# FDA recall Z-2209-2026

> **TANGENT ENDOSCOPY, LLC** · Class II · device recall initiated 2026-03-23.

## Product

Tangent Endoscopy, Tangent Single Use Digital Catheter. Model Numbers:     (1) TNG4002-IND.   (2) TNG-4007-6pk.

## Reason for recall

Affected devices exhibited fractures at the distal shaft tip without complete detachment.

## Distribution

US Nationwide distribution in the states of North Carolina, Arizona, and Nevada.

## Key facts

- **Recall number:** Z-2209-2026
- **Recalling firm:** TANGENT ENDOSCOPY, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-03-23
- **Report date:** 2026-05-27

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Camden, DE, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2209-2026

## Citation

> MORVS. FDA recall Z-2209-2026. Retrieved 2026-10-14 from https://api.morvs.ai/recall/Z-2209-2026. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*