MonojectRecalls & reported problems across all models

We found 35 models of Monoject by Cardinal Health 200, LLC in the FDA's device registry (GUDID). Together they are named in 96 adverse event reports in the FDA's MAUDE database, received between Mar 27, 2017 and Mar 25, 2026 — classified as 3 injuries, 93 malfunctions.

The most frequently reported specific device problem is “Break” (23 reports).

11 FDA recall records name at least one of these models by its device identifier, 11 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

Monoject 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.

1. May 9, 2024Class IIOpen, Classified

   Products in distribution were found by FDA to be to be substantially different from the current cleared 510(k)s with a major change or modification to the device s intended use.

   Z-3074-2024 · Root cause: Other · names 11 of these models · Recall details · FDA record ↗

2. Dec 28, 2023Class IOpen, Classified

   Cardinal Health is expanding their previous product correction actions to a product removal of all sizes of Cardinal Health brand Monoject sterile Syringe Luer-Lock (1, 3, 6, 12, 20, 35, and 60 mL) and Cardinal Health brand Monoject sterile Enteral Syringes with the ENFit connection (1, 3, 6, 12, 35, and 60 mL) due to a change in manufacturing and rebranding efforts.

   Z-0856-2024 · Root cause: Process change control · Recall details · FDA record ↗

3. Dec 28, 2023Class IOpen, Classified

   Cardinal Health is expanding their previous product correction actions to a product removal of all sizes of Cardinal Health brand Monoject sterile Syringe Luer-Lock (1, 3, 6, 12, 20, 35, and 60 mL) and Cardinal Health brand Monoject sterile Enteral Syringes with the ENFit connection (1, 3, 6, 12, 35, and 60 mL) due to a change in manufacturing and rebranding efforts.

   Z-0855-2024 · Root cause: Process change control · Recall details · FDA record ↗

4. Dec 28, 2023Class IOpen, Classified

   Cardinal Health is expanding their previous product correction actions to a product removal of all sizes of Cardinal Health brand Monoject sterile Syringe Luer-Lock (1, 3, 6, 12, 20, 35, and 60 mL) and Cardinal Health brand Monoject sterile Enteral Syringes with the ENFit connection (1, 3, 6, 12, 35, and 60 mL) due to a change in manufacturing and rebranding efforts.

   Z-0853-2024 · Root cause: Process change control · Recall details · FDA record ↗

5. Dec 28, 2023Class IOpen, Classified

   Cardinal Health is expanding their previous product correction actions to a product removal of all sizes of Cardinal Health brand Monoject sterile Syringe Luer-Lock (1, 3, 6, 12, 20, 35, and 60 mL) and Cardinal Health brand Monoject sterile Enteral Syringes with the ENFit connection (1, 3, 6, 12, 35, and 60 mL) due to a change in manufacturing and rebranding efforts.

   Z-0852-2024 · Root cause: Process change control · Recall details · FDA record ↗

6. Dec 28, 2023Class IOpen, Classified

   Cardinal Health is expanding their previous product correction actions to a product removal of all sizes of Cardinal Health brand Monoject sterile Syringe Luer-Lock (1, 3, 6, 12, 20, 35, and 60 mL) and Cardinal Health brand Monoject sterile Enteral Syringes with the ENFit connection (1, 3, 6, 12, 35, and 60 mL) due to a change in manufacturing and rebranding efforts.

   Z-0851-2024 · Root cause: Process change control · Recall details · FDA record ↗

7. Sep 20, 2023Class IOpen, Classified

   Demonstrated recognition and compatibility issues with syringe infusion pumps.

   Z-0149-2024 · Root cause: Vendor change control · Recall details · FDA record ↗

8. Sep 20, 2023Class IOpen, Classified

   Demonstrated recognition and compatibility issues with syringe infusion pumps.

   Z-0148-2024 · Root cause: Vendor change control · Recall details · FDA record ↗

9. Sep 20, 2023Class IOpen, Classified

   Demonstrated recognition and compatibility issues with syringe infusion pumps.

