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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 95770

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

Open FDA event record

Event summary

Timeline bucket
November 27, 2024
Product types
Device
Classifications
Class I
Statuses
Ongoing
Recalling firm wording
Trokamed GmbH

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

4 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 4

Sheath, 20 Fr., 130 mm (REF: WA2PS20S), gastroenterology-urology endoscopic access overtube.

Z-0713-2025
Recall number
Z-0713-2025
Initiated
November 27, 2024
Classification
Class I
Status
Ongoing
Recalling firm
Trokamed GmbH
Quantity
34 units

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
stone fragments

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

If the inflow speed is too quick, it could result in reduced outflow through the shaft due to blood, tissue fragments and kidney stone fragments, and quickly build up of intrarenal pressure.

Code information

REF: WA2PS20S; UDI-DI: 04251303810926; Lot Numbers: 154125

Distribution pattern

US (Domestic) distribution in state of PA and OUS (foreign) to country of Germany. .

device · product 2 of 4

Sheath, 20 Fr., 160 mm (REF: WA2PS20L), gastroenterology-urology endoscopic access overtube.

Z-0714-2025
Recall number
Z-0714-2025
Initiated
November 27, 2024
Classification
Class I
Status
Ongoing
Recalling firm
Trokamed GmbH
Quantity
42 units

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
stone fragments

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

If the inflow speed is too quick, it could result in reduced outflow through the shaft due to blood, tissue fragments and kidney stone fragments, and quickly build up of intrarenal pressure.

Code information

REF: WA2PS20L; UDI-DI: 04251303810919; Lot Numbers: 154236

Distribution pattern

US (Domestic) distribution in state of PA and OUS (foreign) to country of Germany. .

device · product 3 of 4

Sheath, 18 Fr., 130 mm (REF: WA2PS18S), gastroenterology-urology endoscopic access overtube.

Z-0715-2025
Recall number
Z-0715-2025
Initiated
November 27, 2024
Classification
Class I
Status
Ongoing
Recalling firm
Trokamed GmbH
Quantity
53 units

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
stone fragments

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

If the inflow speed is too quick, it could result in reduced outflow through the shaft due to blood, tissue fragments and kidney stone fragments, and quickly build up of intrarenal pressure.

Code information

REF: WA2PS18S; UDI-DI: 04251303810865; Lot Numbers: 159825

Distribution pattern

US (Domestic) distribution in state of PA and OUS (foreign) to country of Germany. .

device · product 4 of 4

Sheath, 18 Fr., 160 mm (REF: WA2PS18L), gastroenterology-urology endoscopic access overtube.

Z-0716-2025
Recall number
Z-0716-2025
Initiated
November 27, 2024
Classification
Class I
Status
Ongoing
Recalling firm
Trokamed GmbH
Quantity
102 units

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
stone fragments

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

If the inflow speed is too quick, it could result in reduced outflow through the shaft due to blood, tissue fragments and kidney stone fragments, and quickly build up of intrarenal pressure.

Code information

REF: WA2PS18L; UDI-DI: 04251303810872; Lot Numbers: 154214

Distribution pattern

US (Domestic) distribution in state of PA and OUS (foreign) to country of Germany. .