EXEL Hypodermic Disposable Needles 26427Recalls & reported problems
Exel International · EXEL Hypodermic Needle, 27Gx1 1/4" · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10020221264279), received between May 10, 2019 and Mar 9, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component1
- Material Integrity Problem1
- No Apparent Adverse Event1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- Vessel Or Plaque, Device Embedded In1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 9, 2026Material Integrity Problem; No Apparent Adverse Event
CUSTOMER REPORTED THE NEEDLES ARE LEAVING A GRAY/SILVER METALLIC RESIDUE ON PATIENT'S SKIN. HOWEVER, AFTER FURTHER CLARIFICATION, THE CUSTOMER CONFIRMED THAT THIS PARTICULAR PRODUCT, PRODUCT #26427, LOT # 231101, DID NOT LEAVE ANY MARK ON PATIENT'S SKIN. THE ISSUE WAS ASSOCIATED WITH A PRODUCT FROM ANOTHER BRAND. FOLLOWING THIS INCIDENT, THE CLINICIANS BEGAN TESTING SEVERAL NEEDLES, INCLUDING PRODUCT # 26427, LOT #231101, BY WIPING THEM WITH WHITE TISSUE PAPERS, WHICH LEFT A GRAY MARK ON THE TISSUE. THERE WAS NO ADVERSE EVENT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24553800 ↗MalfunctionMay 10, 2019Detachment of Device or Device Component; Detachment of Device or Device Component
A 27 GAUGE NEEDLE WAS USED TO CIRCUMFERENTIALLY INJECT LIDOCAINE AROUND THE SOFT TISSUE NECK MASS ON (B)(6) 2019. THE MASS WAS NOT FIXED TO THE SKIN OR UNDERLYING MUSCLE. THE NEEDLE WAS BEING WITHDRAWN WITHOUT DIFFICULTY FROM ONE OF THE SUBCUTANEOUS INJECTION SITES AND SPONTANEOUSLY DETACHED FROM THE HUB, BENEATH THE SKIN. IT WAS NOT BENT OR TORQUED BEFORE OR DURING THE INJECTION PROCESS. THE NEEDLE WAS UNABLE TO BE LOCATED DURING THIS EXCISIONAL BIOPSY PROCEDURE. THE EXCISIONAL BIOPSY WAS COMPLETED HOWEVER. SOFT TISSUE X-RAYS ON (B)(6) 2019 REVEALED AN INTACT, UNBENT NEEDLE BENEATH THE SKIN AND SURGICAL INCISION. IT WAS REMOVED UNDER FLUOROSCOPIC GUIDANCE ON (B)(6) 2019. A SEPARATE NEW INCISION WAS USED FOR THE REMOVAL. A HEMOSTAT WAS USED TO GRASP THE NEEDLE AND IT WAS BENT ONLY AT THE TIME OF EXTRACTION. AT NO TIME WAS THE NEEDLE BENT DURING THE ORIGINAL PROCEDURE. THIS IS CONFIRMED BY X-RAYS PRIOR TO THE EXTRACTION PROCEDURE OF (B)(6) 2019. SURGERY AND LOCALIZATION WERE DIFFICULT AND REQUIRED GENERAL ANESTHESIA FOR THE NEEDLE EXTRACTION PROCEDURE.
Patient problems: Vessel Or Plaque, Device Embedded In
MAUDE report 8600059 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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