   Z-0146-2024 · Root cause: Vendor change control · Recall details · FDA record ↗

10. Sep 20, 2023Class IOpen, Classified

    Demonstrated recognition and compatibility issues with syringe infusion pumps.

    Z-0145-2024 · Root cause: Vendor change control · Recall details · FDA record ↗

11. Sep 13, 2023Class IIOpen, Classified

    Syringe contains conical tip that is not compatible with certain needleless IV connector(s).

    Z-0112-2024 · Root cause: Process change control · Recall details · FDA record ↗

Most reported Monoject problems

Monoject models

35 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Monoject 1180100777

  Syringe, piston
  3 recalls4 reports
• Monoject 1183500777

  Syringe, piston
  2 recalls17 reports
• Monoject 1182000777

  Syringe, piston
  2 recalls9 reports
• Monoject 1180600777

  Syringe, piston
  2 recalls3 reports
• Monoject 1180300777

  Syringe, piston
  1 recall3 reports
• Monoject 11812705

  Syringe, piston
  1 recall1 report
• Monoject 11832510

  Syringe, piston
  1 recall1 report
• Monoject 11813005

  Syringe, piston
  1 recall0 reports
• Monoject 11832010

  Syringe, piston
  1 recall0 reports
• Monoject 11832015

  Syringe, piston
  1 recall0 reports
• Monoject 11832110

  Syringe, piston
  1 recall0 reports
• Monoject 11832115

  Syringe, piston
  1 recall0 reports
• Monoject 11832210

  Syringe, piston
  1 recall0 reports
• Monoject 11832215

  Syringe, piston
  1 recall0 reports
• Monoject 11832310

  Syringe, piston
  1 recall0 reports
• Monoject 11832315

  Syringe, piston
  1 recall0 reports
• Monoject 8881513223

  Syringe, piston
  10 reports
• Monoject 8881135609

  INSTRUMENT, SURGICAL, DISPOSABLE
  9 reports
• Monoject 8881893050

  Syringe, piston
  6 reports
• Monoject 8881512977

  Syringe, piston
  4 reports
• Monoject 1180300555

  Syringe, piston
  4 reports
• Monoject 1186000444

  SYRINGE, IRRIGATING (NON DENTAL)
  3 reports
• Monoject 8881513207

  Syringe, piston
  3 reports
• Monoject 8970Y

  Container, Sharps
  3 reports
• Monoject 11812558

  Syringe, piston
  2 reports
• Monoject 85121

  Container, sharps
  2 reports
• Monoject 8906

  Container, sharps
  2 reports
• Monoject 8881535101

  Syringe, piston
  2 reports
• Monoject 8881513231

  Syringe, piston
  2 reports
• Monoject 8881892950

  Syringe, piston
  1 report
• Monoject 1181621100

  Syringe, piston
  1 report
• Monoject 8881513702

  Syringe, piston
  1 report
• Monoject 8881513934

  Syringe, piston
  1 report
• Monoject 31143699

  Container, sharps
  1 report
• Monoject 8881112083

  Syringe, piston
  1 report

Recent Monoject adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionMar 25, 2026Device Contamination with Chemical or Other Material

  IT WAS REPORTED, BD MONOJECT SYRINGE HAD FOREIGN MATTER, OILY SUBSTANCE INSIDE. ADDITIONAL INFORMATION. SUBSTANCE, ONCE IT WAS DISCOVERED WE DID NOT MAKE THE NORMAL NARCOTIC PCA¿S THAT WE NORMALLY WOULD HAVE, THE SYRINGES WERE SEQUESTERED AND NO PRODUCT WENT TO PATIENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24688532 ↗
• MalfunctionJan 27, 2026Decoupling; Defective Component

  THE CUSTOMER REPORTED AN INCIDENT WITH A CARDINAL SYRINGE COMING APART AND CAUSING A NEEDLE STICK.

