MonojectRecalls & reported problems across all models

We found 164 models of Monoject by Cardinal Health, Inc. in the FDA's device registry (GUDID). Together they are named in 701 adverse event reports in the FDA's MAUDE database, received between Mar 28, 2016 and Sep 2, 2026 — classified as 1 death, 59 injuries, 641 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (135 reports).

7 FDA recall records name at least one of these models by its device identifier, 6 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. Feb 27, 2026Class IIOpen, Classified

   The outer packaging and blister pack labeling identify the product as 1mL Luer Lock Tuberculin Syringe (Product Code 1180100777), however the syringes contained within the packages are U-100 Insulin syringes.

   Z-1768-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

2. Sep 25, 2024Class IOpen, Classified

   Certain lots of listed lots of Cardinal Health Monoject U-100 1 mL Insulin Syringe Luer-Lock with Tip Cap Soft Pack have demonstrated incompatibility with needleless Intravenous (IV) connectors. Cardinal Health recommends that they not be used for administration of IV push insulin via needleless connector.

   Z-0310-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

3. Apr 23, 2024Class IICompleted

   Quarantined product was inadvertently distributed

   Z-2039-2024 · Root cause: Component 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-0857-2024 · 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-0854-2024 · Root cause: Process change control · Recall details · FDA record ↗

6. Sep 20, 2023Class IOpen, Classified

   Demonstrated recognition and compatibility issues with syringe infusion pumps.

   Z-0150-2024 · Root cause: Vendor change control · Recall details · FDA record ↗

7. Sep 20, 2023Class IOpen, Classified

   Demonstrated recognition and compatibility issues with syringe infusion pumps.

   Z-0147-2024 · Root cause: Vendor change control · Recall details · FDA record ↗

Most reported Monoject problems

Monoject models

164 models, 100 per page, most reported first. Each model has its own page with its reports, recalls and device details.

• Monoject 1181200777T

  Syringe, piston
  2 recalls0 reports
• Monoject 1186000777T

  Syringe, piston
  2 recalls0 reports
• Monoject 8881560125

  Syringe, piston
  1 recall17 reports
• Monoject 1188100777

  Syringe, piston
  1 recall9 reports
• Monoject 1180100777

  Syringe, piston
  1 recall1 report
• Monoject 1182000777

  Syringe, piston
  44 reports
• Monoject 1186000777

  Syringe, piston
  42 reports
• Monoject 8881570121

  Saline, vascular access flush
  33 reports
• Monoject 8881501160

  Syringe, piston
  26 reports
• Monoject 1180300777

  Syringe, piston
  23 reports
• Monoject 8881512258

  Syringe, piston
  20 reports
• Monoject 8881540111

  CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY
  19 reports
• Monoject 1180600777

  Syringe, piston
  17 reports
• Monoject 1182510

  Needle, hypodermic, single lumen
  16 reports
• Monoject 8881225190

  Catheter,intravascular,therapeutic,short-term less than 30 days
  14 reports
• Monoject 8881511136

  Syringe, piston
  14 reports
• Monoject 8507SA

  Container, sharps
  13 reports
• Monoject 8881135609

  INSTRUMENT, SURGICAL, DISPOSABLE
  13 reports
• Monoject 1186000777T

  Syringe, piston
  12 reports
• Monoject 8881513934

  Syringe, piston
  11 reports
• Monoject 1183500777

  Syringe, piston
  10 reports
• Monoject 8881540133

  CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY
  10 reports
• Monoject 1181200777T

  Syringe, piston
  8 reports
• Monoject 11811022

  Needle, Aspiration And Injection, Disposable
  8 reports
• Monoject 1188827112

  Needle, hypodermic, single lumen
  7 reports
• Monoject 1182215

  Needle, hypodermic, single lumen
  7 reports
• Monoject 1182558

  Needle, hypodermic, single lumen
  7 reports
• Monoject 8881520673

  Syringe, piston
  7 reports
• Monoject 1181200777

  Syringe, piston
  6 reports
• Monoject 1183500555

  Syringe, piston
  6 reports
• Monoject 8881511110

  Syringe, piston
  6 reports
• Monoject 8881400074

  NEEDLE, DENTAL
  5 reports
• Monoject 8881160629

  Syringe, piston
  5 reports
• Monoject 1180320112

  Syringe, piston
  5 reports
• Monoject 8881225307

  Catheter,intravascular,therapeutic,short-term less than 30 days
  5 reports
• Monoject 8881501400

