CLASS II ONGOING Device recall · Reported 27 Mar 2024 · FDA Enforcement Report

Steris Corporation Endo Cleaning Indicator Verify" Resitest" recalled

Mckesson Medical-Surgical Inc. Corporate Office is recalling Steris Corporation Endo Cleaning Indicator Verify" Resitest", distributed nationwide in the US. The recall was initiated on 9 Jan 2024 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesCatalogue Number: LCC101; UDI/DI: 10724995220072
Quantity recalled25 units

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-1313-2024
FDA event ID
94024
Classification
Class II
Status
Ongoing
Recall initiated
9 Jan 2024
FDA classified
19 Mar 2024
Reported
27 Mar 2024
Type
Voluntary: Firm initiated
Customers notified by
Telephone
Reason category
Temperature Abuse

Timeline

9 Jan 2024Recall initiated by company
19 Mar 2024Classified by FDA+70 days
27 Mar 2024Published in enforcement report+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Facility Critical Temperature Excursions on 08-JAN 2024 in Walk-In refrigerator due to mechanical failures, causing temperatures to fall below the validated range of 35.6 - 46.4 Degrees Fahrenheit (2 - 8 Degrees Celsius) for up to 60 minutes which could increase the probability of an incorrect test result or a delayed test result.

Foods that need refrigeration and were stored or shipped too warm can grow harmful bacteria without any change in look or smell.

Product as listed by the FDA

Steris Corporation Endo Cleaning Indicator VERIFY" RESITEST"

Where it was distributed

US Nationwide distribution in the states of AZ, PA and TX.

Nationwide ArizonaPennsylvaniaTexas

Questions about this recall

Why was it recalled?

Facility Critical Temperature Excursions on 08-JAN 2024 in Walk-In refrigerator due to mechanical failures, causing temperatures to fall below the validated range of 35.6 - 46.4 Degrees Fahrenheit (2 - 8 Degrees Celsius) for up to 60 minutes which could increase the probability of an incorrect test result or a delayed test result.

Which lots are affected?

Catalogue Number: LCC101; UDI/DI: 10724995220072

Where was it sold?

US Nationwide distribution in the states of AZ, PA and TX.

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 II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

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.

Other products in this recall event

4 other products · FDA event 94024

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