STERRAD NX, Product Code: 10033 recallZ-0403-2014 · Advanced Sterilization Products · initiated Nov 11, 2013
Class II Terminated All recalls posted in November 2013
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 and STERRAD 100NX sterilization systems because ASP has determined that the bronchoscopes may contain a polyurethane material in the suction channel location that is not listed in the current claims for interior channels (lumens) for processing in STERRAD systems.
FDA root cause category: Labeling design
What the company is doing
Advanced Sterilization Products sent an Urgent Medical Device Field Safety Notificaiton letter on November 11, 2013, to all affected customers. The letter informed customers of the problems identified and the actions to be taken. Customers were instructed to provide the notice to anyone in their facility that needs to be informed and post this notice where appropriate. Customers were instructed to contact ASP at 1-888-783-7723 for any suspected problems. ASP is collaborating with KARL STORZ Endoskope to determine the sterilization impact of the suction port lumen material. Customers are instructed to contact KARL STORZ Endoskope Technical Support at (800)421-0837, ext 5350 for alternative reprocessing instructions. For questions regarding this recall call 949-453-6400.
Recall details
- Recall number
- Z-0403-2014
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Nov 11, 2013
- Posted by the FDA
- Nov 26, 2013
- Recalling firm
- Advanced Sterilization Products
- Quantity
- Total 4,381 units
- Product code
- MLR
- FDA submissions
- K042116
- Distribution
- Nationwide Distribution
Product description
STERRAD NX, Product Code: 10033 The STERRAD Steri lization System is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.
Code information (models, lots, serial numbers)
Please refer to consignee list
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
Other products in the same recall event
The FDA groups related products into one recall event (event 66815).
- Z-0402-2014 · TerminatedSTERRAD 100NX, Product Code: 10104 The STERRAD Steri lization System is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical…
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