CLASS II Device recall · Reported 9 Oct 2013 · FDA Enforcement Report
The product is labeled in part "***Surgical Laser recalled by PhotoMedex
PhotoMedex is recalling The product is labeled in part "***Surgical Laser Technologies, Inc. Montgomeryville, distributed in Arkansas, Kansas, Ohio. The recall was initiated on 4 Jan 2013 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0005-2014
- FDA event ID
- 64454
- Recalling firm
- PhotoMedex, Montgomeryville, PA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 4 Jan 2013
- FDA classified
- 1 Oct 2013
- Reported
- 9 Oct 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Sterility
- Device type
- Surgical Instruments
Timeline
| 4 Jan 2013 | Recall initiated by company | |
| 1 Oct 2013 | Classified by FDA | +270 days |
| 9 Oct 2013 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Firm became aware that some products within the specified lot may not have been sealed appropriately, thus compromising the sterile barrier.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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.
Where it was distributed
Worldwide Distribution-USA including the states of AR, KS and OH, and the countries of Germany, South Africa and the United Kingdom.
Questions about this recall
Why was it recalled?
Firm became aware that some products within the specified lot may not have been sealed appropriately, thus compromising the sterile barrier.
Which lots are affected?
Lot number 226201
Where was it sold?
Worldwide Distribution-USA including the states of AR, KS and OH, and the countries of Germany, South Africa and the United Kingdom.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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