CLASS II ONGOING Device recall · Reported 12 Aug 2020 · FDA Enforcement Report
Beacon EUS Access System Preloaded Access 90degree Needle recalled
Covidien is recalling Beacon EUS Access System Preloaded Access 90degree Needle sterile, single-use, endoscopic. The recall was initiated on 26 Jun 2020 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-2768-2020
- FDA event ID
- 86001
- Recalling firm
- Covidien, Mansfield, MA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 26 Jun 2020
- FDA classified
- 5 Aug 2020
- Reported
- 12 Aug 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Heart & Vascular Devices
Timeline
| 26 Jun 2020 | Recall initiated by company | |
| 5 Aug 2020 | Classified by FDA | +40 days |
| 12 Aug 2020 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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.
Where it was distributed
world wide distribution
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Model # DSA-090-01 UDI: 10884521722583 Lot #: F2510370X, F2510900X, F2512340X, F2512378X, F2512492X, F2512620X, F2513452X
Where was it sold?
world wide distribution
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.
Other products in this recall event
1 other product · FDA event 86001This product is part of a recall event; the main page for the event is Beacon EUS Access System Preloaded Access 135degree Needle recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Beacon EUS Access System Preloaded Access 135degree Needle recalled | Covidien | Packaging Defects | MA |
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