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AlloX2 Tissue Expander

Sientra, Inc. · Model AlloX2-12SE · UDI-DI 00812790028313

LCJ Prescription

510(k) clearances

5,147

Adverse events (4 deaths)

Recalls

Facilities

Description

Tissue Expander, Smooth Surface, Integrated Ports, Mid Height, 225-280 cc

Recalls

Date	Firm	Reason
2026-02-18	Mentor Texas, LP.	Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.
2026-02-18	Mentor Texas, LP.	Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.
2026-02-18	Mentor Texas, LP.	Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.
2026-02-18	Mentor Texas, LP.	Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.
2026-02-18	Mentor Texas, LP.	Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.
2026-02-18	Mentor Texas, LP.	Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.
2026-02-18	Mentor Texas, LP.	Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.
2026-02-02	B Braun Medical Inc	The potential for the needle tip to be dull/blunt, difficult to advance, and/or break.
2026-02-02	B Braun Medical Inc	The potential for the needle tip to be dull/blunt, difficult to advance, and/or break.
2026-02-02	B Braun Medical Inc	The potential for the needle tip to be dull/blunt, difficult to advance, and/or break.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.