STERRAD NX Sterilizer, Product Code 10033 recallZ-0484-2009 · Advanced Sterilization Products · initiated Oct 7, 2008
Terminated All recalls posted in December 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
ASP has discovered a component defect in some of the UV lamp power supplies used in certain STERRAD NX Sterilizers. This defect can potentially cause the Hydrogen Peroxide Monitor to give inaccurate readings.
FDA root cause category: Nonconforming Material/Component
What the company is doing
The Urgent: Product Correction customer notifications, dated October 6, 2008, were hand delivered by field representatives starting October 7, 2008. The letter advises that Advanced Sterilization Products has discovered a component defect in some of the UV lamp power supplies used in certain STERRAD Sterilizers. This defect can potentially cause the Hydrogen Peroxide Monitor to give inaccurate readings. A list of the affected sterilizer serial numbers is included with the letter. The letter advises that the Field Service Engineer has come to their facility to inspect and, if necessary, replace this power supply. Customers are asked to sign the letter acknowledging receipt of this letter upon completion of the work by the Field Service Engineer.
Recall details
- Recall number
- Z-0484-2009
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Oct 7, 2008
- Posted by the FDA
- Dec 2, 2008
- Recalling firm
- Advanced Sterilization Products
- Quantity
- 32 potentially affected systems in the US - 20 installed, 5 uninstalled, 7 potentially affected. There are also 15 units internationally.
- Product code
- MLR
- FDA submissions
- K042116
- Distribution
- Worldwide Distribution --- USA including states of WV, CA, TN, AZ, WI, NC, MO, NJ, DE, GA, SC, WA, FL, MA, NM, MI, and AL and countries of Ecuador, China, Israel, Japan, Korea, Middle East, Australia, Czech Republic, Spain, Brazil, and Russia.
Product description
STERRAD NX Sterilizer, Product Code 10033 Low temperature sterilizers that use hydrogen peroxide gas plasma to inactivate microorganisms on a broad range of medical and surgical instruments.
Code information (models, lots, serial numbers)
Serial Numbers: 0033081006, 0033081007, 0033081016, 0033081017, 0033081019, 0033081020, 0033081022- 0033081029, 0033081036, 0033081039, 0033081048, 0033081059, 0033081080, 0033081082, 0033081086, 0033081088, 0033081089, 0033081091, 0033081095, 10033060892, 10033060379, 100330050671, 10033070576,10033080067,10033050663, and 10033050661.
Other devices under the same FDA submission
1 device cleared under K042116 — 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 NX™ 10033Advanced Sterilization Products Services Inc. · Sterilizer, chemical132 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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