  Syringe, piston
  5 reports
• Monoject 8881202017

  Needle, hypodermic, single lumen
  5 reports
• Monoject 1182515

  Needle, hypodermic, single lumen
  5 reports
• Monoject 11812705

  Syringe, piston
  5 reports
• Monoject 8881501160

  Syringe, piston
  5 reports
• Monoject 8881250248

  Needle, hypodermic, single lumen
  5 reports
• Monoject 8881535762

  Syringe, piston
  5 reports
• Monoject 8881513231

  Syringe, piston
  5 reports
• Monoject 8881200441

  Needle, hypodermic, single lumen
  5 reports
• Monoject 8881401072

  NEEDLE, DENTAL
  4 reports
• Monoject 8881106028

  Syringe, piston
  4 reports
• Monoject 8506Y

  Container, sharps
  4 reports
• Monoject 8881202033

  Needle, hypodermic, single lumen
  4 reports
• Monoject 8881520657

  Syringe, piston
  4 reports
• Monoject 8881511310

  Syringe, piston
  4 reports
• Monoject 8881200508

  Needle, hypodermic, single lumen
  4 reports
• Monoject 8980S

  Container, sharps
  4 reports
• Monoject 31142222

  Container, sharps
  4 reports
• Monoject 8881112059

  Syringe, piston
  3 reports
• Monoject 8881112083

  Syringe, piston
  3 reports
• Monoject 8881225315

  Catheter,intravascular,therapeutic,short-term less than 30 days
  3 reports
• Monoject 1180600555

  Syringe, piston
  3 reports
• Monoject 8881106010

  Syringe, piston
  3 reports
• Monoject 8881245164

  NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE
  3 reports
• Monoject 85221R

  Container, sharps
  3 reports
• Monoject 8881103066

  Syringe, piston
  3 reports
• Monoject 1182210

  Needle, hypodermic, single lumen
  3 reports
• Monoject 1182705

  Needle, hypodermic, single lumen
  3 reports
• Monoject 8881400058

  NEEDLE, DENTAL
  3 reports
• Monoject 8881401056

  NEEDLE, DENTAL
  3 reports
• Monoject 8881570123

  Saline, vascular access flush
  3 reports
• Monoject 8932PG2

  Container, sharps
  3 reports
• Monoject 8881412012

  Syringe, piston
  2 reports
• Monoject 1188825112

  Needle, hypodermic, single lumen
  2 reports
• Monoject 1188830340

  Needle, hypodermic, single lumen
  2 reports
• Monoject 8881512977

  Syringe, piston
  2 reports
• Monoject 8881513207

  Syringe, piston
  2 reports
• Monoject 8881516200

  Syringe, piston
  2 reports
• Monoject 8881520251

  Syringe, piston
  2 reports
• Monoject 8881560232

  Syringe, piston
  2 reports
• Monoject 8881225265

  Tubes, vacuum sample, with anticoagulant
  2 reports
• Monoject 1188100777

  Syringe, piston
  2 reports
• Monoject 8881247111

  NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE
  2 reports
• Monoject 8303SA

