NORM-JECT® NJ-9166017-02Recalls & reported problems
B. Braun Medical Inc. · NORM-JECT-F 1 ML BBRAUN AIR-TITE · Class 2
All models of NORM-JECT (5)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This B. Braun Norm-Ject syringe is a piston syringe. Reports mostly describe unidentified particles found inside several syringes. There are 26 reports naming its identifier, with no deaths and no injuries. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 26
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 04046955596911), received between Apr 22, 2021 and Sep 15, 2021 — classified as 26 malfunctions.
The most frequently reported specific device problem is “Contamination /Decontamination Problem” (24 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 16, 2026.
Most reported problems
Device problems
- Contamination /Decontamination Problem24
- Contamination1
- Labelling, Instructions for Use or Training Problem1
- Particulates1
Patient problems
- No Clinical Signs, Symptoms or Conditions26
Recent adverse event reports
The 25 most recent of 26 reports, in the reporter's own words as published by the FDA.
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 ↗MalfunctionSep 14, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: EVENT 5. CUSTOMER REPORTED PRESENCE OF UNIDENTIFIED PARTICULATES WITHIN THE SYRINGES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12469311 ↗MalfunctionSep 14, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: EVENT 6 CUSTOMER REPORTED PRESENCE OF UNIDENTIFIED PARTICULATES WITHIN THE SYRINGES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12469310 ↗MalfunctionSep 14, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: EVENT 14 CUSTOMER REPORTED PRESENCE OF UNIDENTIFIED PARTICULATES WITHIN THE SYRINGES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12469308 ↗MalfunctionSep 14, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: EVENT 15. CUSTOMER REPORTED PRESENCE OF UNIDENTIFIED PARTICULATES WITHIN THE SYRINGES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12469306 ↗MalfunctionSep 14, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: EVENT 10. CUSTOMER REPORTED PRESENCE OF UNIDENTIFIED PARTICULATES WITHIN THE SYRINGES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12469301 ↗MalfunctionSep 14, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: EVENT 11. CUSTOMER REPORTED PRESENCE OF UNIDENTIFIED PARTICULATES WITHIN THE SYRINGES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12469300 ↗MalfunctionSep 14, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: EVENT 12. CUSTOMER REPORTED PRESENCE OF UNIDENTIFIED PARTICULATES WITHIN THE SYRINGES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12469299 ↗MalfunctionSep 14, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: EVENT 9. CUSTOMER REPORTED PRESENCE OF UNIDENTIFIED PARTICULATES WITHIN THE SYRINGES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12469298 ↗MalfunctionSep 14, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: EVENT 13. CUSTOMER REPORTED PRESENCE OF UNIDENTIFIED PARTICULATES WITHIN THE SYRINGES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12469297 ↗MalfunctionSep 8, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: EVENT 1: AFTER FILLING .1CC LIQUID INTO TWO A1 SYRINGES, INSPECTION REVEALED TWO MONOFILAMENT FOREIGN PARTICLES WITHIN BOTH OF THE A1 SYRINGES. ON AUGUST 23, 2021, IT WAS REPORTED BY CUSTOMER COMPOUND PREFERRED THAT THE SOURCE OF THE BLUE MONOFILAMENT OBJECTS ORIGINATED FROM THE A1 SYRINGES. A PHOTOGRAPH OF AN UNOPENED A1 SYRINGE REVEALS A SIMILAR STRAND WITHIN THE STERILE PACKAGED 1CC SYRINGE. CORRECTION: CUSTOMER ORIGINALLY REPORTED TWO (2) OCCURRENCES (ONE OCCURRENCE EACH WITH 2 BATCH NUMBERS, B. BRAUN REFERENCE NUMBERS (B)(4)), HOWEVER FURTHER INFORMATION WAS RECEIVED THAT THERE WERE FOURTEEN (14) OCCURRENCES WITH BATCH 21B11C8 BUT FIFTEEN (15) SAMPLES WERE RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12439857 ↗MalfunctionAug 31, 2021Contamination; Particulates
WE ARE A 503B OUTSOURCING FACILITY. AFTER REPACKAGING OF AN AVASTIN LOT, WE OBSERVED TWO BLUE PARTICLES WITHIN FINISHED PRODUCT SYRINGES. A LONG INVESTIGATION ENSUED AND WE WERE ABLE TO DETERMINE THE LOT OF SYRINGES HAVE PARTICLES IN IT FROM THE MANUFACTURER. WE HAD TO REJECT THE LOT OF AVASTIN WE MADE DUE TO THIS. WE PLACED THE LOT OF SYRINGES ON QA HOLD AND ORDERED A NEW LOT. THE NEW LOT ALSO CONTAINS PARTICLES. THE PARTICLES ARE ONLY VISIBLE UNDER MAGNIFICATION; THEREFORE, WE INSPECTED SEALED SYRINGES UNDER 15X MAGNIFICATION BEFORE MAKING ANOTHER LOT (WHICH WAS ALSO SENT FOR SUBVISIBLE PARTICLE TESTING), BUT FEEL AS THROUGH THESE SYRINGES ARE ENTIRELY UNSAFE TO CONTINUE TO BE USED FOR ANY TYPE OF INJECTION. WE HAVE CEASED FURTHER PRODUCTION USING THESE SYRINGES, WHICH ACCOUNTS FOR OVER 60% OF OUR BUSINESS. WE REACHED OUT TO THE MANUFACTURER (AIR-TITE / B. BRAUN) AND THEY HAVE STARTED A COMPLAINT/INVESTIGATION AS WELL (REFERENCE #(B)(4)). WE HAVE INSPECTED UNUSED AND SEALED SYRINGES FROM THREE (3) SEPARATE LOTS, AND ALL HAVE BEEN FOUND TO HAVE VARYING LEVELS OF PARTICLES. ITEM DESCRIPTION NORM-JECT-F LUER SOLO 1 ML (NJ-9166017-02) LOT # DOM, EXP QTY INSPECTED, QTY WITH FOD 21B11C
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12407214 ↗MalfunctionMay 5, 2021Labelling, Instructions for Use or Training Problem; Labelling, Instructions for Use or Training Problem
AS REPORTED BY USER FACILITY: GRADUATION LINES WERE MISALIGNED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11778684 ↗
Other Syringe, piston devices
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- 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
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- 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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