Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported March 7, 2018
Cosmedent's Etching Gel, 3g, 37% Phosphoric Acid, Rx only. Packaged in 3g Luer Lock syringes. Used for etching enamel and dentin.
Product packaged in a syringe that is not a lure lock syringe and the tip cold come off when expressing the material.
Cosmedent, Inc. recalled Cosmedent's Etching Gel, 3g, 37% Phosphoric Acid, Rx only. Packaged in 3g Luer Lock syri… - a moderate-severity action.
Cosmedent's Etching Gel, 3g, 37% Phosphoric Acid, Rx only. Packaged in 3g Luer Lock syri… was recalled by Cosmedent, Inc. in March 7, 2018. Reason: Product packaged in a syringe that is not a lure lock syringe and the tip cold come off when expressing the m…. Check the official notice for the remedy. Verify recall #Z-0741-2018 with the FDA Devices before acting.
The recall
Cosmedent, Inc. issued this moderate-severity FDA Devices recall-Product packaged in a syringe that is not a lure lock syringe and the tip cold come off when expressing the m….
- Moderate
- severity level
- 84 units
- affected scope
- Class II
- classification
- March 7, 2018
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0741-2018 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0741-2018) was formally reported on March 7, 2018, with the manufacturer initiating the action on September 28, 2017. It is classified under Moderate severity (Class II), with a current status of Terminated. Cosmedent, Inc. is listed as the recalling firm, operating out of Chicago, IL. Federal records list the affected scope as 84 units.
The documented reason for this recall is: Product packaged in a syringe that is not a lure lock syringe and the tip cold come off when expressing the material. Distribution data in the federal record shows the product reached: Worldwide Distribution -- USA, to the states of IL, LA, MI, PA, and WI; and, to the countries of Australia, Hungary, and 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
84 units
Related Recalls
6
3 from same agency
Product description
Cosmedent's Etching Gel, 3g, 37% Phosphoric Acid, Rx only. Packaged in 3g Luer Lock syringes. Used for etching enamel and dentin.
Reason for recall
Product packaged in a syringe that is not a lure lock syringe and the tip cold come off when expressing the material.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0741-2018 |
| Date reported | March 7, 2018 |
| Date initiated | September 28, 2017 |
| Recalling firm | Cosmedent, Inc. |
| Firm location | Chicago, IL |
| Affected scope | 84 units |
| Distribution | Worldwide Distribution -- USA, to the states of IL, LA, MI, PA, and WI; and, to the countries of Australia, Hungary, and Spain. |
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-0741-2018) 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's Etching Gel, 3g, 37% Phosphoric Acid, Rx only. Packaged in 3g Luer Lock syringes. Used for etching enamel and dentin.. Recalled by Cosmedent, Inc.. Units affected: 84 units.
Why was this product recalled? ▼
Product packaged in a syringe that is not a lure lock syringe and the tip cold come off when expressing the material.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 7, 2018. Severity: Moderate. Recall number: Z-0741-2018.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution -- USA, to the states of IL, LA, MI, PA, and WI; and, to the countries of Australia, Hungary, and Spain..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0741-2018) 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 March 7, 2018. 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.