FDA Device recall Z-1683-2026
CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: SCPX-107MH, SCPX-117MH,SCPX-127MH, SCPX-135MH, SCPX-146MH, SCPX-156MH…
- FDA Device
- Class II
- ongoing
- Published 2026-04-08
On 2026-04-08 the FDA classified a Class II recall of CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: SCPX-107MH, SCPX-117MH,SCPX-127MH, SCPX-135MH, SCPX-146MH, SCPX-156MH… by Mentor Texas, citing infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1683-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-02-18 |
| Published | 2026-04-08 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Mentor Texas |
| Distribution | US |
Product
CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: SCPX-107MH, SCPX-117MH,SCPX-127MH, SCPX-135MH, SCPX-146MH, SCPX-156MH Smooth Medium Height Tissue Expander, 275cc, 350cc, 450cc, 550cc, 650cc, 800cc
Reason
Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.
Identifiers
| code_info | 10081317028359 10081317028366 10081317028373 10081317028380 10081317028397 10081317028403 |
|---|
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-1683-2026%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.