Advanced Sterilization Products recalls
Advanced Sterilization Products appears in 36 official U.S. recall notices indexed by RecallRadar, most recently on 2017-02-22.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 36 |
|---|---|
| Published | 2012-08-08 to 2017-02-22 |
| By agency | FDA Device (36) |
| By classification | Class II (33), Class III (3) |
| By status | terminated (36) |
| Distribution named in notices | US |
Recalls
- STERRAD NX Sterilization System, Product Code: 10033, 10033-002
FDA Device · Class II · 2017-02-22 · Advanced Sterilization Products
Reason: Advanced Sterilization Products (ASP) has identified that in a rare sequence of events following an external power outage, the system door interlock can be become disengaged during system reboot for a 20-second duration. - EVOTECH Endoscope Cleaner and Reprocessor System 208V, Product Code: 50004 The EVOTECH ECR Endoscope Cleaner and Reprocessor, a washer/disi…
FDA Device · Class II · 2017-01-18 · Advanced Sterilization Products
Reason: Advanced Sterilization Products (ASP) is recalling the EVOTECH Endoscope Cleaner and Reprocessor System because the hose may come loose and cause a leak. - CIDEX OPA Solution, P/N 20390 for use as a high level disinfectant for reprocessing heat sensitive medical devices
FDA Device · Class II · 2015-09-23 · Advanced Sterilization Products
Reason: Advanced Sterilization Products (ASP) is reminding all CIDEX OPA Solution customers to follow the warnings and rinsing procedure in their current labelling around the criticality of proper rinsing of medical device foll… - CIDEX Activated Dialdehyde Solution, 4 bottles/case, P/N: 2266
FDA Device · Class II · 2015-09-02 · Advanced Sterilization Products
Reason: Advanced Sterilization Products (ASP) is recalling the CIDEX Activated Dialdehyde Solution because it may lack the adequate data to support the entire 24-month shelf life. - Wall Chart for STERRAD 100NX System, P/N 10104
FDA Device · Class II · 2015-08-19 · Advanced Sterilization Products
Reason: Advanced Sterilization PRoducts (ASP) is recalling the Wall Chart for STERRAD 100NX System because it incorrectly states "APTIMAX Instrument Trays can be enclosed in either polypropylene wrap or in Tyvek Pouches with ST… - EVOTECH Endoscope Cleaner and Reprocessing System 208V, P/N 50004
FDA Device · Class II · 2015-06-17 · Advanced Sterilization Products
Reason: Advanced Sterilization Products (ASP) is recalling the EVOTECH Endoscope Cleaner and Reprocessor (ECR) because it may not detect an improper endoscope connection on two channels, and subsequently pass the cycle without… - EVOTECH Endoscope Cleaner and Reprocessing System 220-230V, P/N 50004-002
FDA Device · Class II · 2015-06-17 · Advanced Sterilization Products
Reason: Advanced Sterilization Products (ASP) is recalling the EVOTECH Endoscope Cleaner and Reprocessor (ECR) because it may not detect an improper endoscope connection on two channels, and subsequently pass the cycle without… - Tyvek Pouch/Roll with STERRAD Chemical Indicator, P/N 12425
FDA Device · Class II · 2015-04-01 · Advanced Sterilization Products
Reason: Advanced Sterilization Products (ASP) is recalling the Tyvek Rolls with STERRAD Chemical Indicator because they were shipped to customers after its expiration date of May 18, 2013. - STERRAD 100NX, Product Code 10144 The STERRAD Cassettes are used on STERRAD Sterilization System which is a low temperature general purpose…
FDA Device · Class II · 2014-12-31 · Advanced Sterilization Products
Reason: Advanced Sterilization Products is recalling the STERRAD System cassettes because the the leak indicator on the STERRAD System cassettes packaging may not function properly after exposure to hydrogen peroxide. - STERRAD 50, Product Code 10114
FDA Device · Class II · 2014-12-31 · Advanced Sterilization Products
Reason: Advanced Sterilization Products is recalling the STERRAD System cassettes because the the leak indicator on the STERRAD System cassettes packaging may not function properly after exposure to hydrogen peroxide. - STERRAD 200, Product Code 10118 The STERRAD Cassettes are used on STERRAD Sterilization System which is a low temperature general purpose s…
FDA Device · Class II · 2014-12-31 · Advanced Sterilization Products
Reason: Advanced Sterilization Products is recalling the STERRAD System cassettes because the the leak indicator on the STERRAD System cassettes packaging may not function properly after exposure to hydrogen peroxide. - STERRAD NX, Product Code 10133 The STERRAD Cassettes are used on STERRAD Sterilization System which is a low temperature general purpose st…
