CLASS III Device recall · Reported 21 Sep 2022 · FDA Enforcement Report
Verify SixCess Challenge Pack recalled by Steris Corporation Hopkins
Steris Corporation Hopkins Facility is recalling Verify SixCess Challenge Pack, distributed in 31 states. The recall was initiated on 10 Aug 2022 and the FDA has classified it as Class III.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1736-2022
- FDA event ID
- 90763
- Recalling firm
- Steris Corporation Hopkins Facility, Mentor, OH
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 10 Aug 2022
- FDA classified
- 9 Sep 2022
- Reported
- 21 Sep 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Other Medical Devices
Timeline
| 10 Aug 2022 | Recall initiated by company | |
| 9 Sep 2022 | Classified by FDA | +30 days |
| 21 Sep 2022 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Product contains incorrect chemical indicators in packaging.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Verify SixCess Challenge Pack. Used to confirm that critical parameters of steam sterilization have been reached within a challenging test pack design.
Where it was distributed
Distribution in the US only - AK, AR, AZ, CA, CO, FL, GA, IA, ID, IL, IN, KY, LA, MA, MN, MO, MS, NE, NH, NM, NY, OH, OK, PA, SC, TN, TX, UT, VA, WA, and WY
AlaskaArkansasArizonaCaliforniaColoradoFloridaGeorgiaIowaIdahoIllinoisIndianaKentuckyLouisianaMassachusettsMinnesotaMissouriMississippiNebraskaNew HampshireNew Mexico
Questions about this recall
Why was it recalled?
Product contains incorrect chemical indicators in packaging.
Which lots are affected?
UDI-DI (GTIN): 10724995088955 Item Number: LCC003, Lot 3411228A
Where was it sold?
Distribution in the US only - AK, AR, AZ, CA, CO, FL, GA, IA, ID, IL, IN, KY, LA, MA, MN, MO, MS, NE, NH, NM, NY, OH, OK, PA, SC, TN, TX, UT, VA, WA, and WY
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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