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Lower risk Medical device recall · FDA · Published June 23, 2021

Bard Peripheral Vascular Inc: Jamshidi Needles with Non-Sterile Packaging Risk

Bard recalls Jamshidi bone marrow biopsy needles due to incomplete packaging seals that may allow non-sterile product. Affected models include TJM6008 and TJC3513. Consumers should check serial numbers and contact Bard for details.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-2247-2021Medical deviceBard ›
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Contact the company

Recalling firmBard Peripheral Vascular Inc1625 W 3rd St Bldg 1 · Tempe, AZ 85281-2438
✎ GovInfoNow plain-language explainer

Bard is recalling certain bone marrow biopsy needles because their packaging seals might not be properly closed, which could lead to non-sterile product. This is a safety risk for medical procedures requiring sterile conditions. Read more at govinfonow.com/recall/62309-bard-peripheral-vascular-inc-jamshidi-needles-with-non-sterile-packaging.

Source Summary by GovInfoNow · govinfonow.com/recall/62309-bard-peripheral-vascular-inc-jamshidi-needles-with-non-sterile-packaging · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2247-2021

Cite this page

“Bard Peripheral Vascular Inc: Jamshidi Needles with Non-Sterile Packaging Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62309-bard-peripheral-vascular-inc-jamshidi-needles-with-non-sterile-packaging. Based on FDA recall #Z-2247-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2247-2021%22&limit=1).

Bard Peripheral Vascular Inc recalled TJM6008 Jamshidi Crown Bone Marrow Biopsy/Aspiration Needles due to incomplete packaging seals that may render the devices non-sterile, according to an FDA announcement on June 23, 2021. Owners should contact the company for a refund.

How to tell if you have it

  • TJM6008 Jamshidi Crown Bone Marrow Biopsy/Aspiration Needle with Marrow Acquisition Cradle, 8G x 15 cm
  • TJC3513 Jamshidi Bone Marrow Biopsy/Aspiration Needle, 13G x 8.9 cm
  • TJM4011 Jamshidi Crown Bone Marrow Biopsy/Aspiration Needle with Marrow Acquisition Cradle, 11G x 10cm
  • TJC4011 Jamshidi Bone Marrow Biopsy/Aspiration Needle, 11G x 10cm
  • TJM4008 Jamshidi Crown Bone Marrow Biopsy/Aspiration Needle with Marrow Acquisition Cradle, 8G x 10cm
  • TJC4008 Jamshidi Crown Bone Marrow Biopsy/Aspiration Needle with Marrow Acquisition Cradle, 8G x 10cm

The hazard

The FDA stated that complaints regarding incomplete or open packaging seals potentially cause the product to become non-sterile.

Context

GovInfoNow's records show Bard Peripheral Vascular Inc has issued 40 other recalls since September 22, 2017. Recent Bard recalls include a August 20, 2026 notice for the Bard Breast Biopsy System and a December 12, 2025 recall of Broviac Cutdown Trays with SureCuff Cuff due to sterile barrier compromise risks. Other recent recalls of similar products include Medline Blood Culture Kits (June 12, 2026) and Boston Scientific Radial Jaw 4 Biopsy Forceps (June 30, 2026).

How to tell if you have this one

Check for model numbers TJM6008, TJC3513, TJM4011, TJC4011, or TJM4008. Look for serial numbers starting with 0001330707, 0001330400, 0001330400, 0001330400, 0001331232, 0001331230, or 0001334951.

  • Brand
    Bard
  • Product
    TJM6008 Jamshidi" Crown Bone Marrow Biopsy/Aspiration Needle with Marrow Acquisition Cradle. 8G x 15 cm; TJC3513
  • Category
    Medical device
FDA recall event · 3 products

