Endo GIA Auto Suture Universal Articulating Loading Unit 45 mm - 2.0 mm, Item Code 030453 - Produ...

FDA Device Recall #Z-0004-2021 — Class II — August 12, 2020

Recall Summary

Recall Number Z-0004-2021
Classification Class II — Moderate risk
Date Initiated August 12, 2020
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Covidien, LP
Location North Haven, CT
Product Type Devices
Quantity 900,007 total

Product Description

Endo GIA Auto Suture Universal Articulating Loading Unit 45 mm - 2.0 mm, Item Code 030453 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.

Reason for Recall

The device staples may not properly form upon application preventing adequate hemostasis. Use of a product with this assembly error may result in incomplete staple formation.

Distribution Pattern

Worldwide distribution - US Nationwide and Global Distribution.

Lot / Code Information

Lot Numbers: T7F017X T7J023X T7L032X T7L034X T8L100X T7F025X T7J024X T7L033X T7L035X T9F138X T7F026X T7K020X

Other Recalls from Covidien, LP

Recall # Classification Product Date
Z-0485-2026 Class II Covidien Signia" Small Diameter Curved Tip Inte... Sep 25, 2025
Z-0486-2026 Class II Covidien Signia" Small Diameter Curved Tip Inte... Sep 25, 2025
Z-1891-2024 Class II Tri-Staple 2.0 Black Reinforced Intelligent Rel... Apr 15, 2024
Z-1469-2024 Class II Covidien Auto Suture" Blunt Tip Trocar, Product... Feb 28, 2024
Z-1470-2024 Class II Covidien Auto Suture" Blunt Tip Trocar, Product... Feb 28, 2024

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.