Z-1250-2022Class II

Regard Item Number: 800214007 Sterile GS00367 - GASTRO BYPASS - SPARTANBURG. CONMED Catalog No...

Name: Z-1250-2022 Regard Item Number: 800214007 Sterile GS00367 - GASTRO BYPASS - SPARTANBURG. CONMED Catalog No...
Creator: ROi CPS LLC
Published: 2022-05-03
License: https://open.fda.gov/license/

ROi CPS LLC / initiated 2022-05-03 / Terminated / root cause: manufacturing process

FDA source

ROi CPS LLC began a recall of Regard Item Number: 800214007 Sterile GS00367 - GASTRO BYPASS - SPARTANBURG. CONMED Catalog No. 60-5274-944-Needle w/ Stealth ER, 44cm, 5mm on 2022-05-03. FDA classified it as Class II and gives the reason as "Potential for the tip of the electrode to detach during use". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1250-2022
Classification: Class II
Status: Terminated
Initiated: 2022-05-03
Posted: 2022-06-08
Terminated: 2024-05-31
Recalling firm: ROi CPS LLC
Product: Regard Item Number: 800214007 Sterile GS00367 - GASTRO BYPASS - SPARTANBURG. CONMED Catalog No. 60-5274-944-Needle w/ Stealth ER, 44cm, 5mm
Product code: FDE Laparoscopy Kit
Reason for recall: Potential for the tip of the electrode to detach during use.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: The firm sent out a recall notification on 05/03/2022 via email as well as the supplier's recall notice and label template to be used to label affected kits in the consignee's inventory. The recall notification letter informs the consignee to check their inventory, quarantine affected units, label affected kits, reply to the response form, and notify customers that were sent affected product. End users are to remove the affected items and discard them.
Quantity in commerce: 125 units
Distribution: Distributed to North Carolina.
Product codes and lots: Catalog No. 60-5274-944; Item Number: 800214007; Model Number: GS00367G; UDI/DI: 10194717101024; Lot Numbers: 88207G (Exp. Date: 05/11/2023), 88396G (Exp. Date: 05/26/2023), 88472G (Exp. Date: 06/02/2023), 88965G (Exp. Date: 07/02/2023), 91105 (Exp. Date: 01/07/2024)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1250-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1250-2022	Class II	Terminated	Voluntary: Firm initiated	2022-06-15	2022-06-08

Product code FDE

K952204Class IIConmed/aspen Labs Coated Laparoscopic Electrosurgical BladesConmedcorp / cleared 1995-05-25

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)