Tangent Single Use Digital Catheter Recall
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
Tangent Endoscopy, LLC is recalling 53 units of Tangent Single Use Digital Catheter models due to fractures at the distal shaft tip.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on June 11, 2026 and geographically references North Carolina, Arizona, and Nevada. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Devices.
What Happened
Affected devices exhibited fractures at the distal shaft tip without complete detachment.
Which Products Are Affected
Tangent Endoscopy, Tangent Single Use Digital Catheter. Model Numbers: (1) TNG4002-IND (2) TNG-4007-6pk. UDI-DI: 00850061601001. Lot numbers: 2510900, 2512938, and 2601944. 53 units distributed nationwide in North Carolina, Arizona, and Nevada. Recall number Z-2209-2026.
What You Should Do
No specific consumer action steps are provided in the recall data.
Why This Matters
Class II recall of 53 units of single-use digital catheters distributed in three states.
Source
FDA recall Z-2209-2026 (event ID 98654)
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (661 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to June 11, 2026.
Frequently Asked Questions
Common questions about this FDA recall.