YOUNG DH Dry Heat Indicators, PRESSURE SENSITIVE LABELS… recallZ-0555-2022 · Young Dental Mfg Co I LLC · initiated Dec 29, 2021
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Young Dental Mfg Co I LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
The Dry Heat Indicator Labels packaging may contain TTS Indicator Labels instead of Dry Heat Indicator Labels.
FDA root cause category: Under Investigation by firm
What the company is doing
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: [email protected] 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: [email protected].
Recall details
- Recall number
- Z-0555-2022
- Status
- Open, Classified
- Initiated by the company
- Dec 29, 2021
- Recalling firm
- Young Dental Mfg Co I LLC
- Quantity
- 158 units
- Product code
- JOJ
- FDA submissions
- K890761
- Distribution
- US Distribution
Product description
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.
Code information (models, lots, serial numbers)
Lot Number 165892 UDI (01)10302731163120(13)210712(10)165892
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- DH Nyclave Indicator Labels 116312Young Dental Manufacturing I, LLC · Indicator, Physical/Chemical Sterilization Process1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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