The Recall Desk

Manufacturer

Trokamed GmbH

4 recalls in our database name Trokamed GmbH as the manufacturing or recalling firm.

What the numbers show

Total
4
Critical
0
Severe
4
Most recent
2025-01-22

Of the 4 recalls from Trokamed GmbH we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 4 (100%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–4 of 4

  • SevereFDA (Devices)·Z-0716-2025·2025-01-22

    Endoscopic Access Overtube Sheath Recalled Due to Pressure Buildup Risk

    Trokamed GmbH is recalling an endoscopic access overtube sheath due to risk of intrarenal pressure buildup when inflow speed is too fast. No injuries reported.

    Product
    Sheath, 18 Fr., 160 mm (REF: WA2PS18L), gastroenterology-urology endoscopic access overtube.
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-0714-2025·2025-01-22

    Endoscopic Access Overtube Recalled for Risk of Obstruction and Pressure Buildup

    Trokamed is recalling a 20 Fr. endoscopic access overtube due to risk of obstruction and dangerous kidney pressure buildup during procedures. If inflow speed is too quick, rapid fluid flow can restrict outflow and cause intrarenal pressure to accumulate.

    Product
    Sheath, 20 Fr., 160 mm (REF: WA2PS20L), gastroenterology-urology endoscopic access overtube.
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-0715-2025·2025-01-22

    Endoscopic Access Sheath Recalled Due to Risk of Intrarenal Pressure Buildup

    Trokamed GmbH is recalling an endoscopic access sheath (18 Fr., 130 mm) used in gastroenterology and urology. Rapid fluid inflow may block outflow and cause dangerous pressure buildup inside the kidney.

    Product
    Sheath, 18 Fr., 130 mm (REF: WA2PS18S), gastroenterology-urology endoscopic access overtube.
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-0713-2025·2025-01-22

    Endoscopic Access Overtube May Cause Dangerous Pressure Buildup During Procedures

    Trokamed's endoscopic access overtube may cause rapid pressure buildup in the kidney if inflow speed is too fast. The device can become obstructed by tissue and blood fragments, restricting outflow.

    Product
    Sheath, 20 Fr., 130 mm (REF: WA2PS20S), gastroenterology-urology endoscopic access overtube.
    Category
    Medical Device
    Distribution
    1 state