Recall archive / FDA device enforcement
YOUNG DH Dry Heat Indicators, PRESSURE SENSITIVE LABELS with COLOR INDICATOR STRIP, REF 116312 Intended for use by a ... — FDA record Z-0555-2022
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Dec 29, 2021. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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.
- Reason
- The Dry Heat Indicator Labels packaging may contain TTS Indicator Labels instead of Dry Heat Indicator Labels.
- Classification
- Class II
- Recalling firm
- Young Dental Mfg Co I LLC
- Quantity
- 158 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0555-2022
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Lot Number 165892 UDI (01)10302731163120(13)210712(10)165892 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US Distribution
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- Feb 9, 2022
- Recall initiation date
- Dec 29, 2021
- Center classification date
- Feb 2, 2022
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.