thejoe Advanced Sterilization Products

Advanced Sterilization Products: 36 FDA recall reports

Every medical device recall the FDA has published for Advanced Sterilization Products. The fault, and how the agency graded it.

36Reports

0Class I

0Ongoing

2017-02-22Most recent

What the classes mean

The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.

Class	What the FDA is saying
Class I	There is a reasonable probability that using this will cause serious harm or death.
Class II	It may cause temporary or reversible harm. Serious harm is unlikely.
Class III	It breaks a rule but is unlikely to hurt anyone. Often a labelling fault.

Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.

By class

Class	Reports
Class II	33
Class III	3

By year reported

Year	Reports
2012	5
2013	14
2014	9
2015	6
2017	2

Checking whether it affects you

The lot or code number is what matters. Not the product name. A recall covers specific lots. Yours may not be one of them.

Check the code on your package against the report. The FDA keeps the current list at fda.gov/safety/recalls.

The reports

The text below is quoted from the FDA record word for word.

STERRAD NX Sterilization System, Product Code: 10033, 10033-002

Z-1197-2017 · Class II · reported 2017-02-22 · Terminated

Why it was recalled: 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.
Product: STERRAD NX Sterilization System, Product Code: 10033, 10033-002
Where it went: Worldwide Distribution - USA (nationwide) including Puerto Rico and to the countries of : Australia, China, Hong Kong, India, Indonesia, Korea (South), Malaysia, New Zealand, Philippines, Singapore, Sri Lanka, Taiwan, Thailand, Vietnam, Canada, Belgium, Czech Republic, Egypt, France, Germany, Great Britain, Greece, Hungary, Ireland, Israel, Italy, Netherlands, Poland, Portugal, Qatar, Russian Federation, Saudi Arabia, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey, United Arab Emirates, Japan, Argentina, Bolivia, Brazil, Chile, Colombia, Ecuador, Guatemala, Mexico, Panama, Peru, Uruguay, and Venezuela.
How much: 7,694 units total (5,935 units in US)

EVOTECH Endoscope Cleaner and Reprocessor System 208V, Product Code: 50004 The EVOTECH ECR Endoscope Cleane

Z-0965-2017 · Class II · reported 2017-01-18 · Terminated

Why it was recalled: Advanced Sterilization Products (ASP) is recalling the EVOTECH Endoscope Cleaner and Reprocessor System because the 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 achieve cleaning and high level disinfection of heat sensitive (>60¿C} semi-critical endoscopes.
Where it went: US Nationwide Distribution.
How much: 107 units

CIDEX OPA Solution, P/N 20390 for use as a high level disinfectant for reprocessing heat sensitive medical dev

Z-2774-2015 · Class II · reported 2015-09-23 · Terminated

Why it was recalled: 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 following disinfection with CIDEX OPA according to the CIDEX OPA Solution IFU (Instruction For Use).
Product: CIDEX OPA Solution, P/N 20390 for use as a high level disinfectant for reprocessing heat sensitive medical devices.
Where it went: US
How much: 318,632 cases

CIDEX Activated Dialdehyde Solution, 4 bottles/case, P/N: 2266

Z-2459-2015 · Class II · reported 2015-09-02 · Terminated

Why it was recalled: 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.
Product: CIDEX Activated Dialdehyde Solution, 4 bottles/case, P/N: 2266
Where it went: US (nationwide) Distribution
How much: 23,426 cases

Wall Chart for STERRAD 100NX System, P/N 10104. The STERRAD 100NX Sterilizer is designed for sterilization

Z-2375-2015 · Class II · reported 2015-08-19 · Terminated

Why it was recalled: 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 STERRAD Chemical Indicators."
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.
Where it went: Nationwide Distribution.
How much: 1465 units

EVOTECH Endoscope Cleaner and Reprocessing System 220-230V, P/N 50004-002. The ASP EVOTECH ECR Endoscope Cl

Z-1715-2015 · Class II · reported 2015-06-17 · Terminated

Why it was recalled: 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 cancellation if there is a disconnected scope.
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 achieve cleaning and high level disinfection of heat sensitive (>60 ¿C) semi-critical endoscopes.
Where it went: Worldwide Distribution-US (nationwide) and the countries of Australia, Singapore, Canada, and Thailand.
How much: 44 units

EVOTECH Endoscope Cleaner and Reprocessing System 208V, P/N 50004. The ASP EVOTECH ECR Endoscope Cleaner an

Z-1714-2015 · Class II · reported 2015-06-17 · Terminated

Why it was recalled: 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 cancellation if there is a disconnected scope.
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 cleaning and high level disinfection of heat sensitive (>60 ¿C) semi-critical endoscopes.
Where it went: Worldwide Distribution-US (nationwide) and the countries of Australia, Singapore, Canada, and Thailand.
How much: 825 units

Tyvek Pouch/Roll with STERRAD Chemical Indicator, P/N 12425

Z-1312-2015 · Class II · reported 2015-04-01 · Terminated

Why it was recalled: 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.
Product: Tyvek Pouch/Roll with STERRAD Chemical Indicator, P/N 12425
Where it went: Saudi Arabia and Portugal
How much: 2 units