FDA Device · Class II · 2014-12-31 · Advanced Sterilization Products
Reason: Advanced Sterilization Products is recalling the STERRAD System cassettes because the the leak indicator on the STERRAD System cassettes packaging may not function properly after exposure to hydrogen peroxide. - STERRAD 100S, Product Code 10113
FDA Device · Class II · 2014-12-31 · Advanced Sterilization Products
Reason: Advanced Sterilization Products is recalling the STERRAD System cassettes because the the leak indicator on the STERRAD System cassettes packaging may not function properly after exposure to hydrogen peroxide. - STERRAD NX Sterilization System, Product Code: 10033 The STERRAD NX Sterilization System is a general purpose, low temperature sterilizer w…
FDA Device · Class II · 2014-01-22 · Advanced Sterilization Products
Reason: Advanced Sterilization Products (ASP) is recalling the STERRAD NX, STERRAD 50, and STERRAD 100S Sterilization Systems because some healthcare workers detected odors or smells possibly emanating from STERRAD Systems. - STERRAD 100S Sterilization System, Product Code: 10101 The STERRAD 100S Sterilization System is a general purpose, low temperature steriliz…
FDA Device · Class II · 2014-01-22 · Advanced Sterilization Products
Reason: Advanced Sterilization Products (ASP) is recalling the STERRAD NX, STERRAD 50, and STERRAD 100S Sterilization Systems because some healthcare workers detected odors or smells possibly emanating from STERRAD Systems. - STERRAD 50 Sterilization System, Product Code: 10050 The STERRAD 50 Sterilization System is a general purpose, low temperature sterilizer w…
FDA Device · Class II · 2014-01-22 · Advanced Sterilization Products
Reason: Advanced Sterilization Products (ASP) is recalling the STERRAD NX, STERRAD 50, and STERRAD 100S Sterilization Systems because some healthcare workers detected odors or smells possibly emanating from STERRAD Systems. - STERRAD Cyclesure Biological Indicator (BI, Part No. 14324
FDA Device · Class II · 2014-01-08 · Advanced Sterilization Products
Reason: Advanced Sterilization Products (ASP) is recalling the STERRAD Cyclesure Biological Indicator (BI) because ASP has identified a microscopic intermittent and low frequency flaw in the outer vial of the STERRAD Cyclesure… - STERITITE Containers: STERITITE Container Kit, 1/4 size, 3" high, product code: 13902
FDA Device · Class III · 2013-12-11 · Advanced Sterilization Products
Reason: Advanced Sterilization Products (ASP) is recalling the SteriTite containers because they do not have consistent data to show that sterility assurance level of 10(-6) is achieved during the half-cycle test runs on new, u… - STERRAD 100NX, Product Code: 10104 The STERRAD Steri lization System is a low temperature general purpose sterilizer used to sterilize heat…
FDA Device · Class II · 2013-12-04 · Advanced Sterilization Products
Reason: 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 loca… - STERRAD NX, Product Code: 10033 The STERRAD Steri lization System is a low temperature general purpose sterilizer used to sterilize heat an…
FDA Device · Class II · 2013-12-04 · Advanced Sterilization Products
Reason: 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 loca… - Sterrad 100NX, Product Code: 10104
FDA Device · Class II · 2013-11-20 · Advanced Sterilization Products
Reason: Advanced Sterilization Products (ASP) is recalling the Sterrad 100NX Sterilizer some healthcare workers detected odors/smells emanating from the 100NX Sterilizers, and it may be related to normal breakdown of the oil us… - STERRAD 200 Sterilizer (Single Door), Part Number: 10201
FDA Device · Class II · 2013-10-30 · Advanced Sterilization Products
Reason: Advanced Sterilization Products (ASP) is recalling the STERRAD 200 Sterilization System because it may emit an odor or smell into the surrounding environment that is not typical to normal operating conditions. - STERRAD 100NX Cassettes The STERRAD Sterilization System is a low temperature general purpose sterilizer used to sterilize heat and moistur…
FDA Device · Class II · 2013-10-30 · Advanced Sterilization Products
Reason: Advanced Sterilization Products (ASP) is recalling the three lots (13F049, 13F050, 13F051) STERRAD 100NX Cassettes because ASP has determined that the leak indicator on the cassettes is effective for only 12 months of t… - STERRAD 100NX Cassettes, Product Code: 10144 The STERRAD Sterilization System is a low temperature general purpose sterilizer used to steri…
