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Browse Device Recalls

19 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 19 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 19 FDA device recalls.

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DateProductReasonClassFirm
Aug 2, 2024 Brand Name: Vit-l-escence Product Name: Vit-l-escence Singles A3 Model/Cata... Due to a manufacturing issue, red particulates present in the expressed composite. Class II Ultradent Products, Inc.
Aug 2, 2024 Brand Name: Transcend Product Name: Transcend Econo Kit (UB) - Singles Mode... Due to a manufacturing issue, red particulates present in the expressed composite. Class II Ultradent Products, Inc.
Aug 2, 2024 Brand Name: Transcend Product Name: Transcend Singles Universal Body (UB) Re... Due to a manufacturing issue, red particulates present in the expressed composite. Class II Ultradent Products, Inc.
Jun 1, 2022 Peak Universal Bond Self-Etch Bottle Kit, Part: 4541; Peak Universal Bond Sel... SE primer may be missing some or all of the resin portion of the chemistry. The absence of resin ... Class II Ultradent Products, Inc.
Aug 31, 2020 PermaFlo Flowable Composite REF-UP 948 Shade: A2 - Product Usage: is a light ... Due to a potential manufacturing issue (cross contamination), composite is non-homogeneous. Class II Ultradent Products, Inc.
Jul 12, 2018 Enamelast Cool Mint/OT Varnish 5% NaF Mint Label Enamelast Unit Dose 200pk... Dental varnish has the possibility of having an unpleasant and off flavor. Class II Ultradent Products, Inc.
Aug 4, 2017 Ultradent Products, Inc. Paper Points, Size 30 PN #1555, 200 per container, ... The barcode label was placed underneath the sterile barrier and the product was re-wrapped. Class II Ultradent Products, Inc.
Aug 4, 2017 Ultradent Products, Inc. Paper Points, Size 45 PN #1558, 200 per container, ... The barcode label was placed underneath the sterile barrier and the product was re-wrapped. Class II Ultradent Products, Inc.
Aug 4, 2017 Ultradent Products, Inc. Paper Points, Size 20 PN #1560, 200 per container, ... The barcode label was placed underneath the sterile barrier and the product was re-wrapped. Class II Ultradent Products, Inc.
Aug 4, 2017 Ultradent Products, Inc. Paper Points, Size 25 PN #1554, 200 per container, ... The barcode label was placed underneath the sterile barrier and the product was re-wrapped. Class II Ultradent Products, Inc.
Aug 4, 2017 Ultradent Products, Inc. Paper Points, Size 50 PN #1559, 200 per container, ... The barcode label was placed underneath the sterile barrier and the product was re-wrapped. Class II Ultradent Products, Inc.
Dec 14, 2016 NanoTips 30g 20pk, 100pk PN 1240, 1426 Description: NanoTips are injection m... Ultradent Products, Inc. announces a voluntary field action for the NanoTips 30g 20pk, 100pk beca... Class II Ultradent Products, Inc.
Nov 17, 2016 UltraSeal XT Plus Clear Refill. The package contains 4x 1.2 ml UltraSeal XT ... There was a labeling error with product, UltraSeal XT Plus Clear Refill, Part Number (PN) 565, Lo... Class II Ultradent Products, Inc.
Dec 22, 2015 InterGuard 5.5mm Econo Refill, sizes, 4.0mm for short anatomical crowns and 5... Ultradent is recalling InterGuard 5.5mm Econo Refill, lot#s BC2GN and BC4L7 because product was r... Class II Ultradent Products, Inc.
Nov 19, 2013 Opal Orthodontics by Ultradent. Avex CX2 Ceramic Orthodontic Brackets Avex... Ultradent Products Inc. is recalling various lots of Avex CX2 Orthodontic Brackets because the de... Class III Ultradent Products, Inc.
Feb 8, 2013 Avex CX Suite, Avex CX 0.22 UL4,5 HK REF #224-017, Product Usage: Ave... Orthodontic brackets distributed was incorrectly labeled. Class III Ultradent Products, Inc.
Feb 4, 2013 Ultradent Products, Chromaclone PVS, Fast Set heavy body, Bubble Gum Flavor, ... Incorrect packaging of regular set and fast set cartridges. Class III Ultradent Products, Inc.
Feb 4, 2013 Ultradent Products, Chromaclone PVS, Regular Set heavy body, Bubble Gum Flavo... Incorrect packaging of regular set and fast set cartridges. Class III Ultradent Products, Inc.
May 24, 2012 Peak SE Primer Kits (4 syringes per kit) manufactured by Ultradent Products, ... Ultradent is recalling lot B6Z4K of Peak SE Primer as a result of a field complaint, dated May 10... Class II Ultradent Products, 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.