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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 71575

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

Open FDA event record

Event summary

Timeline bucket
June 24, 2015
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Zimmer Surgical 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

2 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 2

18inch Dual Port/Single Bladder Disposable Tourniquet Cuff, Zimmer Surgical, Inc. Tourniquets are intended to be used by qualified medical professionals to exert enough pressure on the arterial blood flow in a limb to produce a bloodless operating field. Single bladder tourniquet cuffs are generally used for operations lasting less than 90 minutes.

Z-2348-2015
Recall number
Z-2348-2015
Initiated
June 24, 2015
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Surgical Inc
Quantity
61 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The inside of the folded Instructions For Use (IFU) pamphlet was missing the usage instructions and warnings.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling False and Misleading

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The inside of the folded Instructions For Use (IFU) pamphlet was missing the usage instructions and warnings.

Code information

Item 60707000300, Lot Z000002044

Distribution pattern

Worldwide Distribution - US including AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV & WY and Internationally to Canada.

device · product 2 of 2

30inch Dual Port/Single Bladder Disposable Tourniquet Cuff with PLC, Zimmer Surgical, Inc. Tourniquets are intended to be used by qualified medical professionals to exert enough pressure on the arterial blood flow in a limb to produce a bloodless operating field. Single bladder tourniquet cuffs are generally used for operations lasting less than 90 minutes.

Z-2349-2015
Recall number
Z-2349-2015
Initiated
June 24, 2015
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Surgical Inc
Quantity
330 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The inside of the folded Instructions For Use (IFU) pamphlet was missing the usage instructions and warnings.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling False and Misleading

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The inside of the folded Instructions For Use (IFU) pamphlet was missing the usage instructions and warnings.

Code information

Item 60707010500, Lot Z000002535 & Item 60707010500, Lot Z000002541.

Distribution pattern

Worldwide Distribution - US including AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV & WY and Internationally to Canada.

Field note

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