  Container, sharps
  2 reports
• Monoject 11832115

  Syringe, piston
  2 reports
• Monoject 11832215

  Syringe, piston
  2 reports
• Monoject 11832310

  Syringe, piston
  2 reports
• Monoject 1182110

  Needle, hypodermic, single lumen
  2 reports
• Monoject 1182315

  Needle, hypodermic, single lumen
  2 reports
• Monoject 1181815

  Needle, hypodermic, single lumen
  2 reports
• Monoject 1183005

  Needle, hypodermic, single lumen
  2 reports
• Monoject 11812558

  Syringe, piston
  2 reports
• Monoject 8881570121D

  Saline, vascular access flush
  2 reports
• Monoject 8881520665

  Syringe, piston
  2 reports
• Monoject 8881560224

  Syringe, piston
  2 reports
• Monoject 8881250305

  Needle, hypodermic, single lumen
  2 reports
• Monoject 8881511144

  Syringe, piston
  2 reports
• Monoject 8881511235

  Syringe, piston
  2 reports
• Monoject 8881250032

  Needle, hypodermic, single lumen
  2 reports
• Monoject 8881114063

  Syringe, piston
  2 reports
• Monoject 8881570125

  Saline, vascular access flush
  2 reports
• Monoject 8881200052

  Needle, hypodermic, single lumen
  2 reports
• Monoject 8881200755

  Needle, hypodermic, single lumen
  2 reports
• Monoject 8935

  Container, sharps
  2 reports
• Monoject 8938

  Container, sharps
  2 reports

Recent Monoject adverse event reports

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

• InjurySep 2, 2026Detachment of Device or Device Component

  It was reported that the physician inserted a 27G 1 1/2" Monoject standard hypodermic needle to provide local anesthetic and when the needle was removed, there was no needle on the hub. Additional information received on 05 AUG 2026 stated that that the needle was retained in the patient and based on follow up CT scan it was deemed unsafe to remove. On (b)(6) 2026 it was stated that the needle is in the patient's lung parenchyma. The patient has been discharged from the hospital.

  Patient problems: Foreign Body In Patient

  MAUDE report 50567869 ↗
• MalfunctionJan 16, 2026Decoupling; Fluid/Blood Leak

  CUSTOMER REPORTED THAT DURING THE INJECTION OF THE VARIVAX, TOWARDS THE END OF THE INJECTION VOLUME AMOUNT, THE NEEDLE SEPARATED/UNSCREWED ITSELF FROM THE SYRINGE. THE REMAINING VOLUME OF VARIVAX LEAKED OUT OF THE SYRINGE AND WAS SUBSEQUENTLY NOT ADMINISTERED TO THE PATIENT. APPROXIMATELY 0.1ML-0.2 ML APPEARED TO BE THE AMOUNT THAT LEAKED OUT. PATIENT RECEIVED MAJORITY OF TOTAL VOLUME AMOUNT. IT APPEARS THAT THE NEEDLE AND SYRINGE DID NOT HAVE A GOOD SEAL, DESPITE MY EFFORTS OF ENSURING A SUFFICIENT SEAL X 2 (BEFORE DRAWING UP THE VACCINE AND AFTER DRAWING UP THE VACCINE), LEADING TO THE DETACHMENT OF THE TWO DEVICES DURING THE INJECTION. MD NOTIFIED, I DISCUSSED WITH DAD THAT I FELT AS IF THE PATIENT RECEIVED THE MAJORITY OF THE VOLUME INJECTION AND DAD AGREED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24092472 ↗
• MalfunctionDec 19, 2025Break

  FROM STAFF: 60ML MONOJECT SYRINGE PLUNGER WAS BROKEN AND SHARP. I WAS DRAWING UP FLUIDS FROM AN IV BAG AND NOTED THE PLUNGER WAS OBVIOUSLY DEFECTIVE, PACKAGING WAS INTACT AND LOOKED NEW. THIS SEEMS TO BE A DEFECTIVE PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23849755 ↗
• MalfunctionDec 15, 2025Device Markings/Labelling Problem

  COVIDIEN MONOJECT 1ML INSULIN SAFETY SYRINGE FOUND TO HAVE MISPRINTED LABEL ON SYRINGE. PRINTING WAS TWISTED AROUND SYRINGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23802102 ↗
• MalfunctionAug 22, 2025Defective Component; Defective Component

  CUSTOMER REPORTED THAT THEY ARE CURRENTLY EXPERIENCING CORED MEDICATION BOTTLES RESULTING IN DEBRIS BEING PRESENT IN THE SYRINGES PRIOR TO ADMINISTRATION. IT WAS FIRST NOTED WITH THE MEDICATION APONVIE BUT NOW HAS OCCURRED WITH TORADOL. THE SAME BRAND NEEDLE WAS USED WITH THE DIFFERENT VIALS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22870265 ↗
• MalfunctionJul 28, 2025Partial Blockage; Partial Blockage

