Use cautionMedical device recall · FDA · Published June 26, 2020
Covidien Beacon EUS Access System: Cannula Detachment Risk During Procedures
Covidien recalls Beacon EUS Access System Preloaded Access 135-degree needle for potential cannula detachment during procedures, risking delayed treatment, biliary leaks, or retained fragments.
This voluntary recall is being conducted following three customer reports of the device cannula detaching during a procedure. In one case, the detached cannula was not retrieved during the procedure. Potential risks associated with a detached cannula include delay in treatment, biliary leak, pain and retained device fragments.
Take action
Contact the company
📍Recalling firmCovidien Llc15 Hampshire St · Mansfield, MA 02048-1113
“Covidien Beacon EUS Access System: Cannula Detachment Risk During Procedures.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/64903-covidien-beacon-eus-access-system-cannula-detachment-risk-during-procedures. Based on FDA recall #Z-2769-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2769-2020%22&limit=1).
The FDA announced on June 26, 2020, that Covidien LLC is recalling its Beacon EUS Access System Preloaded Access 135degree Needle due to the hazard of the device cannula detaching during procedures. Owners should contact the company for a replacement.
How to tell if you have it
Brand: Covidien
Product: Beacon EUS Access System Preloaded Access 135degree Needle
Model #: DSA-135-01
Lot codes: F2510371X, F2510861X, F2512341X, F2512383X, F2512493X, F2513453X
Units affected: 269
The hazard
The recall follows three customer reports of the device cannula detaching during a procedure, with one instance where the detached cannula was not retrieved. Potential risks include delay in treatment, biliary leak, pain, and retained device fragments.
Context
GovInfoNow's records show Covidien LLC has issued 52 other recalls since August 7, 2017. Recent recalls include the Covidien EndoFLIP System recall on May 13, 2026, and the Covidien Mon-a-Therm Temperature Probe Recall on April 23, 2026. Other recent recalls of similar products include the Medtronic EOPA Arterial Cannula Recall (June 24, 2026) and the Medtronic Perfusion Systems EOPA Cannula Recall (June 24, 2026).
How to tell if you have this one
Check for model number DSA-135-01 and lot numbers F2510371X, F2510861X, F2512341X, F2512383X, F2512493X, or F2513453X on the device packaging or label.
Brand
Covidien
Category
Medical device
FDA recall event · 2 products
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Ongoing
Distribution
world wide distribution
Recall number
Product, codes & lots
Quantity
Z-2768-2020
Beacon EUS Access System Preloaded Access 90degree Needle sterile, single-use, endoscopic ultrasound device consisting of a sharp stylet and an 18.5-gauge, echo-enhanced, tip-shaped, nitinol cannula intended to pierce tissue and then act as an access channel to facilitate guidewire placement to locations of the gastrointestinal tract.; Model # DSA-090-01 UDI: 10884521722583 Lot #: F2510370X, F2510900X, F2512340X, F2512378X, F2512492X, F2512620X, F2513452X
375 units
Z-2769-2020
Beacon EUS Access System Preloaded Access 135degree Needle sterile, single-use, endoscopic ultrasound device consisting of a sharp stylet and an 18.5-gauge, echo-enhanced, tip-shaped, nitinol cannula intended to pierce tissue and then act as an access channel to facilitate guidewire placement to locations of the gastrointestinal tract.; Model # DSA-135-01 UDI: 10884521663527 Lot #: F2510371X, F2510861X, F2512341X, F2512383X, F2512493X, F2513453X
269 units
Based on the official FDA remedy
What to do — step by step
Check Device Model
Verify the model number on the device packaging or label to confirm if it matches DSA-135-01.
Contact Manufacturer
Reach out to Covidien for guidance on next steps if the device is part of the recall.
How this recall unfolded
Recall timeline
FDA published this recall 47 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-2769-2020 (June 26, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2769-2020 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.