FDA Device · Class II · 2013-09-18 · Advanced Sterilization Products
Reason: The recall of the STERRAD 100NX Cassettes was initiated because Advanced Sterilization Products (ASP) does not have adequate data to support the effectiveness of the packaging's leak indicator for the entire duration of… - STERRAD CYCLESURE 24 Biological Indicator (BI) The STERRAD CYCLESURE 24 Biological Indicator (BI), is intended to be used as a standard met…
FDA Device · Class II · 2013-05-08 · Advanced Sterilization Products
Reason: Advanced Sterilization Products is recalling certain lots of STERRAD CYCLESURE 24 Biological Indicator product because it may not have adequate data to support the entire duration of the labeled shelf-life. - EVOTECH Endoscope Cleaner & Reprocessor System, P/N 50004 Designed to automatically clean and high-level disinfect flexible, submersible vi…
FDA Device · Class II · 2013-04-24 · Advanced Sterilization Products
Reason: Advanced Sterilization Products (ASP) has determined that a limited number of EVOTECH ECRs manufactured between 2011 and 2012 did not receive sufficient High Potential (HIPOT) DC voltage testing. - EVOTECH Endoscope Cleaner and Reprocessor System, P/N 50004
FDA Device · Class II · 2013-04-24 · Advanced Sterilization Products
Reason: Advanced Sterilization Products (ASP) is recalling the EVOTECH Endoscope Cleaner and Reprocessor (ECR) because they have received reports of smoke emanating from the system due to a circuit board malfunction that may oc… - STERRAD 200 Sterilization System, P/N 10201 Product Usage: The STERRAD 200 Sterilization System is a general purpose, low temperature steri…
FDA Device · Class II · 2013-04-10 · Advanced Sterilization Products
Reason: 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 t… - STERRAD 100NX Sterilization System, P/N 10104 Product Usage: The STERRAD 100NX Sterilization System is a general purpose, low temperature s…
FDA Device · Class II · 2013-04-10 · Advanced Sterilization Products
Reason: 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 t… - STERRAD 200 System Carriage, P/N 10208
FDA Device · Class II · 2013-04-03 · Advanced Sterilization Products
Reason: Advanced Sterilization Products (ASP) is recalling the STERRAD 200 System Carriage because it can potentially become dislodged when an excessive load is applied. - STERRAD NX Cassettes, P/N 10133
FDA Device · Class II · 2013-01-16 · Advanced Sterilization Products
Reason: Advanced Sterilization Products is recalling three lots of STERRAD NX System Cassettes because it does not have adequate data to support the entire duration of the product's labeled shelf-life. - STERRAD CYCLESURE 24 Biological Indicator (BI) product, P/N 14324
FDA Device · Class II · 2012-12-19 · Advanced Sterilization Products
Reason: Advanced Sterilization Products (ASP) is recalling all lots of Sterrad Cyclesure 24 Biological Indicator (BI) manufactured between February 2008 and December 2011 because it may not have adequate data to support the ent… - STERRAD 100S Cassette, Batch # 12A077
FDA Device · Class III · 2012-09-19 · Advanced Sterilization Products
Reason: Advanced Sterilization Products (ASP) is recalling (removing) the Sterrad 100S and Sterrad NX System cassettes because the camera used to verify printing on the Sterrad System cassettes was inadvertently disabled. The S… - STERRAD NX Cassette, Batch # 12A078
FDA Device · Class III · 2012-09-19 · Advanced Sterilization Products
Reason: Advanced Sterilization Products (ASP) is recalling (removing) the Sterrad 100S and Sterrad NX System cassettes because the camera used to verify printing on the Sterrad System cassettes was inadvertently disabled. The S… - CIDEX OPA, High Level Disinfectant Solution, Glutaraldehyde-free (0.55% ortho-phthaladehyde) solution
FDA Device · Class II · 2012-09-05 · Advanced Sterilization Products
Reason: The recall was initiated because Advanced Sterilization Products has discovered instances of missing labels on bottles of CIDEX OPA Solution, Part # 20390 manufactured between May 2011 and April 2012. - STERRAD Cyclesure Biological Indicator (BI), P/N 14324 are sold in cases, packaged as part of STERRAD System Validation kits and STERRAD te…
FDA Device · Class II · 2012-08-08 · Advanced Sterilization Products
Reason: Advanced Sterilization Products (ASP) is recalling certain lots of the STERRAD CYCLESURE 24 Biological Indicator (BI) product because it does not have adequate data to support the entire duration of the product's labele…