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STERIS CORPORATION

United States·US-MF-000016007

Last updated September 17, 2026

Information

Country: United States
Address: 2720, Gunter Park Drive East , Montgomery, United States
Website: www.steris.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +353 (57) 860 6877
PRRC Contact: Becky Aldhizer
EUDAMED SRN: US-MF-000016007
FDA FEI Number: 3003950207
DUNS Number: 868205779

Catalogue (15306)

Page 1 of 307

Device	Model / Reference	Registries	Class	Status
Prolystica Multi-Enzymatic Cleaner	1C38T6EC	EUDAMED	Class I	Active
V. Mueller	OS3080-001	FDA UDI	Class I	Active
V. Mueller	OS911-012	FDA UDI	Class I	Active
V. Mueller	RH551-682	FDA UDI	Class I	Active
Birkova	Table Pads	FDA UDI	Class I	Active
V. Mueller	NL6170	FDA UDI	Class II	Active
HarmonyAIR	G-Series Suspension System	FDA UDI	Class I	Active
V. Mueller	OP0903-451	FDA UDI	Class I	Active
V. Mueller	CH0636	FDA UDI	Class I	Active
Snowden-Pencer	SP8495	FDA UDI	Class II	Active
V. Mueller	SU1149	FDA UDI	Class I	Active
V. Mueller	NL4255-91T	FDA UDI	Class II	Active
V. Mueller	NL4070-076	FDA UDI	Class II	Active
V. Mueller	SU2905	FDA UDI	Class I	Active
Dart	NB215	FDA UDI	Class II	Active
Amsco	Drying Cabinet	FDA UDI	Class II	Active
V. Mueller	R1394-BLACK	FDA UDI	Class II	Active
V. Mueller	CH6572	FDA UDI	Class II	Active
Birkova	Stretcher Pads	FDA UDI	Class I	Active
V. Mueller	S-VAT-SG4800-1	FDA UDI	Class I	Active
V. Mueller	OS08600	FDA UDI	Class I	Active
V. Mueller	SU4057-MM	FDA UDI	Class I	Active
HarmonyAIR	E-Series	FDA UDI	Class II	Unknown
V. Mueller	AU5249	FDA UDI	Class I	Active
HarmonyAIR	G-Series Lighting System	FDA UDI	Class II	Active
HarmonyAIR	E-Series Suspension System	FDA UDI	Class I	Unknown
HarmonyAIR	E-Series Suspension System	FDA UDI	Class I	Unknown
V. Mueller	CH6260	FDA UDI	Class II	Active
V. Mueller	CH03182-S	FDA UDI	Class I	Active
V. Mueller	L-0102	FDA UDI	Class II	Active
V. Mueller	OP2321	FDA UDI	Class I	Active
V. Mueller	DINBP3-2VS	FDA UDI	Class II	Active
V. Mueller	OP0702-001	FDA UDI	Class I	Active
ORLocate	ORLocate Gauze	FDA UDI	Class I	Active
HarmonyAIR	E-Series Suspension System	FDA UDI	Class I	Unknown
V. Mueller	MO9135	FDA UDI	Class I	Active
V. Mueller	SA15110	FDA UDI	Class I	Active
V. Mueller	S-TAKER12SS	FDA UDI	Class I	Active
Snowden-Pencer	89-8957	FDA UDI	Class II	Active
V. Mueller	SA1992	FDA UDI	Class I	Active
V. Mueller	OP0922-201	FDA UDI	Class I	Active
V. Mueller	NL4072-073	FDA UDI	Class II	Active
V. Mueller	NL3785-189	FDA UDI	Class II	Active
Birkova	Table Pads	FDA UDI	Class I	Active
V. Mueller	RH2561	FDA UDI	Class I	Active
V. Mueller	NL4002	FDA UDI	Class I	Active
V. Mueller	SU1755	FDA UDI	Class I	Active
V. Mueller	SU1785	FDA UDI	Class I	Active
V. Mueller	CH5912-T	FDA UDI	Class I	Active
Snowden-Pencer	SP90-7853	FDA UDI	Class II	Active

