Home / Brands / Coltene Whaledent
Coltene Whaledent Recalls
14 recalls on record · August 13, 2014 to March 8, 2023 · Medical Devices
Recalls by year
14
18
20
21
23
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
March 8, 2023Medical DevicesFDA
Coltene Whaledent Inc recalls SciCan STATIS SL S10001 Dental Handpieces-Intended for the removal of carious material, reducing hard tooth structure, c
Hazard: Screw connection between the turbine head and the push button may loosen and fall off during the treatment, and increase the risk of swallowing or inhaling part of the turbines head or the push button
May 5, 2021Medical DevicesFDA
Coltene Whaledent Inc recalls Dental pins - TMS LINK PLUS Self-Threading Pins - Product Usage: implanted into the teeth or for lab use for dental rest
Hazard: The incorrect dental pins were packaged and subsequently distributed.
November 25, 2020Medical DevicesFDA
Coltene Whaledent Inc recalls Strauss 25 Carbide Dental Burs (100057XXV)
Hazard: The FG 557 bur was incorrectly packaged as the FG 57 bur. The FG 557 burs will remove more material than the FG 57 burs.
November 25, 2020Medical DevicesFDA
Coltene Whaledent Inc recalls CEI Cutting Edge Instruments (PTC-57C)
Hazard: The FG 557 bur was incorrectly packaged as the FG 57 bur. The FG 557 burs will remove more material than the FG 57 burs.
November 25, 2020Medical DevicesFDA
Coltene Whaledent Inc recalls Clinic Pack 100 Pieces FG 57 100057C (100057C)
Hazard: The FG 557 bur was incorrectly packaged as the FG 57 bur. The FG 557 burs will remove more material than the FG 57 burs.
November 25, 2020Medical DevicesFDA
Coltene Whaledent Inc recalls FG 57 100057X (100057X)
Hazard: The FG 557 bur was incorrectly packaged as the FG 57 bur. The FG 557 burs will remove more material than the FG 57 burs.
November 25, 2020Medical DevicesFDA
Coltene Whaledent Inc recalls Alpen Clinic 100 Carbide Instruments (R100057C)
Hazard: The FG 557 bur was incorrectly packaged as the FG 57 bur. The FG 557 burs will remove more material than the FG 57 burs.
July 1, 2020Medical DevicesFDA
Coltene Whaledent Inc recalls HYGENIC Wingless Fiesta Kit, Model no. H02790 - Product Usage: The dental dam forceps are intended to be used in conjunc
Hazard: 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.
July 1, 2020Medical DevicesFDA
Coltene Whaledent Inc recalls HYGENIC Winged Fiesta Kit, Model no. H02778 - Product Usage: The dental dam forceps are intended to be used in conjuncti
Hazard: 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.
July 1, 2020Medical DevicesFDA
Coltene Whaledent Inc recalls HYGENIC Simple Dam Kit, Model no. 60019066 - Product Usage: The dental dam forceps are intended to be used in conjunctio
Hazard: 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.
July 1, 2020Medical DevicesFDA
Coltene Whaledent Inc recalls HYGENIC Dental Dam Forceps, Model no. H01262 - Product Usage: The dental dam forceps are intended to be used in conjunct
Hazard: 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.
November 14, 2018Medical DevicesFDA
Coltene Whaledent Inc recalls ParaPost Plus 25 Titanium Alloy Spiral Vented and Serrated Posts Catalog Number: P2845B Dental Posts are impla
Hazard: ParaPost Plus Titanium Posts contain stainless steel post that are a size 4
May 23, 2018Medical DevicesFDA
Coltene Whaledent Inc recalls Alpen Carbide 702 Cross Cut Tapered Fissure FG 10 pack (Carbide Burs), Model R100702 a rotary cutting device made from c
Hazard: The products are labeled with an incorrect product number.
August 13, 2014Medical DevicesFDA
Coltene Whaledent Inc recalls Latex Dental Dams labeled as Non-Latex Dental Dams
Hazard: 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.