Coltene Recalls HYGENIC Simple Dam Kit Forceps Due to Fit Issues
Coltene Whaledent Inc is recalling 7,206 HYGENIC Simple Dam Kit forceps because a pin size defect may prevent them from fitting properly with dental dam clamps.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard is a functional fit issue that may make it difficult to use the device, but no injuries or illnesses are reported, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Coltene Whaledent Inc is recalling 7,206 units of the HYGENIC Simple Dam Kit, Model no. 60019066. The recall involves dental dam forceps intended to be used with rubber dental dams and clamps. The specific defect is that multiple batches have a pin size larger than acceptable, which may make it difficult for the forceps to fit appropriately with the dental dam clamps.
The affected forceps are identified by specific laser-marked batch numbers: 1903, 1904, 1906, 1907, 1909, 1910, 1911, 1915, 1920, 1921, 1923, 1927, 1928, 1930, 1934, and 1940. The distribution pattern is currently listed as pending.
Distributors and end users who received these batches should check the laser-marked batch number on the forceps. If the forceps have one of the listed batch numbers and do not fit with the dental dam clamps, they should be returned to Coltene.
The recalled product
- Product
- HYGENIC Simple Dam Kit, Model no. 60019066 - Product Usage: The dental dam forceps are intended to be used in conjunction with the rubber dental dam and the dental dam clamps. The forceps are used to place and remove the dental dam clamps from the rubber dental dam.
- Manufacturer
- Coltene Whaledent Inc
- Hazard
- Affected units
- 7,206
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 4 recalled by Coltene Whaledent Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 4 products in this recall →Related recalls
Same manufacturer · Coltene Whaledent Inc
See all →- HighDental Handpieces Recalled Due to Detachable Screw Component Risk
FDA (Devices) · 2023-03-08
- ModerateColtene Whaledent Recalls TMS LINK PLUS Self-Threading Dental Pins
FDA (Devices) · 2021-05-05
- ModerateColtene Whaledent Recalls CEI Cutting Edge Instruments Due to Packaging Error
FDA (Devices) · 2020-11-25
- ModerateStrauss 25 Carbide Dental Burs Recalled for Incorrect Packaging
FDA (Devices) · 2020-11-25
- ModerateColtene Whaledent Recalls Mispackaged Alpen Clinic 100 Carbide Instruments
FDA (Devices) · 2020-11-25
Same hazard · functional defect
See all →- HighMaquet Critical Care Recalls Y Sensor Modules for Electrical Safety Testing Omission
FDA (Devices) · 2026-08-26
- HighStryker Ahto Tube Set Recalled for Handpiece Leaking During Use
FDA (Devices) · 2026-08-12
- HighStryker Strykeflow Suction/Irrigator PS Recalled for Leaking During Use
FDA (Devices) · 2026-08-12
- HighAngiodynamics Soft-Vu Angiographic Catheter Guidewire Blockage Risk
FDA (Devices) · 2026-04-29
- SevereGE Healthcare CARESTATION anesthesia systems ventilation malfunction recall
FDA (Devices) · 2025-05-07