  Patient problems: Needle Stick/Puncture

  MAUDE report 24186397 ↗
• 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 ↗
• MalfunctionSep 19, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23099137 ↗
• MalfunctionSep 19, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  MATERIAL INSPECTION FOUND MULTIPLE SYRINGE LOTS WITH FIBERS AND PARTICLES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23098432 ↗
• MalfunctionSep 4, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT BD PCA SET HAD FOREIGN MATTER THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY CUSTOMER THAT MULTIPLE BAGS WITHIN EACH CASE HAD A GREASY/OILY RESIDUE ON THE INSIDE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22974499 ↗
• MalfunctionSep 4, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT BD PCA SET HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING: IT WAS REPORTED BY CUSTOMER THAT MULTIPLE BAGS WITHIN EACH CASE HAD A GREASY/OILY RESIDUE ON THE INSIDE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22974498 ↗
• MalfunctionAug 7, 2025Fail-Safe Problem; Fail-Safe Problem

  THE CUSTOMER REPORTED THAT THE NURSING FLOOR HAS HAD ACCIDENTAL NEEDLESTICK INCIDENTS INVOLVING SYRINGE MODEL 8881892950, ALL DISPENSED BY PHARMACY FOR LONG-ACTING INSULIN ADMINISTRATION. THE CORE SAFETY CONCERN IS THAT THE NEEDLE GUARD ON THIS SYRINGE DOES NOT ENGAGE SMOOTHLY. INITIALLY, IT SLIDES UP AND APPEARS TO STOP, WHICH CAN GIVE THE IMPRESSION THAT THE NEEDLE IS FULLY COVERED. HOWEVER, NURSES NEED TO APPLY ADDITIONAL FORCE BEYOND THIS INITIAL RESISTANCE TO FULLY ACTIVATE THE SAFETY GUARD AND PROPERLY COVER THE NEEDLE. THIS INCOMPLETE CLOSURE CREATES A RISK FOR ACCIDENTAL NEEDLESTICKS. ADDITIONAL INFORMATION RECEIVED ON 24JUL2025 STATED THAT THE NURSES HAD TO DRAW ADDITIONAL EXPOSURE PROTOCOL LAB WORK FOR EACH PATIENT THAT THE NEEDLE STICK OCCURRED WITH AS THEY WERE ALL CONTAMINATED ACCIDENTAL NEEDLE STICKS (I.E. POST INJECTION WITH THE PATIENT). FIRST AID WAS APPLIED TO ALL. THERE WAS EMOTIONAL DISTRESS AND PAPERWORK FOR ALL ENCOUNTERS. ON 29JUL2025 IT WAS CONFIRMED THAT THE NURSES DID NOT REQUIRE LAB WORK OR MEDICATION.

