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EXEL Hypodermic Disposable Needles 26426Recalls & reported problems

Exel International · EXEL Hypodermic Needle, 27Gx1 1/2" · Class 2

Adverse event reports
5
Deaths reported
0
Injuries reported
5
Recalls naming it
0

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10020221264262), received between Feb 7, 2024 and Jul 28, 2026 — classified as 5 injuries.

The most frequently reported specific device problem is “Break” (3 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

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 1 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 1 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 1 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 1 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 1 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Break3
  • Detachment of Device or Device Component1
  • Improper or Incorrect Procedure or Method1
  • Material Twisted/Bent1

Patient problems

  • Foreign Body In Patient2
  • Device Embedded In Tissue or Plaque1
  • Needle Stick/Puncture1
  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

  • InjuryJul 28, 2026Improper or Incorrect Procedure or Method

    After performing a procedure, the customer reported that he pricked his thumb when he tried to re-cap the needle.

    Patient problems: Needle Stick/Puncture

    MAUDE report 50063838 ↗
  • InjuryJun 7, 2025Break; Break

    A COMPLAINANT REPORTED NEEDLE QUALITY ISSUE; THE NEEDLE BROKE OFF BEHIND KNEECAP. A SCALPEL HAD TO BE USED TO OPEN THE PATIENTS KNEECAP TO REMOVE THE NEEDLE. PRIOR TO THE KNEE INJECTION PROCEDURE, THEY ASPIRATED 27 CC OF SEROUS FLUID. AT THE END OF THE ASPIRATION, THEY NOTICED THAT THE NEEDLE HAD DISLODGED DEEP IN THE RETROPATELLAR SPACE. SURGICAL RETRIEVAL OF THE BROKEN OFF NEEDLE WAS REQUIRED, AS THE ENTIRE METALLIC NEEDLE WAS IN THE DEEP RETROPATELLAR SPACE. THE COMPLAINANT STATED THAT THEY WERE ABLE TO RETRIEVE THE BROKEN OFF AND DISLODGED NEEDLE IN ITS ENTIRETY VIA A HEMOSTAT, WITH THE AID OF FLUOROSCOPY AND SURGICAL DISSECTION. THE NEEDLE MEASUREMENT L (3.8 CM WHICH WAS BENT AT 2.9 CM).

    Patient problems: Foreign Body In Patient

    MAUDE report 22162886 ↗
  • InjuryMar 28, 2025Break; Break

    THE CALLER REPORTED THAT DURING NECK SURGERY, THE HYPODERMIC NEEDLE SNAPPED DURING THE PROCEDURE. THE DOCTOR ATTEMPTED TO LOCATE THE NEEDLE DURING THE PROCEDURE BUT COULD NOT FIND IT. THREE DAYS LATER, THE PATIENT WAS ADVISED TO UNDERGO AN X-RAY. THE X-RAY RESULTS CONFIRMED THE NEEDLE HAD BEEN LEFT IN THE PATIENT'S NECK. THE DOCTOR STATED THAT THE PATIENT DID NOT FEEL OR EXPERIENCE ANY PAIN WHEN THE ISSUE WAS INITIALLY REPORTED.

    Patient problems: Device Embedded In Tissue or Plaque

    MAUDE report 21721941 ↗
  • InjuryMay 1, 2024Break; Material Twisted/Bent; Break; Material Twisted/Bent

    TWO NEEDLES WERE BENT IN HALF AND ONE BROKE OFF IN THE PATIENT DURING INJECTION. THE NEEDLE BROKE OFF AT THE PLASTIC TO THE METAL CONNECTION. THE PATIENT HAD TO BE TAKEN BY AMBULANCE TO THE HOSPITAL TO HAVE THE NEEDLE REMOVED.  THE HOSPITAL PERSONNEL IN THE EMERGENCY DEPARTMENT HAD THE PROPER EQUIPMENT TO REMOVE THE NEEDLE BY OPENING THE INJECTION SITE UNDER A LOCAL ANESTHESIA AND WERE ABLE TO REMOVE IT WITHOUT REQUIRING MORE INVASIVE SURGERY. A LOT SEARCH REVEALED ONE (CMP-37) SIMILAR COMPLAINT EVENT FROM THIS PRODUCT/LOT COMBINATION. INVESTIGATION IS ONGOING.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19224303 ↗
  • InjuryFeb 7, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

    PER CLINIC MANAGER: "ON (B)(6) 2024 ONE OF OUR PROVIDER'S REPORTED THE NEEDLE CLEANLY DETACHED ITSELF FROM THE HUB DURING THE PROCEDURE. THERE WAS NO EVIDENCE OF NEEDLE BREAKAGE OR FRACTURE FROM THE HUB. THE NEEDLES WERE PURCHASED FROM MCKESSON." THE FOLLOWING INFORMATION WAS PROVIDED VIA TELEPHONE CONVERSATION BETWEEN EXEL QA SPECIALIST AND THE CLINIC MANAGER: PATIENT WAS AT THE PAIN MANAGEMENT CENTER OF THE HOSPITAL FOR TRIGGER POINT THERAPY TO INJECT LIDOCAINE TO THE SUPERIOR ASPECT OF LUMBAR MIDLINE. IT WAS REPORTED THAT EXEL HYPO NDL 27GX1-1/2" P/N: 26426, LOT #230602 NEEDLE BROKE FROM THE SIRING HUB AND LODGED IN THE PATIENT. THE PROCEDURE WAS COMPLETED USING ANOTHER NEEDLE FROM THE SAME LOT. THE PATIENT WAS SENT TO URGENT CARE WHERE THE PHYSICIAN PERFORMED A SUPERFICIAL INCISION AND WAS ABLE TO SUCCESSFULLY REMOVED THE NEEDLE. THE INCISION WAS SUTURED AND THE PATIENT IS STATED TO BE WELL. THE CLINIC MANAGER REPORTED THAT THIS IS THE FIRST INCIDENT WITH A BROKEN NEEDLE AND THAT ITS NOT HAPPENED BEFORE WITH THE SAME OR OTHER BRANDS. NO IMAGES OF THE DAMAGED NEEDLE WERE TAKEN AND NEITHER THE NEEDLE NOR SYRINGE WERE RETAINED. IT WAS STATED THAT THE PT DID NOT HAVE ANY OTHER ISSU

    Patient problems: Foreign Body In Patient

    MAUDE report 18664758 ↗

Other Needle, Hypodermic, Single Lumen devices

All Needle, Hypodermic, Single Lumen devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.