Coltene Whaledent Inc: Medical Device Recall in 2014 - (Recall #: Z-2151-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

Latex Dental Dams labeled as Non-Latex Dental Dams

Product Classification:

Class II

Date Initiated: December 11, 2013

Date Posted: August 13, 2014

Recall Number: Z-2151-2014

Event ID: 67640

Reason for Recall:

Colt¿ne/Whaledent Inc. received a complaint about the dental dams being the incorrect color. During an internal investigation, the firm found that Latex dental dams had been packaged in Non-Latex packaging.

Status: Terminated

Product Quantity: 32 boxes, 15 individual dams per box

Code Information:

Model/Catalog number 1884-10840 Lot number 103G2 Exp Date 2016/10

Distribution Pattern:

Distributed in Memphis, TN.

Voluntary or Mandated:

Voluntary: Firm initiated