Jamshidi EJM4011Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10885403464157), received between Nov 12, 2021 and Jul 20, 2026 — classified as 1 injury, 8 malfunctions.

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

1 FDA recall record name this device's identifier, 1 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, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Jun 23, 2021Open, Classified

   Due to complaints received regarding incomplete/open packaging seals potentially causing product to non-sterile.

   Z-2248-2021 · Root cause: Packaging process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 20, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25876584 ↗
• MalfunctionFeb 20, 2026Nonstandard Device

  IT WAS REPORTED THAT ON (B)(6), 2025. THE JAMSHIDI NEEDLE INNER STYLET DISENGAGED FROM THE HANDLE CAUSING IT TO GET STUCK AND THEY HAD TO USE A FORCEPS TO REMOVE THE INNER STYLET RESULTING IN PROLONGED PROCEDURE, SPECIMEN NOT COLLECTED APPROPRIATELY. A NEW NEEDLE HAD TO BE USED. BASED ON FOLLOW UP RESPONSE RECEIVED ON 30-JAN-2026 IT WAS FURTHER REPORTED THAT THE ISSUE OCCURRED DURING ADVANCING THE DEVICE INSIDE THE PATIENT DURING THE BONE MARROW BIOPSY PROCEDURE, AS A RESULT ONLY PARTIAL SPECIMEN WAS COLLECTED. THE PARTIAL SAMPLE WAS SENT FOR ANALYSIS. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24407815 ↗
• MalfunctionJan 21, 2026Loose or Intermittent Connection

  IT WAS REPORTED THAT WHEN CONNECTING A LUER LOCK SYRINGE TO THE TOP OF SUCTION PORT, IT DID NOT CREATE A SEAL. DIFFERENT TYPES OF SYRINGES WERE USED, REINSERTION OF NEW JAMSHIDI NEEDLE CAUSING A LONGER PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24131573 ↗
• MalfunctionNov 12, 2025Contamination; Contamination

  IT WAS REPORTED THAT ON 16-OCTOBER-2025, THE JAMSHIDI NEEDLE HAD A PACKAGE ISSUE AS THERE WAS BLUE COLOR SHOWING INSIDE THE PACKAGE. THE ISSUE WAS REPORTED TO BE DETECTED DURING INSTALLATION; HOWEVER, IT WAS ALSO REPORTED THAT THE AFFECTED PRODUCT WAS NOT USED ON A PATIENT. FURTHERMORE, THERE WAS NO IMPACT TO THE PATIENT REPORTED. BASED ON FOLLOW UP RESPONSE, IT WAS FURTHER CONFIRMED THAT THERE WAS NO PATIENT HARM AND THAT THE ISSUE WAS IDENTIFIED WHEN THE PACKAGED WAS BEING OPENED. THE DOCTOR RETURNED TO THE PURCHASE DEPARTMENT PRIOR TO BEING USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23533003 ↗
• MalfunctionDec 5, 2024Break; Break

  IT WAS REPORTED THAT DURING A BONE MARROW BIOPSY PROCEDURE, THE WHITE CAP/HANDLE PART OF THE CRADLE CAME OFF. IT WAS FURTHER REPORTED THAT FORCEPS WERE USED TO REMOVE THE DEVICE FROM THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY. RCC RECEIVED A COMPLAINT VIA EMAIL. WE HAD AN INCIDENT DURING A BONE MARROW PROCEDURE WITH ITEM# EJM4011. WHEN THE PHYSICIAN ASSISTANT WAS COLLECTING THE BIOPSY, THE WHITE CAP/HANDLE PART OF THE CRADLE CAME OFF. THEY WERE ABLE TO USE FORCEPS TO GRIP THE PART AND REMOVE FROM THE PATIENT. LOT NUMBER: 0001578725. DATE OF MANUFACTURER: 2024-07-18.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20859105 ↗
• MalfunctionApr 12, 2022Unsealed Device Packaging; Unsealed Device Packaging

  THE CUSTOMER REPORTED THAT TWO OF 10 PACKAGES WERE OPEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14083944 ↗
• MalfunctionFeb 3, 2022Packaging Problem; Packaging Problem

  THIS IS A REPORT ABOUT AN OPEN PACKAGE. ACCORDING TO THE CUSTOMER'S REPORT, THE PACKAGE WAS FOUND TO BE OPEN BEFORE USE, AND THIS PRODUCT WAS THUS NOT USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13446347 ↗
• MalfunctionNov 12, 2021Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE INNER MEASURING STICK DID NOT HAVE MEASUREMENT LINES. VERBATIM: IT WAS REPORTED THAT THE INNER MEASURING STICK DID NOT HAVE MEASUREMENT LINES DESCRIBE THE EVENT OR PROBLEM: IT WAS REPORTED THAT THE INNER MEASURING STICK DID NOT HAVE MEASUREMENT LINES. MANUFACTURER RESPONSE FOR BONE MARROW BIOPSY NEEDLE, (BRAND NOT PROVIDED) (PER SITE REPORTER) : NONE YET. WHAT WAS THE ORIGINAL INTENDED PROCEDURE? : BONE MARROW BIOPSY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12804133 ↗
• InjuryNov 12, 2021Break; Break

  IT WAS REPORTED THAT DURING A BONE MARROW BIOPSY PROCEDURE, THE DEVICE ALLEGEDLY BROKE. IT WAS FURTHER REPORTED THAT A METAL STRAW PIECE FROM THE DEVICE PUNCTURED THE FINGER OF THE HCP AND AS A RESULT STARTED BLEEDING. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THE PATIENT WAS NOT INJURED AND THE HCP WAS NOTED TO BE IN A STABLE CONDITION.

  Patient problems: Needle Stick/Puncture

  MAUDE report 12804026 ↗