JamshidiRecalls & reported problems across all models
Carefusion 2200, Inc · 18 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names at least one Jamshidi model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 53
- Deaths reported
- 0
- Injuries reported
- 16
- Recalls
- 4
We found 18 models of Jamshidi by Carefusion 2200, Inc in the FDA's device registry (GUDID). Together they are named in 53 adverse event reports in the FDA's MAUDE database, received between Dec 12, 2019 and Apr 1, 2026 — classified as 16 injuries, 37 malfunctions.
The most frequently reported specific device problem is “Break” (14 reports).
4 FDA recall records name at least one of these models by its device 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Jamshidi recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Aug 24, 2021Class IITerminated
Due to misbranded products shipped to customers.
Z-0154-2022 · Root cause: Process control · Recall details · FDA record ↗
- Aug 24, 2021Class IITerminated
Due to misbranded products shipped to customers.
Z-0153-2022 · Root cause: Process control · Recall details · FDA record ↗
- Jun 23, 2021Class IIOpen, Classified
Due to complaints received regarding incomplete/open packaging seals potentially causing product to non-sterile.
Z-2247-2021 · Root cause: Packaging process control · names 5 of these models · Recall details · FDA record ↗
- Aug 1, 2019Class IITerminated
Product Pouches may not be sealed properly and compromise the sterility of the device
Z-2411-2019 · Root cause: Packaging process control · Recall details · FDA record ↗
Most reported Jamshidi problems
Device problems
- Break14
- Contamination12
- Device Contamination with Chemical or Other Material6
- Adverse Event Without Identified Device or Use Problem4
- Device Markings/Labelling Problem4
- Defective Component2
- Fluid/Blood Leak2
- Packaging Problem2
Patient problems
- No Clinical Signs, Symptoms or Conditions38
- Foreign Body In Patient10
- Insufficient Information2
- Needle Stick/Puncture2
- Pain2
- Arthralgia1
- Cardiac Arrest1
- Cough1
Jamshidi models
18 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Jamshidi TJM4008INSTRUMENT, BIOPSY2 recalls1 report
- Jamshidi TJC4011INSTRUMENT, BIOPSY1 recall8 reports
- Jamshidi TJM4011INSTRUMENT, BIOPSY1 recall6 reports
- Jamshidi TJC4008INSTRUMENT, BIOPSY1 recall1 report
- Jamshidi BEK3411INSTRUMENT, BIOPSY1 recall1 report
- Jamshidi TJM6008INSTRUMENT, BIOPSY1 recall0 reports
- Jamshidi BEK4511INSTRUMENT, BIOPSY1 recall0 reports
- Jamshidi DJ4011XINSTRUMENT, BIOPSY17 reports
- Jamshidi DIN1515XNeedle, hypodermic, single lumen4 reports
- Jamshidi BAK4511INSTRUMENT, BIOPSY3 reports
- Jamshidi DIN1518XNeedle, hypodermic, single lumen3 reports
- Jamshidi DJ3513XINSTRUMENT, BIOPSY3 reports
- JAMSHIDI SN1015XTray, surgical, needle1 report
- JAMSHIDI SN7016XTray, surgical, needle1 report
- Jamshidi DJ4008XINSTRUMENT, BIOPSY1 report
- Jamshidi BCTM3411SPInstrument, biopsy1 report
- Jamshidi BEJS4511SPINSTRUMENT, BIOPSY1 report
- Jamshidi BEJS4511INSTRUMENT, BIOPSY1 report
