STERRAD Sterilizers ( Models 100S, 50, 200) Compatible… recallZ-0844-2008 · 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
Outdated Compatibility Lists: Recalling firm has decided to discontinue dissemination of Compatible Medical Device Reference Lists and instrument assessment activities
FDA root cause category: Other
What the company is doing
Notification letters, Urgent Product Correction, were sent to customers beginning on November 13, 2007 via UPS overnight. Customers were notified this action was being taken as a result of an investigation by the firm determined that all brand- and model-specific compatibility lists and associated instrument assessments provided to STERRAD Sterilization System customers are now out-of-date. User were instructed to discontinue their use and destroy them.
Recall details
- Recall number
- Z-0844-2008
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Nov 12, 2007
- Posted by the FDA
- Feb 7, 2008
- Recalling firm
- Advanced Sterilization Products
- Quantity
- 9,686 units
- Product code
- MLR
- FDA submissions
- K030429, K042116, 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,Philippines,Australia,Austria,China, Greece,Ireland,Israel, Japan,Korea,Malaysia,Singapore,Taiwan,Thailand, Turkey, Middle East, Peru,Canada,The Czech Republic,Portugal,S Africa, Spain,Sweden,Hungary,Poland,Brazil,Russia,Egypt,India &Slovenia and Canada
Product description
STERRAD Sterilizers ( Models 100S, 50, 200) Compatible Medical Device Reference List for US Customers, Document Numbers 15-53229 & 15-53230; STERRAD NX Sterilizers Compatible Medical Device Reference List for NX Customers, Product Code 15-53231; STERRAD NX System Brochure, Product Code AD-53421-001, Advanced Sterilization Products, Irvine, CA
Code information (models, lots, serial numbers)
Product Codes: 15-53229 ( Revision A of the list was released 4/5/2005), 15-53230 (Revision A of the list was released 4/5/2005), 15-53231(Revision A of the list was released 4/5/2005) & AD-53421-001( Revision A of the brochure was released 1/14/2006
Other devices under the same FDA submission
3 devices cleared under K030429, K042116, 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 NX™ 10033Advanced Sterilization Products Services Inc. · Sterilizer, chemical132 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.
How recalls are matched to devices · Editorial policy · Report an error on this page