KeySplint Hard Clear dental devices recalled for incorrect instructions
Keystone Industries is recalling 336 units of KeySplint Hard Clear due to incorrect Instructions for Use packaged with the product. Affected units received KeySplint Soft instructions instead.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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: This is a Class II device recall due to incorrect Instructions for Use being packaged with the product. No illnesses or injuries are reported in the source text. This falls under 'minor labeling errors' per the severity rubric.
Plain-English summary
Keystone Industries is recalling 336 units of KeySplint Hard Clear in 1 kg resin bottles distributed in the United States and China. The product was inadvertently packaged with incorrect Instructions for Use—KeySplint Soft instructions were included instead of KeySplint Hard instructions.
KeySplint Hard Clear is a dental resin used to fabricate orthodontic and dental appliances, including mouthguards, nightguards, splints, repositioners, and retainers. Incorrect instructions could result in improper use of the product.
The affected lot is NB3628 (UDI: +H66842200111/$$3251116NB3628L). Consumers who have received this product should verify the instructions included match the product and contact Keystone Industries for correct instructions if needed.
The recalled product
- Product
- KeySplint Hard Clear - Indicated for the fabrication of orthodontic and dental appliances such as mouthguards, nightguards, splints, repositioners, and retainers Item No.: 4220011
- Manufacturer
- Keystone Industries
- Hazard
- Affected units
- 336
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI: UDI +H66842200111/$$3251116NB3628L Lot No. NB3628
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Keystone Industries
See all →- ModerateDHP benzocaine topical anesthetic gel bottles may have incomplete seals
FDA (Drugs) · 2026-06-24
- ModeratePearson Quality benzocaine anesthetic gel bottles may have incomplete seals
FDA (Drugs) · 2026-06-24
- ModerateBurkhart benzocaine topical anesthetic gel bottles may have incomplete seals
FDA (Drugs) · 2026-06-24
- ModeratePureLife benzocaine topical anesthetic gel bottles may have incomplete seals
FDA (Drugs) · 2026-06-24
- ModerateDental City benzocaine anesthetic gel bottles may have incomplete seals
FDA (Drugs) · 2026-06-24
Same hazard · mis labeling
See all →- ModerateAbbott Recalls Amplatzer Amulet Left Atrial Appendage Occluder Devices
FDA (Devices) · 2026-10-28
- ModerateEl Ruisenor De Mexico Recalls Walnuts in Shell for Undeclared Allergen
FDA (Food) · 2026-10-28
- ModerateEl Ruisenor De Mexico Recalls Natural Sesame Seeds for Undeclared Allergen
FDA (Food) · 2026-10-28
- ModerateEl Ruisenor De Mexico Recalls Soybeans for Undeclared Soy Allergen
FDA (Food) · 2026-10-28
- ModerateEl Ruisenor De Mexico Recalls Wheat Bran for Undeclared Wheat Allergen
FDA (Food) · 2026-10-28
Similar recalls
- ModerateKeyPrint Soft Dental Resin Recalled for Incorrect European Labeling
FDA (Devices) · 2021-09-01
- ModerateDenture relining kit recalled for outer box labeling error
FDA (Devices) · 2023-09-20
- ModerateKeystone Dental Recalls Mislabeled Prima Plus Dental Implants
FDA (Devices) · 2018-06-20
- ModerateKeystone Dental Recalls Mislabeled PrimaConnex Tapered Dental Implants
FDA (Devices) · 2013-03-27
- LowUltradent Chromaclone PVS Impression Material Recalled for Packaging Error
FDA (Devices) · 2013-02-20
- ModerateGIBSON Healthcare Membrane Extended Recalled for Incorrect Instructions for Use
FDA (Devices) · 2020-02-05