Autoject 2 AJ1060Recalls & reported problems
Owen Mumford Limited · 1ml glass syringe, non-sterile reusable injector. · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 15016189106015), received between Jan 9, 2020 and Feb 14, 2020 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Break” (1 report).
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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Break1
- Failure to Fire1
- Insufficient Device Problem Information1
Patient problems
- No Known Impact Or Consequence To Patient2
- Anxiety1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 14, 2020Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information
PATIENT'S WIFE REPORTED THAT HIS AUTOJECT HAS NOT BEEN WORKING PROPERLY. NO OTHER DETAILS WERE GIVEN OTHER THAN SHE WAS CONTACT THE MANUFACTURER'S HUB TO OBTAIN A NEW ONE.
Patient problems: Anxiety
MAUDE report 9712127 ↗MalfunctionFeb 6, 2020Break
PATIENT REPORTED TO PHARMACIST THAT HIS AUTOJECT FOR COPAXONE "BROKE". PHARMACIST PROVIDED PATIENT WITH PHONE NUMBER TO SHARED SOLUTIONS TO REQUEST NEW ONE. RX MEDS: COPAXONE INJ 40MG/ML.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9679167 ↗MalfunctionJan 9, 2020Failure to Fire; Failure to Fire
A PATIENT COMPLAINED TO THEIR PHARMACY WHO SUBMITTED A MEDWATCH: PATIENT ATTEMPTED TO USE AUTOJECT DEVICE AND IT WOULD NOT INJECT. DATE OF OCCURRENCE IS UNKNOWN. THE PATIENT USED A PREFILLED SYRINGE TO ADMINISTER THEIR DOSE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9571919 ↗
Other Introducer, Syringe Needle devices
- Accu-Chek Link Assist 04530039001Roche Diabetes Care GmbH · Introducer, Syringe Needle15 reports
- Whisperject 400527460Mylan Pharmaceuticals Inc. · Introducer, Syringe Needle1 report
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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