Whisperject 400527460Recalls & reported problems
Mylan Pharmaceuticals Inc. · The WhisperJECT autoinjector is a non-sterile injection device. It is intended to be used with FDA approved drug products with non-viscous (aqueous) liquid formulations, which are presented in a 1.0 mL pre-filled glass syringe with staked needles. It is a reusable injection device for the subcutaneous injection of FDA approved drugs. · Class 2
Data updated Oct 18, 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 00303789300324), received between Sep 24, 2019 and Sep 24, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Defective Device” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Defective Device1
- Physical Resistance/Sticking1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 24, 2019Defective Device; Physical Resistance/Sticking
MYLAN PRESCRIPTION WHISPER JECT (AUTO-INJECTOR DEVICE) DOES NOT HANDLE THE NEEDLE CAP REMOVAL PROPERLY. THIS WAS REPORTED IMMEDIATELY TO MYLAN (CASE # (B)(4)), WITH SUPPORTING DOCUMENTATION AND PHOTOS, FOLLOWED BY ADDITIONAL TELEPHONE DISCUSSIONS, (THUS THIS REPORT IS HOPEFULLY REDUNDANT TO MYLAN'S REPORT). AFTER THE SYRINGE IS INSERTED INTO THE AUTO-INJECTOR AND THE DEVICE LOCKED, ONE PULLS THE NEEDLE CAP REMOVER FROM THE DEVICE, WHICH REMOVES THE NEEDLE CAP FORM THE SYRINGE. THE NEEDLE CAP IS SUPPOSED TO FALL FREE OUT OF THE NEEDLE CAP REMOVER. INSTEAD THE NEEDLE CAP GETS STUCK INSIDE THE NEEDLE CAP REMOVER. THE AUTO-INJECT DEV ICE CANNOT BE REUSED UNLESS THE NEEDLE CAP IS REMOVED FROM THE NEEDLE CAP REMOVE. PROCEDURES IN THE WHISPERJECT NEEDLE "INSTRUCTIONS FOR USE" MANUAL (IFU:WJECT:R1), STEP 7B, DO NOT DISLODGE THE NEEDLE CAP. PLAINLY, THE MYLAN GLATIRAMER ACETATE 20 MG DAILY INJECTION SYRINGES NEEDLE CAPS ARE LARGER THAN WHAT THE MYLAN WHISPERJECT NEEDLE CAP REMOVER IS BUILT TO HANDLE (WHETHER BY DESIGN OR BY MANUFACTURING ERROR). IT IS NOT CLEAR IF THE FUNDAMENTAL PROBLEM IS WITH A DESIGN NON-COMPLAINT SYRINGE, NON-COMPLAINT AUTO-INJECTOR, OR IF THIS IS A BASIC COMMON DESIGN
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9117890 ↗
Other Introducer, Syringe Needle devices
- Accu-Chek Link Assist 04530039001Roche Diabetes Care GmbH · Introducer, Syringe Needle15 reports
- Autoject 2 AJ1060Owen Mumford Limited · Introducer, Syringe Needle3 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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