  CUSTOMER REPORTED THAT WHEN BEING UTILIZED IT IS DIFFICULT TO PUSH MEDICATIONS THROUGH, AT TIMES UNABLE TO PUSH MEDICATIONS OR FEELS AS IF GETTING PUSH BACK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22628551 ↗
• MalfunctionJul 28, 2025Defective Component; Defective Component

  CUSTOMER REPORTED THAT THEIR CURRENT BLUNT TIP NEEDLE IS CORING THE RUBBER TOPS OF MEDICATION VIALS LEAVING A PIECE OF RUBBER IN THE MEDICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22628536 ↗
• MalfunctionJul 23, 2025Fluid/Blood Leak; Fluid/Blood Leak

  CUSTOMER REPORTED THAT THEY WERE HAVING ISSUES WITH THIS NEEDLE LEAKING. WHEN THEIR LAB WAS DRAWING BLOOD, THE BLOOD STARTS RUNNING OUT THE SIDE OF THE NEEDLE DOWN THE PATIENT'S ARM. THE CUSTOMER ALSO STATED THAT THIS IS ALSO HAPPENING WITH MEDICATION BEING ADMINISTERED TO PATIENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22574109 ↗
• MalfunctionJul 9, 2025Defective Component; Defective Component

  CUSTOMER REPORTED THAT STAFF ARE EXPERIENCING CORING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22456237 ↗
• MalfunctionJul 2, 2025Defective Component; Defective Component

  CUSTOMER REPORTED THAT WHILE PREPARING AN INJECTABLE LOCAL ANAESTHETIC FOR A SUB TENON BLOCK, THEY DREW UP 10CC OF 0.75% BUPIVACAINE. UPON INSPECTION, THEY NOTICED A GRAY PARTICULATE MATERIAL FLOATING IN THE SYRINGE. THEY DISCARDED THE INITIAL BLOCK AND PROCEEDED TO PREPARE A SECOND ONE. DURING THE PREPARATION OF A SEPARATE BLOCK FOR A DIFFERENT CASE, THEY OBSERVED THE SAME GRAY MATERIAL FLOATING IN THE SYRINGE, DESPITE USING A DIFFERENT BOTTLE OF 0.75% BUPIVACAINE THAT ALSO HAD A DIFFERENT LOT NUMBER. UPON FURTHER INVESTIGATION, THEY IDENTIFIED THAT THE GRAY MATERIAL WAS ORIGINATING FROM THE STOPPER OF THE BUPIVACAINE BOTTLE DURING THE ASPIRATION PROCESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22382120 ↗
• MalfunctionJun 17, 2025Fluid/Blood Leak; Fluid/Blood Leak

  CUSTOMER REPORTED THAT THEIR PA WAS INJECTING LIDOCAINE AND WAS SPRAYED IN THE EYE. HE STATES IT WAS COMING OUT THE SIDES AND THAT THERE WAS A HOLE IN THE PLASTIC NEEDLE CONNECTION. THE PA SAID HE WAS ATTEMPTING A TENDON SHEATH INJECTION WHEN THE MEDICATION SPRAYED OUT THE SIDE OF THE PLASTIC HUB-NEEDLE CONNECTION. HE CONFIRMED NEEDLE WAS TWISTED ON TIGHTLY AND ATTEMPTED INJECTION AGAIN AND IT CONTINUED TO SPRAY OUT THE SIDES OF THE HUB, SPRAYING THE PA AND THE PATIENT. INJECTION ABORTED. GAUZE HELD TO PUNCTURE SITE TO OBTAIN HAEMOSTASIS. NEW INJECTION DREW UP AND USED A 25-GAUGE NEEDLE FROM A DIFFERENT LOT # TO PROCEED WITH THE INJECTION SAFELY. NO PATIENT HARM NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22226602 ↗
• MalfunctionMay 29, 2025Decoupling; Decoupling

  "CUSTOMER REPORTED THAT THEY ARE EXPERIENCING A COUPLE OF NEEDLESTICKS WITH THE SYRINGE/NEEDLE SET, MONOJECT 27G X 1/2" NEEDLE. THE NEEDLE STICKS HAVE OCCURRED AFTER ATTEMPTING TO ENGAGE THE SAFETY CAP ON THE NEEDLE BY PRESSING THE WING TAB ON A TABLE OR OTHER HARD SURFACE. THEY ACTUALLY TEACH THIS METHOD VS USING THE OTHER HAND TO ENGAGE SAFETY CAPS. THE NEEDLE PORTION BECAME DISLODGED "POPPED OFF" FLYING BACK AT THE EMPLOYEE AND STICKING INTO THEIR HAND CAUSING A NEEDLE STICK. THE LUER-LOC DOESN'T APPEAR CRACKED OR DISTORTED IN ANY WAY.

