Z-1027-2013Class II

STERRAD 200 Sterilization System, P/N 10201

Name: Z-1027-2013 STERRAD 200 Sterilization System, P/N 10201
Creator: Advanced Sterilization Products
Published: 2013-03-22
License: https://open.fda.gov/license/

Advanced Sterilization Products / initiated 2013-03-22 / Terminated / root cause: manufacturing process

FDA source

Advanced Sterilization Products began a recall of STERRAD 200 Sterilization System, P/N 10201 Product Usage: The STERRAD 200 Sterilization System is a general purpose, low temperature sterilizer which uses the... on 2013-03-22. FDA classified it as Class II and gives the reason as "The recall was initiated because Advanced Sterilization Products (ASP) has determined that the STERRAD 100NX and STERRAD 200 Sterilization Systems may emit an odor or smell into the surrounding environment that is not...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1027-2013
Classification: Class II
Status: Terminated
Initiated: 2013-03-22
Posted: 2013-03-30
Terminated: 2013-09-30
Recalling firm: Advanced Sterilization Products
Product: STERRAD 200 Sterilization System, P/N 10201 Product Usage: The STERRAD 200 Sterilization System is a general purpose, low temperature sterilizer which uses the STERRAD 200 process to inactivate microorganisms on a board range of medical devices and surgical instruments.
Product code: MLR Sterilizer, Chemical
Reason for recall: The recall was initiated because Advanced Sterilization Products (ASP) has determined that the STERRAD 100NX and STERRAD 200 Sterilization Systems may emit an odor or smell into the surrounding environment that is not typical to normal operating conditions.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Advanced Sterilization Products sent an Urgent Medical Device Field Safety Notification letter dated March 22, 2013 to all customers. The letter identified the affected products, problem and actions to be taken. Customers are instructed to report any complaints or suspected problems with their STERRAD 100NX and/or STERRAD 200 System to ASP Professional Services directly at (888) 783-7723 and select option #2.
Quantity in commerce: 1038 units
Distribution: US Nationwide Distribution
Product codes and lots: Codes: 10217 10201-002 10201 10202-001

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1027-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1026-2013	Class II	Terminated	Voluntary: Firm initiated	2013-04-10	2013-03-29
Z-1027-2013	Class II	Terminated	Voluntary: Firm initiated	2013-04-10	2013-03-29

Product code MLR

K030429Class IISterrad 200 SterilizerAdvanced Sterilization Products / cleared 2003-08-18

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)