co_sos
1 records
courtlistener_docket
1 records
Nash v. Steris Plc.
2026-05-19
Federal docket 1:26-cv-05832 (ilnd); matched party 'Steris Plc.'
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EPA (Environmental Protection Agency)
5 records
epa_echo
3 records
fda
75 records
FDA Recall: Steris Corporation — Class II
20251217
Wire connected to the electrical box may shift out of its intended position, which may result in electrical arcing. Electrical arcing remains internal | Product: AMSCO 7052HP Washer/Disinfector Model...
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FDA Recall: Steris Corporation — Class II
20250806
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 | Product: Dual Flat Panel Monitor (DFPM) accesso...
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FDA Recall: Steris Corporation — Class II
20250806
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 | Product: Dual Flat Panel Monitor (DFPM) accesso...
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FDA Device Recall: AMSCO 7052HP Washer/Disinfector Model/Catalog Number: 7052HP Product Descri
2025-12-17
Class II — 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 u...
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FDA Device Recall: AMSCO 7053HP Washer/Disinfector Model/Catalog Number: 7053HP Product Descr
2025-12-17
Class II — 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 u...
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FDA Device Recall: Dual Flat Panel Monitor (DFPM) accessories for HarmonyAIR E-Series Surgical Ligh
2025-08-06
Class II — 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 rat...
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FDA Device Recall: Dual Flat Panel Monitor (DFPM) accessories for HarmonyAIR A-Series Surgical Ligh
2025-08-06
Class II — 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 rat...
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FDA Recall: Steris Corporation — Class II
20240814
IFU for hookup were incorrectly reflected within hookup IFUs and online reference system, Hookup Lookup (HULU). Use of an incorrect hookup connection | Product: Hookup Model/Catalog Number: 2-8-540C...
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FDA Recall: Steris Corporation — Class II
20240124
Bandage Scissors handle cover component contains an incorrect color masterbatch resin carrier. This may allow a pink dye/residue to appear on the Band | Product: V. Mueller Universal Bandage Scissors ...
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FDA Device Recall: Hookup Model/Catalog Number: 2-8-540CAS Product Description: Hookups provide
2024-08-14
Class II — 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 end...
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FDA Device Recall: Hookup Model/Catalog Number: 2-8-540 Product Description: Hookups provide th
2024-08-14
Class II — 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 end...
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FDA Device Recall: Hookup Model/Catalog Number: 2-8-540HAN Product Description: Hookups provide
2024-08-14
Class II — 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 end...
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FDA Device Recall: V. Mueller Universal Bandage Scissors Black Plastic Handles Heavy-Duty, Autoclav
2024-01-24
Class II — 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 pouch...
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FDA Device Recall: Steris Lighting and Visualization Systems, Sterile Light Handle Cover (LB53)- Su
2023-05-10
Class II — 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 inju...
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FDA Device Recall: VERIFY Steam Test Pack (20 Tests and 20 controls) Item Number: S3069 Intende
2023-01-11
Class II — 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 performe...
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FDA Device Recall: VERIFY Dual Species Self-Contained Biological Indicators, 100 per box Item Numb
2023-01-11
Class II — 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 performe...
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FDA Device Recall: GI4000 Electrosurgical Unit - intended to deliver electrosurgical outputs to per
2022-11-23
Class II — 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 ...
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FDA Device Recall: Ultra Pure Non-Woven Sponges Non-Sterile 4-Ply 5,000 per case 25 sleeves of 200
2022-06-01
Class II — Product not approved for release for US distribution
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FDA Recall: Steris Corporation — Class II
20210120
STERIS has identified that certain lots of diluted 4-Zyme may contain bacteria, specifically Pseudomonas fluorescens. The presence of this bacteria c | Product: Medisafe Distal Duck Kit and Duck Bag,...
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FDA Device Recall: OT1000 Series Orthopedic Surgical Tables
2021-03-03
Class II — 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 affect...
