PhotoMedex, Inc.: Medical Device Recall in 2013 - (Recall #: Z-0005-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

The product is labeled in part "***Surgical Laser Technologies, Inc. Montgomeryville, PA***SLT Fiber Delivery System***Sterile***Non-Pyrogenic***. The product is packaged in a flexible pouch and includes the following laser surgery accessories - SLT-SSRH 8, Catalog/Product Number 0041-3082; SLT-SSRH 11, Catalog/Product Number 0041-3112; SLT-SSRH 4-SMA, Catalog/Product Number 0042-0075; SLT-SSRH 5-SMA, Catalog/Product Number 0042-0076; SLT-SSRH 6-SMA, Catalog/Product Number 0042-0077; SLT-SSRH 7-SMA, Catalog/Product Number 0042-0078; SLT-SSRH 8-SMA, Catalog/Product Number 0042-0079; SLT-SSRH 9-SMA, Catalog/Product Number 0041-4931; and SLT-SSRH 10-SMA, Catalog/Product Number 0042-0081. Indicated for the incision, excision, coagulations, and vaporization of soft tissue.

Product Classification:

Class II

Date Initiated: January 4, 2013

Date Posted: October 9, 2013

Recall Number: Z-0005-2014

Event ID: 64454

Reason for Recall:

Firm became aware that some products within the specified lot may not have been sealed appropriately, thus compromising the sterile barrier.

Status: Terminated

Product Quantity: 549

Code Information:

Lot number 226201

Distribution Pattern:

Worldwide Distribution-USA including the states of AR, KS and OH, and the countries of Germany, South Africa and the United Kingdom.

Voluntary or Mandated:

Voluntary: Firm initiated