Recent Jamshidi adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionApr 1, 2026Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT A METAL FRAGMENT WAS NOTED ON THE SPECIMEN UPON TRANSFER TO SPECIMEN CONTAINER POST REMOVAL FROM THE PATIENT. THERE WAS NO DEFECT NOTED ON THE JAMSHIDI BONE MARROW NEEDLE. DURING FOLLOW UP RESPONSE IT WAS FURTHER REPORTED THAT THE FAILURE DID NOT CAUSE A TISSUE MISDIAGNOSIS, AND THE DEVICE WAS REMOVED FROM THE PATIENT WITHOUT INCIDENT. THE METAL WAS REMOVED FROM THE SPECIMEN, AND THE HEALTH CARE PROVIDE ENSURED THERE WAS NO FOREIGN MATTER LEFT IN THE PATIENT. IT WAS CONFIRMED BY THE CUSTOMER THAT THE PATIENT WAS NOT INJURED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 24758832 ↗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 ↗MalfunctionFeb 4, 2026Contamination
IT WAS REPORTED BY THE CUSTOMER THAT JAMSHIDI BONE MARROW ITEM WAS FOUND TO BE DEFECTIVE WHEN ATTEMPTING TO USE IT IN THE CENTRAL PROCESSING ROOM. THIS COMPLAINT IS ABOUT TISSUE SAMPLING FAILURE BEFORE USE. DURING THE FOLLOWUP RESPONSE, IT WAS FURTHER REPORTED THAT THE AFFECTED PRODUCT WAS NOT USED, AS THE DEFECT WAS NOTICED PRIOR USE ON PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24259552 ↗MalfunctionNov 21, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED BY CUSTOMER THAT ON (B)(6) 2025, WHEN THE JAMSHIDI WAS INSERTED, NEEDLE THERE WAS SOME LEAKAGE SO NOT ABLE TO ASPIRATE. NO PATIENT HARM WAS REPORTED. THE CLINICIAN USED ANOTHER JAMSHEDI NEEDLE TO COMPLETE THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23622653 ↗MalfunctionOct 15, 2025Contamination; Contamination
IT WAS REPORTED THAT ON 22-SEP-2025 EIGHT JAMSHIDI NEEDLES WERE IDENTIFIED CONTAINING SOME SORT OF FOREIGN PARTICLES. NO PATIENT IMPACT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23290436 ↗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 ↗InjuryMay 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT ON (B)(6) 2025, A BONE MARROW PROCEDURE WAS PERFORMED. SUBSEQUENTLY, ON (B)(6) 2025, THE PATIENT PRESENTED WITH ARTHRALGIA, ODYNOPHAGIA, PRODUCTIVE COUGH, AND FEVER OF 38.2°C. THE PATIENT WAS DIAGNOSED WITH FEVER AND NEUTROPENIA (LOW WHITE BLOOD CELL COUNT), AND NEUROPATHIC PAIN RELATED TO THE USE OF VENCRISTINA (VENCRISTINE) CHEMOTHERAPY MEDICATION. THE PAIN WAS LOCATED IN THE LEFT LOWER EXTREMITY. FURTHER PHYSICAL EXAMINATION IDENTIFIED THE PAIN WAS ON MEDIAL PALPATION OF THE LEFT LEG. THE PATIENT BLOOD METRICS WERE TAKEN AND BASED ON THE RESULTS THE PATIENT WAS PRESCRIBED CEFEPIME TO TREAT THE FEVER AND NEUTROPENIA (LOW WHITE BLOOD CELL COUNT). IT WAS FURTHER REPORTED THAT AN INCREASE IN VOLUME AND REDNESS WAS OBSERVED, ACCOMPANIED BY A HIGH TEMPERATURE IN THE LEFT INNER THIGH; THEREFORE, INFECTIOUS CELLULITIS WAS DIAGNOSED AND CEPHALOTHIN WAS ALSO PRESCRIBED FOR TREATMENT WHICH WAS LATER SUSPENDED AND REPLACED WITH VANCOMYCIN DUE TO UNFAVORABLE TREATMENT EVOLUTION.
Patient problems: Arthralgia; Cough; Dysphagia/ Odynophagia
MAUDE report 22015452 ↗InjuryMay 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT ON (B)(6) 2025, A BONE MARROW ASPIRATION PROCEDURE WAS PERFORMED. SUBSEQUENTLY, ON (B)(6) 2025, THE PATIENT PRESENTED ERYTHEMA, PAIN, AND HEAT AT THE ASPIRATION PUNCTURE SITE. GIVEN THESE FINDINGS, TREATMENT WITH CEPHALOTHIN WAS INITIATED TO TREAT THE BACTERIAL INFECTION. IT WAS FURTHER REPORTED THAT ON (B)(6) 2025, THE LESION WAS POORLY EVOLVING, AND THE SIZE INCREASED TO APPROXIMATELY 4X3CM. IT WAS ALSO MENTIONED THAT GREATER ERYTHEMA, EDEMA, AND LOCALIZED INDURATION, BLACKISH COLORATION IN THE CENTER OF THE LESION, ACCOMPANIED BY AN INCREASED IN LOCAL TEMPERATURE, WITHOUT THE PRESENCE OF FLUID OR PUS (SEROPURULENT SECRETION) WAS OBSERVED. AN ULTRASOUND