Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported July 1, 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.
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.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Coltene Whaledent Inc recalled HYGENIC Dental Dam Forceps, Model no. H01262 - Product Usage: The dental dam forceps are … - a moderate-severity action.
HYGENIC Dental Dam Forceps, Model no. H01262 - Product Usage: The dental dam forceps are … was recalled by Coltene Whaledent Inc in July 1, 2020. Reason: Multiple Coltene batches of the product have a pin size larger than acceptable, which may make it difficult f…. Check the official notice for the remedy. Verify recall #Z-2419-2020 with the FDA Devices before acting.
The recall
Coltene Whaledent Inc issued this moderate-severity FDA Devices recall-Multiple Coltene batches of the product have a pin size larger than acceptable, which may make it difficult f….
- Moderate
- severity level
- Class II
- classification
- July 1, 2020
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2419-2020 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2419-2020) was formally reported on July 1, 2020, with the manufacturer initiating the action on June 3, 2020. It is classified under Moderate severity (Class II), with a current status of Ongoing. Coltene Whaledent Inc is listed as the recalling firm, operating out of Cuyahoga Falls, OH. Federal records list the affected scope as 7,206 forceps.
The documented reason for this recall is: 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. Distribution data in the federal record shows the product reached: Pending. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
7,206 forceps
Related Recalls
6
3 from same agency
Product description
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.
Reason for 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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-2419-2020 |
| Date reported | July 1, 2020 |
| Date initiated | June 3, 2020 |
| Recalling firm | Coltene Whaledent Inc |
| Firm location | Cuyahoga Falls, OH |
| Affected scope | 7,206 forceps |
| Distribution | Pending |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2419-2020) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Coltene Whaledent Inc. Units affected: 7,206 forceps.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 1, 2020. Severity: Moderate. Recall number: Z-2419-2020.
Where was the recalled product distributed? ▼
Distribution: Pending.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2419-2020) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported July 1, 2020. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.