Dental Devices recalls

426 medical device recalls in the dental devices category are on file with the FDA, from 2012 to 2 Sep 2026. The leading reason is packaging defects.

Total recalls426since 2012

Last 12 months6reported

Class I00% of total

Ongoing70latest 2 Sep 2026

Recalls per month, last 24 months

click a bar for that month

1Oct '24 0 1 4Jan '25 1 6 3Apr 0 2 5Jul 0 0 0Oct 0 0 0Jan '26 1 0 0Apr 2 0 1Jul 1 1

Severity split

Class I 0 0%Class II 413 97%Class III 13 3%

Why dental devices is recalled

Companies

By year

202661%
2025215%
2024194%
2023123%
2022184%
202161%
2020256%
2019113%
2018154%
201782%

Ongoing dental devices recalls

70 active

Reported	Class	Recall	Company	Reason	Where
2 Sep 2026Device	CLASS II	Grandio Universal Nano-Hybrid Restorative Material recalled	Henry Schein	Packaging Defects	Nationwide
19 Aug 2026Device	CLASS II	GM Helix Implant, Endosseous Dental Implant Article No. recalled	Straumann USA	Packaging Defects	Nationwide
15 Jul 2026Device	CLASS II	KL Owen Custom Orthodontic Solution recalled by Klowen Braces	Klowen Braces	Device Malfunction	Nationwide
6 May 2026Device	CLASS II	Straumann n!ce PMMA Full-arch Restoration recalled	Straumann USA	Other	8 states
6 May 2026Device	CLASS II	Straumann n!ce Zr, HT, Full-arch Restoration recalled	Straumann USA	Other	8 states
25 Feb 2026Device	CLASS II	Medline Convenience Kits: Dental Pack recalled by Medline Industries	Medline Industries	Sterility	Nationwide

All dental devices recalls, newest first

426 total

Reported	Class	Recall	Company	Reason	Where
2 Sep 2026Device	CLASS II	Grandio Universal Nano-Hybrid Restorative Material recalled	Henry Schein	Packaging Defects	Nationwide
19 Aug 2026Device	CLASS II	GM Helix Implant, Endosseous Dental Implant Article No. recalled	Straumann USA	Packaging Defects	Nationwide
15 Jul 2026Device	CLASS II	KL Owen Custom Orthodontic Solution recalled by Klowen Braces	Klowen Braces	Device Malfunction	Nationwide
6 May 2026Device	CLASS II	Straumann n!ce PMMA Full-arch Restoration recalled	Straumann USA	Other	8 states
6 May 2026Device	CLASS II	Straumann n!ce Zr, HT, Full-arch Restoration recalled	Straumann USA	Other	8 states
25 Feb 2026Device	CLASS II	Medline Convenience Kits: Dental Pack recalled by Medline Industries	Medline Industries	Sterility	Nationwide
16 Jul 2025Device	CLASS III	TrueDent White, TDM110 recalled by Stratasys	Stratasys	Other	Nationwide
16 Jul 2025Device	CLASS III	TrueDent Magenta, TDM130 recalled by Stratasys	Stratasys	Other	Nationwide
16 Jul 2025Device	CLASS III	TrueDent Cyan, TDM recalled by Stratasys	Stratasys	Other	Nationwide
16 Jul 2025Device	CLASS III	TrueDent Yellow, TDM140 recalled by Stratasys	Stratasys	Other	Nationwide

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.