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FDA Device Recall: Medisafe Distal Duck Kit and Duck Bag, Cleaner, ultrasonic, medical instrument -
2021-01-20
Class II — STERIS has identified that certain lots of diluted 4-Zyme may contain bacteria, specifically Pseudomonas fluorescens. The presence of this bacteria can cause the color of the detergent to ...
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FDA Device Recall: Vis-U-All High Temp 7.5"x13.5" Heat Seal Pouch 200 pouches per box; 5 boxes per
2021-01-13
Class II — Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following steam processing causing cosmetic defects on the exterior of the pouch and in some instances, tr...
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FDA Device Recall: Vis-U-All High Temperature Tubing 9"x100'. One roll per box; 10 boxes per case 6
2021-01-13
Class II — Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following steam processing causing cosmetic defects on the exterior of the pouch and in some instances, tr...
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FDA Device Recall: Vis-U-All High Temp 13"x18" Self Seal Pouch 100 pouches per box; 4 boxes per cas
2021-01-13
Class II — Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following steam processing causing cosmetic defects on the exterior of the pouch and in some instances, tr...
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FDA Device Recall: Vis-U-All High Temp 3.5"x9" Self Seal Pouch 200 pouches per box; 4 boxes per cas
2021-01-13
Class II — Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following steam processing causing cosmetic defects on the exterior of the pouch and in some instances, tr...
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FDA Device Recall: Vis-U-All High Temp 6"x10" Heat Seal Pouch 200 pouches per box; 5 boxes per case
2021-01-13
Class II — Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following steam processing causing cosmetic defects on the exterior of the pouch and in some instances, tr...
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FDA Device Recall: Vis-U-All High Temperature Tubing 6"x100'. One roll per box; 10 boxes per case 1
2021-01-13
Class II — Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following steam processing causing cosmetic defects on the exterior of the pouch and in some instances, tr...
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FDA Device Recall: Vis-U-All High Temp 5.5"x10" Self Seal Pouch 200 pouches per box; 4 boxes per ca
2021-01-13
Class II — Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following steam processing causing cosmetic defects on the exterior of the pouch and in some instances, tr...
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FDA Recall: Steris Corporation — Class II
20190320
The software in the systems may not process the cycle originally intended. This could result in damage to the various medical devices and instruments | Product: AMSCO 5000 Series Washer/Disinfector M...
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FDA Device Recall: Evolution Loading Car and Transfer Carriage- Accessory to the Sterilizer, Steam
2019-12-11
Class II — The locking pin of the front wheel asse mbly of the Evolution Transfer Carriages may not remain full y engaged with the transfer carriage and result in the transfer carriage and loading c...
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FDA Device Recall: AMSCO 5000 Series Washer/Disinfector Model # 5052
2019-03-20
Class II — The software in the systems may not process the cycle originally intended. This could result in damage to the various medical devices and instruments processed in the washer/disinfector or ...
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FDA Device Recall: AMSCO 3000 Series Washer/Disinfector Model # 3052
2019-03-20
Class II — The software in the systems may not process the cycle originally intended. This could result in damage to the various medical devices and instruments processed in the washer/disinfector or ...
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FDA Recall: Steris Corporation — Class II
20180307
On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches may migrate following steam processing causi | Product: Vis-U-All High Temp 4"x8" Heat Seal Po...
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FDA Recall: Steris Corporation — Class II
20180307
On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches may migrate following steam processing causi | Product: Vis-U-All High Temp 10"x15" Heat Seal ...
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FDA Recall: Steris Corporation — Class II
20180307
On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches may migrate following steam processing causi | Product: Vis-U-All High Temp 4.5"x11" Heat Seal...
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FDA Device Recall: Reliance 1227 Cart and Utensil Washer/Disinfector, FW03101, FW03102, FW03S003
2018-07-18
Class II — The firm has become aware that the Reliance 1227 Cart and Utensil Washer/Disinfector s Chemical Low Level alarm, intended to prevent the user from initiating a cycle when a low chemical l...
