Young Dental Mfg Co I LLC YOUNG DH Dry Heat Indicators, PRESSURE SENSITIVE LABELS with COLOR INDICATOR STRIP, REF 116312 Intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor one or more parameters of the sterilization process. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
YOUNG DH Dry Heat Indicators, PRESSURE SENSITIVE LABELS with COLOR INDICATOR STRIP, REF 116312 Intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor one or more parameters of the sterilization process.
Brand
Young Dental Mfg Co I LLC
Lot Codes / Batch Numbers
Lot Number 165892 UDI (01)10302731163120(13)210712(10)165892
Products Sold
Lot Number 165892 UDI (01)10302731163120(13)210712(10)165892
Young Dental Mfg Co I LLC is recalling YOUNG DH Dry Heat Indicators, PRESSURE SENSITIVE LABELS with COLOR INDICATOR STRIP, REF 116312 Inte due to The Dry Heat Indicator Labels packaging may contain TTS Indicator Labels instead of Dry Heat Indicator Labels.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The Dry Heat Indicator Labels packaging may contain TTS Indicator Labels instead of Dry Heat Indicator Labels.
Recommended Action
Per FDA guidance
The firm, Young Dental Manufacturing CO 1, LLC, initiated a "URGENT: MEDICAL DEVICE RECALL" letter dated 12/21/2021 on 12/29/2021 to its customers. The letter provided the reason for the recall and actions to be taken. The customers were instructed to discard or return product to Young Dental, provide additional information as applicable and complete and return the MEDICAL DEVICE RECALL RETURN RESPONSE Acknowledgement and Receipt Form via email: pwhaley@younginnovations.com or mail to: YOUNG DENTAL MANUFACTURING CO 1, LLC, 13705 Shoreline Ct E, Earth City, MO 63045. For further questions, contact VP, QRA at 224-622-7192 Monday through Friday, 8:00 AM to 4:30 PM, Eastern Time or email: jespino@younginnovations.com.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026