Applied Medical Resources recalls GelPOINT Path Transanal Procedural Packs with Epix Electrosurgical L-Hook due to risk of unintended probe tip shifting during procedures.
Unintentional shifting of the tip insulation of the firm's electrosurgical probes.
Applied Medical Resources is recalling GelPOINT Path Transanal Procedural Packs with Epix Electrosurgical L-Hook. The recall is because the electrosurgical probes can shift unintentionally during use, which could lead to complications in medical procedures.
The electrosurgical probes can shift unintentionally during medical procedures. This shifting could cause unintended tissue damage or interfere with the procedure's effectiveness.
Medical professionals using the GelPOINT Path Transanal Access Platform for procedures are affected. Patients undergoing these procedures may be at risk if the probes shift during treatment.
Check for the model number TA211 on the product. The product was sold with lot numbers 1342169 and 1340118. The GelPOINT Path Transanal Access Platform is used for procedures through the anus.
Look for the model number TA211 on the GelPOINT Path Transanal Procedural Pack with Epix Electrosurgical L-Hook.
The electrosurgical probes can shift unintentionally during procedures, which may cause unintended tissue damage or interfere with the procedure.
Check the model number on the product. If it is TA211 with lot numbers 1342169 or 1340118, contact Applied Medical Resources for further instructions.
The recall states a risk of unintended probe tip shifting, but the official notice does not specify that this could cause serious injury in normal use.
We’ve drafted a message you can send Applied Medical Resources Corp to request your refund or repair — edit it as you like.
Subject: Recall Z-0510-2020 — Applied Medical Resources Corp Applied Medical Resources Corp Hello, I own a Applied Medical Resources Corp that is covered by recall Z-0510-2020 from Applied Medical Resources Corp. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.