Z-0891-2013Class II

Technocut Plus, Sterile Single Use Safety Scalpel, Distributed by: Myco Medical

Name: Z-0891-2013 Technocut Plus, Sterile Single Use Safety Scalpel, Distributed by: Myco Medical
Creator: Myco Medical Supplies Inc
Published: 2013-02-07
License: https://open.fda.gov/license/

Myco Medical Supplies Inc / initiated 2013-02-07 / Terminated / root cause: packaging

FDA source

Myco Medical Supplies Inc began a recall of Technocut Plus, Sterile Single Use Safety Scalpel, Distributed by: Myco Medical on 2013-02-07. FDA classified it as Class II and gives the reason as "Pouch labeling/printing errors and defective packaging resulting in possible compromised sterility". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0891-2013
Classification: Class II
Status: Terminated
Initiated: 2013-02-07
Posted: 2013-02-27
Terminated: 2013-07-09
Recalling firm: Myco Medical Supplies Inc
Product: Technocut Plus, Sterile Single Use Safety Scalpel, Distributed by: Myco Medical.
Product code: GDX Scalpel, One-Piece
Reason for recall: Pouch labeling/printing errors and defective packaging resulting in possible compromised sterility.
Root cause tag: packaging
FDA root cause: Packaging
Action: MYCO Medical sent an Advisory Notice dated February 7, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers wsere instructed to review their inventory for the affected product and immediately quarantine the affected product per their internal procedures. Customers were also instructed to complete the attached Material for Return form and return to MYCO via email [email protected] or fax to 919-800-3919. Customers were have the returned material packaged and ready for UPS to pick up at their location. If product was shipped to other customers, customers were asked to contact a MYCO Customer Service Representative with the additional customer's contact and ship-to information. Customers with questions were instructed to call 919-460-2535. For questions regarding this recall call 919-460-2535, ext 105.
Quantity in commerce: 110,768 scalpels in individual pouches
Distribution: Worldwide Distribution - USA including CA, FL, IL, MI, MO, NY, OH, PA, SC, TN, WI and Internationally to Canada
Product codes and lots: Catalogue number: 6008TR-10, 6008TR-11, 6008TR-12, 6008TR-15, 6008TR-20; Batch numbers: 1208235, 1210189, 1211305, 1208276, 1211213, 1208224, 1210105, 1212041, 1208307, 1211192, 1212052, 1210116.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0891-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0891-2013	Class II	Terminated	Voluntary: Firm initiated	2013-03-06	2013-02-27

Product code GDX

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)