STUDY OF THE RIGHT ILIAC CREST AND GLUTEUS SHOWED INFLAMMATORY CHANGES IN THE PUNCTURE SITE, WITH NO EVIDENCE OF COLLECTIONS; THEREFORE, CEPHALOTHIN ANTIBIOTIC MEDICATION WAS SUSPENDED AFTER 10 DAYS OF USE AND THERAPY WITH VANCOMYCIN WAS STARTED TO CONTINUE BACTERIAL INFECTION TREATMENT. HOWEVER, A PURULENT ABSCESS (PUS) DEVELOPED WHICH WAS DRAINED AND CULTURED. ON (B)(6) 2025, THE TREATMENT WAS SUCCESSFUL WITH CLINICAL IMPROVEMENT OF THE WOUND, SO THE PATIENT WAS GIVING CEFEPIME FOR 10 DAYS AND 14 DAYS OF VAN
Patient problems: Erythema; Local Reaction; Pain
MAUDE report 22015451 ↗MalfunctionMar 11, 2025Packaging Problem; Packaging Problem
IT WAS REPORTED THAT PRIOR TO A BONE MARROW PROCEDURE, THE DEVICE TRAY WAS IDENTIFIED DAMAGED RESULTING IN POOR PACKAGE SEAL INTEGRITY. IT WAS FURTHER REPORTED THAT THE DAMAGED TRAY WAS IMMEDIATELY REMOVED FROM THE CASE. THERE WAS NO PATIENT CONTACT. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. RECEIVED TEXT FROM CUSTOMER SURROUNDING DAMAGED CASE OF #BEJS4511. NOTICED DAMAGE TO TRAYS IMMEDIATELY REMOVED FROM CASE IT WAS SHIPPED IN. SAMPLE NOT AVAILABLE. PLEASE SEE ATTACHED PICTURES AND PROVIDE REPLACEMENT 1CA ASAP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21579857 ↗MalfunctionFeb 5, 2025Contamination; Contamination
CUSTOMER RETURNS 10 UN OF MATERIAL TJM4011 - 0001560431 DUE TO QUALITY PROBLEMS IN THE PRODUCT (PRESENCE OF FOREIGN BODY IN 1 UN). (PRESENCE OF FOREIGN BODY IN 1 ONE). ATTACHED EVIDENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21312736 ↗MalfunctionJan 30, 2025Contamination; Contamination
1 EV WITH 10 PCS OF LOT: 0001560431 (1 PC WITH PRESENCE OF FOREIGN BODY; SMALL PLASTIC PARTICLES) IS REJECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21274328 ↗MalfunctionAug 22, 2024Break; Break
IT WAS REPORTED METAL SHAVINGS FROM JAMSHIDI. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. DEFECT DESCRIPTION: METAL SHAVINGS FROM JAMSHIDI. RESPONSE RECEIVED : AUGUST 5, 2024. 1. KINDLY PROVIDE THE MATERIAL NUMBER AND BATCH/LOT NUMBER OF THE PRODUCT. 500357 / UNKNOWN LOT. 2. KINDLY PROVIDE THE DATE OF EVENT. (B)(6) 2024. 3. CAN YOU SHARE ANY PHYSICAL SAMPLE IF AVAILABLE FOR INVESTIGATION? IF YES, PLEASE PROVIDE THE ADDRESS OF THE FACILITY FOR US TO SHIP THE RETURN LABEL? NO PHYSICAL SAMPLE AVAILABLE. 4. COULD YOU PLEASE PROVIDE A FURTHER DESCRIPTION OF THE ISSUE? COMPONENT FLAKED METAL PIECES OFF ONTO THE BONE BIOPSY SAMPLE. 5. WHEN WAS THIS DEFECT OBSERVED? DURING OR BEFORE USE? DURING. 6. IF POSSIBLE, COULD YOU PLEASE PROVIDE PICTURE SAMPLES FOR INVESTIGATION? CUSTOMER RESPONSE RECEIVED PLEASE FIND THE BELOW FILE. 1. WHAT WAS THE IMPACT TO THE PATIENT? NO COMPLICATION STATED. 2. ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? IF YES, PLEASE PROVIDE THE DETAILS. NO. 3. WAS THIS ISSUE REPORTED EARLIER TO BD? IF YES, PLEASE PROVIDE COMPLAINT REFERENCE NUMBER. THERE WAS AN EARLIER COMPLAINT REPORTED IN MAY (B)(4) HOWEVER, THIS IS A SEPARATE INCID
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20024296 ↗MalfunctionAug 19, 2024Break; Break