  Patient problems: Needle Stick/Puncture

  MAUDE report 22106378 ↗
• MalfunctionMay 16, 2025Break; Defective Component; Material Twisted/Bent; Break; Defective Component; Material Twisted/Bent

  THE CUSTOMER REPORTED ISSUES WITH SAFETY NEEDLES RESULTING IN NEEDLE STICKS AND NEAR MISSES HOWEVER SPECIFIC INCIDENT INFORMATION OR A QUANTITY OF INCIDENTS COULD NOT BE PROVIDED. THEY STATED THAT WHEN YOU CLOSE THE SAFETY CAP, IT ACTUALLY JUST BENDS THE NEEDLE. THE NEEDLES DO NOT FIT PROPERLY INTO THEIR SYRINGES, AND IT IS IMPOSSIBLE TO TIGHTEN THEM, AND THEY OFTEN COME UNSCREWED AND FALL OFF. THE PLASTIC SAFETY CAP ALSO BREAKS OFF EASILY OR GETS BENT WHEN MOVING IT OUT OF THE WAY TO GIVE AN INJECTION. MULTIPLE STAFF MEMBERS HAVE HAD EXPOSURES DUE TO NEEDLE POKES OR NEAR MISSES. THEY STATED THIS IS REALLY UNACCEPTABLE AND A MAJOR SAFETY CONCERN FOR THEIR STAFF WHO ARE FREQUENTLY WORKING WITH VIREMIC HIV PATIENTS. ADDITIONALLY THEY STATED THAT THE SAFETY DOESN'T ALWAYS ENGAGE WELL, THE NEEDLE IS MORE LIKELY TO DISLODGE FROM THE HUB THAN OTHER PRODUCTS, AND THE NEEDLES ARE MORE LIKELY TO BEND. ADDITIONAL INFORMATION RECEIVED ON 11OCT2024 STATED THAT THEY HAVE HAD OTHER STAFF MEMBER WHO DID NOT GET STUCK, BUT THE NEEDLE BENT AND ALMOST POKED THEM. ANECDOTALLY, OVER A YEAR AGO NOW THEY HAD THIS EXACT NEEDLE MALFUNCTION AND THEY WERE STUCK AFTER INJECTING A PATIENT AS THEY CLOSED THE S

  Patient problems: Needle Stick/Puncture

  MAUDE report 22035765 ↗
• MalfunctionMay 16, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THEY ARE HAVING ISSUES WITH THE LUER LOCK HUBS NOT LOCKING WHICH HAS CAUSED THE CONTENTS (VACCINE) TO LEAK OUT INSTEAD OF BEING INJECTED INTO THE PATIENT. THEY HAVE ALSO HAD INSTANCES WHERE THE NEEDLE HAS COME OFF THE HUB AND THE VACCINE LEAKS OUT, WITH THE NEEDLE STAYING IN THE PATIENT'S ARM. NO INJURY OR MEDICAL TREATMENT REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22035763 ↗
• MalfunctionMay 16, 2025Defective Component; Defective Component

  THE CUSTOMER REPORTED THAT OVER THE PAST FEW WEEKS SHE HAS NOTICED AN INCREASE OF CORING MEDICATIONS (PARTS OF THE RUBBER STOPPER IS GETTING SLICED BY BLUNT TIP NEEDLES AND BEING IN MEDICATION SYRINGES). THEY ARE SMALL PIECES BUT A RISK OF INJECTING THESE SMALL PIECES OF RUBBER INTO PATIENTS IS VERY POSSIBLE. SOME RUBBER PARTS ARE PREVENTING EASY WITHDRAWAL OF MEDICATIONS FROM VIALS - WHILE OTHER ARE JUST FLOATING AROUND IN THE SYRINGES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22035696 ↗

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