Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported August 12, 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.
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 d…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Covidien Llc recalled Beacon EUS Access System Preloaded Access 135degree Needle sterile, single-use, endoscop… - a moderate-severity action.
Beacon EUS Access System Preloaded Access 135degree Needle sterile, single-use, endoscop… was recalled by Covidien Llc in August 12, 2020. Reason: This voluntary recall is being conducted following three customer reports of the device cannula detaching dur…. Check the official notice for the remedy. Verify recall #Z-2769-2020 with the FDA Devices before acting.
The recall
Covidien Llc issued this moderate-severity FDA Devices recall-This voluntary recall is being conducted following three customer reports of the device cannula detaching dur….
- Moderate
- severity level
- 269 units
- affected scope
- Class II
- classification
- August 12, 2020
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2769-2020 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2769-2020) was formally reported on August 12, 2020, with the manufacturer initiating the action on June 26, 2020. It is classified under Moderate severity (Class II), with a current status of Ongoing. Covidien Llc is listed as the recalling firm, operating out of Mansfield, MA. Federal records list the affected scope as 269 units.
The documented reason for this recall is: 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 ass… Distribution data in the federal record shows the product reached: world wide distribution. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
269 units
Related Recalls
6
3 from same agency
Product description
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-2769-2020 |
| Date reported | August 12, 2020 |
| Date initiated | June 26, 2020 |
| Recalling firm | Covidien Llc |
| Firm location | Mansfield, MA |
| Affected scope | 269 units |
| Distribution | world wide distribution |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2769-2020) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Covidien Llc. Units affected: 269 units.
Why was this product 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 agency issued this recall? ▼
This recall was issued by the FDA Devices on August 12, 2020. Severity: Moderate. Recall number: Z-2769-2020.
Where was the recalled product distributed? ▼
Distribution: world wide distribution.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2769-2020) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported August 12, 2020. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.