The FDA has posted 6 enforcement recalls of single lumen hypodermic needle devices since 2025, including 1 Class I (most serious) recall. Most recent report: Sep 23, 2026.
Retrospectively reported: Pen needles labeled 'For Investigational Use Only' were inadvertently distributed as commercially marketed devices.
Retrospectively reported: Pen needles labeled 'For Investigational Use Only' were inadvertently distributed as commercially marketed devices.
After placement of intraosseous (IO) needle sets, used when intravenous access is difficult or impossible to obtain in emergent, urgent, or medically necessary cases, users may experience difficulty/inability to remove o…
Due to manufacturing error, Intraosseous device built-in stabilizer may not be released properly after deployment and insertion.
Due to manufacturing error, Intraosseous device built-in stabilizer may not be released properly after deployment and insertion.
The VACUETTE SAFELINK Holder with male luer lock may leak blood due to the protective rubber sleeve bunching up and not retracting when using the device.
Source: U.S. FDA openFDA device enforcement reports, updated continuously. Device type per the FDA's RES classification (“Needle, Hypodermic, Single Lumen”). Informational only — verify against the FDA before acting.