FDA Medical Device Recalls (openFDA)
Coltene Whaledent Inc: Latex Dental Dams labeled as Non-Latex Dental Dams
- Recall number
- Z-2151-2014
- Recalling firm
- Coltene Whaledent Inc
- Product
- Latex Dental Dams labeled as Non-Latex Dental Dams
- Status
- Terminated
- Initiated
- 2013-12-11
- Posted
- 2014-08-06
- Terminated
- 2016-08-26
- Reason
- 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
- 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
- 32 boxes, 15 individual dams per box
- Distribution
- Distributed in Memphis, TN.
- Lot, serial or model codes
- Model/Catalog number 1884-10840 Lot number 103G2 Exp Date 2016/10
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- EIE
- Firm FEI
- 2416455
- Firm city
- Cuyahoga Falls
- Firm state
- OH
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28