Lower riskMedical device recall · FDA · Published January 9, 2024
Steris Endo Cleaning Indicator: Risk of Incorrect Test Results Due to Temperature Issues
Steris Corporation recalls Endo Cleaning Indicator VERIFY" RESITEST" due to temperature excursions in refrigerators causing potential incorrect or delayed test results. Affected units sold in the U.S. from January 2024.
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.
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Contact the company
📍Recalling firmMckesson Medical-Surgical Inc. Corporate Office9954 Maryland Drive, Deep Run Iii Ste. 4000 · Richmond, VA 23233
✎ GovInfoNow plain-language explainer
Steris Corporation is recalling Endo Cleaning Indicator VERIFY" RESITEST" devices because refrigerators they were stored in experienced temperature drops below safe levels, which could lead to incorrect or delayed test results. This affects medical facilities using these indicators for critical testing. Read more at govinfonow.com/recall/56351-steris-endo-cleaning-indicator-risk-of-incorrect-test-results-due.
“Steris Endo Cleaning Indicator: Risk of Incorrect Test Results Due to Temperature Issues.” GovInfoNow, updated August 10, 2026. https://govinfonow.com/recall/56351-steris-endo-cleaning-indicator-risk-of-incorrect-test-results-due. Based on FDA recall #Z-1313-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1313-2024%22&limit=1).
The FDA announced on Jan. 9, 2024, that Mckesson Medical-Surgical Inc. Corporate Office is recalling Steris Corporation Endo Cleaning Indicator VERIFY RESITEST units due to facility critical temperature excursions. The hazard involves temperatures falling below the validated range, which could lead to incorrect or delayed test results.
How to tell if you have it
Brand: Steris
Product: Endo Cleaning Indicator VERIFY RESITEST
Catalogue Number: LCC101
UDI/DI: 10724995220072
Quantity: 25 units
Distribution: US Nationwide in AZ, PA and TX
The hazard
Temperatures in a walk-in refrigerator fell below the validated range of 35.6 - 46.4 Degrees Fahrenheit (2 - 8 Degrees Celsius) for up to 60 minutes on Jan. 8, 2024, due to mechanical failures. This excursion could increase the probability of an incorrect test result or a delayed test result.
Context
GovInfoNow's records show Mckesson Medical-Surgical Inc. Corporate Office has 14 other recalls on record since June 2, 2021. Recent recalls include a July 30, 2025, Clearview Strep A Exact II Dipstick Respiratory Kit Recall for license classification errors and an April 25, 2025, Medroxyprogesterone Acetate Injectable Vial Recall for storage issues after shipping delays. Other recent recalls of similar products include a Jan. 23, 2026, I.T.S. Screw System recall for higher MRI temperature risk and April 23, 2026, Covidien Mon-a-Therm Stethoscope and Temperature Probe recalls.
How to tell if you have this one
Check for the Steris Endo Cleaning Indicator VERIFY" RESITEST" with Catalogue Number LCC101. The UDI/DI number 10724995220072 is also associated with this product.
Brand
Steris
Category
Medical device
FDA recall event · 5 products
All 5 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Ongoing
Distribution
US Nationwide distribution in the states of AZ, PA and TX.
Recall number
Product, codes & lots
Quantity
Z-1311-2024
Sekisui Diagnostics Control Kit OSOM¿ BVBLUE¿ Bacterial Vaginosis; Catalogue Number: 184; Lot No. CK233;
1 unit
Z-1312-2024
Abbott Rapid Dx N America LLC Reproductive Endocrinology Control Set McKesson Consult" Pregnancy (hCG) Testing Positive Level / Negative Level 2 X 4 mL; Catalogue Number: 5011; UDI/DI: 612479202788; Lot No. KN00589;
Abbott Point of Care Control Control i-STAT¿ Level 1 10 X 1.7 mL; Catalogue Number: 06F1201; UDI/DI: 54749000463; Lot No: 101164
1 unit
Z-1315-2024
Abbott Point of Care Control Control i-STAT¿ Level 3 1.7 mL; Catalogue Number: 06F1401; UDI/DI: 54749000661; Lot No: 121164;
2 units
Based on the official FDA remedy
What to do — step by step
Check Product Details
Verify the product's Catalogue Number (LCC101) and UDI/DI number (10724995220072) to confirm if it is affected.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 3 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide distribution in the states of AZ, PA and TX.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Arizona, Pennsylvania, Texas.
Recall timeline
FDA published this recall 3 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1313-2024 (January 9, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1313-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 10, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.