Food, drugs, devices › Coltene Whaledent Inc
Device recall: Latex Dental Dams labeled as Non-Latex Dental Dams
Coltene Whaledent Inc (Cuyahoga Falls, OH) initiated this device recall on 11 Dec 2013; FDA lists 1 product record under event 67640, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 90% of the 1,236 device enforcement events initiated in 2013 carry the same class.
Status: Terminated, terminated 26 Aug 2016. Initiation: voluntary: firm initiated. Coltene Whaledent Inc has 7 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Coltene Whaledent Inc, Cuyahoga Falls, OH.
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."
Distribution
"Distributed in Memphis, TN."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2151-2014 | Latex Dental Dams labeled as Non-Latex Dental Dams | 32 boxes, 15 individual dams per box | Class II | Terminated | 13 Aug 2014 |
Context
Other enforcement events for Coltene Whaledent Inc
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 20 Jan 2023 | SciCan STATIS SL S10001 Dental Handpieces-Intended for the removal of carious material, reducing hard tooth structure, c | Device | Class II | 1 |
| 18 Mar 2021 | Dental pins - TMS LINK PLUS Self-Threading Pins - Product Usage: implanted into the teeth or for lab use for dental rest | Device | Class II | 1 |
| 20 Oct 2020 | Alpen Clinic 100 Carbide Instruments (R100057C) | Device | Class II | 5 |
| 3 Jun 2020 | HYGENIC Dental Dam Forceps, Model no. H01262 - Product Usage: The dental dam forceps are intended to be used in conjunct | Device | Class II | 4 |
| 21 Aug 2018 | ParaPost Plus 25 Titanium Alloy Spiral Vented and Serrated Posts Catalog Number: P2845B Dental Posts are implanted into | Device | Class II | 1 |
| 13 Apr 2018 | Alpen Carbide 702 Cross Cut Tapered Fissure FG 10 pack (Carbide Burs), Model R100702 a rotary cutting device made from c | Device | Class II | 1 |
All 7 events for Coltene Whaledent Inc
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "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."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Distributed in Memphis, TN."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 26 Aug 2016. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.