FDAClass II · Medical device · Recall Z-2209-2026 · Recalled May 27, 2026

Tangent Endoscopy recall — TANGENT ENDOSCOPY, LLC

Agency report date: May 27, 2026.

1. Compare your item

This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.

Product named: Tangent Endoscopy
Company / brand: TANGENT ENDOSCOPY
Lot / serial / date codes: (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.

Agency product description and boundaries

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

Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.

If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.

2. Agency hazard and consumer action

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

No consumer remedy instructions are supplied in this record. Check the official notice and listed company contact for the agency’s current instructions.

Class II: may cause temporary or medically reversible health consequences.

Affected product: Tangent Endoscopy recall status

3. Open the official notice or contact

View the official FDA enforcement record (openFDA) ↗

Official recall ID: Z-2209-2026
Brand: All TANGENT ENDOSCOPY recalls
Classification: Class II
Units affected: 53 units
Recall status: Ongoing
Initiated: Voluntary: Firm initiated

Affected products

Tangent Endoscopy recall status

Companies & origin

Recalling firm location: Camden, DE, United States
Firm address: 2140 S Dupont Hwy, 19934-1249

Identifying details (verbatim from the notice)

Product codes / lots: (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.
Firm notified the public via: E-Mail
FDA event ID: 98654
Recall initiated: March 23, 2026
FDA classified: May 15, 2026
FDA report date: May 27, 2026

Other medical device recalls from around the same time

Automated Impella Controller (AIC) recall — Abiomed, Inc.FDA · June 3, 2026
RelayPro Thoracic Stent-Graft System (various sizes) Reference numbers recall — Bolton Medical Inc.FDA · June 3, 2026
NextStep Antegrade Chronic Hemodialysis Catheter recall — ARROW INTERNATIONAL, LLCFDA · May 20, 2026
Cannon II Plus Hemodialysis Catheter recall — ARROW INTERNATIONAL, LLCFDA · May 20, 2026
Arrow-Clark VectorFlow Antegrade Chronic Hemodialysis Catheter recall — ARROW INTERNATIONAL, LLCFDA · May 20, 2026

Verify with the official sources:

CPSC — consumer products ↗ (aggregated here)
NHTSA — vehicles, car seats, tires ↗ (aggregated here; use NHTSA's VIN lookup to check a specific vehicle)
FDA — food, drugs, medical devices ↗ (aggregated here)
USDA FSIS — meat, poultry & processed egg products ↗ (not aggregated here)
Recalls.gov — the U.S. government’s all-agency portal ↗

Found something wrong or missing? Report a data error.

Source: U.S. Food & Drug Administration. Agency excerpts come from the public data feed and may omit tables or later changes; the linked government source is authoritative. Source last checked October 22, 2026 at 6:00 PM UTC. Record retrieved August 25, 2026 at 6:00 PM UTC.

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