Monoject 8881893050Recalls & reported problems
Cardinal Health 200, LLC · Monoject Magellan 1/2 mL Insulin Safety Syringe Permanent Needle 30G x 5/16 in. (0.3 x 8 mm) · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10884521005976), received between Jan 31, 2018 and Nov 25, 2025 — classified as 1 injury, 5 malfunctions.
The most frequently reported specific device problem is “Fail-Safe Problem” (2 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Fail-Safe Problem2
- Device Markings/Labelling Problem1
- Illegible Information1
- Missing Information1
- Shielding Failure1
Patient problems
- Needle Stick/Puncture2
- No Clinical Signs, Symptoms or Conditions2
- No Consequences Or Impact To Patient1
- No Patient Involvement1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 25, 2025Fail-Safe Problem; Fail-Safe Problem
THE CUSTOMER REPORTED THAT THE RN FELT LIKE THEY ENGAGED THE SAFETY NEEDLE MECHANISM BUT LATER HER THUMB WAS SORE. NO BLOOD OR OPEN AREA NOTED. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: Needle Stick/Puncture
MAUDE report 23646984 ↗MalfunctionMar 6, 2024Fail-Safe Problem; Fail-Safe Problem
THE CUSTOMER REPORTED THEY HAVE HAD REPORTS OF THE DEVICES COMING OUT OF THE PACKAGE BROKEN. THE CUSTOMER PROVIDED A PHOTO THAT SHOWS THE SAFETY AND CAP SEPARATED FROM THE SYRINGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18848549 ↗MalfunctionJan 11, 2024
RECENT REPORTS FROM STAFF OF THE 1/2 ML INSULIN SAFETY SYRINGES NOT BEING GOOD QUALITY. THERE ARE MANY COMPLAINTS THAT THE NEEDLE WILL FOLD WHEN ATTEMPTING TO DRAW UP INSULIN OR POKE THROUGH THE CAP WHEN RE-CAPPING. THE STAFF HAVE SAID THEY CAN BE DANGEROUS TO USE. STAFF HAVE TO BE EXTRA CAREFUL WHEN HANDLING THEM BECAUSE THEY BEND SO EASILY, AND THE CAP DOES NOT STAY ON WELL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18491452 ↗MalfunctionJul 24, 2020Illegible Information; Missing Information; Illegible Information; Missing Information
ON (B)(6) 2020 THE MANUFACTURING FACILITY RECEIVED ONE SAMPLE FROM THE CUSTOMER. VISUAL INSPECTION NOTED THAT THE SAMPLE RECEIVED HAD MISSING AND ILLEGIBLE PRINTING OF THE NUMERALS AND GRADUATION LINES FROM THE 30 UNITS MARK TO THE 50 UNITS MARK. THE CUSTOMER DID NOT PREVIOUSLY REPORT THIS ISSUE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10320870 ↗InjuryAug 29, 2018Shielding Failure; Shielding Failure
THE CUSTOMER STATES: THE STAFF MEMBER HAD GIVEN A PATIENT AN INSULIN INJECTION USING THE MAGELLAN SAFETY INSULIN NEEDLE AND HAD ACTIVATED IT BY SLIDING THE SAFETY NEEDLE SHIELD AS PER (INSTRUCTION FOR USE) IFU. HOWEVER, IT HAD NOT ENGAGED AND SUBSEQUENTLY THE STAFF MEMBER RECEIVED A NEEDLE STICK INJURY.
Patient problems: Needle Stick/Puncture
MAUDE report 7826829 ↗MalfunctionJan 31, 2018Device Markings/Labelling Problem; Device Markings/Labelling Problem
THE CUSTOMER REPORTS THE INSCRIPTIONS ON THE SYRINGE WERE NOT VISIBLE AND THE PRODUCT WAS STILL IN THE PACKAGE.
Patient problems: No Patient Involvement
MAUDE report 7230565 ↗
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 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.
How reports and recalls are matched · Editorial policy · Report an error on this page