Z-1836-2017Class II

Valleylab Laparoscopic Handset; Material # E2750; Laproscopic Handset Non-Sterile Bulk; Material # E2750NSB

Name: Z-1836-2017 Valleylab Laparoscopic Handset; Material # E2750; Laproscopic Handset Non-Sterile Bulk; Material # E2750NSB
Creator: Covidien Medtronic
Published: 2017-01-26
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2017-01-26 / Terminated / root cause: design

FDA source

COVIDIEN MEDTRONIC began a recall of Valleylab Laparoscopic Handset; Material # E2750; Laproscopic Handset Non-Sterile Bulk; Material # E2750NSB Product Usage: For use in 5mm cannulas or larger... on 2017-01-26. FDA classified it as Class II and gives the reason as "Customer reports of the device handset continuing to operate after release of the activation button". 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-1836-2017
Classification: Class II
Status: Terminated
Initiated: 2017-01-26
Posted: 2017-04-18
Terminated: 2018-08-08
Recalling firm: Medtronic, Inc.
Product: Valleylab Laparoscopic Handset; Material # E2750; Laproscopic Handset Non-Sterile Bulk; Material # E2750NSB Product Usage: For use in 5mm cannulas or larger cannulas with 5mm adapters during laparoscopic and thorascopic procedures. For use with a minimum peak voltage of 3625V.
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
Reason for recall: Customer reports of the device handset continuing to operate after release of the activation button.
Root cause tag: design
FDA root cause: Device Design
Action: A recall was initiated on January 26, 2017. Customers were notified via Federal Express and the letter instructs customers to discontinue use of the product and return all inventory to Medtronic (Covidien), 195 McDermott Road, North Haven, CT 06473, Attention: Field Returns Department. Disposition of product within Medtronic control and customer returned devices: Will be reworked.
Quantity in commerce: 24,703 Units
Distribution: Worldwide - US Nationwide Distribution in the states of: AR AZ CA CO FL GA IA IL KS KY LA MA MI MN MO MS NC NE NM NY OH OR PA SC SD TN TX VA WA WV
Product codes and lots: E2750: 52990142X 52990142X 52990144X 52990144X 52990147X 52990147X 52990151X 52990151X 53250057X 53250057X 53250061X 53250061X 53250063X 53250063X 53250065X 53250065X 53610053X 53610053X 53610055X 53610055X 53610059X 53610059X 53610061X 53610061X 60240055X 60240055X 60240059X 60240059X 60240061X 60240061X 60240065X 60240065X 60520098X 60520098X 60520104X 60520104X 60870064X 60870064X 61220093X 61220093X 61220095X 61220095X 61220098X 61220098X 61300164X 61300164X 61540145X 61540145X 61540150X 61540150X E2750NSB: 52990145X 53250066X 61220096X 61540146X

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1836-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1836-2017	Class II	Terminated	Voluntary: Firm initiated	2017-04-26	2017-04-17

Product code GEI

K964175Class IIValleylab E2750 Laparoscopic Handset, Valleylab E2770 Series ElectrodesValleylab, Inc. / cleared 1996-12-05

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)