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Browse Device Recalls

2,907 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,907 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 2,907 FDA device recalls in 2015.

Clear
DateProductReasonClassFirm
Nov 25, 2015 Temporary Healing Retention Cylinder Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 Certain EP Healing Abutment 5mm(D) x 6mm(P) x 4mm(H) Item: IWTH564 Dental i... Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 Titanium Square Uniscrew Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 IOL Transfer Impression Coping Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 Gingihue 15 Degree Pre-Angled Post Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 Gingihue Post Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 Certain Gingihue TM 15 degree Angled Post Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 MAKOplasty Hip Array Kit Laminate 150230 Stryker Orthpaedics became aware that there is the potential for the 210540 MAKOplasty Hip Array ... Class II Mako Surgical Corporation
Nov 25, 2015 Battery Power Line II Battery Oscillator, DePuy Synthes Power Tools, The Ansp... Has the incorrect operating directions on the mode switch ring, i.e. its is labeled "FWD, LOCK, R... Class II The Anspach Effort, Inc.
Nov 25, 2015 Certain EP Twist Lock TM Coping Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 Certain Gingihue Post 3.4mm(D) x 3.8mm(P) x 2mm(H) Item: IMAP32G Dental imp... Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 Certain Preformance Temporary Cylinder Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 Preformance Post Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 Conical Abutment Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 Locator Light Retention Replacement Males 4pk Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 Conical Abutment Gold Standard ZR TM Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 Gold Slotted Screw Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 Locator Replacement Males 4pk Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 Temporary Hexed Cylinder Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 Certain Twist Lock TM Coping Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 Certain EP Healing Abutment 4.1mm(D) x 5mm(P) x 2mm(H) Item: ITHA52 Denta... Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 IOL Distal Extension Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 Certain Standard Abutment Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 IOL Healing Cap Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 LDA Screw SBL 3mm(D) Item: SCRSBL1 Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 Gold-Tite Square Uniscrew Item: UNISG Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 Wilson Penile Implantation System Retractor Frame, Retractor Stays & Penile E... The firm was notified by some of their customers that some of the sealed pouches contain tears co... Class II Abeon Medical Corporation
Nov 25, 2015 Certain Gingihue TM 15 degree Angled Post 3.4mm(D) x 3.8mm(P) x 2mm(H) Item:... Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 Certain Gingihue 15 degree Angled Post Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 Certain Pick-up Coping Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 DAL-RO Abutment Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 Certain EP Pick-Up Coping Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 DAL-RO Housing, Female Assembly Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 Reuseable rotary blade/abrader, product number 899751504. The oval burr late... Weak weld in the reusable rotary blade/abrader (burr) may result in inner part breaks at the dist... Class II Richard Wolf Medical Instruments Corp.
Nov 25, 2015 Reuseable rotary blade/abrader, product number 899751305. The round burr is... Weak weld in the reusable rotary blade/abrader (burr) may result in inner part breaks at the dist... Class II Richard Wolf Medical Instruments Corp.
Nov 25, 2015 Gingihue 15 degrees Pre-Angled Post 4mm(D) x 5mm(P) x 2mm(H) Item: PAP452G ... Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 Conical EP Twist Lock TM Coping Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 Certain Micromini Flat Implant Cover Screw Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 Certain Preformance 15 degrees Pre-Angled Post Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 Philips Healthcare IntelliVue Info Center iX, A.0 866023 Reconstructed ECG leads viewed or printed at the Information Center iX may misrepresent the ECG w... Class II Philips Electronics North America Corporation
Nov 25, 2015 RenovoCath RC 120; Temporary Intravascular Occluding Catheter Model number:... Incorrect version of Instructions for Use were shipped to two US customers. Class II RenovoRx, Inc.
Nov 25, 2015 Conical EP Healing Cap Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 Certain Straight Pick-Up Coping 5.0mm(D) x 0mm(P) Item:IWIP50 Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 Philips Healthcare IntelliVue Info Center iX, B.0, 866389 Physiological, P... Reconstructed ECG leads viewed or printed at the Information Center iX may misrepresent the ECG w... Class II Philips Electronics North America Corporation
Nov 25, 2015 Certain Bellatek Encode Healing Abutment Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 Certain Conical 17 degree Angled Abutment Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 Philips Healthcare PIIC Classic Upgrade, 866117 Physiological, Patient Moni... Reconstructed ECG leads viewed or printed at the Information Center iX may misrepresent the ECG w... Class II Philips Electronics North America Corporation
Nov 25, 2015 Certain Gingihue Post 4.1mm(D) x 5mm(P) x 4mm(H) Item: IAPP454G Dental impl... Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 Certain Conical 25 degree Angled Abutment Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 Provide Protection Cap Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC

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.