GelPOINT Path Transanal Procedural Pack with Epix Electrosurgical… — Class II medical device recall Z-0510-2020
Terminated recall by Applied Medical Resources Corp, reported 2019-11-27, distributed nationwide. Unintentional shifting of the tip insulation of the firm's electrosurgical probes.
| Recall number | Z-0510-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Applied Medical Resources Corp, Rancho Santa Margarita, CA, United States |
| Recall initiated | 2018-12-12 |
| Classified | 2019-11-21 |
| Reported by FDA | 2019-11-27 |
| Terminated | 2021-01-22 |
| Distributed | Nationwide (US) |
| Countries outside the US | BE, CH, DE, ES, FI, FR, GB, IL, IN, IT, LB, NL, PT |
| Lot numbers | 1340118, 1342169 |
| Model numbers | TA211 |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0510-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.