Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported December 25, 2013
3M ESPE Imprint II Regular Body , Catalog Number 9379, and Paradigm Regular Body VPS, Catalog Number 5315, Impression Material that are intended to reproduce the structure of a patients teeth. Impression Materials are composed of hydrophilic vinyl polysiloxane impression materials, designed for making precise crown and bridge, inlay, onlay, veneer preparations, removable denture and partial denture impressions.
Specific lots of Imprint II and Paradigm impression material refill packs are being recalled because the moisture displacement feature in both is greatly reduced which may impact …
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
3M Company - Health Care Business recalled 3M ESPE Imprint II Regular Body , Catalog Number 9379, and Paradigm Regular Body VPS, Cat… - a moderate-severity action.
3M ESPE Imprint II Regular Body , Catalog Number 9379, and Paradigm Regular Body VPS, Cat… was recalled by 3M Company - Health Care Business in December 25, 2013. Reason: Specific lots of Imprint II and Paradigm impression material refill packs are being recalled because the mois…. Check the official notice for the remedy. Verify recall #Z-0535-2014 with the FDA Devices before acting.
The recall
3M Company - Health Care Business issued this moderate-severity FDA Devices recall-Specific lots of Imprint II and Paradigm impression material refill packs are being recalled because the mois….
- Moderate
- severity level
- Class II
- classification
- December 25, 2013
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0535-2014 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0535-2014) was formally reported on December 25, 2013, with the manufacturer initiating the action on November 21, 2013. It is classified under Moderate severity (Class II), with a current status of Terminated. 3M Company - Health Care Business is listed as the recalling firm, operating out of Saint Paul, MN. Federal records list the affected scope as 1977 kits.
The documented reason for this recall is: Specific lots of Imprint II and Paradigm impression material refill packs are being recalled because the moisture displacement feature in both is greatly reduced which may impact the quality of the dental impression. Distribution data in the federal record shows the product reached: Worldwide Distribution - USA (nationwide) and the countries of Canada, France, Germany, Hong Kong, Italy, Japan, Korea, Mexico, United Arab and Emirates.. 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
1977 kits
Related Recalls
6
3 from same agency
Product description
3M ESPE Imprint II Regular Body , Catalog Number 9379, and Paradigm Regular Body VPS, Catalog Number 5315, Impression Material that are intended to reproduce the structure of a patients teeth. Impression Materials are composed of hydrophilic vinyl polysiloxane impression materials, designed for making precise crown and bridge, inlay, onlay, veneer preparations, removable denture and partial denture impressions.
Reason for recall
Specific lots of Imprint II and Paradigm impression material refill packs are being recalled because the moisture displacement feature in both is greatly reduced which may impact the quality of the dental impression.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0535-2014 |
| Date reported | December 25, 2013 |
| Date initiated | November 21, 2013 |
| Recalling firm | 3M Company - Health Care Business |
| Firm location | Saint Paul, MN |
| Affected scope | 1977 kits |
| Distribution | Worldwide Distribution - USA (nationwide) and the countries of Canada, France, Germany, Hong Kong, Italy, Japan, Korea, Mexico, United Arab and Emirates. |
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-0535-2014) 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? ▼
3M ESPE Imprint II Regular Body , Catalog Number 9379, and Paradigm Regular Body VPS, Catalog Number 5315, Impression Material that are intended to reproduce the structure of a patients teeth. Impression Materials are composed of hydrophilic vinyl polysiloxane impression materials, designed for making precise crown and bridge, inlay, onlay, veneer preparations, removable denture and partial denture impressions.. Recalled by 3M Company - Health Care Business. Units affected: 1977 kits.
Why was this product recalled? ▼
Specific lots of Imprint II and Paradigm impression material refill packs are being recalled because the moisture displacement feature in both is greatly reduced which may impact the quality of the dental impression.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 25, 2013. Severity: Moderate. Recall number: Z-0535-2014.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - USA (nationwide) and the countries of Canada, France, Germany, Hong Kong, Italy, Japan, Korea, Mexico, United Arab and Emirates..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0535-2014) 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 December 25, 2013. 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.