STERIS SPA

58 recall(s) on record — most severe on record: Class II.

Devices registered here (4)

• Shoulder Prosthesis, Reverse Configuration
  Product code PHX · Class II · Orthopedic · 21 CFR 888.3660
• Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
  Product code KWT · Class II · Orthopedic · 21 CFR 888.3650
• Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented
  Product code MBF · Class II · Orthopedic · 21 CFR 888.3670
• Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
  Product code KWS · Class II · Orthopedic · 21 CFR 888.3660

Recalls & enforcement

• Class IIOngoing2026-05-15
  The the plus and minus buttons (+/-) used to control light intensity on the light heads may detach.
• Class IIOngoing2026-05-15
  There is a potential for paint delamination (chipping/peeling) on the lighting system's light heads.
• Class IIOngoing2025-11-19
  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).
• Class IIOngoing2025-06-23
  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.
• Class IIOngoing2025-05-23
  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.
• Class IIOngoing2024-06-13
  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 o
• Class IIOngoing2023-12-12
  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.
• Class IIOngoing2023-11-16
  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.
• Class IIOngoing2023-11-13
  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.
• Class IIOngoing2023-04-10
  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.
• Class IIOngoing2023-03-17
  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
• Class IIOngoing2022-12-12
  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 steriliza
• Class IITerminated2022-10-17
  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 w
• Class IITerminated2022-09-02
  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.
• Class IITerminated2022-04-22
  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.
• Class IITerminated2022-03-22
  Product not approved for release for US distribution
• Class IITerminated2021-01-21
  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.
• Class IITerminated2020-12-11
  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.
• Class IITerminated2020-12-02
  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, transference of the ink onto the device(s) contained within the pouch
• Class IITerminated2020-11-19
  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 darken over time. There is an improbable risk to users of the product from exposure to thi
• Class IIITerminated2020-10-07
  Potential for cleaning solution intrusion into endoscope
• Class IITerminated2020-06-26
  A recent FDA inspection at the firm identified that the foil test performed during installation of the device does not have clear acceptance criteria.
• Class IITerminated2019-10-22
  Potential for the incorrect pressure safety valve being included in the Preventive Maintenance (PM) kit for the 3000 Small Sterilizers.
• Class IITerminated2019-10-22
  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 car unexpectedly falling forward
• Class IITerminated2018-12-26
  The ATLAS loading car may not remain fully engaged with the latch on the transfer carriage when the loading car is empty, potentially resulting in the loading car unexpectedly sliding forward or falling to one side.
• Class IITerminated2018-12-20
  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 potential for inadequate cleaning or disinfection.
• Class IITerminated2018-07-26
  There is the potential for a scenario where a punctured cup of sterilant expires while the system is powered down, upon power-up the unit will not detect the expired cup of sterilant; allowing for subsequent cycles to be run.
• Class IITerminated2018-05-23
  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 level situation occurs, does not operate as intended. Currently, if a low chemical level sit
• Class IITerminated2017-09-28
  Correction to update sterilizer software to prohibit the use of expired sterilant prior to the start of a sterilization cycle.
• Class IITerminated2017-06-15
  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 the pouch and in some instances, transference of the ink onto the device(s) contained withi
• Class IITerminated2016-10-05
  The Drager Pendula spring arm device has a set of screws located on the spring arm that were not properly secured with Loctite and may become loose.
• Class IITerminated2016-05-23
  STERIS has identified that the pivot pin assembly located on the table top may become loose preventing the table from articulating properly.
• Class IITerminated2015-12-04
  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 Connect processing instructions.
• Class IITerminated2015-11-20
  The firm discovered that information printed on the quick reference magnet is incorrect; specifically, Fahrenheit to Celsius temperature conversions and the default Warming Cabinet temperature.
• Class IIITerminated2015-09-03
  In AMSCO Small Steam Sterilizers equipped with the CS-iQ feature, the sterilizer software inadvertently prevents the capability to operate the foot pedal, which allows the Operator to open and close the sterilizer door.
