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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 74297

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
May 19, 2016
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Devicor Medical Products 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

1 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 1

Mammotome Revolve Dual Vacuum Assist Biopsy System Model number: MST1009 & MST0815. Each disposable probe is packaged within a thermoformed tray and covered with a pre-printed (product code and graphics) Tyvek lid. Each tray is labeled on-demand after sealing with a lot number and expiration date. Trays are kitted into sets of five probes and packaged within a sales carton. Two sales cartons are then packed into a corrugated case and shipped to the global distribution center. Device is labeled as sterile. Intended to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality.

Z-2211-2016
Recall number
Z-2211-2016
Initiated
May 19, 2016
Classification
Class II
Status
Terminated
Quantity
F11537107D1 = 360; F11536423D1 = 80; F11537109D1 = 360

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
A 10 Gauge needle, 9cm long was shipped in an 8 Gauge needle, 15 cm package.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

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Inspect official wording and provenance

Reason for recall

A 10 Gauge needle, 9cm long was shipped in an 8 Gauge needle, 15 cm package.

Code information

MST1009 - Lot F11537107D1 Exp. Date 9-Sept, 2018; MST0815 Lot F11536423D1 Exp. Date 8-Sept, 2018; and, MST1009 Lot F11537109D1 Exp. Date 10-Sept, 2018.

Distribution pattern

Worldwide Distribution -- USA, including the states of AL, AR, CA, CT, DC, FL, GA, IL, KS, KY, LA, MA, MD, ME, MI, MN, MS, NC, NJ, NY, OH, PA, SC, TN, WA and WI; and, the countries of Canada and Japan, Korea, and The Netherlands.