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FDA Recalls (100)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Nov 19, 2025	Z-0910-2026	—	open, classified	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).
Nov 19, 2025	Z-0909-2026	—	open, classified	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).
Jun 23, 2025	Z-2178-2025	—	open, classified	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.
Jun 23, 2025	Z-2177-2025	—	open, classified	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.
May 23, 2025	Z-1361-2026	—	open, classified	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.
Jun 13, 2024	Z-2538-2024	—	open, classified	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
Jun 13, 2024	Z-2539-2024	—	open, classified	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
Jun 13, 2024	Z-2537-2024	—	open, classified	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
Jun 13, 2024	Z-2536-2024	—	open, classified	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
Dec 12, 2023	Z-0984-2024	—	open, classified	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.
Dec 12, 2023	Z-0983-2024	—	open, classified	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.
Nov 16, 2023	Z-0737-2024	—	open, classified	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.
Nov 13, 2023	Z-0617-2024	—	open, classified	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.
Apr 10, 2023	Z-1595-2023	—	open, classified	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.
Mar 17, 2023	Z-1475-2023	—	open, classified	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
Mar 17, 2023	Z-1476-2023	—	open, classified	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
Dec 12, 2022	Z-0780-2023	—	open, classified	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.
Dec 12, 2022	Z-0778-2023	—	open, classified	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.
Dec 12, 2022	Z-0781-2023	—	open, classified	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.
Dec 12, 2022	Z-0779-2023	—	open, classified	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.
Oct 17, 2022	Z-0241-2023	—	terminated	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
Sep 2, 2022	Z-0079-2023	—	terminated	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.
Apr 22, 2022	Z-1256-2022	—	terminated	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.
Mar 22, 2022	Z-1118-2022	—	terminated	Product not approved for release for US distribution
Mar 22, 2022	Z-1119-2022	—	terminated	Product not approved for release for US distribution
Jan 21, 2021	Z-1149-2021	—	terminated	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.
Dec 11, 2020	Z-0876-2021	—	terminated	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.
Dec 2, 2020	Z-0798-2021	—	terminated	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
Dec 2, 2020	Z-0791-2021	—	terminated	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
Dec 2, 2020	Z-0792-2021	—	terminated	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
Dec 2, 2020	Z-0795-2021	—	terminated	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
Dec 2, 2020	Z-0786-2021	—	terminated	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
Dec 2, 2020	Z-0793-2021	—	terminated	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
Dec 2, 2020	Z-0790-2021	—	terminated	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
Dec 2, 2020	Z-0799-2021	—	terminated	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
Dec 2, 2020	Z-0789-2021	—	terminated	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
Dec 2, 2020	Z-0797-2021	—	terminated	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
Dec 2, 2020	Z-0788-2021	—	terminated	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
Dec 2, 2020	Z-0796-2021	—	terminated	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
Dec 2, 2020	Z-0794-2021	—	terminated	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
Dec 2, 2020	Z-0787-2021	—	terminated	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
Nov 19, 2020	Z-0830-2021	—	terminated	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 this bacteria, and no risk to patients.
Oct 7, 2020	Z-0458-2021	—	terminated	Potential for cleaning solution intrusion into endoscope
Jun 26, 2020	Z-2700-2020	—	terminated	A recent FDA inspection at the firm identified that the foil test performed during installation of the device does not have clear acceptance criteria.
Oct 22, 2019	Z-0586-2020	—	terminated	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
Oct 22, 2019	Z-0604-2020	—	terminated	Potential for the incorrect pressure safety valve being included in the Preventive Maintenance (PM) kit for the 3000 Small Sterilizers.
Dec 26, 2018	Z-0824-2019	—	terminated	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.
Dec 20, 2018	Z-0996-2019	—	terminated	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.
Dec 20, 2018	Z-0995-2019	—	terminated	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.
Jul 26, 2018	Z-2959-2018	—	terminated	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.
May 23, 2018	Z-2392-2018	—	terminated	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 situation occurs, the alarm will only be generated at the unit s next power-up or when accessing service mode. The failure of the Reliance 1227 to identify that the chemicals used for cleaning are low or empty could result in bedpans and urinals, basins, case carts, beds, theater shoes and other miscellaneous reusable patient care items not being properly cleaned before disinfection or reuse.
Sep 28, 2017	Z-0772-2018	—	terminated	Correction to update sterilizer software to prohibit the use of expired sterilant prior to the start of a sterilization cycle.
Jun 15, 2017	Z-0743-2018	—	terminated	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 within the pouch.
