STERRAD 100S Sterilizer, Product Code: 10101, Advanced… recallZ-0845-2008 · Advanced Sterilization Products · initiated Nov 12, 2007
Terminated All recalls posted in February 2008
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
User Guide Update: based on user reports about contact with residual hydrogen peroxide from instruments, pouches and trays after sterilization and subsequent light colored residue on these devices after sterilization updated user guidance has been issued.
FDA root cause category: Employee error
What the company is doing
Urgent Product Correction letters were sent to customers beginning on November 13, 2007 via UPS overnight. Customers were notified this action was being taken to clarify instructions contained within the STERRAD System User Guides to reinforce appropriate use and to address two separate issues which have arisen from user reports: (1) User reports about contact with residual hydrogen peroxide from instruments, pouches and trays after sterilization. (2) User reports about light-colored residues observed on instruments, trays and pouches after sterilization. The Product Correction Letters instructed customers to refer to the revised excerpt of the User Guide (attached to the letter) for information about instrument preparation prior to sterilization, particularly with regard to the washing, rinsing and thorough drying of instruments prior to sterilization in the STERRAD Sterilization System. If customers have any questions they were instructed to call ASP Customer Care Center to answer additional questions at (888) 783-7723.
Recall details
- Recall number
- Z-0845-2008
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Nov 12, 2007
- Posted by the FDA
- Feb 8, 2008
- Recalling firm
- Advanced Sterilization Products
- Quantity
- 9,686 units total for recalls Z-0845-0848-2008
- Product code
- MLR
- FDA submissions
- K030429, K981625, K991999
- Distribution
- Worldwide: USA, France, Germany, Italy, The UK, Switzerland, Benelux, Uruguay, Venezuela, Argentina, Chile, Colombia, Ecuador, Belgium, Puerto Rico, Hong Kong, Indonesia, Mexico, The Philippines, Switzerland, Australia, Austria, China, Greece, Ireland, Israel, Japan, Korea, Malaysia, Singapore, Taiwan, Thailand, Turkey, Middle East, Peru, Canada, The Czech Republic, Middle East, Portugal, S Africa, Spain, Sweden, Hungary, Poland, Brazil, Russia, Egypt, India & Slovenia
Product description
STERRAD 100S Sterilizer, Product Code: 10101, Advanced Sterilization Products, Irvine, CA
Code information (models, lots, serial numbers)
All Serial Numbers
Other devices under the same FDA submission
2 devices cleared under K030429, K981625, K991999 — 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
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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