BD Oral Syringe 305207Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 30382903052074), received between Jun 21, 2024 and Feb 18, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Volume Accuracy Problem” (4 reports).

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 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 18, 2026Volume Accuracy Problem

  IT WAS REPORTED THAT BD SYRINGE ORAL 1ML AMBER DEMONSTRATED A VOLUMETRIC ACCURACY ISSUE. IT WAS REPORTED THAT DURING THE VISUAL INSPECTION PRIOR TO THE SECONDARY PACKAGING PROCESS AT CKK CMO FOR JAPAN MARKET, THE FOLLOWING APPEARANCE DEFECTIONS WERE DETECTED. 7.5 MG NUMBER OF UNITS INSPECTED: (B)(4). ACCEPTABLE UNITS: (B)(4); DEFECTIVE UNITS: (B)(4). SYRINGE PRINTING DEFECTS: 3; PLUNGER RUBBER STOPPER DEFECT: 1. 10 MG NUMBER OF UNITS INSPECTED: (B)(4) ACCEPTABLE UNITS: (B)(4); DEFECTIVE UNITS:(B)(4) SYRINGE PRINTING DEFECTS: 2; PLUNGER RUBBER STOPPER DEFECT: 1 INNER SURFACE CONTAMINATION OR FOREIGN MATTER: 2 2.5 MG NUMBER OF UNITS INSPECTED: (B)(4). ACCEPTABLE UNITS: (B)(4); DEFECTIVE UNITS: (B)(4). SYRINGE PRINTING DEFECTS: 2; BELOW THE LOWER LIMIT OF FILL VOLUME: 3. 5 MG NUMBER OF UNITS INSPECTED: (B)(4) ACCEPTABLE UNITS: (B)(4); DEFECTIVE UNIT: (B)(4). PLUNGER RUBBER STOPPER DEFECT: 1.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24383075 ↗
• MalfunctionDec 29, 2024Labelling, Instructions for Use or Training Problem; Volume Accuracy Problem; Labelling, Instructions for Use or Training Problem; Volume Accuracy Problem

  IT WAS REPORTED THAT THE BD SYRINGE ORAL 3ML AMBER HAD A SCALE MARKING ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER TRANSLATED FROM FRENCH TO ENGLISH: - SYRINGE FOR ORAL ADMINISTRATION, 3 ML AMBER CAP, REF: 305210, LOT: 4075022. WE HAVE NOTED THAT THE GRADUATIONS ON THE SYRINGES HAVE FADED. THE SYRINGES HAVE BEEN HANDLED ONLY ONCE, LEAVING BLACK MARKS ON THE HANDS. THESE SYRINGES ARE CURRENTLY BEING USED IN A CLINICAL TRIAL EVALUATING CANNABIDIOL IN ALCOHOL DEPENDENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21032715 ↗
• MalfunctionDec 29, 2024Volume Accuracy Problem; Volume Accuracy Problem

  IT WAS REPORTED THAT THE BD SYRINGE ORAL 1ML AMBER HAD A SCALE MARKING ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER TRANSLATED FROM FRENCH TO ENGLISH: SYRINGE FOR ORAL ADMINISTRATION, 1 ML AMBER WITH CAP, REF: (B)(4), LOT: 3349173 WE HAVE NOTED THAT THE GRADUATIONS ON THE SYRINGES HAVE FADED. THE SYRINGES HAVE BEEN HANDLED ONLY ONCE, LEAVING BLACK MARKS ON THE HANDS. THESE SYRINGES ARE CURRENTLY BEING USED IN A CLINICAL TRIAL EVALUATING CANNABIDIOL IN ALCOHOL DEPENDENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21032714 ↗
• MalfunctionAug 27, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem

  MATERIAL #:305207 BATCH#:UNKNOWN IT WAS REPORTED THAT THE BD SYRINGE ORAL 1ML AMBER LABEL CONTENT WAS INCORRECT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. GTIN / UDI PACKAGING INFORMATION INCORRECT IN GUDID FOR (B)(4) (BD 305207).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20081095 ↗
• MalfunctionJun 21, 2024Volume Accuracy Problem; Volume Accuracy Problem

  NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 19582109 ↗