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FDA Device Recall: Vis-U-All High Temp 4"x8" Heat Seal Pouch 200 pouches per box; 5 boxes per case
2018-03-07
Class II — On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches may migrate following steam processing causing cosmetic defects on the exterior of ...
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FDA Device Recall: Vis-U-All High Temp 10"x15" Heat Seal Pouch 100 pouches per box; 5 boxes per cas
2018-03-07
Class II — On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches may migrate following steam processing causing cosmetic defects on the exterior of ...
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FDA Device Recall: Vis-U-All High Temp 4.5"x11" Heat Seal Pouch 200 pouches per box; 5 boxes per ca
2018-03-07
Class II — On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches may migrate following steam processing causing cosmetic defects on the exterior of ...
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FDA Device Recall: Vis-U-All High Temp 16"x16" Heat Seal Pouch 100 pouches per box; 5 boxes per cas
2018-03-07
Class II — On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches may migrate following steam processing causing cosmetic defects on the exterior of ...
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FDA Device Recall: Vis-U-All High Temp 7.5"x13" Self Seal Pouch 200 pouches per box; 4 boxes per ca
2018-03-07
Class II — On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches may migrate following steam processing causing cosmetic defects on the exterior of ...
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FDA Device Recall: Vis-U-All High Temp 8"x10" Heat Seal Pouch 200 pouches per box; 5 boxes per case
2018-03-07
Class II — On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches may migrate following steam processing causing cosmetic defects on the exterior of ...
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FDA Device Recall: Vis-U-All High Temp 7.5"x13" Self Seal Pouch 200 pouches per box; 4 boxes per ca
2018-03-07
Class II — On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches may migrate following steam processing causing cosmetic defects on the exterior of ...
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FDA Device Recall: Vis-U-All High Temp 3.5"x9" Self Seal Pouch 200 pouches per box; 4 boxes per cas
2018-03-07
Class II — On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches may migrate following steam processing causing cosmetic defects on the exterior of ...
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FDA Device Recall: Vis-U-All High Temp 4"x11" Self Seal Pouch 200 pouches per box; 4 boxes per case
2018-03-07
Class II — On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches may migrate following steam processing causing cosmetic defects on the exterior of ...
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FDA Device Recall: Vis-U-All High Temp 3.5"x22" Self Seal Pouch 200 pouches per box; 4 boxes per ca
2018-03-07
Class II — On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches may migrate following steam processing causing cosmetic defects on the exterior of ...
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FDA Device Recall: Vis-U-All High Temp 13"x18" Self Seal Pouch 100 pouches per box; 4 boxes per cas
2018-03-07
Class II — On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches may migrate following steam processing causing cosmetic defects on the exterior of ...
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FDA Device Recall: Vis-U-All High Temp 3.5"x22" Heat Seal Pouch 200 pouches per box; 5 boxes per ca
2018-03-07
Class II — On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches may migrate following steam processing causing cosmetic defects on the exterior of ...
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FDA Device Recall: Vis-U-All High Temp 6"x10" Heat Seal Pouch 200 pouches per box; 5 boxes per case
2018-03-07
Class II — On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches may migrate following steam processing causing cosmetic defects on the exterior of ...
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FDA Device Recall: Vis-U-All High Temp 13"x18" Heat Seal Pouch 100 pouches per box; 4 boxes per cas
2018-03-07
Class II — On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches may migrate following steam processing causing cosmetic defects on the exterior of ...
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FDA Device Recall: Vis-U-All High Temp 18"x22" Self Seal Pouch 100 pouches per box; 5 boxes per cas
2018-03-07
Class II — On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches may migrate following steam processing causing cosmetic defects on the exterior of ...
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FDA Device Recall: Vis-U-All High Temp 18"x22" Heat Seal Pouch 100 pouches per box; 5 boxes per cas
2018-03-07
Class II — On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches may migrate following steam processing causing cosmetic defects on the exterior of ...
