STERRAD 100S Sterilization System, Product Code: 10101 recallZ-0746-2014 · Advanced Sterilization Products · initiated Dec 16, 2013
Class II Terminated All recalls posted in January 2014
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Advanced Sterilization Products or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was 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.
FDA root cause category: Under Investigation by firm
What the company is doing
Advanced Sterilization Products (ASP) sent an Urgent Medical Device Field Safety Notification dated December 16, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to complete and return the customer response forms. Customers with questions were also instructed to contact ASP Professional Services directly at (888) 783-7723 and select option number 2. For questions regarding this recall call 949-453-6400.
Recall details
- Recall number
- Z-0746-2014
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Dec 16, 2013
- Posted by the FDA
- Jan 14, 2014
- Recalling firm
- Advanced Sterilization Products
- Quantity
- 2366 units
- Product code
- FLF
- FDA submissions
- K023290
- Distribution
- Nationwide Distribution
Product description
STERRAD 100S Sterilization System, Product Code: 10101 The STERRAD 100S Sterilization System is a general purpose, low temperature sterilizer which uses the STERRAD 100S process to inactivate microorganisms on a broad range of medical devices and surgical instruments.
Code information (models, lots, serial numbers)
not available
Other devices under the same FDA submission
2 devices cleared under K023290 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Sterrad 10101Advanced Sterilization Products Services Inc. · Sterilizer, ethylene-oxide gas258 reports
- STERRAD™ 10113Advanced Sterilization Products Services Inc. · Sterilizer, chemical2 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 67043).
- Z-0744-2014 · TerminatedSTERRAD NX Sterilization System, Product Code: 10033 The STERRAD NX Sterilization System is a general purpose, low temperature sterilizer which uses the STERRAD NX process to inac…
- Z-0745-2014 · TerminatedSTERRAD 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 inact…
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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