Jamshidi BAK4511Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10885403057236), received between Sep 27, 2023 and Mar 12, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Contamination” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 12, 2026Contamination

  THE CUSTOMER REPORTED THAT CERTAIN COMPONENTS WITHIN THE JAMSHIDI BONE MARROW TRAY 11G X 4, 15G ASP WERE FOUND TO BE DUSTY OR DIRTY.

  Patient problems: Insufficient Information

  MAUDE report 24580073 ↗
• MalfunctionOct 8, 2025Contamination; Contamination

  IT WAS REPORTED THAT A JAMSHIDI BONE MARROW TRAY CONTAINED A HAIR INSIDE ONE OF THE STERILE BONE MARROW BIOPSY KITS. NO INJURIES OR ADVERSE EVENTS OCCURRED. ONLY ONE KIT WAS AFFECTED, AND NO SAMPLE IS AVAILABLE FOR RETURN AS THE PRACTITIONER DISCARDED THE KIT AND OPENED A NEW ONE BEFORE TAKING A PHOTO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23247885 ↗
• MalfunctionSep 27, 2023Contamination; Contamination

  IT WAS REPORTED BY THE CUSTOMER THAT THEY FOUND A LONG BROWN HUMAN HAIR. VERBATIM: RCC RECEIVED THE COMPLAINT VIA EMAIL. EMAIL(S) AS ATTACHED. DR. GARCIA JUST HANDED ME A BONE MARROW KIT , HE WAS OPENING TO START A STERILE PROCEDURE ON A PATIENT . IN THE KIT, HE FOUND A LONG BROWN HUMAN HAIR . THIS IS QUITE CONCERNING AS THE KITS ARE SUPPOSED TO BE STERILE . ¿ TRAYS, BONE MARROW: JAMSHIDI BONE MARROW TRAY WITH DISPOSABLE 4" NEEDLE (B)(6) ¿ LAST TIME WE PURCHASED WAS ON 8/31/2023 PO # (B)(4) AT THIS TIME, WE WOULD LIKE TO BE SURE OF THE FOLLOWING. 1. THE KITS ARE PREPARED UNDER STERILE PROCESS. 2. WHERE ARE THESE KITS BEING PREPARED FROM? 3. IS THERE A STANDARD POLICY THEY FOLLOW TO PREPARE THESE KITS ? 4. THIS KIT WILL BE TAKEN BACK, AND A CREDIT FOR THE 1 KIT WILL BE APPLIED PLEASE. AS WE PERFORM STERILE BONE MARROW BIOPSY¿S REGULARLY, WE HAVE GREAT CONCERN MOVING FORWARD WITH THIS PRODUCT THAT IS BEING PREPARED AND SHIPPED IS ACTUALLY UNDER STERILE PROCESS. IF YOU CAN PLEASE CONTACT THE MEDLINE TEAM TO IDENTIFY WHAT WILL BE DONE AND HOW THE KITS ARE BEING PREPARED , BY WHOM AND ARE THEY UNDER STERILE PROCESSES ? RESPONSE RECEIVED ON 02-OCT-2023: I JUST RECEIVED THIS REQUEST FOR A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17826114 ↗