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

0Nov '24 1 4 1Feb 6 3 0May 2 5 0Aug 0 0 0Nov 0 0 1Feb 0 0 2May 0 1 1Aug 1 0

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 - Capsules 0.25Gm 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 - Capsules 0.25Gm 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
16 Jul 2025Device	CLASS III	TrueDent Clear, TDM recalled by Stratasys	Stratasys	Other	Nationwide
25 Jun 2025Device	CLASS II	Biomet 3i Certain-compatible Milled Ti Abutment recalled by Preat	Preat	Other	Nationwide
4 Jun 2025Device	CLASS II	Glidewell HT Implant Twist Drill ¿ " recalled by Prismatik Dentalcraft	Prismatik Dentalcraft	Packaging Defects	Nationwide
30 Apr 2025Device	CLASS II	WB XL Anatomic Healing Abutment XC. Endosseous Dental recalled	Straumann USA	Other	Nationwide
23 Apr 2025Device	CLASS II	Medline Convenience kits used for various procedures: Dental Pack-lf recalled	Medline Industries LP - Northfield	Sterility	Nationwide
2 Apr 2025Device	CLASS II	Medline procedure kits labeled as recalled by MEDLINE INDUSTRIES, LP	Medline Industries LP - Northfield	Foreign Material	Nationwide
12 Mar 2025Device	CLASS II	Osstem Implant System - Abutment: ET Multi AbutmentSize recalled	Hiossen	Packaging Defects	Nationwide
12 Mar 2025Device	CLASS II	ET Rigid Abutment (Mini) Size: 4.5D/H 4.0H- Intended recalled by Hiossen	Hiossen	Packaging Defects	Nationwide
12 Mar 2025Device	CLASS II	ET Rigid Abutment (Mini) SIze: 4.5D/H 7.0H - Intended recalled	Hiossen	Packaging Defects	Nationwide
12 Mar 2025Device	CLASS II	ET Rigid Abutment (Mini) Size 4.5D/H 5.0H - Intended recalled by Hiossen	Hiossen	Packaging Defects	Nationwide
12 Mar 2025Device	CLASS II	Osstem Implant System - Abutment ET Multi Abutment Size recalled	Hiossen	Packaging Defects	Nationwide
12 Mar 2025Device	CLASS II	ET Rigid Abutment (Mini) SIze: 4.5D/H 4.0H - Intended recalled	Hiossen	Packaging Defects	Nationwide
12 Feb 2025Device	CLASS II	Nobel Biocare N1 TiUltra TCC RP 4.0x9mm . Nobel Biocare N1 recalled	Nobel Biocare	Sterility	Nationwide
22 Jan 2025Device	CLASS II	Econo Sterile medical procedure kits labeled as recalled	Sklar Instruments	Sterility	Nationwide
22 Jan 2025Device	CLASS II	Cardinal Health Presource Kits: 1 ) Kit, Major Oral Surgery recalled	Cardinal Health 200	Sterility	Nationwide
8 Jan 2025Device	CLASS II	Transbond Plus Self-Etching Primer recalled by 3M Unitek	3M Unitek	Device Malfunction	Nationwide
1 Jan 2025Device	CLASS II	Clarity Precision Grip Attachments, for use in orthodontic treatment recalled	3M Company - Health Care Business	Device Malfunction	Nationwide
11 Dec 2024Device	CLASS II	Medline convenience kits labeled as: Oral Surgery PK Rfid recalled	Medline Industries LP - Northfield	Other	Nationwide
30 Oct 2024Device	CLASS II	Medline Dental Pack recalled by MEDLINE INDUSTRIES, LP	Medline Industries LP - Northfield	Sterility	Nationwide
18 Sep 2024Device	CLASS II	Medline convenience kits containing semi-rigid suction recalled	Medline Industries LP - Northfield	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.