EGIA 60 CURVED TIP ART MED THICK SULU, EGIA60CTAMT

FDA Device Recall #Z-1830-2019 — Class II — May 17, 2019

Recall Summary

Recall Number Z-1830-2019
Classification Class II — Moderate risk
Date Initiated May 17, 2019
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Covidien LLC
Location North Haven, CT
Product Type Devices
Quantity 3,113,280

Product Description

EGIA 60 CURVED TIP ART MED THICK SULU, EGIA60CTAMT

Reason for Recall

The device may be missing one of two pin components that maintain alignment of the device jaws, resulting in incomplete staple formation which may lead to bleeding, anastomotic leak, peritonitis, or pneumothorax which can result in the potential for infection and/or sepsis.

Distribution Pattern

Nationwide domestic distribution, worldwide foreign distribution.

Lot / Code Information

N8L0311KY N8M0063KY

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Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.