• Class IITerminated2015-02-19
  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, it is possible that the ultrasonic generator may stop working. The machine does not prov
• Class IITerminated2015-02-19
  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 coincide with a processing cycle. This may result in a procedure delay.
• Class IITerminated2014-11-26
  STERIS has learned that groups of LED lights (modules) contained within the vLED light head may illuminate inconsistently.
• Class IITerminated2014-10-10
  The 5085 and 5085SRT stainless steel column shrouds may become damaged as a result of misalignment during extreme table articulation, excessive side force on the table column, or pressure on the base of the table. Severe damage to the shrouds may prevent the user from raising o
• Class IIITerminated2014-06-30
  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 handle pin occur there is a potential for the washer door to become inoperable.
• Class IITerminated2014-06-27
  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 become unlocked due to the loss of hydraulic pressure, there is a potential for the table ha
• Class IITerminated2014-04-04
  Potential for the welded seam in affected monitor spring arms to crack and/or break.
• Class IITerminated2013-12-19
  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.
• Class IITerminated2013-11-21
  Customers indicated fluctuations in environmental conditions sites and gradual degradation/deformation of check valve o-rings following frequent contact with S40 sterilant use solution result in nuisance aborts.
• Class IITerminated2013-10-18
  The firm discovered that unlatching can occur when overloaded transfer carriages are pulled or maneuvered incorrectly or with excessive force.
• Class IITerminated2013-09-10
  STERIS has identified that the population of the G. stearothermophilus spores that monitor STEAM sterilization cycles does not meet specifications for Lot # 131004 of the Verify Dual Species Self-Contained Biological Indicators. As a result the spore count on the affected produc
• Class IITerminated2013-08-29
  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/water channel within the light guide (LG) connection head and, as a result, the air pipe
• Class IITerminated2013-08-15
  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 supply unit controls the motorized adjustment of the height and rotation of the supply colum
• Class IITerminated2013-05-20
  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 substituted per a change order. The change order authorized use of the substitute bushing in asse
• Class IITerminated2013-03-04
  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 highlighted the opportunity to combine two existing quick connects into a single product whil
• Class IITerminated2013-02-12
  The control boards alarm set points and temperature tolerances allowed for erroneous activation of the AD (analog/digital) alarm as temperature fluctuated during operation. When this alarm occurs, the sterilizer locks up and cannot be used until serviced, causing Customer nuisan
• Class IITerminated2012-08-10
  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 (7) models in one quick connect. Due to the unavailability of these two validation device
• Class IIITerminated2012-08-02
  On 7/20/2012 the firm became aware that a lot of tubing was distributed by the supplier after it was rejected by Steris due to failing process indicators.
• Class IITerminated2012-08-01
  The firm initiated a recall after complaint investigations revealed that when the units are left on and not in use at night and/or on weekends the hose disconnects/separates resulting in water leakage that can cause damage to property.
• Class IITerminated2012-07-14
  To ensure that users are properly operating the Reliance 130 and 130L Cart Washers, a door close confirmation button and door open delay will be installed on your cart washer.
• Class IITerminated2012-07-03
  STERIS has learned that the Verify Bowie Dick Test Cards are not performing to product specifications. Specifically, test cards have resulted in false fail results when sterilizer performance is within acceptable ranges.
• Class IITerminated2012-04-06
  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 the table hydraulic column to become misaligned; if the damage is severe, the up/down movem
• Class IITerminated2010-02-17
  Customers may be storing objects on the base and/or around the column of the surgical table. This prohibited practice and misuse known by the customers can damage the override switch assembly located at the top of the column cover. Depending upon the nature and severity of the

Related

• All facilities operated by STERIS Corporation
• Synergy Health Ede BV (NL)
• Synergy Health Radeberg GMBH (DE)
• Synergy Health Westport Ltd (IE)
• Synergy Health Ede BV (NL)
• STERIS SPA (IT)
• Synergy Health Allershausen GmbH (DE)
• STERIS TOMOE (Thailand) Ltd. (TH)
• Synergy Health Sterilisation UK Ltd (GB)
• Synergy Health Ireland Ltd (IE)
• SYNERGY HEALTH STERILISATION UK LTD (GB)
• Synergy Sterilisation (M) Sdn Bhd (MY)

Source: U.S. FDA via openFDA (device registration & enforcement). Data as of 2026-08-13. Verify this facility record at FDA →