All 3 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Ongoing
  • Distribution
    U.S Nationwide Distribution in the states of .: AZ, CT, DC, FL, IL, MA, MI, MO, NY, OK, TX, and VA O.U.S.: Australia, Belgium, China, EMEA, Japan, Mexico, Saudi Arabia, Singapore, Taiwan
Recall numberProduct, codes & lotsQuantity
Z-2247-2021TJM6008 Jamshidi" Crown Bone Marrow Biopsy/Aspiration Needle with Marrow Acquisition Cradle. 8G x 15 cm; TJC3513 Jamshidi" Bone Marrow Biopsy/Aspiration Needle. 13G x 8.9 cm; TJM4011 Jamshidi" Crown Bone Marrow Biopsy/Aspiration Needle with Marrow Acquisition Cradle. 11G x 10cm; TJC4011 Jamshidi" Bone Marrow Biopsy/Aspiration Needle. 11G x 10cm; TJM4008 Jamshidi" Crown Bone Marrow Biopsy/Aspiration Needle with Marrow Acquisition Cradle. 8G x 10cm; TJC4008 Jamshidi" Crown Bone Marrow Biopsy/Aspiration Needle with Marrow Acquisition Cradle. 8G x 10cm;; Catalog Number//UDI: TJM6008/(01)10885403044595(17)241031(10)0001330707; TJC3513/(01)1088540344014(17)241031(10)0001330400; TJM4011/(01)10885403044588(17)241031(10)0001330949; TJC4011/(01)10885403044052(17)241031(10)0001331232; TJM4008/(01)10885403044564(10)0001331230(17)241031; TJC4008/(01)10885403044038(17)241130(10)0001334951; Serial Numbers: 0001330707; 0001330400; 0001330400; 0001330400; 0001331232; 0001331230; 0001334951;3,961 devices
Z-2248-2021EJM4011 Jamshidi Evolve" Bone Marrow Biopsy/Aspiration Needle with Specimen Cradle. 11G x 10cm; Catalog Number/UDI: EJM4011/ (01)10885403464157(17)241031(10)0001330769; Serial Numbers: 0001330769; 0001331231;560 devices
Z-2249-2021TIN3018 Illinois Bone Marrow Aspiration/Intraosseous Infusion Needle 18G x 79mm TIN3015 Illinois Bone Marrow Aspiration/Intraosseous Infusion Needle 15G x 79mm; Catalog Number/UDI: TIN3018/(01)10885403043819(17)241031(10)0001330956; TIN3015/(01)10885403043796(17)241031(10)0001331229; Serial Numbers: 0001330956; 0001331229;1,200 device
Based on the official FDA remedy

What to do — step by step

  1. Check Product Serial Number

    Look for serial numbers starting with 0001330707, 0001330400, 0001330400, 0001330400, 0001331232, 0001331230, or 0001334951.

  2. Contact Bard for Details

    Reach out to Bard Peripheral Vascular Inc to confirm if your specific model is affected and get instructions.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 11 states.

Alaska: nationwideAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: nationwideWAIdaho: nationwideIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: nationwideMNIllinois: named in the noticeILWisconsin: nationwideWIMichigan: named in the noticeMINew York: named in the noticeNYRhode Island: nationwideRIMassachusetts: named in the noticeMAOregon: nationwideORNevada: nationwideNVWyoming: nationwideWYSouth Dakota: nationwideSDIowa: nationwideIAIndiana: nationwideINOhio: nationwideOHPennsylvania: nationwidePANew Jersey: nationwideNJConnecticut: named in the noticeCTCalifornia: nationwideCAUtah: nationwideUTColorado: nationwideCONebraska: nationwideNEMissouri: named in the noticeMOKentucky: nationwideKYWest Virginia: nationwideWVVirginia: named in the noticeVAMaryland: nationwideMDDelaware: nationwideDEArizona: named in the noticeAZNew Mexico: nationwideNMKansas: nationwideKSArkansas: nationwideARTennessee: nationwideTNNorth Carolina: nationwideNCSouth Carolina: nationwideSCDistrict of Columbia: named in the noticeDCOklahoma: named in the noticeOKLouisiana: nationwideLAMississippi: nationwideMSAlabama: nationwideALGeorgia: nationwideGAHawaii: nationwideHITexas: named in the noticeTXFlorida: named in the noticeFL

FDA distribution: “U.S Nationwide Distribution in the states of .: AZ, CT, DC, FL, IL, MA, MI, MO, NY, OK, TX, and VA O.U.S.: Australia, Belgium, China, EMEA, Japan, Mexico, Saudi Arabia, Singapore, Taiwan” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Arizona, Connecticut, District of Columbia, Florida, Illinois, Massachusetts, Michigan, Missouri, New York, Oklahoma, Texas, Virginia.

Recall timeline

FDA published this recall 56 days after the firm started it.

1. Firm started the recall: Jun 23, 202112. FDA classified it Class II: Aug 11, 202123. Published in FDA’s Enforcement Report: Aug 18, 202132021
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

Are these needles safe to use?

The recall is due to potential non-sterile packaging, so affected needles should not be used until confirmed safe by Bard.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-2247-2021 (June 23, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2247-2021 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA