Henry Schein 5702701Recalls & reported problems
Henry Schein, Inc. · Needle Disposable Safety 23Gx1 · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10304040154158), received between Sep 19, 2025 and Sep 19, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Decoupling” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Decoupling1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 19, 2025Decoupling; Decoupling
THE CUSTOMER REPORTS THAT WHEN THE NURSE WAS RECAPPING THE NEEDLE AFTER GIVING A VACCINE THE SAFETY CAP SNAPPED OFF THE DEVICE AS THEY PRESSED IT CLOSED. THE SECOND INCIDENT WAS WHEN THE NURSE HAD JUST DRAWN UP A VACCINE AND WAS IN THE PROCESS OF SWITCHING OUT TO A DIFFERENT NEEDLE BUT WHEN UNSCREWED IT THE SYRINGE SEPARATED FROM THE NEEDLE TUBE/HOLE. THERE ARE NO PHOTOS OF THE BROKEN NEEDLES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23095880 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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