Coltene Whaledent Inc: Medical Device Recall in 2020 - (Recall #: Z-2420-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: June 3, 2020

Date Posted: July 1, 2020

Recall Number: Z-2420-2020

Event ID: 85794

Reason for Recall:

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.

Status: Ongoing

Product Quantity: 7,206 forceps

Code Information:

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

Distribution Pattern:

Pending

Voluntary or Mandated:

Voluntary: Firm initiated