Steris Corporation: 112 FDA recall reports
Every medical device recall the FDA has published for Steris Corporation. The fault, and how the agency graded it.
112Reports
0Class I
23Ongoing
2026-06-24Most 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 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
By year reported
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.
HarmonyAIR A-Series Surgical Lighting System
Z-2449-2026 · Class II · reported 2026-06-24 · Ongoing
- Why it was recalled
- The the plus and minus buttons (+/-) used to control light intensity on the light heads may detach.
- Product
- HarmonyAIR A-Series Surgical Lighting System
- Where it went
- Worldwide - US Nationwide distribution.
- How much
- 2101 units
HarmonyAIR A-Series Surgical Lighting System
Z-2448-2026 · Class II · reported 2026-06-24 · Ongoing
- Why it was recalled
- There is a potential for paint delamination (chipping/peeling) on the lighting system's light heads.
- Product
- HarmonyAIR A-Series Surgical Lighting System
- Where it went
- Worldwide distribution - US Nationwide and the countries of Australia, Canada, India, New Zealand, Panama.
- How much
- 4138 units
ALYON Surgical Lighting System
Z-2450-2026 · Class II · reported 2026-06-24 · Ongoing
- Why it was recalled
- The the plus and minus buttons (+/-) used to control light intensity on the light heads may detach.
- Product
- ALYON Surgical Lighting System
- Where it went
- Worldwide - US Nationwide distribution.
- How much
- 549 units
Barco MNA with the HexaVue IP Integration System, Model/Catalog Number: MNA-6x0-H
Z-1361-2026 · Class II · reported 2026-02-18 · Ongoing
- Why it was recalled
- This is a sub-recall of event RES 96885. The supplier identified that during their manufacturing process for a limited batch of MNA-6x0 (adapter) components the incorrect configuration file was used.
- Product
- Barco MNA with the HexaVue IP Integration System, Model/Catalog Number: MNA-6x0-H
- Where it went
- US Nationwide distribution in the states of FL, NC, NY, OH, TN, TX, and VA.
- How much
- 10 units
AMSCO 7052HP Washer/Disinfector Model/Catalog Number: 7052HP Product Description: The AMSCO 7052HP Washer
Z-0909-2026 · Class II · reported 2025-12-17 · Ongoing
- Why it was recalled
- Wire connected to the electrical box may shift out of its intended position, which may result in electrical arcing. Electrical arcing remains internal within the unit (no risk of shock to users).
- Product
- AMSCO 7052HP Washer/Disinfector Model/Catalog Number: 7052HP Product Description: The AMSCO 7052HP Washer/Disinfector is intended for use in the cleaning and intermediate-level disinfection of soiled reusable simple hard-surfaced rigid surgical instruments (such as forceps and clamps), utensils (such as bedpans, urinals, trays, bowl, basin and kidney dishes), rubber and plastic goods, theatre shoes and other similar and related articles found in healthcare facilities.
- Where it went
- Worldwide - US Nationwide distribution in the states of Arizona, Colorado, Florida, Georgia, Illinois, Kentucky, Louisiana, Michigan, New Hampshire, New York, North Carolina, Pennsylvania, Tennessee, Texas, Utah, Victoria, Virginia, Washington, Wisconsin and the countries of Australia.
- How much
- 10
AMSCO 7053HP Washer/Disinfector Model/Catalog Number: 7053HP Product Description: The AMSCO 7053HP Washe
Z-0910-2026 · Class II · reported 2025-12-17 · Ongoing
- Why it was recalled
- Wire connected to the electrical box may shift out of its intended position, which may result in electrical arcing. Electrical arcing remains internal within the unit (no risk of shock to users).
- Product
- AMSCO 7053HP Washer/Disinfector Model/Catalog Number: 7053HP Product Description: The AMSCO 7053HP Washer/Disinfector is intended for use in the cleaning and intermediate-level disinfection of soiled reusable simple hard-surfaced rigid surgical instruments (such as forceps and clamps), utensils (such as bedpans, urinals, trays, bowl, basin and kidney dishes), rubber and plastic goods, theatre shoes and other similar and related articles found in healthcare facilities.
