Lower risk Medical device recall · FDA · Published June 3, 2020

Coltene HYGENIC Wingless Fiesta Kit Recall: Forceps May Not Fit Dental Dam Clamps

Coltene recalls HYGENIC Wingless Fiesta Kit (Model H02790) with batch numbers 1903-1940 due to forceps that may not fit dental dam clamps properly. Affected users should check batch numbers and return if issues occur.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-2422-2020Medical device Coltene ›

Lower-risk recall

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.

Take action

Contact the company

Recalling firmColtene Whaledent Inc235 Ascot Pkwy · Cuyahoga Falls, OH 44223-3701

✎ GovInfoNow plain-language explainer

Coltene is recalling dental dam forceps from the HYGENIC Wingless Fiesta Kit (Model H02790) because some batches have a pin size too large, making it hard for the forceps to fit with dental dam clamps. This could lead to improper use during dental procedures. Read more at govinfonow.com/recall/65060-coltene-hygenic-wingless-fiesta-kit-recall-forceps-may-not-fit.

Source Summary by GovInfoNow · govinfonow.com/recall/65060-coltene-hygenic-wingless-fiesta-kit-recall-forceps-may-not-fit · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2422-2020

Cite this page

“Coltene HYGENIC Wingless Fiesta Kit Recall: Forceps May Not Fit Dental Dam Clamps.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/65060-coltene-hygenic-wingless-fiesta-kit-recall-forceps-may-not-fit. Based on FDA recall #Z-2422-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2422-2020%22&limit=1).

Coltene Whaledent Inc recalled HYGENIC Wingless Fiesta Kit, Model no. H02790, due to a pin size hazard that may prevent proper fit with dental dam clamps, the FDA said on June 3, 2020.

How to tell if you have it

Brand: Coltene
Product: HYGENIC Wingless Fiesta Kit
Model no.: H02790
Laser marked batch numbers: 1903, 1904, 1906, 1907, 1909, 1910, 1911, 1915, 1920, 1921, 1923, 1927, 1928, 1930, 1934, 1940
Units affected: 7,206 forceps

The hazard

Multiple batches have a pin size larger than acceptable, which may make it difficult for the forceps to fit appropriately with dental dam clamps.

Context

GovInfoNow's records show Coltene Whaledent Inc has 5 other recalls on record since April 13, 2018. Other recent recalls of similar products include Coltene Whaledent SciCan STATIS SL S10001 Dental Handpieces Recall (Jan. 20, 2023), Coltene Whaledent Dental Pins Recall (March 18, 2021), and Colt: CEI Cutting Edge Instruments PTC-57C Recall (Oct. 20, 2020).

How to tell if you have this one

Check the batch number laser marked on the forceps. Affected units have batch numbers 1903, 1904, 1906, 1907, 1909, 1910, 1911, 1915, 1920, 1921, 1923, 1927, 1928, 1930, 1934, or 1940.

Brand
Coltene
Category
Medical device

FDA recall event · 4 products

All 4 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Ongoing
Distribution
Pending

Recall number	Product, codes & lots
Z-2419-2020	HYGENIC Dental Dam Forceps, Model no. H01262 - 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.; Batch numbers: J16743 J16745 J29784 J31289 J33607 J44177 J44178 J44840 J47109 J47110 J49167 J67132 J73572 J73785 J74711 If a distributor or end user received one of the batches listed above, they need to look at the batch number laser marked on the forceps themselves. If the forceps has any of the following batch numbers laser marked on them and the forceps do not fit with the dental dam clamps, the forceps should be returned to Coltene. Laser marked batch number: 1903 1904 1906 1907 1909 1910 1911 1915 1920 1921 1923 1927 1928 1930 1934 1940
Z-2420-2020	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.; Batch numbers: J73571 If a distributor or end user received one of the batches listed above, they need to look at the batch number laser marked on the forceps themselves. If the forceps has any of the following batch numbers laser marked on them and the forceps do not fit with the dental dam clamps, the forceps should be returned to Coltene. Laser marked batch number: 1903 1904 1906 1907 1909 1910 1911 1915 1920 1921 1923 1927 1928 1930 1934 1940
Z-2421-2020	HYGENIC Winged Fiesta Kit, Model no. H02778 - 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.; Batch numbers: J38382 J28715 J24868 J28716 J33647 J43944 J50980 J47108 J57802 J57061 J67133 J74174 J68563 J72691 If a distributor or end user received one of the batches listed above, they need to look at the batch number laser marked on the forceps themselves. If the forceps has any of the following batch numbers laser marked on them and the forceps do not fit with the dental dam clamps, the forceps should be returned to Coltene. Laser marked batch number: 1903 1904 1906 1907 1909 1910 1911 1915 1920 1921 1923 1927 1928 1930 1934 1940
Z-2422-2020	HYGENIC Wingless Fiesta Kit, Model no. H02790 - 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.; Batch numbers: J74546 J74184 If a distributor or end user received one of the batches listed above, they need to look at the batch number laser marked on the forceps themselves. If the forceps has any of the following batch numbers laser marked on them and the forceps do not fit with the dental dam clamps, the forceps should be returned to Coltene. Laser marked batch number: 1903 1904 1906 1907 1909 1910 1911 1915 1920 1921 1923 1927 1928 1930 1934 1940

Based on the official FDA remedy

What to do — step by step

Check Batch Number
Look for the batch number laser marked on the forceps. If it matches the listed batch numbers (1903-1940), the forceps may not fit properly with dental dam clamps.
Return if Needed
If the forceps do not fit with dental dam clamps, return them to Coltene for replacement.

How this recall unfolded

Recall timeline

FDA published this recall 28 days after the firm started it.

Jun 3, 2020Firm started the recall
Jun 23, 2020FDA classified it Class II
Jul 1, 2020Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

Similar recalls

Latest medical device recalls

Keep exploring

More Coltene recalls

Link to this recall

<a href="https://govinfonow.com/recall/65060-coltene-hygenic-wingless-fiesta-kit-recall-forceps-may-not-fit">Coltene HYGENIC Wingless Fiesta Kit Recall: Forceps May Not Fit Dental Dam Clamps (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-2422-2020 (June 3, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2422-2020 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.