FDA Medical devices recall ·
Tangent Endoscopy, Tangent Single Use Digital Catheter recall
- Recall number
- Z-2209-2026
- Date
- (initiated March 23, 2026)
- Company / brand
- Tangent Endoscopy, LLC
2140 S Dupont Hwy, Camden, DE, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 53 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Tangent Endoscopy, Tangent Single Use Digital Catheter. Model Numbers: (1) TNG4002-IND. (2) TNG-4007-6pk.
Why was it recalled?
Affected devices exhibited fractures at the distal shaft tip without complete detachment.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
(1) Model Number: TNG4002-IND; UDI-DI: (1) 00850061601001; Lot numbers: 2510900, 2512938, and 2601944. (2) Model Number: TNG-4007-6pk; UDI-DI: 00850061601001; Lot numbers: 2510900, 2512938, and 2601944
Distribution
US Nationwide distribution in the states of North Carolina, Arizona, and Nevada.
States: Arizona North Carolina Nevada
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2209-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.