- Where it went
- Worldwide - US Nationwide distribution in the states of Arizona, Colorado, Florida, Georgia, Illinois, Kentucky, Louisiana, Michigan, New Hampshire, New York, North Carolina, Pennsylvania, Tennessee, Texas, Utah, Victoria, Virginia, Washington, Wisconsin and the countries of Australia.
- How much
- 22
Dual Flat Panel Monitor (DFPM) accessories for HarmonyAIR E-Series Surgical Lighting Systems
Z-2178-2025 · Class II · reported 2025-08-06 · Ongoing
- Why it was recalled
- The DFPM yoke assembly ("yoke assembly") may detach from the spring arm. Should the yoke assembly detach from the spring arm, the yoke assembly would not be expected to fully detach but rather hang from the wiring within the yoke assembly.
- Product
- Dual Flat Panel Monitor (DFPM) accessories for HarmonyAIR E-Series Surgical Lighting Systems
- Where it went
- Worldwide - US Nationwide and Puerto Rico and the country of Canada.
- How much
- 59 units
Dual Flat Panel Monitor (DFPM) accessories for HarmonyAIR A-Series Surgical Lighting Systems
Z-2177-2025 · Class II · reported 2025-08-06 · Ongoing
- Why it was recalled
- The DFPM yoke assembly ("yoke assembly") may detach from the spring arm. Should the yoke assembly detach from the spring arm, the yoke assembly would not be expected to fully detach but rather hang from the wiring within the yoke assembly.
- Product
- Dual Flat Panel Monitor (DFPM) accessories for HarmonyAIR A-Series Surgical Lighting Systems
- Where it went
- Worldwide - US Nationwide and Puerto Rico and the country of Canada.
- How much
- 167 units
Hookup Model/Catalog Number: 2-8-540CAS Product Description: Hookups provide the interface between an Adva
Z-2538-2024 · Class II · reported 2024-08-14 · Ongoing
- Why it was recalled
- IFU for hookup were incorrectly reflected within hookup IFUs and online reference system, Hookup Lookup (HULU). Use of an incorrect hookup connection and/or parameter set may prevent an endoscope from being properly disinfected, which may present a risk of patient contamination or infection
- Product
- Hookup Model/Catalog Number: 2-8-540CAS Product Description: Hookups provide the interface between an Advantage Plus" Automated Endoscope Reprocessor and Advantage Plus" Pass-Thru Automated Endoscope Reprocessor ( AER ) and endoscopes, which allow perfusion of liquids dispensed by the AER to contact and high-level disinfect the channels of flexible endoscopes.
- Where it went
- Worldwide distribution - United States Nationwide and the countries of Canada, Belgium, Czech Republic, Denmark, Germany, Spain, Italy, Slovenia, Slovakia, Australia, Israel, Jordan, Kuwait, Namibia, Saudi Arabia, South Africa, Cote d Ivoire, Afghanistan, Albania, Belarus, Botswana, Kazakhstan, Malaysia, Qatar, Ukraine, United Arab Emirates, Nicaragua, and Nigeria.
- How much
- 6
Hookup Model/Catalog Number: 2-8-540 Product Description: Hookups provide the interface between an Advanta
Z-2536-2024 · Class II · reported 2024-08-14 · Ongoing
- Why it was recalled
- IFU for hookup were incorrectly reflected within hookup IFUs and online reference system, Hookup Lookup (HULU). Use of an incorrect hookup connection and/or parameter set may prevent an endoscope from being properly disinfected, which may present a risk of patient contamination or infection
- Product
- Hookup Model/Catalog Number: 2-8-540 Product Description: Hookups provide the interface between an Advantage Plus" Automated Endoscope Reprocessor and Advantage Plus" Pass-Thru Automated Endoscope Reprocessor ( AER ) and endoscopes, which allow perfusion of liquids dispensed by the AER to contact and high-level disinfect the channels of flexible endoscopes.
