CLASS II Device recall · Reported 10 Apr 2013 · FDA Enforcement Report
Sterrad 200 Sterilization System recalled by Advanced Sterilization
Advanced Sterilization Products is recalling Sterrad 200 Sterilization System, distributed nationwide in the US. The recall was initiated on 22 Mar 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-1027-2013
- FDA event ID
- 64692
- Recalling firm
- Advanced Sterilization Products, Irvine, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 22 Mar 2013
- FDA classified
- 29 Mar 2013
- Reported
- 10 Apr 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Surgical Instruments
Timeline
| 22 Mar 2013 | Recall initiated by company | |
| 29 Mar 2013 | Classified by FDA | +7 days |
| 10 Apr 2013 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The recall was initiated because Advanced Sterilization Products (ASP) has determined that the STERRAD 100NX and STERRAD 200 Sterilization Systems may emit an odor or smell into the surrounding environment that is not typical to normal operating conditions.
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 Sterilization System, P/N 10201 Product Usage: The STERRAD 200 Sterilization System is a general purpose, low temperature sterilizer which uses the STERRAD 200 process to inactivate microorganisms on a board range of medical devices and surgical instruments.
Where it was distributed
US Nationwide Distribution
Questions about this recall
Why was it recalled?
The recall was initiated because Advanced Sterilization Products (ASP) has determined that the STERRAD 100NX and STERRAD 200 Sterilization Systems may emit an odor or smell into the surrounding environment that is not typical to normal operating conditions.
Which lots are affected?
Codes: 10217 10201-002 10201 10202-001
Where was it sold?
US Nationwide Distribution
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.
Other products in this recall event
1 other product · FDA event 64692| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Sterrad 100NX Sterilization System recalled by Advanced Sterilization | Advanced Sterilization Products | Sterility | Nationwide |
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 |
Other Surgical Instruments recalls
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|---|---|---|---|---|---|
| Device | CLASS II | Square Driver recalled by Think Surgical | Think Surgical | Other | Nationwide |
| Device | CLASS II | Medline surgical convenience kits labeled as: EAR recalled | Medline Industries | Packaging Defects | Nationwide |
| Device | CLASS II | Convenience Kits containing Conmed AirSeal Access Ports recalled | Medline Industries | Packaging Defects | Nationwide |
| Device | CLASS II | Medline surgical convenience kits labeled as recalled | Medline Industries | Packaging Defects | Nationwide |
| Device | CLASS II | Scout MD recalled by Merit Medical Systems | Merit Medical Systems | Other | 7 states |