Z-1740-2018Class II

ReNew Dolphin Nose Disposable Dissector Tip, Catalog Number: 3312, UDI: 00811099011989 The ReNew single...

Name: Z-1740-2018 ReNew Dolphin Nose Disposable Dissector Tip, Catalog Number: 3312, UDI: 00811099011989 The ReNew single...
Creator: Microline Surgical, Inc.
Published: 2017-11-01
License: https://open.fda.gov/license/

Microline Surgical, Inc / initiated 2017-11-01 / Terminated / root cause: manufacturing process

FDA source

Microline Surgical, Inc. began a recall of ReNew Dolphin Nose Disposable Dissector Tip, Catalog Number: 3312, UDI: 00811099011989 The ReNew single patient use disposable tips are to be used with the... on 2017-11-01. FDA classified it as Class II and gives the reason as "Certain lots of disposable laparoscopic instrument tips may potentially have a compromised sterile barrier". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1740-2018
Classification: Class II
Status: Terminated
Initiated: 2017-11-01
Posted: 2018-05-08
Terminated: 2019-09-17
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.
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
Reason for recall: Certain lots of disposable laparoscopic instrument tips may potentially have a compromised sterile barrier.
Root cause tag: manufacturing process
FDA 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 in commerce: 12 box of 10 tips each
Distribution: Distributed in the following U.S. states: FL, MA, MI, OH, OK TN, and Netherlands.
Product codes and lots: Lot Numbers: 70208, 70209, 70210 UDI: 00811099011989

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1740-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1740-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-16	2018-05-08
Z-1741-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-16	2018-05-08

Product code GEI

K981389Class IIDisposable Re-New ForcepsMicroline Pentax, Inc. / cleared 1998-05-29

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)