- Where it went
- Worldwide distribution - United States Nationwide and the countries of Canada, Belgium, Czech Republic, Denmark, Germany, Spain, Italy, Slovenia, Slovakia, Australia, Israel, Jordan, Kuwait, Namibia, Saudi Arabia, South Africa, Cote d Ivoire, Afghanistan, Albania, Belarus, Botswana, Kazakhstan, Malaysia, Qatar, Ukraine, United Arab Emirates, Nicaragua, and Nigeria.
- How much
- 37
Hookup Model/Catalog Number: 2-8-540HAN Product Description: Hookups provide the interface between an Adva
Z-2537-2024 · Class II · reported 2024-08-14 · Ongoing
- Why it was recalled
- IFU for hookup were incorrectly reflected within hookup IFUs and online reference system, Hookup Lookup (HULU). Use of an incorrect hookup connection and/or parameter set may prevent an endoscope from being properly disinfected, which may present a risk of patient contamination or infection
- Product
- Hookup Model/Catalog Number: 2-8-540HAN Product Description: Hookups provide the interface between an Advantage Plus" Automated Endoscope Reprocessor and Advantage Plus" Pass-Thru Automated Endoscope Reprocessor ( AER ) and endoscopes, which allow perfusion of liquids dispensed by the AER to contact and high-level disinfect the channels of flexible endoscopes.
- Where it went
- Worldwide distribution - United States Nationwide and the countries of Canada, Belgium, Czech Republic, Denmark, Germany, Spain, Italy, Slovenia, Slovakia, Australia, Israel, Jordan, Kuwait, Namibia, Saudi Arabia, South Africa, Cote d Ivoire, Afghanistan, Albania, Belarus, Botswana, Kazakhstan, Malaysia, Qatar, Ukraine, United Arab Emirates, Nicaragua, and Nigeria.
- How much
- 129
Hookup Model/Catalog Number: DSD-110-HU0163 Product Description: Hookups provide the interface between DSD
Z-2539-2024 · Class II · reported 2024-08-14 · Ongoing
- Why it was recalled
- IFU for hookup were incorrectly reflected within hookup IFUs and online reference system, Hookup Lookup (HULU). Use of an incorrect hookup connection and/or parameter set may prevent an endoscope from being properly disinfected, which may present a risk of patient contamination or infection
- Product
- Hookup Model/Catalog Number: DSD-110-HU0163 Product Description: Hookups provide the interface between DSD Automated Endoscope Reprocessors ( AER ) and endoscopes, which allow perfusion of liquids dispensed by the AER to contact and high-level disinfect the channels of flexible endoscopes. Component: N/A
- Where it went
- Worldwide distribution - United States Nationwide and the countries of Canada, Belgium, Czech Republic, Denmark, Germany, Spain, Italy, Slovenia, Slovakia, Australia, Israel, Jordan, Kuwait, Namibia, Saudi Arabia, South Africa, Cote d Ivoire, Afghanistan, Albania, Belarus, Botswana, Kazakhstan, Malaysia, Qatar, Ukraine, United Arab Emirates, Nicaragua, and Nigeria.
- How much
- 1082
Dual Articulating Headrest, Pad Ret P/N P141210805, REF BF754
Z-0983-2024 · Class II · reported 2024-02-14 · Ongoing
- Why it was recalled
- Dual-articulating head rest may not stay in place or may fail to lock into position during a patient procedure which could result in an injury to the patient or a procedural delay.
- Product
- Dual Articulating Headrest, Pad Ret P/N P141210805, REF BF754
- Where it went
- Worldwide - US Nationwide distribution in the states of AZ, CA, FL, IL, IN, IA, KS, LA, MN, MS, NV, NJ, OH, OK, OR, PA, TN, TX, UT, WA, WI & Puerto Rico, and the countries of Australia, Canada, Mexico & New Zealand.
