Z-1635-2014Class II

Microline Renew Fenestrated Control Tip Grasper, Single Patient Use, Product Number: 3222 The ReNew...

Name: Z-1635-2014 Microline Renew Fenestrated Control Tip Grasper, Single Patient Use, Product Number: 3222 The ReNew...
Creator: Microline Surgical
Published: 2014-04-14
License: https://open.fda.gov/license/

Microline Surgical, Inc / initiated 2014-04-14 / Terminated / root cause: manufacturing process

FDA source

Microline Surgical began a recall of Microline Renew Fenestrated Control Tip Grasper, Single Patient Use, Product Number: 3222 The ReNew Fenestrated Grasper Forceps Tips are intended to cut... on 2014-04-14. FDA classified it as Class II and gives the reason as "Grasper jaw may break when force is applied to the jaw". 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-1635-2014
Classification: Class II
Status: Terminated
Initiated: 2014-04-14
Posted: 2014-05-20
Terminated: 2015-09-02
Recalling firm: Microline Surgical, Inc
Product: Microline Renew Fenestrated Control Tip Grasper, Single Patient Use, Product Number: 3222 The ReNew Fenestrated Grasper Forceps Tips are intended to cut, grasp, and dissect various abdominal tissue for use in endoscopic, including laproscopic surgical procedures where instruments are introduced onto the body through a cannula.
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
Reason for recall: Grasper jaw may break when force is applied to the jaw
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Microline Surgical sent an Recall Notice dated April 14, 2014, via overnight mail to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Immediately examine your inventory and quarantine product subject to this recall. In addition, if you have further distributed this product, please identify your customers and notify them at once of this product recall. Your notification to your customers may be enhanced by including a copy of this recall notification letter. Please contact Microline Customer Service ( 978) 922-9810 for a RGA number to return all unused product. This recall should be carried out to the hospital level. Please complete and return the enclosed response form as soon as possible.
Quantity in commerce: 540 units
Distribution: Worldwide Distribution - US including the states of TX, IL, TN and NY, and the country of Chile.
Product codes and lots: Lot Numbers: 00116169 and 00115866

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1635-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1635-2014	Class II	Terminated	Voluntary: Firm initiated	2014-05-28	2014-05-20

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)