The product is labeled in part "***Surgical Laser Technologies — Class II medical device recall Z-0005-2014
Terminated recall by PhotoMedex, Inc., reported 2013-10-09, distributed in AR, KS, OH. Firm became aware that some products within the specified lot may not have been sealed appropriately, thus com
| Recall number | Z-0005-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | PhotoMedex, Inc., Montgomeryville, PA, United States |
| Recall initiated | 2013-01-04 |
| Classified | 2013-10-01 |
| Reported by FDA | 2013-10-09 |
| Terminated | 2014-04-16 |
| Distributed | AR, KS, OH |
| Countries outside the US | DE, GB, ZA |
| Quantity | 549 |
| Reason classes | sterility |
| Lot numbers | 226201 |
Product
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.
Reason for recall
Firm became aware that some products within the specified lot may not have been sealed appropriately, thus compromising the sterile barrier.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0005-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.