- How much
- 2
Dual Articulating Headrest, Velcro P/N P141210813, REF BF753
Z-0984-2024 · Class II · reported 2024-02-14 · Ongoing
- Why it was recalled
- Dual-articulating head rest may not stay in place or may fail to lock into position during a patient procedure which could result in an injury to the patient or a procedural delay.
- Product
- Dual Articulating Headrest, Velcro P/N P141210813, REF BF753
- Where it went
- Worldwide - US Nationwide distribution in the states of AZ, CA, FL, IL, IN, IA, KS, LA, MN, MS, NV, NJ, OH, OK, OR, PA, TN, TX, UT, WA, WI & Puerto Rico, and the countries of Australia, Canada, Mexico & New Zealand.
- How much
- 80
V. Mueller Universal Bandage Scissors Black Plastic Handles Heavy-Duty, Autoclavable, Overall Length 7 (18 cm
Z-0737-2024 · Class II · reported 2024-01-24 · Ongoing
- Why it was recalled
- Bandage Scissors handle cover component contains an incorrect color masterbatch resin carrier. This may allow a pink dye/residue to appear on the Bandage Scissors and/or sterilization pouches after processing.
- Product
- V. Mueller Universal Bandage Scissors Black Plastic Handles Heavy-Duty, Autoclavable, Overall Length 7 (18 cm)- Intended to cut through tape and bandages Model: SU2014-001
- Where it went
- US Nationwide distribution.
- How much
- 4,214 units
Hookup Accessories used with MEDIVATORS ADVANTAGE PLUS and ADVANTAGE PLUS Pass Thru Automated Endoscope Repro
Z-0617-2024 · Class II · reported 2024-01-03 · Ongoing
- Why it was recalled
- Identification label on affected hookups could become illegible over time due to the label's ink coming off. This may potentially prevent users from being able to effectively identify the hookup and may ultimately result in postponement of patient procedures.
- Product
- Hookup Accessories used with MEDIVATORS ADVANTAGE PLUS and ADVANTAGE PLUS Pass Thru Automated Endoscope Reprocessors Model # Model Description 2-8-001 HU ZERO CHANNEL NO LT 2-8-010 ASSY, HOOK-UP, OLYMPUS 2-8-014 HOOKUP, OPTIM LT 2-8-030 ASSY, HOOKUP, PENTAX-0K 2-8-040 ASSY, HKUP STORZ 0K 2-8-070 ASSY, HU VISION SCIENCE 2-8-112 ASSY, HOOKUP OLMPUS 1K 2-8-120 ASSY, HOOKUP FUJI 1K 2-8-210 ASSY, HOOK-UP OLYMPUS 2K 2-8-213 ASSY, HOOKUP, OLYMPUS-2K 2-8-218 ASSY HOOKUP OLY 2K 2-8-236 ASSY, HOOKUP FUJINON 2K 2-8-244 ASSY, HOOKUP, STORZ 2K 2-8-245 ASSY, HOOK-UP, STORZ 2K 2-8-246 ASSY, HKUP, PENTAX-2K 2-8-260 ASSY, HOOK-UP WOLF 2-K 2-8-280 ASSY HOOKUP 2-8-312 ASSY, HOOK-UP OLYMPUS-3K 2-8-330 ASSY, HOOK-UP, PENTAX-3K 2-8-332 ASSEMBLY, HOOK-UP, PENTAX 2-8-334 ASSEMBLY, HOOK-UP, PENTAX 2-8-335 ASSY, HOOKUP, OLYMPUS, 3K 2-8-336 ASSY,HKUP FUJI 70 BRONC 2-8-338 ASSY, HU, FUJI BRONCH U/S 2-8-421 ASSY, HOOKUP, FUJIFILM 2-8-428 ASSY, ED-580XX 2-8-431 ASSY, HOOKUP, PENTAX 2-8-432 ASSY, HOOK-UP, PENTAX 2-8-460 HOOKUP, ASSY WOLF 4K 2-8-511 ASSY, HOOK-UP, OLY 2-8-513 ASSY HOOKUP OLY 4K ESOPHA 2-8-522 ASSY, FUJINON 4K-JET 2-8-523 ASSY, HKUP, FUJI 4K SER 5 ...
