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This is to inform all concerned healthcare professionals and establishments that the Voluntary Recall of affected batches of HYGENIC® Dental Dam Forceps p/n H01262 that may have been sold as part of Hygenic Simple Dam Kit™, p/n 60019066, Hygenic Winged Fiesta Kit™, p/n H02778 and Hygenic Wingless Fiesta Kit™, p/n H02790, manufactured by Coltene/Whaledent, Inc. and imported by Dent1st Corp. as shown in the table below is completed and hereby closed by the Food and Drug Administration (FDA).

Forceps Batches


Simple Dam Kit


Winged (H02778) Wingless (H02790)
J16743 J73571 J38382 J74546
J16745 J28715 J74184
J29784 J24868
J31289 J28716
J33607 J33647
J44177 J43944
J44178 J50980
J44840 J47108
J47109 J57802
J47110 J57061
J49167 J67133
J67132 J74174
J73572 J68563
J73785 J72691

As stated in the FDA Advisory No. 2020-1808 dated 05 October 2020, Dent1st Corp. has conducted the voluntary recall of the aforementioned product due to identified multiple batches of the said products have a pin size larger than acceptable size. This larger pin size may make it difficult for the forceps to fit appropriately with the HYGENIC branded or Fiesta branded dental dam clamps. There are no safety concerns to the patient or user as the larger sized pins on the forceps just render the forceps unusable.

After due and thorough evaluation of the submitted documents by Dent1st Corp., FDA has determined that reasonable efforts have been made to recall and properly returned to the source country the affected product batches in accordance with FDA Circular No. 2016-012, known as the Guidelines on Product Recall.

The issuance of this advisory shall not in any manner preclude this Office from issuing subsequent orders it may deem necessary and appropriate, should there be subsequent findings of any violation of existing FDA laws, rules and regulations.

All FDA Regional Field Offices and Regulatory Enforcement Units in coordination with law enforcement agencies and Local Government Units are requested to monitor and seize the cited product lots if still found available in the market.

For more information and inquiries, kindly contact the FDA Center for Device Regulation, Radiation Health and Research through e-mail at [email protected], or call (02) 8857-1900 local 8301.

Dissemination of this advisory to all concerned is hereby requested