The Recall Desk

Manufacturer

Advanced Sterilization Products

36 recalls in our database name Advanced Sterilization Products as the manufacturing or recalling firm.

What the numbers show

Total
36
Critical
0
Severe
1
Most recent
2017-02-22

Of the 36 recalls from Advanced Sterilization Products we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (3%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–25 of 36

  • HighFDA (Devices)·Z-1197-2017·2017-02-22

    Advanced Sterilization Products Recalls STERRAD NX Sterilization Systems

    Advanced Sterilization Products is recalling STERRAD NX Sterilization Systems because the door interlock may disengage for 20 seconds after a power outage.

    Product
    STERRAD NX Sterilization System, Product Code: 10033, 10033-002
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0965-2017·2017-01-18

    ASP Recalls EVOTECH Endoscope Cleaner Due to Hose Leak Risk

    Advanced Sterilization Products is recalling 107 EVOTECH Endoscope Cleaner and Reprocessor Systems because a hose may come loose and cause a leak.

    Product
    EVOTECH Endoscope Cleaner and Reprocessor System 208V, Product Code: 50004 The EVOTECH ECR Endoscope Cleaner and Reprocessor, a washer/disinfector, is indicated for use with high-level disinfectant CIDEX OPA Concentrate Solution and an enzymatic detergent (CIDEZYME XTRA) to ac
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2774-2015·2015-09-23

    Advanced Sterilization Products Recalls CIDEX OPA Solution for Rinsing Labeling

    Advanced Sterilization Products is reminding customers to follow rinsing instructions for CIDEX OPA Solution to ensure proper disinfection of medical devices.

    Product
    CIDEX OPA Solution, P/N 20390 for use as a high level disinfectant for reprocessing heat sensitive medical devices.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2459-2015·2015-09-02

    Advanced Sterilization Products Recalls CIDEX Activated Dialdehyde Solution

    Advanced Sterilization Products is recalling CIDEX Activated Dialdehyde Solution because it may lack adequate data to support its 24-month shelf life.

    Product
    CIDEX Activated Dialdehyde Solution, 4 bottles/case, P/N: 2266
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2375-2015·2015-08-19

    Advanced Sterilization Products Recalls STERRAD 100NX Wall Charts for Incorrect Instructions

    Advanced Sterilization Products is recalling 1,465 STERRAD 100NX wall charts because they contain incorrect instructions regarding instrument tray wrapping.

    Product
    Wall Chart for STERRAD 100NX System, P/N 10104. The STERRAD 100NX Sterilizer is designed for sterilization of both metal and nonmetal medical devices at low temperatures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1714-2015·2015-06-17

    ASP Recalls EVOTECH Endoscope Cleaner for Connection Detection Failure

    Advanced Sterilization Products is recalling EVOTECH Endoscope Cleaner and Reprocessor units because they may fail to detect disconnected endoscopes, allowing the cleaning cycle to complete without proper processing.

    Product
    EVOTECH Endoscope Cleaner and Reprocessing System 208V, P/N 50004. The ASP EVOTECH ECR Endoscope Cleaner and Reprocessor is a washer/disinfector, which is indicated for use with high-level disinfectant CIDEX OPA Concentrate and an enzymatic detergent (CIDEZYME Gl) to achieve c
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1715-2015·2015-06-17

    ASP Recalls EVOTECH Endoscope Cleaner Due to Connection Detection Failure

    Advanced Sterilization Products is recalling EVOTECH Endoscope Cleaner and Reprocessor units because they may fail to detect disconnected endoscopes, potentially allowing incomplete disinfection cycles.

    Product
    EVOTECH Endoscope Cleaner and Reprocessing System 220-230V, P/N 50004-002. The ASP EVOTECH ECR Endoscope Cleaner and Reprocessor is a washer/disinfector, which is indicated for use with high-level disinfectant CIDEX OPA Concentrate and an enzymatic detergent (CIDEZYME Gl) to a
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0842-2015·2014-12-31

    Advanced Sterilization Products Recalls STERRAD 50 Cassettes Due to Leak Indicator Defect

    Advanced Sterilization Products is recalling STERRAD 50 cassettes because the leak indicator on the packaging may not function properly after exposure to hydrogen peroxide.

    Product
    STERRAD 50, Product Code 10114. The STERRAD Cassettes are used on STERRAD Sterilization System which is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0844-2015·2014-12-31

    Advanced Sterilization Products Recalls STERRAD 200 Cassettes Due to Leak Indicator Defect

    Advanced Sterilization Products is recalling STERRAD 200 cassettes because the leak indicator on the packaging may not function properly after exposure to hydrogen peroxide.

    Product
    STERRAD 200, Product Code 10118 The STERRAD Cassettes are used on STERRAD Sterilization System which is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0846-2015·2014-12-31

    Advanced Sterilization Products Recalls STERRAD 100NX Cassettes Due to Leak Indicator Defect

    Advanced Sterilization Products is recalling STERRAD 100NX cassettes because the leak indicator on the packaging may not function properly after exposure to hydrogen peroxide.

    Product
    STERRAD 100NX, Product Code 10144 The STERRAD Cassettes are used on STERRAD Sterilization System which is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0845-2015·2014-12-31

    Advanced Sterilization Products Recalls STERRAD System Cassettes Due to Leak Indicator Defect

    Advanced Sterilization Products is recalling STERRAD System cassettes because the leak indicator on the packaging may not function properly after exposure to hydrogen peroxide.

    Product
    STERRAD NX, Product Code 10133 The STERRAD Cassettes are used on STERRAD Sterilization System which is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0843-2015·2014-12-31

    Advanced Sterilization Products Recalls STERRAD 100S Cassettes for Leak Indicator Defect

    Advanced Sterilization Products is recalling STERRAD 100S cassettes because the leak indicator on the packaging may not function properly after exposure to hydrogen peroxide.

