SIGNIA TRI-STAPLE 2.0 CURVED TIP 60MM MEDIUM/ THIC , SIG60CTAMT
FDA Device Recall #Z-1836-2019 — Class II — May 17, 2019
Recall Summary
| Recall Number | Z-1836-2019 |
| 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
SIGNIA TRI-STAPLE 2.0 CURVED TIP 60MM MEDIUM/ THIC , SIG60CTAMT
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
N6E0295UX N6H0576UX N6J1092UX N6K0230UX N6K0938UX N6L0422URX N6L0777UX N6M0607UX N7A0415UX N7C0112X N7D1013X N7E1089X N7F0275X N7F1126X N7G0444X N7H0047X N7H1067X N7J0175X N7L0825X N8A0249X N8A0655X N8B0455X N8B0945X N8C0757X N8C1213X N8D0593X N8D0907X N8E0015X N8G0648X N8J0764X N8K0823KY N8K0840Y N8L0166Y N8L0436Y N8M0845Y N9A0204Y N9B0455Y
Other Recalls from Covidien LLC
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1557-2026 | Class II | HealthCast "Vital Sync" Remote Patient Monitori... | Jan 30, 2026 |
| Z-1775-2022 | Class II | Puritan Bennett 560 Ventilator, PB560, CFN 4096600 | Aug 19, 2022 |
| Z-1318-2022 | Class I | Palindrome SI Chronic Catheter, Sterile, Single... | Jun 8, 2022 |
| Z-1319-2022 | Class I | Palindrome HSI Chronic Catheter, Sterile, Singl... | Jun 8, 2022 |
| Z-1315-2022 | Class I | Palindrome Precision HSI Chronic Catheter, Ster... | Jun 8, 2022 |
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.