IT WAS REPORTED BY CUSTOMER THAT METAL SHAVINGS FROM JAMSHIDI. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. METAL SHAVINGS FROM JAMSHIDI. CUSTOMER RESPONSE ON AUG 02, 2024. 1. COULD YOU PLEASE PROVIDE A FURTHER DESCRIPTION OF THE ISSUE? METAL SHAVINGS FLAKED OFF FROM THE JAMSHIDI NEEDLE. 2. WHEN WAS THIS DEFECT OBSERVED? DURING OR BEFORE USE? DURING. 3. WHAT WAS THE IMPACT TO THE PATIENT? NO. 4. ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? IF YES, PLEASE PROVIDE THE DETAILS. NO. 5. CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENT IN FORMAT DD-MMM-YYYY? (B)(6) 2024. 6. ANY PHYSICAL SAMPLE AVAILABLE FOR INVESTIGATION? IF YES, ARE YOU ABLE TO PROVIDE THE ADDRESS OF THE FACILITY FOR US TO SHIP THE RETURN LABEL? NO. 7. IF POSSIBLE, COULD YOU PLEASE PROVIDE PICTURE SAMPLES FOR INVESTIGATION? SEE PHOTOS 8. WAS THIS REPORTED EARLIER TO BD? IF YES, PLEASE PROVIDE COMPLAINT REFERENCE NUMBER. NO.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19999690 ↗InjuryJun 19, 2024Break; Break
IT WAS REPORTED BY CUSTOMER THAT THE PATIENT WAS HAVING A BONE MARROW BIOPSY AND THE NEEDLE BROKE OFF INSIDE THE PATIENT'S BONE IN HIS HIP. UNABLE TO REMOVE. ORTHOPEDIC CONSULT MADE. VERBATIM: PATIENT WAS HAVING A BONE MARROW BIOPSY AND THE NEEDLE BROKE OFF INSIDE THE PATIENT'S BONE IN HIS HIP. UNABLE TO REMOVE. ORTHOPEDIC CONSULT MADE. DESCRIBE PATIENT / (HCP) / USER IMPACT: ACTUAL / POTENTIAL ADVERSE OUTCOME/MODERATE INJURY REQUIRING MEDICAL TREATMENT. PROVIDED LOT NUMBER 0001547644 BELONGS TO MATERIAL NUMBER DJ4011X. ASKA 06/05/2024. CUSTOMER RESPONSE RECEIVED ON 06-JUN-2024. 1. WHAT WAS THE IMPACT TO THE PATIENT? 2. WAS THERE ANY MEDICAL INTERVENTION REQUIRED INCLUDING DIAGNOSTICS, PROCEDURES, AND TREATMENT DELAY? 3. HOW WAS ITEM PIECE RETRIEVED FROM PATIENT/PROCEDURE? 4. IS THERE A PHOTO OR SAMPLE AVAILABLE SHOWING THE REPORTED ISSUE FOR THE EVALUATION? 1. THE PATIENT (A CHILD), FAMILY AND PHYSICIAN EXPERIENCED GREAT DISTRESS WITH A NEEDLE BREAKING OFF IN THE PATIENT¿S BACK. THE FAMILY WAS VERY UPSET AND THE PHYSICIAN WAS HORRIFIED THAT THIS HAD HAPPENED TO A PATIENT. 2. THE PATIENT HAD TO UNDERGO AND XRAY AND CT THAT DAY. THE BONE MARROW SAMPLE WAS NOT OBTAINED SO WILL HAVE T
Patient problems: Foreign Body In Patient
MAUDE report 19567503 ↗InjuryJun 19, 2024Break; Break
IT WAS REPORTED BY CUSTOMER WHILE USING THE PEDIATRIC JAMSHIDI (DJ3513X) NEEDLE ON A PATIENT, THE DISTAL PORTION BROKE OFF AND BECAME LODGED IN THE RIGHT ANTERIOR ILIAC SPINE. VERBATIM: WHILE USING THE PEDIATRIC JAMSHIDI (DJ3513X) NEEDLE ON A PATIENT, THE DISTAL PORTION BROKE OFF AND BECAME LODGED IN THE RIGHT ANTERIOR ILIAC SPINE. DESCRIBE PATIENT / (HCP) / USER IMPACT: ORTHOPEDIC SURGERY IS GOING TO SEE THE PATIENT TOMORROW AFTERNOON TO EVALUATE. CUSTOMER RESPONSE RECEIVED ON 18-JUN-2024: 1. CAN YOU PLEASE PROVIDE THE LOT NUMBER ASSOCIATED WITH REPORTED ISSUE? I DON'T HAVE THIS. 2. WAS THE JAMSHIDI NEEDLE BROKEN OFF IN RIGHT ANTERIOR ILIAC SPINE? YES, RIGHT ANTERIOR ILIAC SPINE. 3. HOW WAS ITEM PIECE RETRIEVED FROM PATIENT/PROCEDURE? TIP OF DEVICE REMAINS LODGED IN THE PATIENT. 4. WAS THERE ANY MEDICAL INTERVENTION REQUIRED INCLUDING DIAGNOSTICS, PROCEDURES, AND TREATMENT DELAY? ADDITIONAL RADIOGRAPHS WERE OBTAINED TO LOCATE TIP OF DEVICE AND PATIENT FOLLOWED UP WITH ORTHOPEDIC SURGERY FOR EVALUATION. 5. WHAT WAS THE IMPACT TO THE PATIENT? ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? IF YES, PLEASE PROVIDE THE DETAILS. PATIENT NOW HAS FOREIG
Patient problems: Foreign Body In Patient
MAUDE report 19566941 ↗
Other Carefusion 2200, Inc products
All Carefusion 2200, Inc devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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