Endo GIA Auto Suture Universal Articulating Loading Unit 45 mm - 3.5 mm, Item Code 030455 - Produ...

FDA Device Recall #Z-0006-2021 — Class II — August 12, 2020

Recall Summary

Recall Number Z-0006-2021
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 - 3.5 mm, Item Code 030455 - 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: T0A019X T7K037X T8H021X T8L102X T9E097X T0A105X T7K038X T8H050X T8L103X T9E098X T0A117X T7K039X T8J044X T8M010X T9F025X T0A141X T7K040X T8J045X T9A037X T9F047X T0B132X T7K041X T8J060X T9A128X T9F048X T0C045X T7L040X T8K044X T9B002X T9F098X T0C102X T7L041X T8K045X T9B003X T9H112X T0C128X T8B042X T8K046X T9C065X T9H146X T0D057X T8B043X T8K052X T9C066X T9K003X T0D120X T8C032X T8K075X T9C111X T9L039X T7G002X T8C033X T8K076X T9C145X T9M029X T7H005X T8E059X T8K092X T9D140X T9M049X T7H008X T8E060X T8L033X T9E027X T9M050X T7K036X T8H020X T8L099X

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.