Z-0507-2018Class II

The ReNew Reusable Grasper and Dissector Tips are to be used with the ReNew Laparoscopic Handpieces and they...

Name: Z-0507-2018 The ReNew Reusable Grasper and Dissector Tips are to be used with the ReNew Laparoscopic Handpieces and they...
Creator: Microline Surgical, Inc.
Published: 2017-07-13
License: https://open.fda.gov/license/

Microline Surgical, Inc / initiated 2017-07-13 / Terminated / root cause: design

FDA source

Microline Surgical, Inc. began a recall of The ReNew Reusable Grasper and Dissector Tips are to be used with the ReNew Laparoscopic Handpieces and they are indicated for cutting, grasping, dissecting... on 2017-07-13. FDA classified it as Class II and gives the reason as "The heat-shrink insulation tube may split during autoclave sterilization/re-sterilization. If a split occurs, the heat-shrink could fall off during a surgical procedure and if cautery is needed, there is a potential for...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0507-2018
Classification: Class II
Status: Terminated
Initiated: 2017-07-13
Posted: 2018-02-02
Terminated: 2020-02-06
Recalling firm: Microline Surgical, Inc
Product: The ReNew Reusable Grasper and Dissector Tips are to be used with the ReNew Laparoscopic Handpieces 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: The heat-shrink insulation tube may split during autoclave sterilization/re-sterilization. If a split occurs, the heat-shrink could fall off during a surgical procedure and if cautery is needed, there is a potential for burn due to insulation failure.
Root cause tag: design
FDA root cause: Device Design
Action: The firm, Microline Surgical, Inc., sent a "URGENT: MEDICAL DEVICE RECALL" letter dated July 13, 2017 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately determine if you are in possession of the product and stop use; quarantine all products both new un-opened Reusable Tips AND Reusable Tips that have been used or are in current use (regardless of whether you have observed the malfunction); If you are a distributor or further distributed this product, we require that you immediately remove affected products from inventory and stop sales and shipping; identify customers immediately and notify them of this product recall; and all customers/distributors complete and return the MEDICAL DEVICE RECALL RETURN RESPONSE Acknowledgement and Receipt Form (even if you have never received any of these products or have none in stock) by E-MAILING A SCANNED COPY TO: [email protected] or Fax to: 978-522-8490, ATTN: Reusable Tip Recall, or MAIL TO: Microline Surgical, Inc, 50 Dunham Road, Suite 1500, Beverly, MA 01915, ATTN: Recall Department. Microline has discontinued manufacture of the affected ReNew Reusable Tips and has initiated a ship-hold and new orders-hold for these products. For more information, please email [email protected] or contact Director of RA & QA at 978-922-9810 or email: [email protected].
Quantity in commerce: 61,769 units
Distribution: Worldwide Distribution-US (Nationwide) and countries of: Australia, Brazil, Canada, Chile, China, Colombia, El Salvador, Hong Kong, India, Indonesia, Malaysia, Mexico, Panama, Peru, Argentina, South Korea, Sri Lanka, Taiwan, Thailand, Uruguay & Vietnam.
Product codes and lots: All lots of product codes: 3201,3221,3231,3241,3251,3261,3271,3281,3291,3301,3311,3321,3331,3341, 3351,3361,3371,3381,3401,3411,3421,3431 UDI's for listed lots of product codes: 3201-UDI 00811099011644, 3221-UDI 00811099011651, 3231-UDI 00811099011668, 3241-UDI 00811099011675, 3251-UDI 00811099011682, 3261-UDI 00811099011699, 3271-UDI 00811099011705, 3281-UDI 00811099011712, 3291-UDI 00811099011729, 3301-UDI 00811099011859, 3311-UDI 00811099011736, 3321-UDI 00811099011743, 3331-UDI 00811099011767, 3341-UDI 00811099011774, 3351-UDI 00811099011781, 3371-UDI 00811099011804, 3381-UDI 00811099011811, 3401-UDI 00811099011828, 3411-UDI 00811099011835, 3421-UDI 00811099011842, 3431-UDI 00811099011644

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0507-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0507-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-14	2018-02-02

Product code GEI

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)