CLASS II Device recall · Reported 22 Jan 2014 · FDA Enforcement Report
Sterrad 50 Sterilization System, Product recalled
Advanced Sterilization Products is recalling Sterrad 50 Sterilization System, Product, distributed nationwide in the US. The recall was initiated on 16 Dec 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-0745-2014
- FDA event ID
- 67043
- Recalling firm
- Advanced Sterilization Products, Irvine, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 16 Dec 2013
- FDA classified
- 14 Jan 2014
- Reported
- 22 Jan 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Surgical Instruments
Timeline
| 16 Dec 2013 | Recall initiated by company | |
| 14 Jan 2014 | Classified by FDA | +29 days |
| 22 Jan 2014 | 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 NX, STERRAD 50, and STERRAD 100S Sterilization Systems because some healthcare workers detected odors or smells possibly emanating from STERRAD Systems.
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 50 Sterilization System, Product Code: 10050 The STERRAD 50 Sterilization System is a general purpose, low temperature sterilizer which uses the STERRAD 50 process to inactivate microorganisms on a broad range of medical devices and surgical instruments.
Where it was distributed
Nationwide Distribution
Questions about this recall
Is Sterrad 50 Sterilization System, Product recalled?
Yes. Advanced Sterilization Products recalled Sterrad 50 Sterilization System, Product on 16 Dec 2013. The recall is Class II and its status is Terminated. Recall number Z-0745-2014.
Why was it recalled?
Advanced Sterilization Products (ASP) is recalling the STERRAD NX, STERRAD 50, and STERRAD 100S Sterilization Systems because some healthcare workers detected odors or smells possibly emanating from STERRAD Systems.
Which lots are affected?
not available
Where was it sold?
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 21 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 | Foreign Material | Nationwide |
Other Surgical Instruments recalls
All 3,809| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline Convenience Kits: IV Start KIT recalled by Medline Industries | Medline Industries | Sterility | Nationwide |
| Device | CLASS II | Medline Convenience Kits containing BD ChloraPrep Clear recalled | Medline Industries | Lead & Heavy Metals | Nationwide |
| Device | CLASS II | Medline convenience kits labeled as: Open Heart Pack, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline convenience kits labeled as: GYN Robotic CDS, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Linvatec Genesys CrossFT Suture Anchor with Disposable Driver recalled | ConMed | Sterility | Nationwide |