Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
The product is labeled in part "***Surgical Laser Technologies Recalled by PhotoMedex, Inc. Due to Firm became aware that some products within the...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact PhotoMedex, Inc. directly.
Affected Products
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.
Quantity: 549
Why Was This Recalled?
Firm became aware that some products within the specified lot may not have been sealed appropriately, thus compromising the sterile barrier.
Where Was This Sold?
This product was distributed to 3 states: AR, KS, OH
About PhotoMedex, Inc.
PhotoMedex, Inc. has 2 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report