AcuJect G22526Recalls & reported problems
Cook Incorporated · Acujet Variable Injection Needle · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00827002225268), received between May 27, 2026 and May 27, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).
1 FDA recall record name this device's identifier.
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
Recalls naming this device
- Jun 14, 2019Terminated
Potential for occluded injection needles.
Z-2089-2019 · Root cause: Employee error · FDA record ↗
Most reported problems
Device problems
- Detachment of Device or Device Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 27, 2026Detachment of Device or Device Component
IN PREPARATION FOR A PROCEDURE, THE PHYSICIAN SELECTED TWO A COOK ACUJECT VARIABLE INJECTION NEEDLES. IT WAS INITIALLY REPORTED THAT BEFORE USE [THE PHYSICIAN] REMOVED THE INJECTION NEEDLE FROM THE PACKAGING BOX ACCORDING TO THE GUIDANCE AND TESTED WHETHER THE NEEDLE COULD BE RETRACTED AND EXTENDED NORMALLY. IT WAS FOUND THAT THE NEEDLE CORE COULD NOT BE FLEXIBLY ADVANCED AND RETRACTED ACCORDING TO THE HANDLE OPERATION. ANOTHER OF THE SAME DEVICE WAS USED FOR CONTINUED TREATMENT. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. OUR EVALUATION OF THE RETURNED DEVICE ON 01 MAY 2026 DETERMINED THAT THE HANDLE IS DETACHED FROM THE INNER CATHETER [UNABLE TO INJECT - SUBJECT OF REPORT]. THIS OCCURRED PRIOR TO PATIENT CONTACT; THERE WAS NO IMPACT TO THE PATIENT. IN ADDITION, THE USER SUSTAINED NO CLINICAL CONSEQUENCE AND THERE WERE NO ADVERSE EFFECTS TO THE USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25300608 ↗
Other endoscopic injection needle, gastroenterology-urology devices
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- n.a. 27030NKarl Storz GmbH & Co. KG · endoscopic injection needle, gastroenterology-urology1 recall0 reports
- injeTAK Adjustable Tip Needle 70cm DIS201Laborie Medical Technologies Canada ULC · endoscopic injection needle, gastroenterology-urology1 recall0 reports
- Single Use Injector NM-401L-0425Olympus Medical Systems Corp. · endoscopic injection needle, gastroenterology-urology28 reports
- Single Use Injector NM-401L-0423Olympus Medical Systems Corp. · endoscopic injection needle, gastroenterology-urology27 reports
- Single Use Injector NM-401L-0425Olympus Medical Systems Corp. · endoscopic injection needle, gastroenterology-urology26 reports
- Single Use Injector NM-401L-0423Olympus Medical Systems Corp. · endoscopic injection needle, gastroenterology-urology20 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 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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