FDA Device recall Z-2633-2026
CRE Wireguided 8-10mm 240cm
- FDA Device
- Class II
- ongoing
- Published 2026-07-08
On 2026-07-08 the FDA classified a Class II recall of CRE Wireguided 8-10mm 240cm by Boston Scientific, citing potential sterile breach of the pouches in which devices are packaged.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2633-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-05-21 |
| Published | 2026-07-08 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Boston Scientific |
| Distribution | US |
Product
CRE Wireguided 8-10mm 240cm
Reason
Potential sterile breach of the pouches in which devices are packaged.
Identifiers
| code_info | UPN: M00558460; GTIN: 8714729339397; Lot No. 38064055, 38099717, 38100033, 38100034, 38164759, 38165000, 38165003, 3829…UPN: M00558460; GTIN: 8714729339397; Lot No. 38064055, 38099717, 38100033, 38100034, 38164759, 38165000, 38165003, 38293337, 38293338, 38293339, 38333957, 38347335, 38347336, 38398764, 38398765, 38398766, 38529517, 38552112, 38552113, 38596880, 38680056, 38680057, 38739675; Exp. October 27, 2028 January 31, 2029. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2633-2026%22
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