What was recalled and why?

TANGENT ENDOSCOPY, LLC recalled Tangent Endoscopy, Tangent Single Use Digital Catheter. Model Numbers: (1) TNG4002-IND. (2) TNG-4007-6pk.. FDA's record states the reason for recall as: Affected devices exhibited fractures at the distal shaft tip without complete detachment.. The recall is logged under FDA recall number Z-2209-2026 with a Class II classification.

What should someone who has this product do?

Because this recall carries FDA's middle severity classification, anyone who has this product should stop using it and follow the recalling firm's instructions, even though serious harm is considered unlikely for this classification. Check the product against FDA's description (Tangent Endoscopy, Tangent Single Use Digital Catheter. Model Numbers: (1) TNG4002-IND. (2) TNG-4007-6pk.) and recall number Z-2209-2026, then follow TANGENT ENDOSCOPY, LLC's recall instructions.

Has TANGENT ENDOSCOPY, LLC had other FDA recalls or enforcement actions?

This is the only FDA action Argus HQ has on file for TANGENT ENDOSCOPY, LLC so far. Argus ingests new FDA enforcement records daily.

FDA Class II Recall: Tangent Endoscopy, Tangent Single Use Digital Catheter. Model… by TANGENT ENDOSCOPY, LLC

Key facts

Recalling firm	TANGENT ENDOSCOPY, LLC
Manufacturer	Not disclosed in the FDA record.
Brand name	Not disclosed in the FDA record.
Product description	Tangent Endoscopy, Tangent Single Use Digital Catheter. Model Numbers: (1) TNG4002-IND. (2) TNG-4007-6pk.
Classification	Class II
Recall number	Z-2209-2026
Report date	Not disclosed in the FDA record.
Status	Ongoing
Reason for recall	Affected devices exhibited fractures at the distal shaft tip without complete detachment.

In short: TANGENT ENDOSCOPY, LLC recalled Tangent Endoscopy, Tangent Single Use Digital Catheter. Model Numbers: (1) TNG4002-IND. (2) TNG-4007-6pk. on 2026-05-27. FDA classified this action as a Class II recall (recall number Z-2209-2026). Reason for recall: Affected devices exhibited fractures at the distal shaft tip without complete detachment.. Recall status: Ongoing. This is a device-category FDA recall record. FDA maintains a public enforcement report database so that consumers, physicians, and purchasers can look up the exact product identifiers involved before deciding what to do.

What consumers should do

Because this recall carries FDA's middle severity classification, anyone who has this product should stop using it and follow the recalling firm's instructions, even though serious harm is considered unlikely for this classification. Specifically, check whether the product in your possession matches the description on file with FDA -- Tangent Endoscopy, Tangent Single Use Digital Catheter. Model Numbers: (1) TNG4002-IND. (2) TNG-4007-6pk. -- and the recall number Z-2209-2026. If it matches, stop using or distributing it and contact TANGENT ENDOSCOPY, LLC or the point of purchase for return or replacement instructions. Retailers and distributors holding affected inventory should quarantine it and follow the firm's written recall notice. FDA maintains a public enforcement report database so that consumers, physicians, and purchasers can look up the exact product identifiers involved before deciding what to do.

What this classification means

FDA classifies a recall as Class II when using the recalled product, or being exposed to it, may cause temporary or medically reversible adverse health consequences, or when the probability of serious adverse health consequences is remote. In this case, the recalling firm is TANGENT ENDOSCOPY, LLC and the affected product is described in FDA's record as: Tangent Endoscopy, Tangent Single Use Digital Catheter. Model Numbers: (1) TNG4002-IND. (2) TNG-4007-6pk.. FDA's stated reason for the recall is: Affected devices exhibited fractures at the distal shaft tip without complete detachment.. The recall is tracked under FDA recall number Z-2209-2026 and carries a status of Ongoing as of the most recent FDA enforcement report. This classification reflects FDA's assessment of the product defect described above, not a prediction about any specific patient outcome. FDA maintains a public enforcement report database so that consumers, physicians, and purchasers can look up the exact product identifiers involved before deciding what to do. Recall status can change while FDA and the recalling firm continue corrective actions, so checking the firm's own notice for the most current guidance is recommended. Adverse events believed to be related to a recalled product can be reported to FDA's MedWatch program, which FDA uses to monitor safety signals after a recall is opened.

TANGENT ENDOSCOPY, LLC’s FDA history

Argus HQ has recorded 1 total FDA action tied to TANGENT ENDOSCOPY, LLC: 0 warning letters, 1 recall, 0 approval records, and 0 Form 483 inspection citations.

Frequently asked questions

What was recalled and why?: TANGENT ENDOSCOPY, LLC recalled Tangent Endoscopy, Tangent Single Use Digital Catheter. Model Numbers: (1) TNG4002-IND. (2) TNG-4007-6pk.. FDA's record states the reason for recall as: Affected devices exhibited fractures at the distal shaft tip without complete detachment.. The recall is logged under FDA recall number Z-2209-2026 with a Class II classification.
How serious is this recall?: FDA classifies a recall as Class II when using the recalled product, or being exposed to it, may cause temporary or medically reversible adverse health consequences, or when the probability of serious adverse health consequences is remote.
What should someone who has this product do?: Because this recall carries FDA's middle severity classification, anyone who has this product should stop using it and follow the recalling firm's instructions, even though serious harm is considered unlikely for this classification. Check the product against FDA's description (Tangent Endoscopy, Tangent Single Use Digital Catheter. Model Numbers: (1) TNG4002-IND. (2) TNG-4007-6pk.) and recall number Z-2209-2026, then follow TANGENT ENDOSCOPY, LLC's recall instructions.
Has TANGENT ENDOSCOPY, LLC had other FDA recalls or enforcement actions?: This is the only FDA action Argus HQ has on file for TANGENT ENDOSCOPY, LLC so far. Argus ingests new FDA enforcement records daily.

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Full FDA history for TANGENT ENDOSCOPY, LLC

Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder

Cite this record

Reusing this data in reporting or research? Here’s a ready-made citation.

APA

Argus HQ Research (2026). FDA Class II Recall: Tangent Endoscopy, Tangent Single Use Digital Catheter. Model… by TANGENT ENDOSCOPY, LLC. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/recall/fda-recall-tangent-endoscopy-llc-z-2209-2026

MLA

"FDA Class II Recall: Tangent Endoscopy, Tangent Single Use Digital Catheter. Model… by TANGENT ENDOSCOPY, LLC." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/recall/fda-recall-tangent-endoscopy-llc-z-2209-2026.

Chicago

Argus HQ Research. "FDA Class II Recall: Tangent Endoscopy, Tangent Single Use Digital Catheter. Model… by TANGENT ENDOSCOPY, LLC." Digital Empire Holdings LLC. Accessed August 13, 2026. https://argushq.ai/recall/fda-recall-tangent-endoscopy-llc-z-2209-2026.

BibTeX

@misc{argushq_argushq_ai_recall_fda_recall_tangent_endoscopy_llc_z_2209_2026_2026,
  title = {FDA Class II Recall: Tangent Endoscopy, Tangent Single Use Digital Catheter. Model… by TANGENT ENDOSCOPY, LLC},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/recall/fda-recall-tangent-endoscopy-llc-z-2209-2026},
  note = {Accessed: August 13, 2026}
}

Source: FDA.gov — Recalls ↗