Jun 15, 2017	Z-0757-2018	—	terminated	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 within the pouch.
Jun 15, 2017	Z-0752-2018	—	terminated	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 within the pouch.
Jun 15, 2017	Z-0753-2018	—	terminated	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 within the pouch.
Jun 15, 2017	Z-0765-2018	—	terminated	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 within the pouch.
Jun 15, 2017	Z-0747-2018	—	terminated	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 within the pouch.
Jun 15, 2017	Z-0744-2018	—	terminated	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 within the pouch.
Jun 15, 2017	Z-0745-2018	—	terminated	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 within the pouch.
Jun 15, 2017	Z-0761-2018	—	terminated	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 within the pouch.
Jun 15, 2017	Z-0766-2018	—	terminated	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 within the pouch.
Jun 15, 2017	Z-0751-2018	—	terminated	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 within the pouch.
Jun 15, 2017	Z-0750-2018	—	terminated	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 within the pouch.
Jun 15, 2017	Z-0758-2018	—	terminated	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 within the pouch.
Jun 15, 2017	Z-0771-2018	—	terminated	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 within the pouch.
Jun 15, 2017	Z-0769-2018	—	terminated	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 within the pouch.
Jun 15, 2017	Z-0748-2018	—	terminated	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 within the pouch.
Jun 15, 2017	Z-0755-2018	—	terminated	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 within the pouch.
Jun 15, 2017	Z-0756-2018	—	terminated	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 within the pouch.
Jun 15, 2017	Z-0768-2018	—	terminated	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 within the pouch.
Jun 15, 2017	Z-0764-2018	—	terminated	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 within the pouch.
Jun 15, 2017	Z-0759-2018	—	terminated	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 within the pouch.
Jun 15, 2017	Z-0770-2018	—	terminated	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 within the pouch.
Jun 15, 2017	Z-0762-2018	—	terminated	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 within the pouch.
Jun 15, 2017	Z-0749-2018	—	terminated	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 within the pouch.
Jun 15, 2017	Z-0754-2018	—	terminated	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 within the pouch.
Jun 15, 2017	Z-0767-2018	—	terminated	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 within the pouch.
Jun 15, 2017	Z-0760-2018	—	terminated	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 within the pouch.
Jun 15, 2017	Z-0746-2018	—	terminated	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 within the pouch.
Jun 15, 2017	Z-0763-2018	—	terminated	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 within the pouch.
Oct 5, 2016	Z-0746-2017	—	terminated	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.
May 23, 2016	Z-2248-2016	—	terminated	STERIS has identified that the pivot pin assembly located on the table top may become loose preventing the table from articulating properly.
Dec 4, 2015	Z-1180-2016	—	terminated	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.
Nov 20, 2015	Z-0603-2016	—	terminated	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.
Sep 3, 2015	Z-0210-2016	—	terminated	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.
Feb 19, 2015	Z-1561-2015	—	terminated	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.
Feb 19, 2015	Z-1559-2015	—	terminated	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 provide an alert notifying the user of this device malfunction.
Nov 26, 2014	Z-0930-2015	—	terminated	STERIS has learned that groups of LED lights (modules) contained within the vLED light head may illuminate inconsistently.
Oct 10, 2014	Z-0196-2015	—	terminated	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 or lowering the surgical table.
Jun 30, 2014	Z-2036-2014	—	terminated	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.
Jun 27, 2014	Z-2026-2014	—	terminated	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 hand control to incorrectly indicate that the floor lock feet are locked.
Apr 4, 2014	Z-1850-2014	—	terminated	Potential for the welded seam in affected monitor spring arms to crack and/or break.
Dec 19, 2013	Z-1166-2014	—	terminated	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.
Nov 21, 2013	Z-0616-2014	—	terminated	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.
Oct 18, 2013	Z-0478-2014	—	terminated	The firm discovered that unlatching can occur when overloaded transfer carriages are pulled or maneuvered incorrectly or with excessive force.
Sep 10, 2013	Z-0605-2014	—	terminated	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 product is lower than the labeled minimum and the product may incorrectly indicate that a 5-log spore kill was achieved.
Aug 29, 2013	Z-2263-2013	—	terminated	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 does not receive forced flow during the Reliance EPS processing cycle.
Aug 15, 2013	Z-0141-2014	—	terminated	Drger 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 column. Should a break occur in the drive screw, there is potential for the adjustable arm to drop down, causing the EMS sys
May 20, 2013	Z-1786-2013	—	terminated	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 assembly of the Fine Traction Accessory; however, inadvertently the new part was not implemented. During complaint evaluati

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Steris Spa SERIATE Bergamo · IT FEI 3002806470