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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 84316

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

Open FDA event record

Event summary

Timeline bucket
November 06, 2019
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Stryker Instruments Div. of Stryker Corporation

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

Color Cuff Disposable Tourniquet Cuff, 18 inch X 3 inch, 1BLA (Single Bladder), 1PRT(Single Port) Quick Connect Connector, Product Number 5921-018-135 - Product Usage: The Stryker Disposable Tourniquet Cuff (cuff) is indicated for use in surgical procedures that require the temporary occlusion of blood flow in a patients extremities during surgical procedures to produce greater visualization of the operative field.

Z-0592-2020
Recall number
Z-0592-2020
Initiated
November 06, 2019
Classification
Class II
Status
Terminated
Quantity
16,380 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for the cuff to leak air leading to a loss of vascular occlusion.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for the cuff to leak air leading to a loss of vascular occlusion.

Code information

GTIN: 37613154599258, Lot Numbers 60180348, 60180373

Distribution pattern

Worldwide distributions - US Nationwide distributions in the states of AL, CD, HI, IA, ID, IN, KS, KY, MA, ME, MI, MN, MT, NC, NE, NH, NJ, NV, NY, OK, OR, PA, SC, SD, TN, VA, WI, WV, and WY. Countries of Argentina, Australia, Canada, and Netherlands.

device · product 2 of 2

Color Cuff Disposable Tourniquet Cuff, 18 inch X 3 inch, 1BLA (Single Bladder), 2PRT(Dual Port) Quick Connect Connector, Product Number 5921-018-235 - Product Usage: The Stryker Disposable Tourniquet Cuff (cuff) is indicated for use in surgical procedures that require the temporary occlusion of blood flow in a patients extremities during surgical procedures to produce greater visualization of the operative field.

Z-0593-2020
Recall number
Z-0593-2020
Initiated
November 06, 2019
Classification
Class II
Status
Terminated
Quantity
16,380 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for the cuff to leak air leading to a loss of vascular occlusion.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for the cuff to leak air leading to a loss of vascular occlusion.

Code information

GTIN: 37613154599296, Lot Numbers 60180374, 60181194

Distribution pattern

Worldwide distributions - US Nationwide distributions in the states of AL, CD, HI, IA, ID, IN, KS, KY, MA, ME, MI, MN, MT, NC, NE, NH, NJ, NV, NY, OK, OR, PA, SC, SD, TN, VA, WI, WV, and WY. Countries of Argentina, Australia, Canada, and Netherlands.