- Where it went
- Domestic distribution nationwide. Foreign distribution to Australia Canada China Hong Kong Italy Malaysia Netherlands New Zealand Singapore Thailand
- How much
- 2545 US; 992 OUS
Reliance Vision Multi-Chamber Washer/Disinfector, Reference Number FH83062
Z-1595-2023 · Class II · reported 2023-05-24 · Ongoing
- Why it was recalled
- In the remote occurrence in which the electrical contactor component present in the drying chambers of the Reliance Vision Multi-Chamber Washer/Disinfector malfunctions, the heating elements in the drying chamber could overheat, eventually resulting in smoke and/or fire.
- Product
- Reliance Vision Multi-Chamber Washer/Disinfector, Reference Number FH83062
- Where it went
- Worldwide Distribution: US (Nationwide) and OUS (Foreign) to countries of: China, Lithuania, Saudi Arabia, Korea, Republic of, Canada, Taiwan, United Kingdom, Spain, Australia, New Zealand, Spain, Brazil, Bahrain, Switzerland, Great Britain, South Africa, Hong Kong, Qatar.
- How much
- 322 units
Steris Lighting and Visualization Systems, Sterile Light Handle Cover (LB53)- Surgical light handle covers, in
Z-1475-2023 · Class II · reported 2023-05-10 · Ongoing
- Why it was recalled
- Light handle covers may separate from the light handle (detach and fall off) during use, this could result in a procedure delay and/or impact the sterile field which could result in an injury to the patient
- Product
- Steris Lighting and Visualization Systems, Sterile Light Handle Cover (LB53)- Surgical light handle covers, including disposable surgical light handle covers are designed to fit over surgical light handles for sterile surgeon control. REF: LB53
- Where it went
- Worldwide - US Nationwide distribution including Puerto Rico and the countries of Canada, Australia.
- How much
- 1,358,520 covers
Steris Lighting and Visualization Systems, Sterile Light handle Cover LB44 -Sterilizable consumables (dispos
Z-1476-2023 · Class II · reported 2023-05-10 · Ongoing
- Why it was recalled
- Light handle covers may separate from the light handle (detach and fall off) during use, this could result in a procedure delay and/or impact the sterile field which could result in an injury to the patient
- Product
- Steris Lighting and Visualization Systems, Sterile Light handle Cover LB44 -Sterilizable consumables (disposable, single use) used to drape the lighthandle of STERIS surgical lighting systems for the purpose of maintaining a sterile surgical environment. REF: LB44
- Where it went
- Worldwide - US Nationwide distribution including Puerto Rico and the countries of Canada, Australia.
- How much
- 263,280 covers
VERIFY Steam Test Pack (20 Tests and 20 controls) Item Number: S3069 Intended for use in installation test
Z-0781-2023 · Class II · reported 2023-01-11 · Ongoing
- Why it was recalled
- Biological indicator (BI) used to promote growth of the G. stearothermophilus and B. atrophaeus spores was inconsistent in promoting growth throughout lot , some BIs within the lot performed as intended while others did not. When used to monitor steam and ethylene oxide sterilization cycles, the potential hazard is that the BI will show no growth indicating that the cycle was effective, even if it may not have been.
- Product
- VERIFY Steam Test Pack (20 Tests and 20 controls) Item Number: S3069 Intended for use in installation testing and routine monitoring of steam and ethylene oxide sterilization processes
- Where it went
- Nationwide Foreign: AE AT CA CO ES FI GU IN IT JP MX SG TH TW ZA
- How much
- 105 boxes
VERIFY Dual Species Self-Contained Biological Indicators, 100 per box Item Number: S3061 Intended for use
Z-0779-2023 · Class II · reported 2023-01-11 · Ongoing
- Why it was recalled
- Biological indicator (BI) used to promote growth of the G. stearothermophilus and B. atrophaeus spores was inconsistent in promoting growth throughout lot , some BIs within the lot performed as intended while others did not. When used to monitor steam and ethylene oxide sterilization cycles, the potential hazard is that the BI will show no growth indicating that the cycle was effective, even if it may not have been.
