Z-1347-2013Class II

PROGRESSIVE MEDICAL Laparoscopic Electrode PTFE Coated L Hook 33cm. Intended for the cutting of soft tissue...

Name: Z-1347-2013 PROGRESSIVE MEDICAL Laparoscopic Electrode PTFE Coated L Hook 33cm. Intended for the cutting of soft tissue...
Creator: Unimed Surgical Products, Inc.
Published: 2013-02-15
License: https://open.fda.gov/license/

Unimed Surgical Products, Inc. / initiated 2013-02-15 / Terminated

FDA source

Unimed Surgical Products, Inc. began a recall of PROGRESSIVE MEDICAL Laparoscopic Electrode PTFE Coated L Hook 33cm. Intended for the cutting of soft tissue and coagulation on 2013-02-15. FDA classified it as Class II and gives the reason as "Firm is recalling due to concerns regarding changes that were made to the PTFE coating materials". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1347-2013
Classification: Class II
Status: Terminated
Initiated: 2013-02-15
Posted: 2013-05-22
Terminated: 2013-08-07
Recalling firm: Unimed Surgical Products, Inc.
Product: PROGRESSIVE MEDICAL Laparoscopic Electrode PTFE Coated L Hook 33cm. Intended for the cutting of soft tissue and coagulation.
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
Reason for recall: Firm is recalling due to concerns regarding changes that were made to the PTFE coating materials.
FDA root cause: No Marketing Application
Action: Unimed Surgical Products, Inc. issued a Medical Device Correction and Removal letter dated February 15, 2013 to its customers. Customers were instructed to quarantine any undistributed product, and notify its customers of the recall to retrieve any unused product. For further information, contact Unimed Surgical Products Inc. at 1-800-531-2627.
Quantity in commerce: 120,416 units
Distribution: Distributed in the states of MO, TN, and PA.
Product codes and lots: Lot Numbers: 071212-02, 071212-03, 071212-05, 071212-01, 071212-06, 082712-02, 071212-04, 082712-04, 082712-05, 082712-13, 071212-07, 082712-07, 082712-09, 082712-03, 082712-15, 082712-14, 081712-06, 082712-01, 082712-10, 081512-06, 080612-01, 081512-07, 082712-12, 081512-04, 082712-11, 081012-01, 080612-03, 080612-02, 080612-04, 071612-05, 071612-04, 080612-05, 080612-07, 081312-11, 071612-03, 081312-10, 071912-01, 071912-02, 092812-02, 092812-03, 092812-04, 092812-05, 092812-06, 092812-07, 091312-01, 100812-02, 072312-01, 080612-08, 081312-01, 100112-01, 091312-04, 082312-04, 082312-03, 082312-06, 082312-05, 082812-02, 111212-01, 111212-03, 111212-02, 082312-02, 092812-02, 092812-07, 092812-06, 111212-19, 111212-18, 111212-18, 111212-19, 100212-01, 100312-06, 111212-11, 111212-07, 081512-05, 111212-04, 100312-01, 100312-03, 091312-02, 091312-03, 100312-08, 100312-09, 100312-10, 100312-01, 100312-03, 100312-04, 111212-14, 111212-10, 111212-08, 111212-07, 111212-17, 111212-20, 111212-21, 121012-03, 120612-01, 111212-12, 121012-01, 112112-01, 112112-02, 112112-03, 112112-04, 112112-06, 011113-04, 100312-02, 011013-10, 092812-01, 091912-02, 100312-05, 011013-12, 011013-05, 092812-02, 111212-16, 011013-04, 011013-07, 011013-08, 100312-13, 011013-02, 111212-09, 111212-11, 011013-11, 111212-13, 111212-15, 092812-03, 012213-02, 111212-12, 011013-13, 012213-01, 012213-04 011013-09, 011413-02, 012213-03, 011413-03, 011413-04, 111212-16, 011013-06, 012913-01, 012913-02, 111212-05, 012913-03, 012913-09, 012813-01.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1347-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1347-2013	Class II	Terminated	Voluntary: Firm initiated	2013-05-29	2013-05-21

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)