NORM-JECTRecalls & reported problems across all models
B. Braun Medical Inc. · 5 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
2 open recalls name at least one NORM-JECT model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 31
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 2
We found 5 models of NORM-JECT by B. Braun Medical Inc. in the FDA's device registry (GUDID). Together they are named in 31 adverse event reports in the FDA's MAUDE database, received between Sep 21, 2020 and Sep 18, 2026 — classified as 31 malfunctions.
The most frequently reported specific device problem is “Contamination /Decontamination Problem” (29 reports).
2 FDA recall records name at least one of these models by its device identifier, 2 still open.
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
NORM-JECT recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Aug 7, 2023Open, Classified
The sterile blister packaging may be damaged, and sterility may be compromised
Z-2644-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Aug 7, 2023Open, Classified
The sterile blister packaging may be damaged, and sterility may be compromised
Z-2643-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported NORM-JECT problems
Device problems
- Contamination /Decontamination Problem29
- Contamination1
- Labelling, Instructions for Use or Training Problem1
- Particulates1
Patient problems
- No Clinical Signs, Symptoms or Conditions31
NORM-JECT models
5 models, most reported first. Each model has its own page with its reports, recalls and device details.
- NORM-JECT® NJ-4606108-02Syringe, piston1 recall1 report
- NORM-JECT® NJ-4606728-02Syringe, piston1 recall0 reports
- NORM-JECT® NJ-9166017-02Syringe, piston26 reports
- NORM-JECT® NJ-4606205-02Syringe, piston3 reports
- NORM-JECT® NJ-4606701-02Syringe, piston1 report
Recent NORM-JECT adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 18, 2026Contamination /Decontamination Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50822368 ↗MalfunctionSep 17, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: DURING THE PACKAGING PROCESS AT PCI (PACKAGING COORDINATORS INC.), AN UNKNOWN SUBSTANCE WAS DISCOVERED INSIDE OF THE PACKAGING AND ON THE SYRINGE PLUNGER. NOTIFICATION OF NON-CONFORMING MATERIAL WAS REPORTED TO BOSTON SCIENTIFIC, (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12488723 ↗MalfunctionSep 15, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY USER FACILITY: EVENT 5 . CUSTOMER REPORTED THE PRESENCE OF UNIDENTIFIED PARTICULATES IN SEVERAL OF THE SYRINGES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12474675 ↗MalfunctionSep 15, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY USER FACILITY: EVENT 7. CUSTOMER REPORTED THE PRESENCE OF UNIDENTIFIED PARTICULATES IN SEVERAL OF THE SYRINGES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12474674 ↗MalfunctionSep 15, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY USER FACILITY: EVENT 1. CUSTOMER REPORTED THE PRESENCE OF UNIDENTIFIED PARTICULATES IN SEVERAL OF THE SYRINGES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12474671 ↗MalfunctionSep 15, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY USER FACILITY: EVENT 2. CUSTOMER REPORTED THE PRESENCE OF UNIDENTIFIED PARTICULATES IN SEVERAL OF THE SYRINGES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12474670 ↗MalfunctionSep 15, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY USER FACILITY: EVENT 4 CUSTOMER REPORTED THE PRESENCE OF UNIDENTIFIED PARTICULATES IN SEVERAL OF THE SYRINGES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12474668 ↗MalfunctionSep 15, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY USER FACILITY: EVENT 3 CUSTOMER REPORTED THE PRESENCE OF UNIDENTIFIED PARTICULATES IN SEVERAL OF THE SYRINGES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12474667 ↗MalfunctionSep 15, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY USER FACILITY: EVENT 8. CUSTOMER REPORTED THE PRESENCE OF UNIDENTIFIED PARTICULATES IN SEVERAL OF THE SYRINGES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12474666 ↗MalfunctionSep 15, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY USER FACILITY: EVENT 6. CUSTOMER REPORTED THE PRESENCE OF UNIDENTIFIED PARTICULATES IN SEVERAL OF THE SYRINGES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12474665 ↗MalfunctionSep 14, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: EVENT 8. CUSTOMER REPORTED PRESENCE OF UNIDENTIFIED PARTICULATES WITHIN THE SYRINGES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12469325 ↗MalfunctionSep 14, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: EVENT 7. CUSTOMER REPORTED PRESENCE OF UNIDENTIFIED PARTICULATES WITHIN THE SYRINGES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12469321 ↗MalfunctionSep 14, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: EVENT 4. CUSTOMER REPORTED PRESENCE OF UNIDENTIFIED PARTICULATES WITHIN THE SYRINGES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12469314 ↗MalfunctionSep 14, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: EVENT 2. CUSTOMER REPORTED PRESENCE OF UNIDENTIFIED PARTICULATES WITHIN THE SYRINGES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12469313 ↗MalfunctionSep 14, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: EVENT 3 CUSTOMER REPORTED PRESENCE OF UNIDENTIFIED PARTICULATES WITHIN THE SYRINGES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12469312 ↗
Other B. Braun Medical Inc. products
- Infusomat54 models · 2,783 reports · 30 recalls
- IV Administration Set153 models · 281 reports · 68 recalls
- Hemodialysis Bloodlines9 models · 2,179 reports · 14 recalls
- Outlook25 models · 195 reports · 24 recalls
- Perifix57 models · 224 reports · 20 recalls
- Extension Set41 models · 101 reports · 16 recalls
- Design Options116 models · 132 reports · 14 recalls
- Blood Administration Set24 models · 177 reports · 13 recalls
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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