FDA Device recall Z-0997-2023
RELAY PRO, THORACIC STENT-GRAFT SYSTEM, REF 28-M4-XX-XXX-XXX
- FDA Device
- Class II
- ongoing
- Published 2023-01-25
On 2023-01-25 the FDA classified a Class II recall of RELAY PRO, THORACIC STENT-GRAFT SYSTEM, REF 28-M4-XX-XXX-XXX by Bolton Medical, citing the product may be shorter than packaging indicates.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0997-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-12-20 |
| Published | 2023-01-25 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Bolton Medical |
| Distribution | US |
Product
RELAY PRO, THORACIC STENT-GRAFT SYSTEM, REF 28-M4-XX-XXX-XXX
Reason
The product may be shorter than packaging indicates
Identifiers
| code_info | UDI/DI 00843576100268: REF 28-M4-22-190-22S, Lot Numbers: B210925203 UDI/DI 00843576149731, REF 28-M4-24-150-24U, Lot…UDI/DI 00843576100268: REF 28-M4-22-190-22S, Lot Numbers: B210925203 UDI/DI 00843576149731, REF 28-M4-24-150-24U, Lot Numbers: 2204210015, 2208250004, 2208250003; UDI/DI 00843576149618, REF 28-M4-26-095-26U, Lot Numbers: 2112210189; UDI/DI 00843576149748, REF 28-M4-26-155-26U, Lot Numbers: 2208240053, 2208250164, 2208220204; UDI/DI 00843576100039, REF 28-M4-28-095-28S, Lot Numbers: B220211367, B220129307, B220211163; UDI/DI 00843576149625, REF 28-M4-28-095-28U, Lot Numbers: 2208220081; UDI/DI 00843576150119, REF 28-M4-28-155-24U, Lot Numbers: 2210110060, 2202150279, 2202150279; UDI/DI 00843576100169, REF 28-M4-28-155-28S, Lot Numbers: B220209262; UDI/DI 00843576149755, REF 28-M4-28-155-28U, Lot Numbers: 2208240183; UDI/DI 00843576150218, REF 28-M4-28-195-24U, Lot Numbers: 2202030119; UDI/DI 00843576149885, REF 28-M4-28-195-28U, Lot Numbers: 2109150299; UDI/DI 00843576150317, REF 28-M4-28-250-24U, Lot Numbers: 2202100029; UDI/DI 00843576150010, REF 28-M4-28-250-28U |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0997-2023%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.