CLASS II ONGOING Device recall · Reported 27 May 2026 · FDA Enforcement Report
Tangent Single Use Digital Catheter recalled by Tangent Endoscopy
Tangent Endoscopy is recalling Tangent Single Use Digital Catheter, distributed nationwide in the US. The recall was initiated on 23 Mar 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2209-2026
- FDA event ID
- 98654
- Recalling firm
- Tangent Endoscopy, Camden, DE
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 23 Mar 2026
- FDA classified
- 15 May 2026
- Reported
- 27 May 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Heart & Vascular Devices
Timeline
| 23 Mar 2026 | Recall initiated by company | |
| 15 May 2026 | Classified by FDA | +53 days |
| 27 May 2026 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Affected devices exhibited fractures at the distal shaft tip without complete detachment.
Product as listed by the FDA
Tangent Endoscopy, Tangent Single Use Digital Catheter. Model Numbers: (1) TNG4002-IND. (2) TNG-4007-6pk.
Where it was distributed
US Nationwide distribution in the states of North Carolina, Arizona, and Nevada.
Questions about this recall
Why was it recalled?
Affected devices exhibited fractures at the distal shaft tip without complete detachment.
Which lots are affected?
(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
Where was it sold?
US Nationwide distribution in the states of North Carolina, Arizona, and Nevada.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Getinge PVC Thoracic Catheter, Firm PVC Straight recalled | Atrium Medical | Potency & Assay | Nationwide |