    Product
    STERRAD 100S, Product Code 10113. The STERRAD Cassettes are used on STERRAD Sterilization System which is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0744-2014·2014-01-22

    Advanced Sterilization Products Recalls STERRAD Sterilization Systems Due to Odors

    Advanced Sterilization Products is recalling STERRAD NX, 50, and 100S sterilization systems because healthcare workers detected odors possibly emanating from the devices.

    Product
    STERRAD NX Sterilization System, Product Code: 10033 The STERRAD NX Sterilization System is a general purpose, low temperature sterilizer which uses the STERRAD NX process to inactivate microorganisms on a broad range of medical devices and surgical instruments.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0745-2014·2014-01-22

    Advanced Sterilization Products Recalls STERRAD Sterilization Systems Due to Odor Reports

    Advanced Sterilization Products is recalling STERRAD 50, NX, and 100S sterilization systems because healthcare workers detected odors possibly emanating from the devices.

    Product
    STERRAD 50 Sterilization System, Product Code: 10050 The STERRAD 50 Sterilization System is a general purpose, low temperature sterilizer which uses the STERRAD 50 process to inactivate microorganisms on a broad range of medical devices and surgical instruments.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0746-2014·2014-01-22

    Advanced Sterilization Products Recalls STERRAD Sterilization Systems Due to Odors

    Advanced Sterilization Products is recalling STERRAD NX, 50, and 100S sterilization systems because healthcare workers detected odors possibly emanating from the devices.

    Product
    STERRAD 100S Sterilization System, Product Code: 10101 The STERRAD 100S Sterilization System is a general purpose, low temperature sterilizer which uses the STERRAD 100S process to inactivate microorganisms on a broad range of medical devices and surgical instruments.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0604-2014·2014-01-08

    Advanced Sterilization Products Recalls STERRAD Cyclesure Biological Indicators

    Advanced Sterilization Products is recalling STERRAD Cyclesure Biological Indicators due to a microscopic flaw in the outer vial.

    Product
    STERRAD Cyclesure Biological Indicator (BI, Part No. 14324. Intended to be used as a standard method for frequent monitoring of the STERRAD Sterilization System cycles.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0434-2014·2013-12-11

    Advanced Sterilization Products Recalls SteriTite Containers Due to Sterility Assurance Concerns

    Advanced Sterilization Products is recalling SteriTite containers because data does not consistently show that the required sterility assurance level is achieved during testing.

    Product
    STERITITE Containers: STERITITE Container Kit, 1/4 size, 3" high, product code: 13902; STERITITE Mini Mid Size, 3" high, product code: 13903; STERITITE Container Kit, 1/2 size, 4" high, product code: 13904; STERITITE Container Kit, 3/4 size, 4" high, product code: 13905; STERITIT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0403-2014·2013-12-04

    Advanced Sterilization Products Recalls STERRAD NX Sterilization Systems

    Advanced Sterilization Products is recalling STERRAD NX and STERRAD 100NX sterilization systems because bronchoscopes may contain unlisted polyurethane material in the suction channel.

    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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0402-2014·2013-12-04

    Advanced Sterilization Products Recalls STERRAD Sterilization Systems

    Advanced Sterilization Products is recalling STERRAD NX and 100NX sterilizers because bronchoscopes may contain unlisted polyurethane material in the suction channel.

    Product
    STERRAD 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 devices.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0190-2014·2013-11-20

    Advanced Sterilization Products Recalls Sterrad 100NX Sterilizers Due to Odor Reports

    Advanced Sterilization Products is recalling Sterrad 100NX sterilizers because healthcare workers detected odors, potentially linked to vacuum pump oil breakdown.

    Product
    Sterrad 100NX, Product Code: 10104. Used to sterilize heat and moisture sensitive reusable medical devices.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0044-2014·2013-10-30

    Advanced Sterilization Products Recalls STERRAD 100NX Cassettes Due to Leak Indicator Issue

    Advanced Sterilization Products is recalling STERRAD 100NX Cassettes because the leak indicator is effective for only 12 months, not the labeled 15 months.

    Product
    STERRAD 100NX Cassettes The STERRAD Sterilization System is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0043-2014·2013-10-30

    Advanced Sterilization Products Recalls STERRAD 200 Sterilizers for Odor Emission

    Advanced Sterilization Products is recalling STERRAD 200 Sterilizers because they may emit unusual odors into the surrounding environment.

    Product
    STERRAD 200 Sterilizer (Single Door), Part Number: 10201. STERRAD 200 Sterilizer (Double Door), Part Number: 10202. The STERRAD Sterilization System is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2174-2013·2013-09-18

    Advanced Sterilization Products Recalls STERRAD 100NX Cassettes Due to Packaging Data Gaps

    Advanced Sterilization Products is recalling 1,923 STERRAD 100NX Cassettes because it lacks adequate data to support the packaging's leak indicator effectiveness for the full 15-month shelf life.

    Product
    STERRAD 100NX Cassettes, Product Code: 10144 The STERRAD Sterilization System is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1180-2013·2013-05-08

    Advanced Sterilization Products Recalls STERRAD CYCLESURE 24 Biological Indicators

    Advanced Sterilization Products is recalling STERRAD CYCLESURE 24 Biological Indicators because the company lacks adequate data to support the entire labeled shelf-life.

    Product
    STERRAD CYCLESURE 24 Biological Indicator (BI) The STERRAD CYCLESURE 24 Biological Indicator (BI), is intended to be used as a standard method for frequent monitoring of the STERRAD Sterilization System cycles.
    Category
    Medical Device
    Distribution
    Distributed nationwide