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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 85388

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

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Event summary

Timeline bucket
January 09, 2019
Product types
Device
Classifications
Class III
Statuses
Terminated
Recalling firm wording
Karl Storz 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

Insufflation tubing to be used with varies insufflator units. REF 031200-10; REF 031322-10; REF 031532-10; REF 031622-10

Z-1942-2020
Recall number
Z-1942-2020
Initiated
January 09, 2019
Classification
Class III
Status
Terminated
Recalling firm
Karl Storz Endoscopy
Quantity
543 boxes were distributed; 10 ea per box.

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The sterile single-use tubing may contain higher ethylene oxide (EO) residues than the acceptable level.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Vendor change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The sterile single-use tubing may contain higher ethylene oxide (EO) residues than the acceptable level.

Code information

Model/Lot Number: 031200-10/Lot W-027781, W-029058, W-028738; 031322-10/ Lot W-027197, W-028171, W-027939, W-028207; 031532-10/ Lot W-026437, W-027332, W-026871; 031622-10/Lot W-029555

Distribution pattern

57 consignees in the US. AL,AZ,CA,CT,DE,FL,GA,IL,LA,MA,MD,ME,MI,MN,NE,NH,NJ,NY,OH,OK,PA,SC,TX,VA,VT,WA and WI