CLASS II ONGOING Device recall · Reported 18 Aug 2021 · FDA Enforcement Report

EJM4011 Jamshidi Evolve" Bone Marrow Biopsy/Aspiration recalled

Bard Peripheral Vascular is recalling EJM4011 Jamshidi Evolve" Bone Marrow Biopsy/Aspiration Needle with Specimen Cradle, distributed nationwide in the US. The recall was initiated on 23 Jun 2021 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesCatalog Number/UDI: EJM4011/ (01)10885403464157(17)241031(10)0001330769; Serial Numbers: 0001330769; 0001331231;

Quantity recalled560 devices

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2248-2021
FDA event ID: 88314
Recalling firm: Bard Peripheral Vascular, Tempe, AZ
Classification: Class II
Status: Ongoing
Recall initiated: 23 Jun 2021
FDA classified: 11 Aug 2021
Reported: 18 Aug 2021
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Syringes & Needles

Timeline

23 Jun 2021	Recall initiated by company
11 Aug 2021	Classified by FDA	+49 days
18 Aug 2021	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

EJM4011 Jamshidi Evolve" Bone Marrow Biopsy/Aspiration Needle with Specimen Cradle. 11G x 10cm

Where it was distributed

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

Nationwide Arizona Connecticut District of Columbia Florida Illinois Massachusetts Michigan Missouri New York Oklahoma Texas Virginia

Questions about this recall

Is EJM4011 Jamshidi Evolve" Bone Marrow Biopsy/Aspiration Needle with Specimen Cradle recalled?

Yes. Bard Peripheral Vascular recalled EJM4011 Jamshidi Evolve" Bone Marrow Biopsy/Aspiration Needle with Specimen Cradle on 23 Jun 2021. The recall is Class II and its status is Ongoing. Recall number Z-2248-2021.

Why was it recalled?

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

Which lots are affected?

Catalog Number/UDI: EJM4011/ (01)10885403464157(17)241031(10)0001330769; Serial Numbers: 0001330769; 0001331231;

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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