GelPOINT Path Transanal Procedural Pack with Epix Electrosurgical L-Hook with Smoke Evacuation, 4...
FDA Device Recall #Z-0510-2020 — Class II — December 12, 2018
Recall Summary
| Recall Number | Z-0510-2020 |
| Classification | Class II — Moderate risk |
| Date Initiated | December 12, 2018 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Applied Medical Resources Corp |
| Location | Rancho Santa Margarita, CA |
| Product Type | Devices |
| Quantity | 39 units Domestically and 112 units Internationally |
Product Description
GelPOINT Path Transanal Procedural Pack with Epix Electrosurgical L-Hook with Smoke Evacuation, 4x5.5cm and 5mm x 42cm REF TA211 Product Usage: The GelPOINT Path Transanal Access Platform is indicated for multiple instrument or camera access through the anus to perform various diagnostic and/or therapeutic procedures by using additional instruments.
Reason for Recall
Unintentional shifting of the tip insulation of the firm's electrosurgical probes.
Distribution Pattern
Worldwide distribution - US Nationwide distribution and countries of Belgium; Germany; Switzerland; Spain; Finland; France; Great Britain; Israel; India; Italy; Lebanon; Netherlands; and Portugal.
Lot / Code Information
Model Number: TA211 Lot Numbers: 1342169 and 1340118
Other Recalls from Applied Medical Resources Corp
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1010-2026 | Class II | Kii Low Profile, Bladed Dual Pack , Qty. 1 5x55... | Dec 11, 2025 |
| Z-1388-2024 | Class II | Epix Universal Clip Applier, REF: CA500, STERILEEO | Jan 30, 2024 |
| Z-1389-2024 | Class II | Epix Universal Clip Applier, REF: CA500, STERIL... | Jan 30, 2024 |
| Z-2160-2020 | Class II | DR. THAMES - LAP CHOLE, REF: K0880, UDI: (01)3... | Mar 17, 2020 |
| Z-2161-2020 | Class II | Clip Applier Kit, REF: K2887, UDI: (01)30607915... | Mar 17, 2020 |
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.