Z-0555-2022Class II

YOUNG DH Dry Heat Indicators, PRESSURE SENSITIVE LABELS with COLOR INDICATOR STRIP, REF 116312 Intended for...

Name: Z-0555-2022 YOUNG DH Dry Heat Indicators, PRESSURE SENSITIVE LABELS with COLOR INDICATOR STRIP, REF 116312 Intended for...
Creator: Young Dental Mfg Co I LLC
Published: 2021-12-29
License: https://open.fda.gov/license/

Young Dental Manufacturing Co 1, LLC. / initiated 2021-12-29 / Open, Classified / root cause: labeling and UDI

FDA source

Young Dental Mfg Co I LLC began a recall of 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... on 2021-12-29. FDA classified it as Class II and gives the reason as "The Dry Heat Indicator Labels packaging may contain TTS Indicator Labels instead of Dry Heat Indicator Labels". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0555-2022
Classification: Class II
Status: Open, Classified
Initiated: 2021-12-29
Posted: 2022-02-02
Recalling firm: Young Dental Manufacturing Co 1, LLC.
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.
Product code: JOJ Indicator, Physical/Chemical Sterilization Process
Reason for recall: The Dry Heat Indicator Labels packaging may contain TTS Indicator Labels instead of Dry Heat Indicator Labels.
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: 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].
Quantity in commerce: 158 units
Distribution: US Distribution
Product codes and lots: Lot Number 165892 UDI (01)10302731163120(13)210712(10)165892

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0555-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0555-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-02-09	2022-02-02

Product code JOJ

K890761Class IIStrip, Sterilization Indicator; Dry HeatSpsmedical Supply Corp. / cleared 1989-08-07

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)