SIGNIA TRI-STAPLE 2.0 CURVED TIP 45MM MEDIUM/ THIC , SIG45CTAMT
FDA Device Recall #Z-1835-2019 — Class II — May 17, 2019
Recall Summary
| Recall Number | Z-1835-2019 |
| 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 45MM MEDIUM/ THIC , SIG45CTAMT
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
N6E0296UX N6J1034UX N6J1035UX N6J1036UX N6L0007UX N6L0365UX N6L0721UX N6M0608UX N7A0414UX N7A0844UX N7B0401UX N7C0194X N7E0781X N7F0551X N7F1021X N7F1125X N7H0540X N7H1065X N7K0033X N7K0564X N7L0401X N7M0203X N7M0759X N8A0152X N8A0404X N8A0977X N8B0943X N8C0165X N8C0854X N8D0508X N8D1062X N8E0561X N8E0932X N8E0989X N8E1006X N8E1009X N8E1028X N8J0178X N8M0424Y N8M0530Y N8M0531Y
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.