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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.

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DateProductReasonClassFirm
Nov 25, 2015 Standard Abutment Transfer Coping Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 Reuseable rotary blade/abrader, product number 899751514. The oval burr fron... 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 Preformance 15 degrees pre-angled post Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 Certain Temporary Non-Hexed Cylinder Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 LDA Screw SBL 4mm(D) Item: SCRSBL2 Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 Certain Gingihue 15 degree Angled Post 4.1mm(D) x 5mm(P) x 4mm(H) Item: IPAP... Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 Standard Abutment Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 Conical Abutment Pick-up Coping Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 O-Ring Abutment 4.1mm(D) x 2mm(H) Item: OSO20 Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 Locator Extended Range Males 4pk Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 O-Ring Abutment 4.1mm(D) x 4mm(H) Item: OSO40 Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 IOL Titanium Temporary Cylinder Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 Certain Non-Hexed Implant Pick-up Coping Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 Certain EP Healing Abutment Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 Certain Straight Pick Up Coping Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 Locator Abutment Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 Certain Gingihue 15 degree Pre- Angled Post Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 EP Healing Abutment Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 Certain Titanium Large Hexed Screw Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 Certain Flat Implant Cover Screw Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 Titanium Hexed Uniscrew Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 Prep-Tite Post Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 Conical 17 degree Angled Abutment Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 ActiV.A.C. 300ml Canister (with Gel) for ActiV.A.C. Therapy System for the ap... There is potential for small holes, the size of a pin, to develop in the pouches of the ActiV.A.C... Class II KCI USA, INC.
Nov 25, 2015 Boston Scientific ACUITY Pro Coronary Sinus Guide Catheter, 9 Fr. Model 8104... Potential for separation of the proximal handle from the shaft. Class II Boston Scientific Corporation
Nov 25, 2015 Conical EP Pick-Up Coping (Hexed) Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 TLC¿ Self Retaining Retractor System Contents 1-RETRACTOR FRAME 6-ELASTIC STA... 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 Temporary Hexed Cylinder Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 Certain Pick-Up Coping 4.1mm(D) x 5mm(P) Item: IIIC12 Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 Implant EP Twist Lock TM Coping Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 Standard Abutment Pick -Up Coping Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 O-Ring Abutment 4.1mm(D) x 6mm(H) Item: OSO60 Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 Provide Impression Coping 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 5.6mm(P) x 4mm(H) Item: IWTH54 Dental ... Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 TLC¿ Self-Retaining Retractor Frames SINGLE USE ONLY Rx ONLY (USA) Indica... 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 Drill Stop Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 IOL Abutment and Screw Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 Implant Cover Screw Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 Certain Gingihue Post 5mm(D) x 5mm(P) x 2mm(H) Item: IWPP552G Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 Locator Replacement Housing Kit Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 Healing Abutment Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 Certain Gingihue Post Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 Certain Pick-Up Coping 4.1mm(D) x 4.1mm(P) Item: IIIC41 Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 Certain Straight Healing Abutment Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 Implant EP Pick-Up Coping Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 Preformance Temporary Cylinder Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 Bellatek Encode Healing Abutment Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 Cover Screw Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 Conical 25 degree Angled Abutment Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 Quickbridge TM 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.