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FDA Device Recall: Vis-U-All High Temp 7.5"x13.5" Heat Seal Pouch 200 pouches per box; 5 boxes per
2018-03-07
Class II — On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches may migrate following steam processing causing cosmetic defects on the exterior of ...
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FDA Device Recall: Vis-U-All High Temp 3"x8" Heat Seal Pouch 200 pouches per box; 5 boxes per case
2018-03-07
Class II — On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches may migrate following steam processing causing cosmetic defects on the exterior of ...
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FDA Device Recall: Vis-U-All High Temp 8"x16" Heat Seal Pouch 100 pouches per box; 9 boxes per case
2018-03-07
Class II — On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches may migrate following steam processing causing cosmetic defects on the exterior of ...
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FDA Device Recall: Vis-U-All High Temp 16"x16" Self Seal Pouch 100 pouches per box; 6 boxes per cas
2018-03-07
Class II — On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches may migrate following steam processing causing cosmetic defects on the exterior of ...
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FDA Device Recall: Vis-U-All High Temp 5"x15" Self Seal Pouch 200 pouches per box; 4 boxes per case
2018-03-07
Class II — On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches may migrate following steam processing causing cosmetic defects on the exterior of ...
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FDA Device Recall: Quick Connects. Steris Corporation. Model numbers: QKC1736E, QKC1736INT, QKC173
2016-03-23
Class II — The firm discovered that one of the hysteroscope models listed for processing in four existing Quick Connects has one inlet port rather than two inlet ports as indicated in the Quick Connec...
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FDA Device Recall: AMSCO¿ Warming Cabinet. Manufactured by: STERIS Corporation To raise the tem
2016-01-13
Class II — The firm discovered that information printed on the quick reference magnet is incorrect; specifically, Fahrenheit to Celsius temperature conversions and the default Warming Cabinet temperat...
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FDA Drug Recall: Kindest Kare Antimicrobial Foaming Handwash, Hand Soap, 0.75% Triclosan, 444 ml
2015-12-16
Class II — Labeling: Not Elsewhere Classified; Incorrect/Undeclared Excipients: Outdated previous version of label applied to products that incorrectly states one inactive ingredient.
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FDA Device Recall: AMSCO C and AMSCO 400 Steam Sterilizers, STERIS Corporation. AMSCO C Small St
2015-05-06
Class II — STERIS has identified that the control board software in select AMSCO 400 and AMSCO C units will interrupt and cancel a processing cycle should the selected sterilizer shutdown time coincid...
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FDA Device Recall: Caviwave Pro Ultrasonic Cleaning System, Product Usage: To wash (remove tis
2015-05-06
Class II — Should the Caviwave Pro Ultrasonic Cleaning System experience a temporary interruption in electrical power during a processing cycle, the circulation pump may stop functioning. In addition...
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FDA Device Recall: Harmony¿ vLED Surgical Lighting System, one unit packaged per box The Harmony¿
2015-01-14
Class II — STERIS has learned that groups of LED lights (modules) contained within the vLED light head may illuminate inconsistently.
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FDA Device Recall: Reliance 1227 Cart and Utensil Washer/Disinfector Product Usage: Usage: The
2014-07-16
Class III — STERIS has identified that deformation of the washers door handle pin may occur when the door handle is rotated with sufficient force. Should deformation and/or breakage of the door hand...
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FDA Device Recall: The STERIS 4085 General Surgical Table Product Usage: is an electro-hydrauli
2014-07-16
Class II — STERIS engineering analysis has determined the D1 pressure switch in the hydraulic column manifold does not adequately detect pressure level. If one or more of the table floor lock feet b...
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FDA Device Recall: Vertical Spring Arm for Single or Dual Monitor Mount (Harmony LL 500 and Harmony
2014-07-02
Class II — Potential for the welded seam in affected monitor spring arms to crack and/or break.
