Food, drugs, devices › Steris Corporation

Device recall: VERIFY¿ SixCess 270FP Challenge Pack, STERIS Corporation, 5960 Heisley Road, Mentor, OH 44060, 440-354-2600. The VERIFY¿

FDA enforcement event 67308 · Class II · initiated 19 Dec 2013 · status Terminated · terminated 26 Mar 2014

DeviceVoluntary: Firm initiated1 product recordMentor, OH

FDA enforcement event 67308 is a device recall by Steris Corporation of Mentor, OH, initiated 19 Dec 2013 and classified Class II, with 1 product record.

FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 90% of the 1,236 device enforcement events initiated in 2013 carry the same class.

Status: Terminated, terminated 26 Mar 2014. Initiation: voluntary: firm initiated. Steris Corporation has 58 enforcement events on this register, with a median of 1 product record per event.

Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.

Recalling firm

Steris Corporation, Mentor, OH.

Reason for recall

"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."

Distribution

"Worldwide Distribution: US (nationwide) including states of: IL, LA, ME, MI, NC, OH, OK, VA, WI & WV; and to the country of: Canada. Product was also shipped to Canada."

Product records

Recall number	Product	Quantity	Class	Status	Report date
Z-1166-2014	VERIFY¿ SixCess 270FP Challenge Pack, STERIS Corporation, 5960 Heisley Road, Mentor, OH 44060, 440-354-2600. The VERIFY¿ SixCess 270FP Challenge Pack is used to monitor steam sterilization loads processed at 270¿F using typical healthcare dynamic air removal steam sterilization cycles.	94 boxes/20 units	Class II	Terminated	19 Mar 2014

Context

90%of 2013 device events are Class II1,236 events that year

1product record in this eventfirm median: 1

58events on this register for the firm

Other enforcement events for Steris Corporation

Initiated	Product (first record)	Type	Class	Records
15 May 2026	HarmonyAIR A-Series Surgical Lighting System	Device	Class II	1
15 May 2026	HarmonyAIR A-Series Surgical Lighting System	Device	Class II	2
19 Nov 2025	AMSCO 7052HP Washer/Disinfector Model/Catalog Number: 7052HP Product Description: The AMSCO 7052HP Washer/Disinfector is	Device	Class II	2
23 Jun 2025	Dual Flat Panel Monitor (DFPM) accessories for HarmonyAIR A-Series Surgical Lighting Systems	Device	Class II	2
23 May 2025	Barco MNA with the HexaVue IP Integration System, Model/Catalog Number: MNA-6x0-H	Device	Class II	1
13 Jun 2024	Hookup Model/Catalog Number: 2-8-540 Product Description: Hookups provide the interface between an Advantage Plus" Autom	Device	Class II	4
12 Dec 2023	Dual Articulating Headrest, Pad Ret P/N P141210805, REF BF754	Device	Class II	2
16 Nov 2023	V. Mueller Universal Bandage Scissors Black Plastic Handles Heavy-Duty, Autoclavable, Overall Length 7 (18 cm)- Intended	Device	Class II	1
13 Nov 2023	Hookup Accessories used with MEDIVATORS ADVANTAGE PLUS and ADVANTAGE PLUS Pass Thru Automated Endoscope Reprocessors Mod	Device	Class II	1
10 Apr 2023	Reliance Vision Multi-Chamber Washer/Disinfector, Reference Number FH83062	Device	Class II	1

All 58 events for Steris Corporation

Questions and answers

Why was this device recalled?

FDA's record gives the reason for recall as: "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."

What does Class II mean?

FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

Where was the product distributed?

FDA's distribution pattern field reads: "Worldwide Distribution: US (nationwide) including states of: IL, LA, ME, MI, NC, OH, OK, VA, WI & WV; and to the country of: Canada. Product was also shipped to Canada."

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 26 Mar 2014. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

Provenance

Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.