Limited official informationFDA Medical Device Enforcement ReportsRecall date: May 27, 2026

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

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Affected variants from the official event record
Product or model	Codes and lots	Quantity	Recall number
Tangent Endoscopy, Tangent Single Use Digital Catheter. Model Numbers: (1) TNG4002-IND. (2) TNG-4007-6pk.	(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	53 units	Z-2209-2026

The agency's statement is shown without a site-authored severity score.

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

Agency classification: Class II

Only instructions associated with this recall event qualify as an action.

Consumer action is not available in the associated official record. The site does not infer or generate a replacement.

The linked agency record controls if any information differs.

Official scope

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

Distribution is context, not a confirmed item match. Compare the model, lot, UPC, NDC, or serial number above.

No material affected-item, risk, action, or status change has been recorded since this page entered the tracker.