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FDA Device Recall: VERIFY¿ SixCess 270FP Challenge Pack, STERIS Corporation, 5960 Heisley Road, Men
2014-03-19
Class II — STERIS has identified that the outer shipping package for one lot (Lot #024552A) of VERIFY¿ SixCess Challenge Packs incorrectly identifies the lot as Lot #024522A.
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FDA Device Recall: SYSTEM 1E Liquid Chemical Sterilant Processing System, Distributed by STERIS Cor
2014-01-08
Class II — Customers indicated fluctuations in environmental conditions sites and gradual degradation/deformation of check valve o-rings following frequent contact with S40 sterilant use solution resu...
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FDA Device Recall: AMSCO¿ Evolution¿ steam sterilizer Transfer Carriage. Product Usage: Mobile
2013-12-18
Class II — The firm discovered that unlatching can occur when overloaded transfer carriages are pulled or maneuvered incorrectly or with excessive force.
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FDA Device Recall: Harmony Equipment Management System, Model #603X/80XX, STERIS Corporation, Mento
2013-11-13
Class II — Dr¿ger Medical GmbH has notified STERIS of the potential for a break in the drive screw contained in the motorized ceiling supply unit, a component of the Harmony EMS system. The ceiling s...
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FDA Device Recall: Reliance Endoscope Processing System (REPS), STERIS Corporation, 5960 Heisley Ro
2013-10-02
Class II — The air pipe that delivers unfiltered ambient air from the procedure room into the water bottle on the listed FUJINON G5 & G8 type flexible GI endoscopes does not connect to the main air/wa...
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FDA Device Recall: STERIS Fine Traction Device, one unit per box Product Usage: The Fine Tracti
2013-07-31
Class II — A bearing used in the assembly of the Fine Traction Device did not perform successfully in pre-release reliability testing; a replacement bushing passed reliability testing and was substit...
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FDA Device Recall: Quick Connect QLC1677E, QRC1699E, QPC1721E and QFC1683E. STERIS Corporation, Men
2013-07-03
Class II — During a routine label review, the firm identified four SYSTEM 1E Quick Connects that will be updated to reflect the removal of obsolete device models. This labeling review process also hi...
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FDA Device Recall: STERIS 5085 and 5085 SRT Surgical Tables, Product Usage: The 5085 is a ge
2012-09-26
Class II — STERIS has learned from Customer feedback and field service experience that damage from external impact to the table hydraulic column can cause the stainless steel shroud sections covering ...
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FDA Device Recall: QKC1692E The QKC1692E Quick Connect device connects endoscopes to the steril
2012-09-05
Class II — STERIS has been actively seeking devices for quick connect revalidation projects. STERIS was unable to obtain two (2) of the needed devices; these two devices represent the design of seven...
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fda_adverse
1 records
lobbying
1 records
ny_corps
1 records
NY Corp: STERIS CORPORATION
2003-07-11
FOREIGN BUSINESS CORPORATION | County: New York | Jurisdiction: Ohio
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SEC EDGAR
1 records
USASpending
6 records
Federal Award: STERIS CORPORATION — $2,096,790
2025-02-07
SPS EQUIPMENT PM&R -STERILIZER TRAILER | MOBILE SPD FACILITY FOR THE LEBANON VAMC
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Federal Award: STERIS CORPORATION — $1,902,035
2024-03-01
STERIS EQUIPMENT MAINT - VISN 23
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Federal Award: STERIS CORPORATION — $2,311,421
2023-03-01
STERIS EQUIPMENT PREVENTATIVE AND REPAIR MAINTENANCE FOR THE COLUMBIA, MO VAMC, EASTERN KANSAS HEALTHCARE SYSTEM (EKHCS), MARION, IL VAMC, AND POPLAR BLUFF, MO VAMC.
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Federal Award: STERIS CORPORATION — $1,001,289
2022-08-01
STERIS STERILIZERS REPAIR-MAINTENANCE/STERIS CORPORATION/VISN2/BROOKLYN CAMPUS & MANHATTAN CAMPUS/FY22
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