FDA Device recall Z-2632-2026
CRE Wireguided 6-8mm 240cm
- FDA Device
- Class II
- ongoing
- Published 2026-07-08
On 2026-07-08 the FDA classified a Class II recall of CRE Wireguided 6-8mm 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-2632-2026 |
| 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 6-8mm 240cm
Reason
Potential sterile breach of the pouches in which devices are packaged.
Identifiers
| code_info | UPN: M00558450; GTIN: 8714729339380; Lot No. 38064056, 38064057, 38200574, 38200575, 38204501, 38204504, 38204506, 3820…UPN: M00558450; GTIN: 8714729339380; Lot No. 38064056, 38064057, 38200574, 38200575, 38204501, 38204504, 38204506, 38204508, 38628161, 38640993, 38767490, 38904960, 38904961, 38946757, 38946758, 38946759; Exp. October 27, 2028 February 24, 2029. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
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FDA Device · Class II · 2026-09-09 · Boston Scientific
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2632-2026%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.