BD Ultra-FineRecalls & reported problems across all models
Becton, Dickinson and Company Inc · 9 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1,383
- Deaths reported
- 0
- Injuries reported
- 32
- Recalls
- 0
We found 9 models of BD Ultra-Fine by Becton, Dickinson and Company Inc in the FDA's device registry (GUDID). Together they are named in 1,383 adverse event reports in the FDA's MAUDE database, received between Oct 17, 2017 and Sep 30, 2026 — classified as 32 injuries, 1,351 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (478 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported BD Ultra-Fine problems
Device problems
- Leak/Splash478
- Failure to Deliver164
- Break150
- Device Markings/Labelling Problem146
- Device Contamination with Chemical or Other Material120
- Volume Accuracy Problem101
- Defective Device63
- Material Separation32
Patient problems
- No Known Impact Or Consequence To Patient535
- No Clinical Signs, Symptoms or Conditions461
- No Consequences Or Impact To Patient272
- No Patient Involvement61
- Needle Stick/Puncture20
- Foreign Body In Patient17
- No Information12
- Pain10
BD Ultra-Fine models
9 models, most reported first. Each model has its own page with its reports, recalls and device details.
- BD Ultra-Fine 328468Syringe, piston323 reports
- BD Ultra-Fine 328438Syringe, piston316 reports
- BD Ultra-Fine 328418Syringe, piston222 reports
- BD Ultra-Fine 328440Syringe, piston209 reports
- BD Ultra-Fine 328466Syringe, piston134 reports
- BD Ultra-Fine 328411Syringe, piston98 reports
- BD Ultra-Fine 328431Syringe, piston78 reports
- BD Ultra-Fine 328291Syringe, piston2 reports
- BD Ultra-Fine 328289Syringe, piston1 report
Recent BD Ultra-Fine adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Volume Accuracy Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50946521 ↗MalfunctionSep 30, 2026Volume Accuracy Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50946374 ↗MalfunctionSep 30, 2026Volume Accuracy Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50946143 ↗MalfunctionSep 30, 2026Volume Accuracy Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50945952 ↗MalfunctionSep 30, 2026Volume Accuracy Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50945699 ↗MalfunctionSep 30, 2026Volume Accuracy Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50945586 ↗MalfunctionSep 30, 2026Volume Accuracy Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50945332 ↗MalfunctionSep 30, 2026Volume Accuracy Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50945228 ↗MalfunctionSep 30, 2026Volume Accuracy Problem
0.3cc 31G Syr.10*10 8mm 100'S/BX ¿¿:3219230, It has been opened. The customer reported that the product quantity was 88 pieces and the scale was inaccurate. (Buy a box of 100 pieces)tmaik 19September2024 additional information attachedMaterial: Item number: 0.3cc 31G Syr.10*10 8mm 100'S/BX Batch number: 3219230.reason:Consumer printing accuracy questionable(Consumers believe that the printing accuracy of 88 out of 100 purchased in a box is questionable)Current status:1) Consumers only provide photos, quantities and batch numbers, so they can only upload current information.2) Whether the customer has communicated with the consumer or not is a subjective factor of personal judgment.3) The customer contacted the consumer about the batch number, but the consumer did not call back.Second email info attachment:1) The batch number 3219230 is correctly linked to the catalog number 328440.Because the model number was not filled in on the customer letter (as shown below),The product number was verbally reported incorrectly during the telephone inquiry, and was subsequently reconfirmed to be 328440.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50945019 ↗MalfunctionSep 30, 2026Volume Accuracy Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50944485 ↗MalfunctionSep 30, 2026Volume Accuracy Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50944354 ↗MalfunctionSep 30, 2026Volume Accuracy Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50944162 ↗MalfunctionSep 30, 2026Volume Accuracy Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50943921 ↗MalfunctionSep 30, 2026Volume Accuracy Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50943657 ↗MalfunctionSep 30, 2026Volume Accuracy Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50943569 ↗
Other Becton, Dickinson and Company Inc products
All Becton, Dickinson and Company Inc devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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