ReNew recallZ-1740-2018 · Microline Surgical, Inc. · initiated Nov 1, 2017
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Microline Surgical, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Certain lots of disposable laparoscopic instrument tips may potentially have a compromised sterile barrier.
FDA root cause category: Process control
What the company is doing
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.
Recall details
- Recall number
- Z-1740-2018
- Status
- Terminated
- Initiated by the company
- Nov 1, 2017
- Recalling firm
- Microline Surgical, Inc.
- Quantity
- 12 box of 10 tips each
- Product code
- GEI
- FDA submissions
- K981389
- Distribution
- Distributed in the following U.S. states: FL, MA, MI, OH, OK TN, and Netherlands.
Product description
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.
Code information (models, lots, serial numbers)
Lot Numbers: 70208, 70209, 70210 UDI: 00811099011989
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- ReNew 3312Microline Surgical, Inc. · Electrosurgical, Cutting & Coagulation & Accessories1 recall0 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 79435).
- Z-1741-2018 · TerminatedReNew Endocut Scissor Disposable Tip, Catalog Number: 3142, UDI: 00811099012115 The ReNew single patient use disposable tips are to be used with the ReNew Laparoscopic Hand Pieces…
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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