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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 76497

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

Open FDA event record

Event summary

Timeline bucket
February 08, 2017
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Medtronic

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

5 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 5

BNX Fine Need Aspiration System (19GA); Material/Part #: DSN-19-01

Z-1472-2017
Recall number
Z-1472-2017
Initiated
February 08, 2017
Classification
Class II
Status
Terminated
Recalling firm
Medtronic
Quantity
1,096 Units (total for all products)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Handle may break during use.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Handle may break during use.

Code information

Lot Number: B000000176, B000000181

Distribution pattern

US Distribution to AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, WA, WI; and countries of DK and DE

device · product 2 of 5

SharkCore Fine Needle Biopsy System (22 GA); Material/Part #s: DSC-22-01

Z-1473-2017
Recall number
Z-1473-2017
Initiated
February 08, 2017
Classification
Class II
Status
Terminated
Recalling firm
Medtronic
Quantity
1,096 Units (total for all products)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Handle may break during use.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Handle may break during use.

Code information

Lot Number: B000000164, B000000170, B000000173, B000000178

Distribution pattern

US Distribution to AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, WA, WI; and countries of DK and DE

device · product 3 of 5

SharkCore Fine Needle Biopsy System (25GA); Material/Part#: DSC-25-01

Z-1474-2017
Recall number
Z-1474-2017
Initiated
February 08, 2017
Classification
Class II
Status
Terminated
Recalling firm
Medtronic
Quantity
1,096 Units (total for all products)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Handle may break during use.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Handle may break during use.

Code information

Lot number: B000000174

Distribution pattern

US Distribution to AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, WA, WI; and countries of DK and DE

device · product 4 of 5

SharkCore LG Fine Needle Biopsy System (19GA); Material/Part#: DSL-19-01

Z-1475-2017
Recall number
Z-1475-2017
Initiated
February 08, 2017
Classification
Class II
Status
Terminated
Recalling firm
Medtronic
Quantity
1,096 Units (total for all products)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Handle may break during use.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Handle may break during use.

Code information

Lot number: B000000166

Distribution pattern

US Distribution to AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, WA, WI; and countries of DK and DE

device · product 5 of 5

BNX Fine Need Aspiration System (22GA); Material/Part#: DSN-22-01

Z-1476-2017
Recall number
Z-1476-2017
Initiated
February 08, 2017
Classification
Class II
Status
Terminated
Recalling firm
Medtronic
Quantity
1,096 Units (total for all products)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Handle may break during use.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Handle may break during use.

Code information

Lot number: B000000167

Distribution pattern

US Distribution to AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, WA, WI; and countries of DK and DE