  Patient problems: Needle Stick/Puncture

  MAUDE report 22743839 ↗
• MalfunctionJan 13, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT THE RUBBER STOPPER ON THE END OF THE PLUNGERS ON THE INSIDE OF THE SYRINGES ARE NOT SEATED CORRECTLY. SOME ARE NOT ATTACHED, OR SIDEWAYS. FLUID LEAKS OUT OF THEM AND THEY ARE UNABLE TO USE THEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21143242 ↗
• MalfunctionNov 7, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT THEY ARE FROM A VETERINARY PRACTICE THAT HAS USED MONOJECT 3 ML X 22 G X 1" NEEDLE/SYRINGE COMBOS FOR YEARS. RECENTLY, THEY HAVE HAD ISSUES WITH THE SYRINGES BEING CRACKED. THE SYRINGES ARE IN THE PLASTIC HARD PACK AND SEEM UNDAMAGED. ONCE THE SYRINGE IS TAKEN OUT OF THE HARD PACK AND THE SYRINGE FILLED, IT BECOMES QUITE CLEAR THAT THERE IS A CRACK IN THE WALL OF THE SYRINGE AND THE PRODUCT THAT THEY HAVE TRIED TO FILL THE SYRINGE WITH LEAKS OUT. THEY HAVE WASTED QUITE A FEW DOSES OF VACCINES AND MOST RECENTLY A COSTLY BIOLOGICAL WAS WASTED. UNFORTUNATELY, SINCE THE EVENTS STARTED OUT RANDOMLY THERE WAS NOT A NOTATION OF THE BATCH OR LOT # THE SYRINGE CAME FROM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20633509 ↗
• MalfunctionOct 25, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THAT FEW SYRINGES THEY OPEN, THERE'S NO TIP ON THE SYRINGE WHICH MAKES DRAWING UP VACCINES WITH NEEDLES RATHER DIFFICULT. THE DOCTOR STATED THAT HE HAD A NEEDLE BREAK OFF THE SYRINGE WHILE VACCINATING A CAT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20532399 ↗
• MalfunctionOct 22, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED LEAKAGE OF LIQUID (MEDICATIONS) THROUGH THE PLUNGER OF THE SYRINGES. THE PROBLEM MAY OCCUR ON MORE THAN HALF OF THE SYRINGES IN THE SAME TRAY. ON SOME SYRINGES, THE PRODUCT LEAKS BETWEEN THE 2 THEORETICALLY SEALED SECTIONS OF THE PISTON. ON OTHER SYRINGES, THE DRUG FLOWS AND COMES OUT OF THE SYRINGE FROM THE PLUNGER. THE CUSTOMER FURTHER STATED THAT THE SYRINGES ARE NOT LEAK-PROOF AND DO NOT MAINTAIN THE STERILITY OF MEDICATIONS. RISK OF DRUG LOSS (INCOMPLETE DOSE) AND CONTAMINATION OF DOSES WITH MICROORGANISMS. IN ADDITION, THE SYRINGES ARE INTERPOSED INSIDE THE TRAY. THIS MEANS THAT PHARMACY DISPENSERS CANNOT PROTECT CRITICAL SYRINGE SITES EASILY (GO OVER THE SYRINGE TIPS IN THE ROW BELOW WHEN TRYING TO PICK UP SYRINGES FROM THE TOP ROW). THIS INCREASES THE RISK OF CONTAMINATING SUPPLIES DURING HANDING. THEY HAVE LOST MANY DOSES OF MEDICATION BECAUSE THE MEDICATION HAD LEAKED INTO THE PLUNGER OF THE SYRINGE (THE PRODUCT IS NO LONGER CONSIDERED STERILE). THE DOSES HAVE BEEN REDONE. TO SOLVE THIS ISSUE, THEY HAVE CHANGED THE PREPARATION OF SEVERAL DRUGS TO 5ML SYRINGES DESPITE A RISK THAT THE VOLUME WILL BE LESS ACCURATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20502203 ↗
• MalfunctionOct 17, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT THE SYRINGES HAVE NO SUCTION AND ARE LEAKING PAST THE BLACK RUBBER AND IT IS VERY DIFFICULT TO GET PLASTIC CASING OFF AND PLUNGERS ARE TOO TIGHT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20469986 ↗
• MalfunctionOct 15, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT THE SYRINGES HAVE NO SUCTION AND ARE LEAKING PAST THE BLACK RUBBER AND IT IS VERY DIFFICULT TO GET PLASTIC CASING OFF AND PLUNGERS ARE TOO TIGHT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20452267 ↗
• MalfunctionOct 1, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED A CRACKED SYRINGE. ADDITIONAL INFORMATION RECEIVED ON 26SEP2024 CONFIRMED THERE WAS LEAKING FROM THE CRACK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20344996 ↗

Other Cardinal Health 200, LLC products

• JACKSON-PRATT20 models · 13 reports · 19 recalls
• CONVERTORS38 models · 40 reports · 11 recalls
• Argyle33 models · 58 reports · 7 recalls
• Salem Sump31 models · 40 reports · 7 recalls
• Dover45 models · 241 reports · 2 recalls
• Kendall31 models · 51 reports · 3 recalls
• Kangaroo35 models · 130 reports
• NOVAPLUS7 models · 75 reports · 1 recall