Jamshidi DJ4008XRecalls & reported problems

Carefusion 2200, Inc · Jamshidi Bone Marrow Biopsy/Aspiration Needle, with Luer-Lock Adapter 8GX4 ASP · Class 2

All models of Jamshidi (18)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885403087134), received between Apr 12, 2021 and Apr 12, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Tear, Rip or Hole in Device Packaging” (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.

Most reported problems

Device problems

Tear, Rip or Hole in Device Packaging1

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.

MalfunctionApr 12, 2021Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
THIS IS A REPORT ABOUT PACKAGE SEAL INTEGRITY. ACCORDING TO THE CUSTOMER'S REPORT, THERE WAS A SEALING DEFECT ON THE PACKAGE. THE PACKAGE WAS OPENED. IT WAS FOUND BEFORE USE. THE CUSTOMER DOESN'T REPORTED ANY OTHER DEFECT OTHER THAN PACKAGE WAS OPENED. BDJ RECEIVED AN ACTUAL UNOPENED SAMPLE AND CONFIRMED THE SEALING OF PACKAGE WAS OPENED AT THE LENGTH OF 5 CM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11649361 ↗

Device details

UDI-DI	`10885403087134`
Brand	Jamshidi
Model	DJ4008X
Company	Carefusion 2200, Inc
Product code	KNW · INSTRUMENT, BIOPSY
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Jan 16, 2025

Device type (GMDN): Bone marrow biopsy needle, single-use

A sterile, sharp bevel-edged, hollow tubular metal instrument designed to obtain a specimen of bone marrow percutaneously. The device is typically available in a variety of large bores, and is sufficiently robust to penetrate bone (usually the hip bone or posterior iliac crest) with the force of pressure and twisting manually applied to its proximal handgrip. The resultant specimen is typically used for the pathological analysis of the source of blood cellular elements. This is a single-use device.

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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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