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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 88314

3 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
June 23, 2021
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Bard Peripheral Vascular Inc

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

3 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 3

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;

Z-2247-2021
Recall number
Z-2247-2021
Initiated
June 23, 2021
Classification
Class II
Status
Ongoing
Quantity
3,961 devices

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
open packaging

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

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;

Distribution pattern

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

device · product 2 of 3

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

Z-2248-2021
Recall number
Z-2248-2021
Initiated
June 23, 2021
Classification
Class II
Status
Ongoing
Quantity
560 devices

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
open packaging

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

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

Distribution pattern

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

device · product 3 of 3

TIN3018 Illinois Bone Marrow Aspiration/Intraosseous Infusion Needle 18G x 79mm TIN3015 Illinois Bone Marrow Aspiration/Intraosseous Infusion Needle 15G x 79mm

Z-2249-2021
Recall number
Z-2249-2021
Initiated
June 23, 2021
Classification
Class II
Status
Ongoing
Quantity
1,200 device

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
open packaging

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Catalog Number/UDI: TIN3018/(01)10885403043819(17)241031(10)0001330956; TIN3015/(01)10885403043796(17)241031(10)0001331229; Serial Numbers: 0001330956; 0001331229;

Distribution pattern

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