Beacon EUS Access System Preloaded Access 135degree Needle sterile — Class II medical device recall Z-2769-2020
Ongoing recall by Covidien Llc, reported 2020-08-12. This voluntary recall is being conducted following three customer reports of the device cannula detaching duri
| Recall number | Z-2769-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Covidien Llc, Mansfield, MA, United States |
| Recall initiated | 2020-06-26 |
| Classified | 2020-08-05 |
| Reported by FDA | 2020-08-12 |
| Quantity | 269 units |
| Reason classes | packaging, device malfunction |
| UPC / GTIN / UDI-DI | 10884521663527 |
| Lot numbers | F2510371X, F2510861X, F2512341X, F2512383X, F2512493X, F2513453X |
| Model numbers | DSA-135-01 |
Product
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2769-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.