FDA Medical Device Recalls (openFDA)
Microline Surgical, Inc.: TLS2 Thermal Ligating Shears, Catalog Number 132-131D
- Recall number
- Z-1698-2019
- Recalling firm
- Microline Surgical, Inc.
- Product
- TLS2 Thermal Ligating Shears, Catalog Number 132-131D
- Status
- Terminated
- Initiated
- 2019-03-22
- Posted
- not on file
- Terminated
- 2020-07-30
- Reason
- 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.
- Root cause
- Under Investigation by firm
- Action
- Urgent Medical Device Recall letters dated 3/22/19 were sent to customers.
- Quantity
- 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.
- Lot, serial or model codes
- UDI: 811099011439; Lot Numbers: 807118, 807119, 807120, 811076
- 510(k) numbers
- ["K062257"]
- PMA numbers
- not on file
- Product code
- GEI
- Firm FEI
- 1000137656
- Firm city
- Beverly
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28