NORM-JECT® NJ-4606755BMSRecalls & reported problems
B. Braun Melsungen Aktiengesellschaft · 10 ML NORM-JECT® LL BMS · 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 04046955635825), received between May 8, 2026 and May 8, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Contamination” (1 report).
2 other recalls cover devices cleared under the same FDA submission (K063280); they may or may not involve this specific model.
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
- Contamination1
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.
MalfunctionMay 8, 2026Contamination
ACCORDING TO THE EVENT DESCRIPTION: AFTER RECONSTITUTING THE VIAL A "BLUE FLOATING THING" WAS NOTED IN THE VIAL. "I THINK PROBABLY A PIECE OF THE SYRINGE BECAUSE THERE IS BLUE PRINTING ON THE SYRINGE THAT COMES WITH THE VIAL" THE PARTICLE OBSERVED/EXHIBITED AN ELONGATED STRIP OR UNEVEN RIBBON-SHAPE EXHIBITING A BLUE COLORATION. AN UNEVEN YET RELATIVELY SMOOTH SURFACE TEXTURE WAS OBSERVED. THE PARTICLE EXHIBITS A NEGATIVE REACTION TO A MAGNET AND A NON-BUOYANT BEHAVIOR. THE PARTICLE OBSERVED WAS NOT VISUALLY CONSISTENT WITH THE STOPPER MATERIAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25124148 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K063280. One submission often covers many models, so check the product and lot details in each record.
- Z-2644-2023 · Aug 7, 2023 · Open, ClassifiedB.Braun NORM-JECT Luer Lock Solo, 10 ml, Sterile-Intended to be used to deliver (inject) or withdraw an accurate metered dose of a fluid to/from the body. Distributed by: Air-Tit
- Z-2643-2023 · Aug 7, 2023 · Open, ClassifiedB. Braun NORM-JECT Luer Solo, 10 ml, Sterile-Intended to be used to deliver (inject) or withdraw an accurate metered dose of a fluid to/from the body. Distributed by: Air-Tite Pro
Other Syringe, piston devices
- BD Luer-Lok 309657Becton, Dickinson And Company · Syringe, piston1,266 reports
- BD Luer-Lok 309653Becton, Dickinson And Company · Syringe, piston948 reports
- BD Luer-Lok 309628Becton, Dickinson And Company · Syringe, piston862 reports
- N/A 302995Becton, Dickinson And Company · Syringe, piston1 recall537 reports
- BD Plastipak Syringe 300865Becton, Dickinson And Company · Syringe, piston515 reports
- N/A 302830Becton, Dickinson And Company · Syringe, piston462 reports
- N/A 302832Becton, Dickinson And Company · Syringe, piston424 reports
- BD Ultra-Fine 328468Becton, Dickinson and Company Inc · Syringe, piston323 reports
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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