Henry Schein 5701401Recalls & reported problems
Henry Schein, Inc. · Dental syringe Luer Lock 12 cc Non sterile · Class 1
- 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 10304040108762), received between Apr 14, 2024 and Apr 14, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Insufficient Device Problem Information1
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.
MalfunctionApr 14, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
THE CUSTOMER REPORT THAT THE SYRINGE IS LEAKING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19102904 ↗
Other SYRINGE, PERIODONTIC, ENDODONTIC, IRRIGATING devices
- VDW Eddy Flexcanula 21419Produits dentaires S.A. · Syringe, Periodontic, Endodontic, Irrigating55 reports
- Maxi-probe Irrigation Needle MAXP301TTulsa Dental Products LLC · SYRINGE, PERIODONTIC, ENDODONTIC, IRRIGATING9 reports
- Henry Schein 5701403Henry Schein, Inc. · SYRINGE, PERIODONTIC, ENDODONTIC, IRRIGATING1 report
- Monoject 1180327114ECardinal Health, Inc. · SYRINGE, PERIODONTIC, ENDODONTIC, IRRIGATING1 report
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.