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Lower risk Medical device recall · FDA · Published December 29, 2021

Young Dental Dry Heat Indicator Labels Recall: Wrong Labels May Be Used

Young Dental recalls dry heat indicator labels that might have incorrect labels instead of the proper dry heat indicator labels for sterilization monitoring.

🇺🇸 FDA recall #Z-0555-2022Medical deviceYoung Dental ›
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Contact the company

Recalling firmYoung Dental Mfg Co I LLC13705 Shoreline Ct E · Earth City, MO 63045-1202
✎ GovInfoNow plain-language explainer

Young Dental is recalling dry heat indicator labels that may contain TTS Indicator Labels instead of the correct dry heat indicator labels. This could lead to improper sterilization monitoring if used in medical sterilization processes. Read more at govinfonow.com/recall/61329-young-dental-dry-heat-indicator-labels-recall-wrong-labels-may.

Source Summary by GovInfoNow · govinfonow.com/recall/61329-young-dental-dry-heat-indicator-labels-recall-wrong-labels-may · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0555-2022

Cite this page

“Young Dental Dry Heat Indicator Labels Recall: Wrong Labels May Be Used.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61329-young-dental-dry-heat-indicator-labels-recall-wrong-labels-may. Based on FDA recall #Z-0555-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0555-2022%22&limit=1).

Young Dental Mfg Co I LLC voluntarily recalled YOUNG DH Dry Heat Indicators on Dec. 29, 2021, after the FDA announced the hazard. The packaging may contain TTS Indicator Labels instead of Dry Heat Indicator Labels.

How to tell if you have it

  • Brand: Young Dental
  • Product: YOUNG DH Dry Heat Indicators, PRESSURE SENSITIVE LABELS with COLOR INDICATOR STRIP, REF 116312
  • UPC: 10302731163120
  • Lot Number: 165892
  • Units affected: 158

The hazard

The Dry Heat Indicator Labels packaging may contain TTS Indicator Labels instead of Dry Heat Indicator Labels. The FDA said the error could affect the monitoring of sterilization parameters.

Context

GovInfoNow's records show other recent recalls of similar products include Medline Convenience Kits Recall: Calibration Issues May Affect Sterility (2026-01-07) and Medline Convenience Kits Recall: Sterility Risk from Calibration Issues (2026-01-07).

How to tell if you have this one

Check for the label with the model number REF 116312 and lot number 16589:10302731163120. The product is intended for healthcare providers to monitor sterilization processes.

  • Brand
    Young Dental
  • Product
    YOUNG DH Dry Heat Indicators, PRESSURE SENSITIVE LABELS with COLOR INDICATOR STRIP, REF 116312 Intended for use by a
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Labels

    Verify the label has the correct dry heat indicator labels, not TTS indicator labels.

How this recall unfolded

Recall timeline

FDA published this recall 42 days after the firm started it.

1. Firm started the recall: Dec 29, 202112. FDA classified it Class II: Feb 2, 202223. Published in FDA’s Enforcement Report: Feb 9, 2022320212022
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

What is the product name?

Young DH Dry Heat Indicators, PRESSURE SENSITIVE LABELS with COLOR INDICATOR STRIP, REF 116312

What should I do if I have the product?

Check the labels to ensure they are the correct dry heat indicator labels; no specific action is required if they are correct.

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Where this comes from

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-0555-2022 (December 29, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0555-2022 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 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.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA