3M ESPE Imprint II and Paradigm Impression Materials Recalled for Quality Issues
3M is recalling specific lots of Imprint II and Paradigm dental impression materials because a defect reduces moisture displacement, potentially affecting impression quality.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text indicates the defect impacts the quality of the impression rather than causing direct patient injury or illness, aligning with moderate severity criteria for functional defects without reported harm.
Plain-English summary
3M Company - Health Care Business is recalling specific lots of 3M ESPE Imprint II Regular Body (Catalog Number 9379) and Paradigm Regular Body VPS (Catalog Number 5315) impression materials. These products are intended to reproduce the structure of a patient's teeth for dental procedures such as crowns, bridges, and dentures. The affected lots are N510884, N510889, and N511952.
The recall is being conducted because the moisture displacement feature in both products is greatly reduced. This defect may impact the quality of the dental impression taken by the dental professional. The agency has classified this as a Class II recall.
A total of 1,977 kits were distributed worldwide, including the United States, Canada, France, Germany, Hong Kong, Italy, Japan, Korea, Mexico, and the United Arab Emirates. Consumers and dental professionals should check their inventory for the specific lot codes listed above and stop using these products if they match the recalled lots.
The recalled product
- Product
- 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 mater
- Manufacturer
- 3M Company - Health Care Business
- Affected units
- 1,977
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot codes: N510884
- N510889
- and N511952
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · 3M Company - Health Care Business
See all →- High3M Clarity Precision Orthodontic Attachments Recall for Improper Tooth Mating
FDA (Devices) · 2025-01-01
- High3M Tegaderm CHG I.V. Dressing Recalled for Foreign Contamination
FDA (Devices) · 2024-10-16
- Moderate3M Durapore Surgical Tape incorrectly labeled with extended shelf life
FDA (Devices) · 2024-05-01
- Moderate3M Tube Securement Devices Recalled for Missing Film Layer and Shape Defects
FDA (Devices) · 2024-04-10
- High3M Surgical Clipper Blade Assembly Recalled Due to Burn Risk
FDA (Devices) · 2024-02-28
Same hazard · quality defect
See all →- ModerateDicyclomine Hydrochloride Capsules Recalled for Empty Capsules
FDA (Drugs) · 2026-08-12
- ModerateMethohexital Sodium for Injection Recalled for Failed Impurities and Degradation Specifications
FDA (Drugs) · 2026-07-15
- ModerateMedline Lidocaine HCL Injection Ampules Recalled for Quality Issues
FDA (Devices) · 2026-07-08
- ModerateMedline Convenience Kits Block Tray recalled due to quality defects
FDA (Devices) · 2026-07-08
- ModerateMedline Ophthalmic Pack with Lidocaine Injection Kits Recalled
FDA (Devices) · 2026-07-08