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
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
- Recalling firm
- Mckesson Medical-Surgical Inc. Corporate Office, Richmond, VA
- 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
- Device type
- Other Medical Devices
Timeline
| 9 Jan 2024 | Recall initiated by company | |
| 19 Mar 2024 | Classified by FDA | +70 days |
| 27 Mar 2024 | Published 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.
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 94024More recalls from Mckesson Medical-Surgical Inc. Corporate Office
All 276| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Clearview Strep A Exact II Dipstick Respiratory Kit, CLIA Waived recalled | Mckesson Medical-Surgical Inc. Corporate Office | Other | Nationwide |
| Drug | CLASS II | Prolia (denosumab), injection, 60mg/mL, For Subcutaneous Use Only recalledProlia | Mckesson Medical-Surgical Inc. Corporate Office | Manufacturing (CGMP) Deviations | FL, VA |
| Drug | CLASS II | Benlysta (belimumab) for injection, 400 mg/ vial recalledBenlysta | Mckesson Medical-Surgical Inc. Corporate Office | Manufacturing (CGMP) Deviations | FL, VA |
| Drug | CLASS II | Evenity, (romosozumab -aqqg) injection, 105mg recalledEvenity | Mckesson Medical-Surgical Inc. Corporate Office | Manufacturing (CGMP) Deviations | FL, VA |
| Device | CLASS II | Abbott Diagnostics Alinity I Anti-ccps Reagent recalled | Mckesson Medical-Surgical Inc. Corporate Office | Device Malfunction | Nationwide |
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| Device | CLASS I | Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | AMS Convenience Kit: Dsaek Pack - RX recalled | Windstone Medical Packaging | Device Malfunction | Nationwide |