Z-2800-2015Class II

PenBlade Safety Scalpel, for the incision of human skin and tissue, and to cut or trim sutures and catheters...

Name: Z-2800-2015 PenBlade Safety Scalpel, for the incision of human skin and tissue, and to cut or trim sutures and catheters...
Creator: Zien Medical Technologies, Inc
Published: 2015-08-18
License: https://open.fda.gov/license/

Zien Medical Technologies LLC / initiated 2015-08-18 / Terminated / root cause: packaging

FDA source

Zien Medical Technologies, Inc began a recall of PenBlade Safety Scalpel, for the incision of human skin and tissue, and to cut or trim sutures and catheters up to 6Fr. Models PB-M-10, PB-M-11P, PB-M-15 on 2015-08-18. FDA classified it as Class II and gives the reason as "Cracks were discovered in the PET tray of a small population of sterile product. These cracks create a risk of loss of sterile barrier for the product. Sampling and root cause analysis indicated that the risk could...". 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-2800-2015
Classification: Class II
Status: Terminated
Initiated: 2015-08-18
Posted: 2015-09-21
Terminated: 2015-12-09
Recalling firm: Zien Medical Technologies LLC
Product: PenBlade Safety Scalpel, for the incision of human skin and tissue, and to cut or trim sutures and catheters up to 6Fr. Models PB-M-10, PB-M-11P, PB-M-15
Product code: GDX Scalpel, One-Piece
Reason for recall: Cracks were discovered in the PET tray of a small population of sterile product. These cracks create a risk of loss of sterile barrier for the product. Sampling and root cause analysis indicated that the risk could extend throughout the lots manufactured from September 2014-July 2015. This led to the decision to recall the product.
Root cause tag: packaging
FDA root cause: Packaging process control
Action: All consignees have been notified via email with an attached copy of the recall letter. Telephone calls with be made to all customers and distributors that do not respond directly to email notification to ensure compliance to the recall.
Quantity in commerce: 28,284
Distribution: Worldwide distribution to U.S. nationwide, Germany and England.
Product codes and lots: Product Code PB-M-10, Lots 140901J-A, 150228PB10, 150509PB10, 150510PB10; Product Code PB-M-11P, Lots 140901J-B, 150227PB11, 150318PB11, 150509PB11, 150510PB11; Product Code PB-M-15, Lots 140901J-C, 150226PB15, 150326PB15, 150511PB15, 150512PB15, 150529PB15.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2800-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2800-2015	Class II	Terminated	Voluntary: Firm initiated	2015-09-30	2015-09-21

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)