Z-0510-2020Class II

GelPOINT Path Transanal Procedural Pack with Epix Electrosurgical L-Hook with Smoke Evacuation, 4x5.5cm and...

Name: Z-0510-2020 GelPOINT Path Transanal Procedural Pack with Epix Electrosurgical L-Hook with Smoke Evacuation, 4x5.5cm and...
Creator: Applied Medical Resources Corp
Published: 2018-12-12
License: https://open.fda.gov/license/

Applied Medical Resources Corp / initiated 2018-12-12 / Terminated / root cause: design

FDA source

Applied Medical Resources Corp began a recall of 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... on 2018-12-12. FDA classified it as Class II and gives the reason as "Unintentional shifting of the tip insulation of the firm's electrosurgical probes". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0510-2020
Classification: Class II
Status: Terminated
Initiated: 2018-12-12
Posted: 2019-11-21
Terminated: 2021-01-22
Recalling firm: Applied Medical Resources Corp
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.
Product code: FER Anoscope And Accessories
Reason for recall: Unintentional shifting of the tip insulation of the firm's electrosurgical probes.
Root cause tag: design
FDA root cause: Device Design
Action: On12/12/2018, the firm sent an "URGENT; MEDICAL DEVICE RECALL" notification to customers via UPS informing them that this voluntary recall is being conducted due to the possibility that the insulation near the device tip may unintentionally shift. Customers are asked to: Check their inventory for recalled product. Complete the attached Recall Notification Confirmation Form to acknowledge the recall and indicate if their facility is returning or has already used units or kits from the lots listed. o If no product is being returned, to please indicate that on the Recall Notification Confirmation Form. Provide a no-charge P.O. number if replacement units or kits are requested. If customer is a distributor, they are instructed to notify any facilities to which they distributed units or kits from the affected lots, and to have them complete the appropriate sections of the Recall Notification Confirmation Form. Return the completed Recall Notification Confirmation Form to Applied Medical by emailing it to [email protected] or faxing it to 949-713-8871. Return affected product and a copy of the Recall Notification Confirmation Form to Applied Medical following the instructions provided. For product return questions, please contact the Manager of Customer Relations, RGA Dept. at (949) 713-8622 or by email at [email protected]. For regulatory questions, to contact (949) 713-8767 or by email at [email protected].
Quantity in commerce: 39 units Domestically and 112 units Internationally
Distribution: Worldwide distribution - US Nationwide distribution and countries of Belgium; Germany; Switzerland; Spain; Finland; France; Great Britain; Israel; India; Italy; Lebanon; Netherlands; and Portugal.
Product codes and lots: Model Number: TA211 Lot Numbers: 1342169 and 1340118

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0510-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0509-2020	Class II	Terminated	Voluntary: Firm initiated	2019-11-27	2019-11-21
Z-0510-2020	Class II	Terminated	Voluntary: Firm initiated	2019-11-27	2019-11-21

Product code FER

K171701Class IIGelPOINT Path Transanal Access PlatformApplied Medical Resources Corp. / cleared 2017-07-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)