The FDA has posted 10 enforcement recalls of tissue expander and accessories devices since 2025, none of them Class I (most serious). Most recent report: Apr 8, 2026.
Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.
Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.
Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.
Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.
Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.
Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.
Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.
The potential for the needle tip to be dull/blunt, difficult to advance, and/or break.
The potential for the needle tip to be dull/blunt, difficult to advance, and/or break.
The potential for the needle tip to be dull/blunt, difficult to advance, and/or break.
Source: U.S. FDA openFDA device enforcement reports, updated continuously. Device type per the FDA's RES classification (“Tissue Expander And Accessories”). Informational only — verify against the FDA before acting.