STERRAD NX, Product Code 10133 The STERRAD Cassettes are used on STERRAD Sterilization System which is a lo

Z-0845-2015 · Class II · reported 2014-12-31 · Terminated

Why it was recalled: 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.
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.
Where it went: Worldwide Distribution.
How much: 19,978 units total (9,792 units in US)

STERRAD 200, Product Code 10118 The STERRAD Cassettes are used on STERRAD Sterilization System which is a l

Z-0844-2015 · Class II · reported 2014-12-31 · Terminated

Why it was recalled: 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.
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.
Where it went: Worldwide Distribution.
How much: 19,978 units total (9,792 units in US)

STERRAD 100S, Product Code 10113. The STERRAD Cassettes are used on STERRAD Sterilization System which is a

Z-0843-2015 · Class II · reported 2014-12-31 · Terminated

Why it was recalled: 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.
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.
Where it went: Worldwide Distribution.
How much: 19,978 units total (9,792 units in US)

STERRAD 100NX, Product Code 10144 The STERRAD Cassettes are used on STERRAD Sterilization System which is a

Z-0846-2015 · Class II · reported 2014-12-31 · Terminated

Why it was recalled: 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.
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.
Where it went: Worldwide Distribution.
How much: 19,978 units total (9,792 units in US)

STERRAD 50, Product Code 10114. The STERRAD Cassettes are used on STERRAD Sterilization System which is a l

Z-0842-2015 · Class II · reported 2014-12-31 · Terminated

Why it was recalled: 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.
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.
Where it went: Worldwide Distribution.
How much: 19,978 units total (9,792 units in US)

STERRAD 100S Sterilization System, Product Code: 10101 The STERRAD 100S Sterilization System is a general pur

Z-0746-2014 · Class II · reported 2014-01-22 · Terminated

Why it was recalled: 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.
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.
Where it went: Nationwide Distribution
How much: 2366 units

STERRAD NX Sterilization System, Product Code: 10033 The STERRAD NX Sterilization System is a general purpo

Z-0744-2014 · Class II · reported 2014-01-22 · Terminated

Why it was recalled: 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.
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.
Where it went: Nationwide Distribution
How much: 5584 units

STERRAD 50 Sterilization System, Product Code: 10050 The STERRAD 50 Sterilization System is a general purpose

Z-0745-2014 · Class II · reported 2014-01-22 · Terminated

Why it was recalled: 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.
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.
Where it went: Nationwide Distribution
How much: 233 units

STERRAD Cyclesure Biological Indicator (BI, Part No. 14324. Intended to be used as a standard method for fr

Z-0604-2014 · Class II · reported 2014-01-08 · Terminated

Why it was recalled: 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 24 Biological Indicator.
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.
Where it went: Worldwide Distribution.
How much: 4048 units total (4014 units in US)

STERITITE Containers: STERITITE Container Kit, 1/4 size, 3" high, product code: 13902; STERITITE Mini Mid Size

Z-0434-2014 · Class III · reported 2013-12-11 · Terminated

Why it was recalled: 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, unprocessed containers.
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; STERITITE Container Kit, Full size, 4" high, product code: 13906. The ASP STERITITE sealed container system provides an efficient and cost-effective way to package and protect surgical instruments for sterilization, transportation, storage, and aseptic presentation of contents.
Where it went: Worldwide Distribution - USA (nationwide) and the countries of Australia, Vietnam, Thailand, Malaysia, China, Korea (South), Mexico, Spain, Singapore, Hong Kong and Portugal.
How much: 267 units total (252 units in US)

STERRAD 100NX, Product Code: 10104 The STERRAD Steri lization System is a low temperature general purpose s

Z-0402-2014 · Class II · reported 2013-12-04 · Terminated

Why it was recalled: 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.
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.
Where it went: Nationwide Distribution
How much: Total 4,381 units

STERRAD NX, Product Code: 10033 The STERRAD Steri lization System is a low temperature general purpose ster

Z-0403-2014 · Class II · reported 2013-12-04 · Terminated

Why it was recalled: 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.
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.
Where it went: Nationwide Distribution
How much: Total 4,381 units

Sterrad 100NX, Product Code: 10104. Used to sterilize heat and moisture sensitive reusable medical devices.

Z-0190-2014 · Class II · reported 2013-11-20 · Terminated

Why it was recalled: 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 used in the Sterrad 200 vacuum pumps.
Product: Sterrad 100NX, Product Code: 10104. Used to sterilize heat and moisture sensitive reusable medical devices.
Where it went: Worldwide Distribution-USA (nationwide) and the countries of EMEA, APAC, Japan, Canada. AE, AU, BE, BH, CA, CH, CL, CN, CO, DE, EC, ES, GB, GR, HK, HU, IL, IN, IT, JP, KR, KW, MX, MY, NX, PA, PH, PK, PL, PR, QA, RU, SA, SG, SI, TH, VE, VN, ZA, and Tripoli.
How much: 2106 units total (1224 units in US)

STERRAD 100NX Cassettes The STERRAD Sterilization System is a low temperature general purpose sterilizer us

