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Endo GIA Auto Suture Universal Articulating Loading Unit 60 mm - 3.5 mm, Item Code 030458 - Produ...

FDA Device Recall #Z-0008-2021 — Class II — August 12, 2020

Recall Summary

Recall Number Z-0008-2021
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 60 mm - 3.5 mm, Item Code 030458 - 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: T0A013X T7L050X T8E048X T8K051X T9F118X T0A051X T7L051X T8E055X T8K093X T9G028X T0A085X T7L052X T8E056X T8L129X T9G030X T0B025X T7M021X T8E061X T8L130X T9G038X T0B032X T7M022X T8E062X T8M009X T9G088X T0B046X T8A001X T8E067X T8M011X T9G089X T0B047X T8A002X T8E068X T8M097X T9G090X T0B056X T8A003X T8F001X T9A009X T9G094X T0B073X T8A004X T8F002X T9A031X T9G159X T0B081X T8A045X T8F026X T9A056X T9G160X T0C043X T8A046X T8F045X T9A099X T9H042X T0C068X T8A060X T8F046X T9B001X T9H100X T0C069X T8A061X T8F047X T9B004X T9H101X T0C070X T8B003X T8F077X T9B005X T9H113X T0C103X T8B037X T8H001X T9B038X T9H114X T0D054X T8B038X T8H002X T9C007X T9J030X T0D059X T8B039X T8H003X T9C008X T9J035X T0D061X T8B040X T8H005X T9C069X T9J048X T0D115X T8B041X T8H006X T9C070X T9J073X T0E050X T8C012X T8H019X T9C071X T9J096X T7F019X T8C034X T8H051X T9C156X T9J097X T7F021X T8C035X T8H052X T9E030X T9J098X T7F022X T8C041X T8H072X T9E069X T9K002X T7J003X T8C042X T8J027X T9E070X T9K068X T7J004X T8C044X T8J038X T9E071X T9K104X T7J005X T8D011X T8J041X T9E072X T9K105X T7J013X T8D057X T8J042X T9E111X T9L019X T7J020X T8D058X T8J058X T9E119X T9L074X T7J032X T8D059X T8J067X T9E120X T9L075X T7L028X T8D060X T8K007X T9F026X T9L102X T7L029X T8D061X T8K009X T9F049X T9L103X T7L030X T8D062X T8K043X T9F050X T9M109X T7L048X T8E047X T8K050X T9F078X T9M110X T7L049X

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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.

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