CLASS II Device recall · Reported 3 Apr 2013 · FDA Enforcement Report
Sterrad 200 System Carriage recalled by Advanced Sterilization
Advanced Sterilization Products is recalling Sterrad 200 System Carriage, distributed nationwide in the US. The recall was initiated on 13 Mar 2012 and the FDA has classified it as Class II.
Recall details
- Recall number
- Z-0998-2013
- FDA event ID
- 64609
- Recalling firm
- Advanced Sterilization Products, Irvine, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 13 Mar 2012
- FDA classified
- 26 Mar 2013
- Reported
- 3 Apr 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 13 Mar 2012 | Recall initiated by company | |
| 26 Mar 2013 | Classified by FDA | +378 days |
| 3 Apr 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
Advanced Sterilization Products (ASP) is recalling the STERRAD 200 System Carriage because it can potentially become dislodged when an excessive load is applied.
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
STERRAD 200 System Carriage, P/N 10208. Used as a tool to expedite loading and unloading processed items from a STERRAD 200 sterilizer.
Where it was distributed
Worldwide Distribution-USA (nationwide) and the countries of Egypt, Germany, Italy, France, Saudi Arabia, UAE, Japan, Singapore, China, Thailand, Hong Kong, Hungary, Israel, Slovania, Poland, Czech Republic, Taiwan, Sweden, Greece, Korea, Ireland, and United Kingdom.
Questions about this recall
Why was it recalled?
Advanced Sterilization Products (ASP) is recalling the STERRAD 200 System Carriage because it can potentially become dislodged when an excessive load is applied.
Where was it sold?
Worldwide Distribution-USA (nationwide) and the countries of Egypt, Germany, Italy, France, Saudi Arabia, UAE, Japan, Singapore, China, Thailand, Hong Kong, Hungary, Israel, Slovania, Poland, Czech Republic, Taiwan, Sweden, Greece, Korea, Ireland, and 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.
More recalls from Advanced Sterilization Products
All 36| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Sterrad NX Sterilization System, Product recalled | Advanced Sterilization Products | Sterility | Nationwide |
| Device | CLASS II | Evotech Endoscope Cleaner and Reprocessor System 208V, Product recalled | Advanced Sterilization Products | Sterility | Nationwide |
| Device | CLASS II | Cidex OPA Solution recalled by Advanced Sterilization | Advanced Sterilization Products | Sterility | CA |
| Device | CLASS II | Cidex Activated Dialdehyde Solution/case recalled | Advanced Sterilization Products | Sterility | Nationwide |
| Device | CLASS II | Wall Chart for Sterrad 100NX System recalled by Advanced Sterilization | Advanced Sterilization Products | Sterility | Nationwide |
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