CLASS II Device recall · Reported 7 Mar 2018 · FDA Enforcement Report
Etching Gel, 37% Phosphoric Acid recalled by Cosmedent
Cosmedent is recalling Cosmedent's Etching Gel, 37% Phosphoric Acid, distributed in Illinois, Louisiana, Michigan, Pennsylvania, Wisconsin. The recall was initiated on 28 Sep 2017 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0741-2018
- FDA event ID
- 78479
- Recalling firm
- Cosmedent, Chicago, IL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 28 Sep 2017
- FDA classified
- 27 Feb 2018
- Reported
- 7 Mar 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Syringes & Needles
Timeline
| 28 Sep 2017 | Recall initiated by company | |
| 27 Feb 2018 | Classified by FDA | +152 days |
| 7 Mar 2018 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Cosmedent's Etching Gel, 3g, 37% Phosphoric Acid, Rx only. Packaged in 3g Luer Lock syringes. Used for etching enamel and dentin.
Where it was distributed
Worldwide Distribution -- USA, to the states of IL, LA, MI, PA, and WI; and, to the countries of Australia, Hungary, and Spain.
Questions about this recall
Is Etching Gel, 37% Phosphoric Acid recalled?
Yes. Cosmedent recalled Etching Gel, 37% Phosphoric Acid on 28 Sep 2017. The recall is Class II and its status is Terminated. Recall number Z-0741-2018.
Why was it recalled?
Product packaged in a syringe that is not a lure lock syringe and the tip cold come off when expressing the material.
Which lots are affected?
SKU #663-103, Lot No. 164222A, Exp. Date 10/31/2019
Where was it sold?
Worldwide Distribution -- USA, to the states of IL, LA, MI, PA, and WI; and, to the countries of Australia, Hungary, and Spain.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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