Z-1986-2014Class II

Microline Surgical ReNew Laproscopic Fenestrated Grasper Forceps Tips Ref 3221

Name: Z-1986-2014 Microline Surgical ReNew Laproscopic Fenestrated Grasper Forceps Tips Ref 3221
Creator: Microline Surgical, Inc.
Published: 2014-05-12
License: https://open.fda.gov/license/

Microline Surgical, Inc / initiated 2014-05-12 / Terminated / root cause: manufacturing process

FDA source

Microline Surgical, Inc. began a recall of Microline Surgical ReNew Laproscopic Fenestrated Grasper Forceps Tips Ref 3221 on 2014-05-12. FDA classified it as Class II and gives the reason as "Potential for the Fenestrated Grasper Tip jaw to 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-1986-2014
Classification: Class II
Status: Terminated
Initiated: 2014-05-12
Posted: 2014-07-02
Terminated: 2015-08-13
Recalling firm: Microline Surgical, Inc
Product: Microline Surgical ReNew Laproscopic Fenestrated Grasper Forceps Tips Ref 3221
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
Reason for recall: Potential for the Fenestrated Grasper Tip jaw to break when force is applied to the jaw
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Microline Surgical notified Distributors, Hospitals (Customers/End Users) and Suppliers via letter dated May 15, 2014 with labeling, pictures, and Recall Response Forms via UPS Overnight Air, email, and/or fax. Product is requested to be returned and a RMA number will be issued. Contact 978-867-1775 for questions.
Quantity in commerce: 150 units
Distribution: Worldwide Distribution-USA including the states of CA, HI, ID, MA, MI, MS, PA, TN, UT, and TX. and the countries of Belgium, France, Ireland, Germany, Indonesia, Korea, Norway, Saudi Arabia, Switzerland, Turkey, and UK.
Product codes and lots: Lot Numbers: 00115342

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1986-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1986-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-09	2014-07-02
Z-1987-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-09	2014-07-02

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)