Z-0403-2014Class II

Sterrad Nx

Name: Z-0403-2014 Sterrad Nx
Creator: Advanced Sterilization Products
Published: 2013-11-11
License: https://open.fda.gov/license/

Advanced Sterilization Products / initiated 2013-11-11 / Terminated / root cause: labeling and UDI

FDA source

Advanced Sterilization Products began a recall of STERRAD NX, Product Code: 10033 The STERRAD Steri lization System is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive... on 2013-11-11. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0403-2014
Classification: Class II
Status: Terminated
Initiated: 2013-11-11
Posted: 2013-11-26
Terminated: 2014-01-22
Recalling firm: Advanced Sterilization Products
Product: 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.
Product code: MLR Sterilizer, Chemical
Reason for recall: 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.
Root cause tag: labeling and UDI
FDA root cause: Labeling design
Action: 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.
Quantity in commerce: Total 4,381 units
Distribution: Nationwide Distribution
Product codes and lots: Please refer to consignee list

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0403-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0402-2014	Class II	Terminated	Voluntary: Firm initiated	2013-12-04	2013-11-26
Z-0403-2014	Class II	Terminated	Voluntary: Firm initiated	2013-12-04	2013-11-26

Product code MLR

K042116Class IISterrad Nx SterilizerAdvanced Sterilization Products / cleared 2005-04-22

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)