160-2026. 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.