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.

26–36 of 36

SevereFDA (Devices)·Z-1150-2013·2013-04-24
Advanced Sterilization Products Recalls EVOTECH Endoscope Cleaner Due to Smoke Risk
Advanced Sterilization Products is recalling 761 EVOTECH Endoscope Cleaner and Reprocessor systems because a circuit board malfunction can cause smoke to emanate from the device.
Product
EVOTECH Endoscope Cleaner and Reprocessor System, P/N 50004. Designed to automatically clean and high-level disinfect flexible, submersible video or fiber-optic endoscopes.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1123-2013·2013-04-24
Advanced Sterilization Products Recalls EVOTECH Endoscope Cleaner Systems
Advanced Sterilization Products is recalling 273 EVOTECH Endoscope Cleaner & Reprocessor Systems because they did not receive sufficient High Potential (HIPOT) DC voltage testing.
Product
EVOTECH Endoscope Cleaner & Reprocessor System, P/N 50004 Designed to automatically clean and high-level disinfect flexible, submersible video or fiber-optic endoscopes.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1026-2013·2013-04-10
Advanced Sterilization Products Recalls STERRAD 100NX Sterilization Systems
Advanced Sterilization Products is recalling STERRAD 100NX Sterilization Systems because they may emit unusual odors into the surrounding environment.
Product
STERRAD 100NX Sterilization System, P/N 10104 Product Usage: The STERRAD 100NX Sterilization System is a general purpose, low temperature sterilizer which uses the STERRAD 100NX process to inactivate microorganisms on a board range of medical devices and surgical instruments.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1027-2013·2013-04-10
Advanced Sterilization Products Recalls STERRAD 200 Sterilization Systems
Advanced Sterilization Products is recalling STERRAD 200 Sterilization Systems because they may emit unusual odors into the surrounding environment.
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.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0998-2013·2013-04-03
Advanced Sterilization Products Recalls STERRAD 200 System Carriage Units
Advanced Sterilization Products is recalling STERRAD 200 System Carriages because they may become dislodged under excessive load.
Product
STERRAD 200 System Carriage, P/N 10208. Used as a tool to expedite loading and unloading processed items from a STERRAD 200 sterilizer.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0661-2013·2013-01-16
Advanced Sterilization Products Recalls STERRAD NX Cassettes Due to Shelf-Life Data
Advanced Sterilization Products is recalling 12,280 STERRAD NX Cassettes because it lacks adequate data to support the product's labeled shelf-life.
Product
STERRAD NX Cassettes, P/N 10133. The STERRAD NX sterilizations systems are low-temperature general purpose sterilizers used to sterilize heat and moisture sensitive reusable medical devices. The sterilant used is hydrogen peroxide supplied in cassette form as a separate access
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0520-2013·2012-12-19
Advanced Sterilization Products Recalls Sterrad Cyclesure 24 Biological Indicators
Advanced Sterilization Products is recalling Sterrad Cyclesure 24 Biological Indicators because the manufacturer lacks adequate data to support the full labeled shelf-life.
Product
STERRAD CYCLESURE 24 Biological Indicator (BI) product, P/N 14324. Validation kits with Sterrad Cyclesure 24 BI products: Codes/Serial Numbers, Product Description: 14324 Sterrad Cyclesure 24 Biological Indicator. 14324-02 Sterrad Cyclesure 24 Biological Indicator. 10
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2338-2012·2012-09-19
Advanced Sterilization Products Recalls STERRAD NX Cassettes Due to Printing Verification Failure
Advanced Sterilization Products is recalling STERRAD NX cassettes because the camera used to verify printing was disabled, resulting in unverified product labels.
Product
STERRAD NX Cassette, Batch # 12A078. The STERRAD 100S and STERRAD NX sterilizations systems are low-temperature general purpose sterilizers used to sterilize heat and moisture sensitive reusable medical devices. The sterilant used is hydrogen peroxide supplied in cassette form
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2337-2012·2012-09-19
Advanced Sterilization Products Recalls STERRAD 100S and NX Cassettes
Advanced Sterilization Products is recalling STERRAD 100S and NX cassettes because a camera used to verify printing was disabled, resulting in unverified product labels.
Product
STERRAD 100S Cassette, Batch # 12A077. The STERRAD 100S and STERRAD NX sterilizations systems are low-temperature general purpose sterilizers used to sterilize heat and moisture sensitive reusable medical devices. The sterilant used is hydrogen peroxide supplied in cassette fo
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2276-2012·2012-09-05
Advanced Sterilization Products Recalls CIDEX OPA Solution Due to Missing Labels
Advanced Sterilization Products is recalling CIDEX OPA Solution bottles manufactured between May 2011 and April 2012 because some are missing labels.
Product
CIDEX OPA, High Level Disinfectant Solution, Glutaraldehyde-free (0.55% ortho-phthaladehyde) solution. The CIDEX OPA solution is intended for automated and manual cleaning and disinfection.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2100-2012·2012-08-08
Advanced Sterilization Products Recalls STERRAD Biological Indicators Due to Shelf-Life Data Gaps
Advanced Sterilization Products is recalling specific lots of STERRAD CYCLESURE 24 Biological Indicators because the company lacks adequate data to support the product's full labeled shelf-life.
Product
STERRAD Cyclesure Biological Indicator (BI), P/N 14324 are sold in cases, packaged as part of STERRAD System Validation kits and STERRAD test packs. The STERRAD CYCLESURE 24 Biological Indicator (BI), P/N 14324 is intended to be used as a standard method for frequent monitorin
Category
Medical Device
Distribution
Distributed nationwide