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Browse Device Recalls

34 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 34 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Medical Device Recalls

Browse 34 FDA device recalls.

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DateProductReasonClassFirm
Dec 21, 2023 Article No. NA6050411, Valiant PhD No. 1 Econo Affected product may not perform as expected; the amalgam powder may not triturate correctly and ... Class II Ivoclar Vivadent, Inc.
Aug 3, 2017 Heliomolar Refill 20x0.25g 210/A3, Product code 541503AN, Catalog number 541503 Complaints were filed claiming the material consistency was too soft and too sticky in comparison... Class III Ivoclar Vivadent, Inc.
Aug 3, 2017 Heliomolar Refill 20x0.25g 110T, Product code 550559AN, Catalog number 550559 Complaints were filed claiming the material consistency was too soft and too sticky in comparison... Class III Ivoclar Vivadent, Inc.
Aug 3, 2017 Heliomolar Refill 20x0.25g 140/A2, Product code 541502AN, Catalog number 541502 Complaints were filed claiming the material consistency was too soft and too sticky in comparison... Class III Ivoclar Vivadent, Inc.
Aug 3, 2017 Heliomolar Refill 20x0.25g 110/A1, Product code 541501AN, Catalog number 541501 Complaints were filed claiming the material consistency was too soft and too sticky in comparison... Class III Ivoclar Vivadent, Inc.
Nov 9, 2016 Virtual XD Refill Light Body Fast Set Wash Material, 2X50 ml, REF #/Product C... The firm received complaints claiming the dental material failed to set up. As the dental materi... Class II Ivoclar Vivadent, Inc.
Nov 9, 2016 Virtual XD Refill Light Body Regular Set Wash Material, 2X50 ml, REF #/Produc... The firm received complaints claiming the dental material failed to set up. As the dental materi... Class II Ivoclar Vivadent, Inc.
Nov 9, 2016 Virtual XD Test Pack Heavy/Light Fast Set, 2 x 50 ml, REF #/Product Code 6464... The firm received complaints claiming the dental material failed to set up. As the dental materi... Class II Ivoclar Vivadent, Inc.
Jul 11, 2016 OptraPol Polishing Discs, Rx ONLY: OptraPol Refill Cup /10: REF/Product ID 63... After a few seconds of polishing with moderate force, parts of the OptraPol cup are breaking away... Class II Ivoclar Vivadent, Inc.
May 27, 2016 Zenostar MT Color C3 60ml, art. no. 681061. Product Usage: For coloring de... The primary packaging of these products may show leaks in individual cases. As a consequence, the... Class II Ivoclar Vivadent, Inc.
May 27, 2016 Zenostar MT Color A3 60ml, art. no. 681052. Product Usage: For coloring... The primary packaging of these products may show leaks in individual cases. As a consequence, the... Class II Ivoclar Vivadent, Inc.
May 27, 2016 Zenostar MT Color C1 60ml, art. no. 681059. Product Usage: For coloring ... The primary packaging of these products may show leaks in individual cases. As a consequence, the... Class II Ivoclar Vivadent, Inc.
May 27, 2016 Zenostar MT Color B2 60ml, art. no. 681056. Product Usage: For coloring... The primary packaging of these products may show leaks in individual cases. As a consequence, the... Class II Ivoclar Vivadent, Inc.
May 27, 2016 Zenostar MT Color B4 60ml, art. no. 681058. Product Usage: For coloring de... The primary packaging of these products may show leaks in individual cases. As a consequence, the... Class II Ivoclar Vivadent, Inc.
May 27, 2016 Zenostar MT Color D2 60ml, art. no. 681063. Product Usage: For coloring ... The primary packaging of these products may show leaks in individual cases. As a consequence, the... Class II Ivoclar Vivadent, Inc.
May 27, 2016 Zenostar MT Color C4 60ml, art. no. 681062. Product Usage: For coloring... The primary packaging of these products may show leaks in individual cases. As a consequence, the... Class II Ivoclar Vivadent, Inc.
May 27, 2016 Zenostar MT Color B1 60ml, art. no. 681055. Product Usage: For coloring ... The primary packaging of these products may show leaks in individual cases. As a consequence, the... Class II Ivoclar Vivadent, Inc.
