Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported November 8, 2023
Cosmedent FlexiCup Composite Finishing & Polishing System, Six Pack, Autoclavable Aluminum Oxide Polishing Instrument, Medium (Blue), REF #403-101, Rx.
Reports were received the elastomer cup material is crumbling.
Cosmedent, Inc. recalled Cosmedent FlexiCup Composite Finishing & Polishing System, Six Pack, Autoclavable Aluminu… - a moderate-severity action.
Cosmedent FlexiCup Composite Finishing & Polishing System, Six Pack, Autoclavable Aluminu… was recalled by Cosmedent, Inc. in November 8, 2023. Reason: Reports were received the elastomer cup material is crumbling.. Check the official notice for the remedy. Verify recall #Z-0211-2024 with the FDA Devices before acting.
The recall
Cosmedent, Inc. issued this moderate-severity FDA Devices recall-Reports were received the elastomer cup material is crumbling..
- Moderate
- severity level
- Class II
- classification
- November 8, 2023
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0211-2024 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0211-2024) was formally reported on November 8, 2023, with the manufacturer initiating the action on July 20, 2023. It is classified under Moderate severity (Class II), with a current status of Ongoing. Cosmedent, Inc. is listed as the recalling firm, operating out of Chicago, IL. Federal records list the affected scope as 7,400 packs of 6.
The documented reason for this recall is: Reports were received the elastomer cup material is crumbling. Distribution data in the federal record shows the product reached: Worldwide distribution - US Nationwide and the countries of Australia, Colombia, Denmark Ecuador, Estonia, Greece, Hungary, Iran, Israel, Japan, Lithuania, Mexico, Netherlands, New Zealand, Paraguay, Philippines, Spain,…. 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 85,745 recalls with an agency hazard classification, 17,990 are high severity, 63,355 moderate, and 4,400 low. A further 15,959 CPSC/NHTSA recalls have no agency class and are excluded from this split. 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
7,400 packs of 6
Related Recalls
6
3 from same agency
Product description
Cosmedent FlexiCup Composite Finishing & Polishing System, Six Pack, Autoclavable Aluminum Oxide Polishing Instrument, Medium (Blue), REF #403-101, Rx.
Reason for recall
Reports were received the elastomer cup material is crumbling.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-0211-2024 |
| Date reported | November 8, 2023 |
| Date initiated | July 20, 2023 |
| Recalling firm | Cosmedent, Inc. |
| Firm location | Chicago, IL |
| Affected scope | 7,400 packs of 6 |
| Distribution | Worldwide distribution - US Nationwide and the countries of Australia, Colombia, Denmark Ecuador, Estonia, Greece, Hungary, Iran, Israel, Japan, Lithuania, Mexico, Netherlands, New Zealand, Paraguay, Philippines, Spain, Sweden, UAE, and Un… |
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-0211-2024) 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? ▼
Cosmedent FlexiCup Composite Finishing & Polishing System, Six Pack, Autoclavable Aluminum Oxide Polishing Instrument, Medium (Blue), REF #403-101, Rx.. Recalled by Cosmedent, Inc.. Units affected: 7,400 packs of 6.
Why was this product recalled? ▼
Reports were received the elastomer cup material is crumbling.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 8, 2023. Severity: Moderate. Recall number: Z-0211-2024.
Where was the recalled product distributed? ▼
Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Colombia, Denmark Ecuador, Estonia, Greece, Hungary, Iran, Israel, Japan, Lithuania, Mexico, Netherlands, New Zealand, Paraguay, Philippines, Spain, Sweden, UAE, and United Kingdom..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0211-2024) 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.
Nearby Recalls in This Category
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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 November 8, 2023. 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.