Z-0044-2014 · Class II · reported 2013-10-30 · Terminated

Why it was recalled: 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 the cassette's labeled 15-month shelf-life.
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.
Where it went: Nationwide Distribution
How much: 2,995 units

STERRAD 200 Sterilizer (Single Door), Part Number: 10201. STERRAD 200 Sterilizer (Double Door), Part Number:

Z-0043-2014 · Class II · reported 2013-10-30 · Terminated

Why it was recalled: 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.
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.
Where it went: Worldwide Distribution - USA (nationwide) and the countries of EA (Europe Middle East and Asia), APAC (Asia Pacific), Japan and Canada
How much: 1,305 units total (654 units in US , 651 OUS )

STERRAD 100NX Cassettes, Product Code: 10144 The STERRAD Sterilization System is a low temperature general

Z-2174-2013 · Class II · reported 2013-09-18 · Terminated

Why it was recalled: 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 the STERRAD 100 NX System cassette's 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.
Where it went: Worldwide Distribution - USA (nationwide) and internationally to RU, VE, KW, SA, HU, GB, IT, HK, IL, MX, ZA, PH, GR, AE, IN, CO, KR, AU, IN, ES, SG, MY, TH, TR, TW, SI, BE, PL, EC, CN, JP, PA, DE, VN, CL, and Switzerland, United Kingdom. Israel. Slovenia, Qatar, Panama, Venezuela.
How much: 1,923 units

STERRAD CYCLESURE 24 Biological Indicator (BI) The STERRAD CYCLESURE 24 Biological Indicator (BI), is inten

Z-1180-2013 · Class II · reported 2013-05-08 · Terminated

Why it was recalled: 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.
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.
Where it went: Worldwide Distribution - Nationwide Distribution including the states of AR, AL, AK, AZ, CA, CT, CO, DE, FL, GA, HI, IA, IL, IN, ID, KY, LA, MA, ME, MD, MI, MS, MN, MO, MT, NC, ND, NE, NJ, NY, NV, NH, NM, OH, OR, OK, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI and WV., and the countries of AR, AU, BE, BR, CA, CL, CN, CO, DO, EC, GT, HK, ID, IN, JP, KR, MV, MX, PA, PE, PH, PR, RU, SG, TH, TW, UY, VE and VN.
How much: 69,994 cases

EVOTECH Endoscope Cleaner and Reprocessor System, P/N 50004. Designed to automatically clean and high-level

Z-1150-2013 · Class II · reported 2013-04-24 · Terminated

Why it was recalled: 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 occur in the Channel Control Manifold sub-assembly.
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.
Where it went: Nationwide Distribution
How much: 761 units

EVOTECH Endoscope Cleaner & Reprocessor System, P/N 50004 Designed to automatically clean and high-level di

Z-1123-2013 · Class II · reported 2013-04-24 · Terminated

Why it was recalled: 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.
Product: EVOTECH Endoscope Cleaner & Reprocessor System, P/N 50004 Designed to automatically clean and high-level disinfect flexible, submersible video or fiber-optic endoscopes.
Where it went: Nationwide Distribution-USA including DC and the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, ME, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, and WI.
How much: 273 units

STERRAD 200 Sterilization System, P/N 10201 Product Usage: The STERRAD 200 Sterilization System is a gener

Z-1027-2013 · Class II · reported 2013-04-10 · Terminated

Why it was recalled: 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.
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.
Where it went: US Nationwide Distribution
How much: 1038 units

STERRAD 100NX Sterilization System, P/N 10104 Product Usage: The STERRAD 100NX Sterilization System is a g

Z-1026-2013 · Class II · reported 2013-04-10 · Terminated

Why it was recalled: 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.
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.
Where it went: US Nationwide Distribution
How much: 1500 units

STERRAD 200 System Carriage, P/N 10208. Used as a tool to expedite loading and unloading processed items fr

Z-0998-2013 · Class II · reported 2013-04-03 · Terminated

Why it was recalled: Advanced Sterilization Products (ASP) is recalling the STERRAD 200 System Carriage because it can potentially become dislodged when an excessive load is applied.
Product: STERRAD 200 System Carriage, P/N 10208. Used as a tool to expedite loading and unloading processed items from a STERRAD 200 sterilizer.
Where it went: Worldwide Distribution-USA (nationwide) and the countries of Egypt, Germany, Italy, France, Saudi Arabia, UAE, Japan, Singapore, China, Thailand, Hong Kong, Hungary, Israel, Slovania, Poland, Czech Republic, Taiwan, Sweden, Greece, Korea, Ireland, and United Kingdom.
How much: 2,457 units

Showing the 30 most recent of 36. The rest are searchable at the FDA enforcement report database.

Read these counts with three things in mind

A firm with more recalls usually makes more products. A contract packer runs hundreds of lines. It will out-recall a company with one product whatever either does. This is not a safety ranking.

Most recalls here are voluntary. A firm found its own fault and pulled the stock. That is the system working. It lands in this database looking the same as a recall the FDA had to push for.

Terminated means the FDA considers the recall finished. It is not a verdict. It does not mean anyone was harmed.

Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.

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