- Product
- VERIFY Dual Species Self-Contained Biological Indicators, 100 per box Item Number: S3061 Intended for use in installation testing and routine monitoring of steam and ethylene oxide sterilization processes
- Where it went
- Nationwide Foreign: AE AT CA CO ES FI GU IN IT JP MX SG TH TW ZA
- How much
- 857 boxes
VERIFY Steam Test Pack (20 Tests and 5 controls) Item Number: S3065 Intended for use in installation testi
Z-0780-2023 · Class II · reported 2023-01-11 · Ongoing
- Why it was recalled
- Biological indicator (BI) used to promote growth of the G. stearothermophilus and B. atrophaeus spores was inconsistent in promoting growth throughout lot , some BIs within the lot performed as intended while others did not. When used to monitor steam and ethylene oxide sterilization cycles, the potential hazard is that the BI will show no growth indicating that the cycle was effective, even if it may not have been.
- Product
- VERIFY Steam Test Pack (20 Tests and 5 controls) Item Number: S3065 Intended for use in installation testing and routine monitoring of steam and ethylene oxide sterilization processes
- Where it went
- Nationwide Foreign: AE AT CA CO ES FI GU IN IT JP MX SG TH TW ZA
- How much
- 60 boxes
VERIFY Dual Species Self-Contained Biological Indicators, 50 per box Item Number: S3060 Intended for use i
Z-0778-2023 · Class II · reported 2023-01-11 · Ongoing
- Why it was recalled
- Biological indicator (BI) used to promote growth of the G. stearothermophilus and B. atrophaeus spores was inconsistent in promoting growth throughout lot , some BIs within the lot performed as intended while others did not. When used to monitor steam and ethylene oxide sterilization cycles, the potential hazard is that the BI will show no growth indicating that the cycle was effective, even if it may not have been.
- Product
- VERIFY Dual Species Self-Contained Biological Indicators, 50 per box Item Number: S3060 Intended for use in installation testing and routine monitoring of steam and ethylene oxide sterilization processes
- Where it went
- Nationwide Foreign: AE AT CA CO ES FI GU IN IT JP MX SG TH TW ZA
- How much
- 338 boxes
GI4000 Electrosurgical Unit - intended to deliver electrosurgical outputs to perform cutting and/or coagulatio
Z-0241-2023 · Class II · reported 2022-11-23 · Terminated
- Why it was recalled
- Two electronic diode components (D1 & D4) placed in the reverse orientation on the controller printed circuit board assembly may result in premature wear of the power regulator, leading to the regulators failure which could cause a full power loss. If the regulator failure were to occur during a patient procedure, a procedural delay may result
- Product
- GI4000 Electrosurgical Unit - intended to deliver electrosurgical outputs to perform cutting and/or coagulation and coagulation with or without delivery of argon gas, in flexible endoscopic applications. MODEL #(s): G1110001
- Where it went
- US Nationwide distribution in the states of Arizona, Illinois, Tennessee, Virginia.
- How much
- 5 units
Hu-Friedy K360 Scalpel Handle, 360 Degree Scalpel Handle, REF K360
Z-0079-2023 · Class II · reported 2022-10-19 · Terminated
- Why it was recalled
- The scalpel holder may separate from the handle for certain lots. If the tip falls off during use, it could fall into the patient's mouth which may result in a cut to the patient's mouth and also presents a choking hazard.
- Product
- Hu-Friedy K360 Scalpel Handle, 360 Degree Scalpel Handle, REF K360
- Where it went
- Distribution to US states of IL, MA, NC, SC, and TN, Canada, China, Japan, Malaysia, Turkey, Great Britain, and India.
