Browse Device Recalls

1,506 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 1,506 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 1,506 FDA device recalls in FL.

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DateProductReasonClassFirm
Jan 29, 2016 Trinity Acetabular Shell Product Usage: Total Hip Replacement. Potential for abrasion of the sterile barrier pouches of the new packaging system. Class II Corin USA Limited
Jan 29, 2016 Trinity Acetabular Shell Product Usage Total Hip Replacement. Potential for abrasion of the sterile barrier pouches of the new packaging system. Class II Corin USA Limited
Jan 29, 2016 Trinity Acetabular System Product Usage - Total Hip Replacement. Potential for abrasion of the sterile barrier pouches of the new packaging system. Class II Corin USA Limited
Jan 19, 2016 HeaterBaum Foot & Ankle Heating Pad, Heating Soft Compression Therapeutic Boo... Products are marketed without a cleared 510k. Class II Ergoactives, Llc
Jan 15, 2016 Restoris Multicompartmental Knee (MCK) System RESTORIS MCK is indicated fo... Reports where the Mylar/Tyvek pouch for RESTORIS MCK Baseplate in the clamshell packaging configu... Class II Mako Surgical Corporation
Jan 15, 2016 Universal Battery Charger II (UBC II) The device is reported to enter safe mode and is no longer able to charge batteries. Class II The Anspach Effort, Inc.
Jan 11, 2016 Arthrex Deltoid Ligament Reconstruction Implant System. Intended as a fixa... Potential for a component contained in the Implant System to be non-sterile. Class II Arthrex, Inc.
Jan 7, 2016 HeartWare Ventricular Assist System: HeartWare Battery, Lithium Ion, 14.8 V, ... Heartware Ventricular Assist System Battery Cell experiencing premature depletion. Class I Heartware, Inc.
Dec 31, 2015 CORDIS AVANTI + CATHETER SHEATH INTRODUCER SYSTEM The product includes a C... Incorrect cannula of the sheath introducer (smaller than intended). Class II Cordis Corporation
Dec 29, 2015 PharmaCaribe PulmoSal 7% Sodium chloride, Inhalation Solution, 7% Sterile, Pr... Vials were labeled as USP 7% Hypertonic saline instead of PulmoSal 7% (pH+) Class II Pharmacaribe llc
Dec 17, 2015 Arthrex IBalance TKA Tibial Tray Size 2 - Catalog # AR-503-TTTC, Size 3 - Cat... Devices reported to have a smooth texture to the outer surface of the metal, which differed from ... Class II Arthrex, Inc.
Nov 25, 2015 Gold -Tite Hexed Retaining Screw Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 Locator Extra Light Retention Males 4pk Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 Certain Hex Try-in Screw (5 pk) Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 Certain Preformance Post Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 Cover Screw, Headless Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 Certain Provide Abutment Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 Locator Extra Light Angled Replacement Males 4pk Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 Temporary Non-Hexed Cylinder Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 Pick-Up Impression Coping Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 IOL Pick-Up Impression Coping Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 Certain Implant EP Twist Lock TM Coping Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 DAL-RO Threaded Female Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 Certain Conical Abutment Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 Certain IOL Abutment 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 Conical EP Pick-Up Coping (Non-Hexed) Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 Prep-tite Cap Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 Implant Twist Lock TM Coping Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 Certain Cover Screw Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 Locator Replacement Housing Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
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 Locator Abutment Impression Coping Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 Certain Implant Straight Cover Screw Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 Conical Healing Cap Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 Certain Implant Cover Screw Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 Certain Twist Lock TM Straight Transfer Coping Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 Index Coping Surgical Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 Certain Locator Abutment Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 Gold-Tite Hexed Retaining Screw 3mm Item: GSH30 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 2mm(H) Item: IWTH52 Dental ... Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 Certain Pick-Up Coping 5mm(D) x 5mm(P) Item:IWIP55 Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 Standard Abutment Temporary Screw Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
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 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

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.