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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 68624

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

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Event summary

Timeline bucket
June 20, 2014
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Stryker Endoscopy

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

Disposable StrykeFlow Tip, Stryker Disposable Suction/I irrigator Tip; Sterile, Rx only, Latex Free. Stryker Suction Irrigation system, used to provide a clean and clear operative site through the evacuation and aspiration of irrigant solution. for endoscopic use.

Z-2080-2014
Recall number
Z-2080-2014
Initiated
June 20, 2014
Classification
Class II
Status
Terminated
Recalling firm
Stryker Endoscopy
Quantity
496 boxes (6 tips per box)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Internal review found that six lots of Disposable StrykeFlow Tips were shipped with a potentially deformed blister pouch which could impact sterility of the product.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

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Inspect official wording and provenance

Reason for recall

Internal review found that six lots of Disposable StrykeFlow Tips were shipped with a potentially deformed blister pouch which could impact sterility of the product.

Code information

P/N 0250070505; Lot numbers: 14021FG2, 13337FG2, 13343FG2, 13347FG2, 14007FG2, 14016FG2.

Distribution pattern

Worldwide Distribution - USA (nationwide) and Internationally tAustralia, Canada, France, Greece, Netherlands, United kingdom and South Korea.