Z-2151-2014Class II

Latex Dental Dams labeled as Non-Latex Dental Dams

Name: Z-2151-2014 Latex Dental Dams labeled as Non-Latex Dental Dams
Creator: Coltene Whaledent Inc
Published: 2013-12-11
License: https://open.fda.gov/license/

Coltene /Whaledent AG / initiated 2013-12-11 / Terminated / root cause: packaging

FDA source

Coltene Whaledent Inc began a recall of Latex Dental Dams labeled as Non-Latex Dental Dams on 2013-12-11. FDA classified it as Class II and gives the reason as "Coltne/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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2151-2014
Classification: Class II
Status: Terminated
Initiated: 2013-12-11
Posted: 2014-08-06
Terminated: 2016-08-26
Recalling firm: Coltene /Whaledent AG
Product: Latex Dental Dams labeled as Non-Latex Dental Dams
Product code: EIE Dam, Rubber
Reason for recall: Coltne/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.
Root cause tag: packaging
FDA root cause: Packaging change control
Action: The firm issued a press release, called the distributor and sent a certified letter. The firm obtained the distributor's distribution list and sent recall notifications to all of these consignees.The firm included envelopes and return/reply cards, via response form mailed, certified mailing with return receipt.
Quantity in commerce: 32 boxes, 15 individual dams per box
Distribution: Distributed in Memphis, TN.
Product codes and lots: Model/Catalog number 1884-10840 Lot number 103G2 Exp Date 2016/10

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2151-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2151-2014	Class II	Terminated	Voluntary: Firm initiated	2014-08-13	2014-08-06

Product code EIE

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)