FDA Device recall Z-0998-2023
RELAY PRO, THORACIC STENT-GRAFT SYSTEM, REF 28-N4-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-N4-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-0998-2023 |
| 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-N4-XX-XXX-XXX
Reason
The product may be shorter than packaging indicates
Identifiers
| code_info | UDIUDI/DI 00843576100954, REF 28-N4-22-159-22S, Lot Numbers: B210719245, B210619174; UDI/DI 00843576100831, REF 28-N4…UDIUDI/DI 00843576100954, REF 28-N4-22-159-22S, Lot Numbers: B210719245, B210619174; UDI/DI 00843576100831, REF 28-N4-24-099-24S, Lot Numbers: B220323028, B211222140; UDI/DI 00843576150423, REF 28-N4-24-099-24U, Lot Numbers: 2204210157, 2204210158, 2208230256, 2208250035; UDI/DI 00843576100961, REF 28-N4-24-159-24S, Lot Numbers: B220104035, B220824113, B210612293, B220201173; UDI/DI 00843576150553, REF 28-N4-24-159-24U, Lot Numbers: 2202090215, 2202090293; UDI/DI 00843576101227, REF 28-N4-24-259-24S, Lot Numbers: B220210257, B220210257; UDI/DI 00843576150812, REF 28-N4-24-259-24U, Lot Numbers: 2210110048, 2210110049, 2210100193; UDI/DI 00843576100848, REF 28-N4-26-104-26S, Lot Numbers: B220226088, B220414055; UDI/DI 00843576150430, REF 28-N4-26-104-26U, Lot Numbers: 2110070047, 2202020135, 2202010164, 2112210201, 2202120154, 2202260085, 2204140202; UDI/DI 00843576100978, REF 28-N4-26-164-26S, Lot Numbers: B220316171, B210927313, B210602367, B220303176, B22031 |
|---|
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-0998-2023%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.