- How much
- 5 US; 62 OUS
Reliance Synergy Washer/Disinfector
Z-1256-2022 · Class II · reported 2022-06-15 · Terminated
- Why it was recalled
- The firm identified that when the electrical contactor component in the drying chamber of the Washer/Disinfector malfunctions, the heating elements in the drying chamber could overheat, eventually resulting in smoke and/or fire.
- Product
- Reliance Synergy Washer/Disinfector
- Where it went
- Worldwide distribution - US Nationwide.
- How much
- 3,863 total units (2,776 US; 1,087 OUS)
Ultra Pure Non-Woven Sponges Non-Sterile 4-Ply 5,000 per case 25 sleeves of 200 2 in x 2 in / 5.1 cm x 5.1 cm
Z-1118-2022 · Class II · reported 2022-06-01 · Terminated
- Why it was recalled
- Product not approved for release for US distribution
- Product
- Ultra Pure Non-Woven Sponges Non-Sterile 4-Ply 5,000 per case 25 sleeves of 200 2 in x 2 in / 5.1 cm x 5.1 cm Model Number: ENC100
- Where it went
- Nationwide
- How much
- 103 cases
Ultra Pure Non-Woven Sponges Non-Sterile 4-Ply 2,000 per case 10 sleeves of 200 4 in x 4 in / 10.2 cm x 10.2 c
Z-1119-2022 · Class II · reported 2022-06-01 · Terminated
- Why it was recalled
- Product not approved for release for US distribution
- Product
- Ultra Pure Non-Woven Sponges Non-Sterile 4-Ply 2,000 per case 10 sleeves of 200 4 in x 4 in / 10.2 cm x 10.2 cm Model Number: ENC4100
- Where it went
- Nationwide
- How much
- 152 cases
OT1000 Series Orthopedic Surgical Tables
Z-1149-2021 · Class II · reported 2021-03-03 · Terminated
- Why it was recalled
- On January 7, 2021, STERIS identified that the glued bond between the beam and the leg spar assembly may begin to separate over time. This could result in unexpected movement of the affected leg spar if the separation occurred during a patient procedure.
- Product
- OT1000 Series Orthopedic Surgical Tables
- Where it went
- Domestic: AL, AK, AR, AZ, CA, CO, CT, DC, FL, GA, ID, IL IN, IW, KS, KY, LA, ME, MD, MI, MN, MO, NE, NV, NJ, NY, NC, ND, OH, OK, OR, PA, PR, SC, TX, UT, VT, VA, WA, WV, WI. Foreign: Canada, South Korea, Panama, Qatar, Thailand.
- How much
- 272 tables total (Domestic: 227 tables, Foreign 45 tables)
Reliance Vision Single-Chamber Washer/Disinfector - Product Usage: intended for use in the cleaning and interm
Z-0876-2021 · Class II · reported 2021-01-27 · Terminated
- Why it was recalled
- The electrical contactor component present in the drying chamber of the Reliance Vision Single-Chamber Washer/Disinfector may malfunction, potentially leading to the heating elements in the drying chamber to overheat, eventually resulting in smoke and/or fire.
- Product
- Reliance Vision Single-Chamber Washer/Disinfector - Product Usage: intended for use in the cleaning and intermediate level disinfection of soiled reusable utensils, trays, glassware, bedpans and urinals, rubber and plastic goods, simple hard-surfaced rigid surgical instruments, such as forceps and clamps, theatre shoes, and other similar and related articles found in healthcare facilities.
- Where it went
- Worldwide distribution - US Nationwide distribution and the countries of Australia, Belgium, Brazil, Bulgaria, Canada, Chile, China, Ecuador, France, Germany, Hong Kong, Ireland, Israel, Italy, Japan, Korea, Republic of Malaysia, Mexico, New Zealand, Panama, Portugal, Russian Federation, Saudi Arabia, Singapore, Spain, Switzerland, Taiwan, United Arab Emirates, United Kingdom, Venezuela.
- How much
- 3405
Showing the 30 most recent of 112. 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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