Coltene Whaledent Inc HYGENIC Simple Dam Kit, Model no. 60019066 - Product Usage: The dental dam forceps are intended to be used in conjunction with the rubber dental dam and the dental dam clamps. The forceps are used to place and remove the dental dam clamps from the rubber dental dam. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
HYGENIC Simple Dam Kit, Model no. 60019066 - Product Usage: The dental dam forceps are intended to be used in conjunction with the rubber dental dam and the dental dam clamps. The forceps are used to place and remove the dental dam clamps from the rubber dental dam.
Brand
Coltene Whaledent Inc
Lot Codes / Batch Numbers
Batch numbers: J73571 If a distributor or end user received one of the batches listed above
Products Sold
Batch numbers: J73571 If a distributor or end user received one of the batches listed above, they need to look at the batch number laser marked on the forceps themselves. If the forceps has any of the following batch numbers laser marked on them and the forceps do not fit with the dental dam clamps, the forceps should be returned to Coltene. Laser marked batch number: 1903 1904 1906 1907 1909 1910 1911 1915 1920 1921 1923 1927 1928 1930 1934 1940
Coltene Whaledent Inc is recalling HYGENIC Simple Dam Kit, Model no. 60019066 - Product Usage: The dental dam forceps are intended to b due to Multiple Coltene batches of the product have a pin size larger than acceptable, which may make it difficult for the forceps to fit appropriately with . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Multiple Coltene batches of the product have a pin size larger than acceptable, which may make it difficult for the forceps to fit appropriately with dental dam clamps.
Recommended Action
Per FDA guidance
The firm notified affected customers on June 3, 2020 by sending out Urgent Medical Device Recall letters. Customers were informed that multiple batches of the product do not meet specification. If you received one of the affected batches, please check the laser marked batch number on the forceps. If the laser marked batch number directly on the forceps matches one of the listed numbers, you should return the forceps. The recalling firm will replace your product at no cost. If you have already used the product, please inform the firm. If you should have additional questions, please contact: Tricia Cregger, Ph.D., RAC, CBA Director of Regulatory / R&D Coltene/Whaledent, Inc. 235 Ascot Parkway Cuyahoga Falls, OH 44223 USA Tricia.Cregger@coltene.com Phone: 330-916-8817 Fax: 330-916-7093
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