FDA Medical Device Recalls (openFDA)
LINA Medical ApS: LiNA Loop Endoscopic Monopolar Loop for LSH (Laparoscopic Supracervical Hysterectomy). Large loop, 4mm connector, 1 X REF: EL-200-4 and 10 X REF: EL-200-4, Manufactured by LiNA Medical ApS, Surgery Division.
- Recall number
- Z-2688-2011
- Recalling firm
- LINA Medical ApS
- Product
- LiNA Loop Endoscopic Monopolar Loop for LSH (Laparoscopic Supracervical Hysterectomy). Large loop, 4mm connector, 1 X REF: EL-200-4 and 10 X REF: EL-200-4, Manufactured by LiNA Medical ApS, Surgery Division.
- Status
- Terminated
- Initiated
- 2009-12-01
- Posted
- 2011-06-28
- Terminated
- 2012-02-23
- Reason
- Potential for the LiNA Loop to break during operating procedure.
- Root cause
- Labeling design
- Action
- Lina Medical Aps notified customers by newsletter in December 2009 followed by a letter to distributors including warnings added to instructions for use in January 2010.
- Quantity
- 200 pieces
- Distribution
- GA, MN, PA, WA, TN, MA, IN, Ontario Canada
- Lot, serial or model codes
- Batch 7415, 8283, 8453, 9081
- 510(k) numbers
- ["K070315"]
- PMA numbers
- not on file
- Product code
- KNF
- Firm FEI
- 3002626775
- Firm city
- Glostrup
- Firm state
- not on file
- Firm country
- Denmark
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