FDA Medical Device Recalls (openFDA)
Microline Surgical, Inc.: ReNew Dolphin Nose Disposable Dissector Tip, Catalog Number: 3312, UDI: 00811099011989 The ReNew single patient use disposable tips are to be used with the ReNew Laparoscopic Hand Pieces and they are indicated for cutting, grasping, dissecting and coagulation of tissue in endoscopic and laparoscopic surgical procedures.
- Recall number
- Z-1740-2018
- Recalling firm
- Microline Surgical, Inc.
- Product
- ReNew Dolphin Nose Disposable Dissector Tip, Catalog Number: 3312, UDI: 00811099011989 The ReNew single patient use disposable tips are to be used with the ReNew Laparoscopic Hand Pieces and they are indicated for cutting, grasping, dissecting and coagulation of tissue in endoscopic and laparoscopic surgical procedures.
- Status
- Terminated
- Initiated
- 2017-11-01
- Posted
- not on file
- Terminated
- 2019-09-17
- Reason
- Certain lots of disposable laparoscopic instrument tips may potentially have a compromised sterile barrier.
- Root cause
- Process control
- Action
- Microline Surgical sent an Urgent Medical Device Recall letter dated November 1, 2017. Actions to be taken by the Customer/User: Please locate those products you have, quarantine them, and arrange for their return by contacting Microline Customer Service to receive an RMA number. Alternatively, you may wish to contact your Microline Distributor or Sales Representative to help with this. If you have used some or all of the identified product, please provide the item number, lot number, and the amount used so that we can track the progress of the recall. T To date, we have no evidence to suggest that the sterile barrier provided by the sealed pouches were damaged because of the rework, but are initiating this recall out of an abundance of caution because if a sterile barrier was compromised, there is potential that use of the device could result in an infection. If you experience any adverse events or quality problems with the use of this product, you should report this to FDAs MedWatch Adverse Event Reporting Program and to Microline as soon as possible. All product returned will be replaced at no cost. We regret any inconvenience and encourage you to contact Microline Customer Service at 978- 922-9810 or inf o@m icr olinesur g ical.com. with any further questions. For further questions, please call (978) 867-1758.
- Quantity
- 12 box of 10 tips each
- Distribution
- Distributed in the following U.S. states: FL, MA, MI, OH, OK TN, and Netherlands.
- Lot, serial or model codes
- Lot Numbers: 70208, 70209, 70210 UDI: 00811099011989
- 510(k) numbers
- ["K981389"]
- 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