Agency classClass IIOur severity:Severe FDA (Devices)·Z-2769-2020·Announced 2020-08-12

Beacon EUS Access System Needle Recalled Due to Cannula Detachment

Covidien is voluntarily recalling 269 Beacon EUS Access System needles because the cannula detached during procedures in three reported cases.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II and involves a device failure (cannula detachment) that resulted in a retained foreign object in one case, posing significant injury risks such as biliary leak and pain.

Plain-English summary

The U.S. Food and Drug Administration (FDA) has issued a Class II voluntary recall for the Beacon EUS Access System Preloaded Access 135-degree Needle. The device is a sterile, single-use endoscopic ultrasound instrument manufactured by Covidien LLC. It consists of a sharp stylet and an 18.5-gauge, echo-enhanced, tip-shaped, nitinol cannula intended to pierce tissue and facilitate guidewire placement to locations of the gastrointestinal tract.

The recall was initiated following three customer reports that the device cannula detached during a procedure. In one of these instances, the detached cannula was not retrieved during the procedure. The source text identifies potential risks associated with a detached cannula, including delay in treatment, biliary leak, pain, and retained device fragments.

A total of 269 units were distributed worldwide. The affected units are identified by Model # DSA-135-01, UDI 10884521663527, and Lot numbers F2510371X, F2510861X, F2512341X, F2512383X, F2512493X, and F2513453X. Healthcare providers and facilities should stop using the affected devices and contact the recalling firm for further instructions.

The recalled product

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…
Manufacturer: Covidien Llc
Category: Medical Device — Endoscopic Ultrasound
Hazard: device-detachment
retained-foreign-object
biliary-leak
Affected units: 269

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (6)

Model # DSA-135-01 UDI: 10884521663527 Lot #: F2510371X
F2510861X
F2512341X
F2512383X
F2512493X
F2513453X

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 2 recalled by Covidien Llc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same manufacturer · Covidien Llc

See all →

Moderate
EndoFLIP System Recall Due to Incorrect Catheter Expiration Flags
FDA (Devices) · 2026-08-26
Moderate
Covidien Shiley Disposable Decannulation Plug product labeling error
FDA (Devices) · 2026-07-08
Moderate
Covidien 9 Fr Mon-a-Therm temperature probes lack FDA clearance
FDA (Devices) · 2026-06-10
Moderate
Covidien esophageal stethoscope temperature sensors lack FDA clearance
FDA (Devices) · 2026-06-10
Moderate
Shiley tracheostomy tubes recalled over incorrect display box labeling
FDA (Devices) · 2026-06-10

Same hazard · device detachment