May 27, 2016 Zenostar MT Color Impulse brown, art. no. 681169 Product Usage: For color... The primary packaging of these products may show leaks in individual cases. As a consequence, the... Class II Ivoclar Vivadent, Inc.
May 27, 2016 Zenostar MT Color A4 60ml, art. no. 681054. Product Usage: For coloring ... The primary packaging of these products may show leaks in individual cases. As a consequence, the... Class II Ivoclar Vivadent, Inc.
May 27, 2016 Zenostar MT Color B3 60ml, art. no. 681057. Product Usage: For coloring ... The primary packaging of these products may show leaks in individual cases. As a consequence, the... Class II Ivoclar Vivadent, Inc.
May 27, 2016 Zenostar MT Color Impulse grey, art. no. 681167 Product Usage: For colori... The primary packaging of these products may show leaks in individual cases. As a consequence, the... Class II Ivoclar Vivadent, Inc.
May 27, 2016 Zenostar MT Color Impulse blue, Art. no. 681165 Product Usage: For colori... The primary packaging of these products may show leaks in individual cases. As a consequence, the... Class II Ivoclar Vivadent, Inc.
May 27, 2016 Zenostar MT Color D4 60ml, art. no. 681065. Product Usage: For coloring ... The primary packaging of these products may show leaks in individual cases. As a consequence, the... Class II Ivoclar Vivadent, Inc.
May 27, 2016 Zenostar MT Color Impulse violet, art. no. 681166 Product Usage: For colo... The primary packaging of these products may show leaks in individual cases. As a consequence, the... Class II Ivoclar Vivadent, Inc.
May 27, 2016 Zenostar MT Color A3.5 60ml, art. no. 681053. Product Usage: For colorin... The primary packaging of these products may show leaks in individual cases. As a consequence, the... Class II Ivoclar Vivadent, Inc.
May 27, 2016 Zenostar MT Color C2 60ml art. no. 681060. Product Usage: For coloring d... The primary packaging of these products may show leaks in individual cases. As a consequence, the... Class II Ivoclar Vivadent, Inc.
May 27, 2016 Zenostar MT Color D3 60ml, art. no. 681064. Product Usage: For coloring ... The primary packaging of these products may show leaks in individual cases. As a consequence, the... Class II Ivoclar Vivadent, Inc.
May 27, 2016 Zenostar MT Color Impulse orange, art. no. 681168. Product Usage: For c... The primary packaging of these products may show leaks in individual cases. As a consequence, the... Class II Ivoclar Vivadent, Inc.
May 27, 2016 Zenostar MT Color A1 60ml, art. no. 681050, Product Usage: For coloring ... The primary packaging of these products may show leaks in individual cases. As a consequence, the... Class II Ivoclar Vivadent, Inc.
May 27, 2016 Zenostar MT Color A2 60ml, art. no. 681051. Product Usage: For coloring ... The primary packaging of these products may show leaks in individual cases. As a consequence, the... Class II Ivoclar Vivadent, Inc.
Feb 12, 2016 Helioseal Clear Refill 1 x 1.25 g, REF/Product Code/Art. No. 558521AN and He... Complaints were received claiming the material failed to polymerize under the curing light. Afte... Class II Ivoclar Vivadent, Inc.
Jul 9, 2015 IPS Empress Universal Glaze Spray 270 mL, Product Code/Model/Catalog Number 6... Complaints were received of coarse particles in the glazed surface of IPS e.max Ceram restoration... Class II Ivoclar Vivadent, Inc.
Apr 14, 2014 bluephase style Light probe Pin-point 6>2 mm black REF # 636 241. The access... A stock check revealed broken glass fibers between the connector and the fiber bundle in a large ... Class II Ivoclar Vivadent, Inc.
Sep 23, 2013 ExciTE F DSC Soft touch Single Dose, Dual-curing Regular Ref. 50 dental a... Ivoclar Vivadent, Inc. is recalling a lot of ExciTE F DSC Dental Adhesive found to produce a blue... Class II Ivoclar Vivadent, Inc.

Frequently Asked Questions

When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.

All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.

Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.