Z-2291-2012Class II

Product is labeled in part: "MEDLINEStandard PTFE Coated Needle with Extended Insulation 2.75 (6.99cm)...

Name: Z-2291-2012 Product is labeled in part: "***MEDLINE***Standard PTFE Coated Needle with Extended Insulation 2.75 (6.99cm)...
Creator: Unimed Surgical Products, Inc.
Published: 2010-06-16
License: https://open.fda.gov/license/

Unimed Surgical Products, Inc. / initiated 2010-06-16 / Terminated / root cause: manufacturing process

FDA source

Unimed Surgical Products, Inc. began a recall of Product is labeled in part: "***MEDLINE***Standard PTFE Coated Needle with Extended Insulation 2.75 (6.99cm) Length***Reorder: ES0013M***Contents: 1... on 2010-06-16. FDA classified it as Class II and gives the reason as "On 6/16/2010 Unimed Surgical Products, Inc., 10401 Belcher Road, Largo, FL 33777 initiated a recall of the Medline Industries, Inc. Electrosurgical electrodes used for cutting and coagulation of soft tissue due to...". 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-2291-2012
Classification: Class II
Status: Terminated
Initiated: 2010-06-16
Posted: 2012-08-28
Terminated: 2012-08-30
Recalling firm: Unimed Surgical Products, Inc.
Product: Product is labeled in part: "***MEDLINE***Standard PTFE Coated Needle with Extended Insulation 2.75 (6.99cm) Length***Reorder: ES0013M***Contents: 1 Each***SINGLE USE ONLY**latexfree***RX Only***STERILE EO***www.medline.com Manufactured for Medline Industries, Inc. MEDLINE is a registered trademark of Medline Industries, Inc. 1-800-MEDLINE***Mundelein, IL 60060 USA Made in USA.***" Part # ES0013M -- Lot # 042209-02 Product Usage: Intended for cutting and coagulation of soft tissue.
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
Reason for recall: On 6/16/2010 Unimed Surgical Products, Inc., 10401 Belcher Road, Largo, FL 33777 initiated a recall of the Medline Industries, Inc. Electrosurgical electrodes used for cutting and coagulation of soft tissue due to concerns of sterility.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Unimed Surgical Products, Inc. issued a Medical Device Removal letter dated June 4, 2010 to Medline Industries, Inc. The letter identified the affected product, problem and actions to be taken. Medline was instructed to quarantine any undistributed product and notify its customers of the recall. For further information, contact Unimed Surgical Product, Inc. by phone 800-531-2627 or FAX 800-886-1225.
Quantity in commerce: 1800 each
Distribution: US Nationwide Distribution - including the state of IL.
Product codes and lots: Lot # 030509-07, 062309-02.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2291-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2286-2012	Class II	Terminated	Voluntary: Firm initiated	2012-09-05	2012-08-28
Z-2287-2012	Class II	Terminated	Voluntary: Firm initiated	2012-09-05	2012-08-28
Z-2288-2012	Class II	Terminated	Voluntary: Firm initiated	2012-09-05	2012-08-28
Z-2289-2012	Class II	Terminated	Voluntary: Firm initiated	2012-09-05	2012-08-28
Z-2290-2012	Class II	Terminated	Voluntary: Firm initiated	2012-09-05	2012-08-28
Z-2291-2012	Class II	Terminated	Voluntary: Firm initiated	2012-09-05	2012-08-28
Z-2292-2012	Class II	Terminated	Voluntary: Firm initiated	2012-09-05	2012-08-28
Z-2293-2012	Class II	Terminated	Voluntary: Firm initiated	2012-09-05	2012-08-28
Z-2294-2012	Class II	Terminated	Voluntary: Firm initiated	2012-09-05	2012-08-28
Z-2295-2012	Class II	Terminated	Voluntary: Firm initiated	2012-09-05	2012-08-28
Z-2296-2012	Class II	Terminated	Voluntary: Firm initiated	2012-09-05	2012-08-28

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)