Z-1698-2019Class II

TLS2 Thermal Ligating Shears, Catalog Number 132-131D

Name: Z-1698-2019 TLS2 Thermal Ligating Shears, Catalog Number 132-131D
Creator: Microline Surgical, Inc.
Published: 2019-03-22
License: https://open.fda.gov/license/

Microline Surgical, Inc / initiated 2019-03-22 / Terminated

FDA source

Microline Surgical, Inc. began a recall of TLS2 Thermal Ligating Shears, Catalog Number 132-131D on 2019-03-22. FDA classified it as Class II and gives the reason as "The shears exhibited a high rate of complete or intermittent failure to actuate. As a result, they do not perform their intended function in surgical procedures". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1698-2019
Classification: Class II
Status: Terminated
Initiated: 2019-03-22
Posted: 2019-06-01
Terminated: 2020-07-30
Recalling firm: Microline Surgical, Inc
Product: TLS2 Thermal Ligating Shears, Catalog Number 132-131D
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
Reason for recall: The shears exhibited a high rate of complete or intermittent failure to actuate. As a result, they do not perform their intended function in surgical procedures.
FDA root cause: Under Investigation by firm
Action: Urgent Medical Device Recall letters dated 3/22/19 were sent to customers.
Quantity in commerce: 115 units
Distribution: The products were distributed to the following US states: ND and NY. The products were distributed to the following foreign countries: Germany, Netherlands.
Product codes and lots: UDI: 811099011439; Lot Numbers: 807118, 807119, 807120, 811076

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1698-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1698-2019	Class II	Terminated	Voluntary: Firm initiated	2019-06-12	2019-05-31

Product code GEI

K062257Class IIStarion Instruments Thermal Litigating ShearsStarion Instruments / cleared 2006-10-10

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)