FDA Device Intelligence
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Tissue Expander And Accessories

FDA product code LCJ · Class U · Unknown

2,298
Registered devices
5,205
Adverse events
21
Recalls
55
510(k) clearances

Devices with this code

INTEGRA® — PMT CORPORATIONINTEGRA® — PMT CORPORATIONSoftspan Tissue Expander — Sientra, Inc.INTEGRA® — PMT CORPORATIONMENTOR CPX 3 Breast Tissue Expander with Suturing Tabs — MENTOR TEXAS L.P.INTEGRA — PMT CORPORATIONNatrelle 133 Plus Tissue Expanders — Allergan, Inc.INTEGRA® — PMT CORPORATIONINTEGRA® — PMT CORPORATIONSoftspan Tissue Expander — Sientra, Inc.Natrelle® Style 133 Tissue Expanders — Allergan, Inc.Integra — PMT CORPORATIONINTEGRA® — PMT CORPORATIONSoftspan Tissue Expander — Sientra, Inc.INTEGRA® — PMT CORPORATIONAlloX2 Tissue Expander — SPECIALTY SURGICAL PRODUCTS INCINTEGRA® — PMT CORPORATIONINTEGRA® — PMT CORPORATIONINTEGRA® — PMT CORPORATIONMentor CPX4 with suture tabs, med height, smooth — MENTOR TEXAS L.P.Softspan Tissue Expander — Sientra, Inc.Softspan Tissue Expander — Sientra, Inc.Natrelle 133S Tissue Expanders — Allergan, Inc.INTEGRA® — PMT CORPORATION

Recent recalls

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

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.