RELAY PRO — Class II medical device recall Z-0997-2023
Ongoing recall by Bolton Medical Inc., reported 2023-01-25, distributed nationwide. The product may be shorter than packaging indicates
| Recall number | Z-0997-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Bolton Medical Inc., Sunrise, FL, United States |
| Recall initiated | 2022-12-20 |
| Classified | 2023-01-19 |
| Reported by FDA | 2023-01-25 |
| Distributed | Nationwide (US) |
| Countries outside the US | CL, CN, DE, FR, GB, IT, JP, NL |
| Quantity | 129 units |
| UPC / GTIN / UDI-DI | 00843576100039, 00843576100046, 00843576100053, 00843576100077, 00843576100084, 00843576100091, 00843576100121, 00843576100169, 00843576100176, 00843576100183, 00843576100190, 00843576100206, 00843576100213, 00843576100268, 00843576100305, 00843576100329, 00843576100350, 00843576100374, 00843576100381, 00843576100473, 00843576100510, 00843576100541, 00843576100558, 00843576100589, 00843576100596 and 47 more |
| Lot numbers | 2109100260, 2109140012, 2109150299, 2109150326, 2110120002, 2110120025, 2110120028, 2112110191, 2112130139, 2112140029, 2112180035, 2112210189, 2112280069, 2201170418, 2201170430, 2201280546, 2202010127, 2202030116, 2202030119, 2202070140, 2202080066, 2202100029, 2202100215, 2202100265, 2202110370, 2202120100, 2202150279, 2202160194, 2202160200, 2202170219, 2202170235, 2202170278, 2202170286, 2202260090, 2203010243, 2203030290, 2203080218, 2204140072, 2204200130, 2204210015 and 84 more |
| Model numbers | 28-M4-22-190-22S, 28-M4-24-150-24U, 28-M4-26-095-26U, 28-M4-26-155-26U, 28-M4-28-095-28S, 28-M4-28-095-28U, 28-M4-28-155-24U, 28-M4-28-155-28S, 28-M4-28-155-28U, 28-M4-28-195-24U, 28-M4-28-195-28U, 28-M4-28-250-24U, 28-M4-28-250-28U, 28-M4-30-095-30S, 28-M4-30-095-30U, 28-M4-30-155-26U, 28-M4-30-155-30S, 28-M4-30-155-30U, 28-M4-30-200-26S, 28-M4-30-200-30S, 28-M4-30-250-26S, 28-M4-30-250-30U, 28-M4-32-095-32S, 28-M4-32-155-28S, 28-M4-32-155-32S and 48 more |
Product
RELAY PRO, THORACIC STENT-GRAFT SYSTEM, REF 28-M4-XX-XXX-XXX
Reason for recall
The product may be shorter than packaging indicates
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-0997-2023. 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.