Browse Device Recalls

1,516 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 1,516 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 1,516 FDA device recalls in FL.

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DateProductReasonClassFirm
Jun 10, 2026 Abiomed REF: 0052-3006, Introducer Kit for Impella Hemostatic Peel Away Int... Due to manufacturing issues, there is a potential for the 14Fr and 23Fr introducer sheaths to lea... Class I Oscor Inc.
Jun 10, 2026 Abiomed REF: 0052-3021, Introducer Kit for Impella Hemostatic Peel Away Int... Due to manufacturing issues, there is a potential for the 14Fr and 23Fr introducer sheaths to lea... Class I Oscor Inc.
Jun 10, 2026 Abiomed REF: 0052-3025, Introducer Kit for Impella Hemostatic Peel Away Int... Due to manufacturing issues, there is a potential for the 14Fr and 23Fr introducer sheaths to lea... Class I Oscor Inc.
May 1, 2026 CGuard Prime Carotid Stent System, 135cm, 10mmx30mm Model/Catalog Number: C... Stent delivery system may encounter complications during deployment which may result in high resi... Class II INSPIREMD Inc
May 1, 2026 Brand Name: CGuard Prime Carotid Stent System, 135cm, 9mx40mm Model/Catalog ... Stent delivery system may encounter complications during deployment which may result in high resi... Class II INSPIREMD Inc
May 1, 2026 CGuard¿ Prime Carotid Stent System, 135cm, 10mmx40mm Model/Catalog Number: ... Stent delivery system may encounter complications during deployment which may result in high resi... Class II INSPIREMD Inc
May 1, 2026 CGuard Prime Carotid Stent System, 135cm, 9mx30mm Model/Catalog Number: CND... Stent delivery system may encounter complications during deployment which may result in high resi... Class II INSPIREMD Inc
May 1, 2026 Brand Name: CGuard¿ Prime Carotid Stent System, 135cm, 8mmx30mm Model/Catalo... Stent delivery system may encounter complications during deployment which may result in high resi... Class II INSPIREMD Inc
May 1, 2026 Brand Name: CGuard¿ Prime Carotid Stent System, 135cm, 8mmx40mm Model/Catalo... Stent delivery system may encounter complications during deployment which may result in high resi... Class II INSPIREMD Inc
Apr 23, 2026 OneLIF Interbody Cage (REF/Description): 010-107-1007/Small 7 Degree 10mm X ... Intervertebral body fusion system straight inserter failed to properly attach to affected cages, ... Class II Novapproach Spine, LLC
Apr 22, 2026 RelayPro Thoracic Stent-Graft System (various sizes) Reference numbers: 28-N... Labeling update concerning proximal clasp disconnection from the outer control tube which may pre... Class I Bolton Medical Inc.
Apr 15, 2026 Fresh Roast Systems ColorTrack. Model Name: ColorTrack. Model Number: BENCH ... A defect has been identified in the manufacture of the Fresh Roast Systems ColorTrack instrument ... Class II Fresh Roast Systems Inc
Feb 6, 2026 Owner's Booklets and Instructions for Use that are used with the following bl... The system labeling (user manual and online labeling) did not provide adequate directions for lay... Class I Trividia Health, Inc.
Feb 6, 2026 Owner's Booklets and Instructions for Use that are used with the following bl... The system labeling (user manual and online labeling) did not provide adequate directions for lay... Class I Trividia Health, Inc.
Feb 6, 2026 Owner's Booklets and Instructions for Use that are used with the following bl... The system labeling (user manual and online labeling) did not provide adequate directions for lay... Class I Trividia Health, Inc.
Feb 6, 2026 Owner's Booklets and Instructions for Use that are used with the following bl... The system labeling (user manual and online labeling) did not provide adequate directions for lay... Class I Trividia Health, Inc.
Feb 3, 2026 Brand Name: Equinoxe Product Name: Equinoxe Core Instrument Kit Model/Cata... Impactor handle may be missing cross-pin Class II Exactech, Inc.
Feb 3, 2026 Brand Name: Equinoxe Ergo Product Name: Ergo Modular Impactor Handle Model/... Impactor handle may be missing cross-pin Class II Exactech, Inc.
Jan 9, 2026 Diowave Laser System, REF: Diowave 250W Software update is needed for laser systems, for topical infrared heating to provide temporary re... Class II Technological Medical Advancements LLC
Dec 23, 2025 CellMek SPS Sample Preparation System, REF: C44603, with software Sample preparation system designed to automate staining, lysing, cell washing has a software erro... Class II Beckman Coulter, Inc.
Dec 23, 2025 Focalyx Fusion Software device that is an accessory for image-guided interventional and diagnostic procedures in... Class II Focalyx Technologies, LLC.
Nov 10, 2025 COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For us... Due to specific lots of diluents contributing to elevated platelet Daily Checks background counts... Class II Beckman Coulter, Inc.
Oct 27, 2025 Hemodialysis System, Surdial DX REF: MC+SDX01 Rx Only Screw may loosen or fallout of Hemodialysis system Class II Nipro Medical Corporation
Oct 13, 2025 DermaSensor. Model/Catalog Number: 10101. Software Version: 3.0.2. Softwar... Potential for device to not meet specifications resulting in incorrect results or delay of referr... Class II DERMASENSOR INC
Oct 7, 2025 Good Neighbor Pharmacy, TRUE METRIX Self Monitoring Blood Glucose Meter. Mode... Manufacturing defect causing LCD display issues with missing or partial segments (ghosting) that ... Class II Trividia Health, Inc.
Oct 2, 2025 CEREPAK Detachable Coil System - Name/REF: UNIFORM 2MM X 2.5 CM/FCX100202, UN... Detachable coils system may fail to detach, which could result in hemorrhagic and ischemic stroke... Class I Cerenovus Inc
Oct 1, 2025 Brand Name: ReQuest Measles IgG Product Name: Rubeola IgG Enzyme Linked Immu... Due to distributing the measles IgG IVD without a premarket approved/cleared. Class II Quest International, Inc.
Sep 8, 2025 CellMek SPS Sample Preparation System, REF: C44603. Software versions 2.2.122... Automated pipetting, diluting and specimen processing workstations for flow cytometric analysis d... Class II Beckman Coulter, Inc.
Sep 5, 2025 Brand Name: Equinoxe Ergo Product Name: Adjustable Angle rTSA Reamer, 42mm ... Due to products that have not completed design updates and performance testing being released/dis... Class II Exactech, Inc.
Sep 5, 2025 Brand Name: Equinoxe Ergo Product Name: Ergo Augments Pilot Tip Converter M... Due to products that have not completed design updates and performance testing being released/dis... Class II Exactech, Inc.
Sep 5, 2025 Brand Name: Equinoxe Ergo Product Name: Adjustable Angle rTSA Reamer, 46mm ... Due to products that have not completed design updates and performance testing being released/dis... Class II Exactech, Inc.
Aug 15, 2025 Exactech Equinoxe, Reverse Shoulder Humeral Liners, REF: 320-38-00,145-DEG ... Reverse Shoulder humeral liners have an articular surface position outside of the dimensional spe... Class II Exactech, Inc.
Aug 15, 2025 Exactech Equinoxe, Reverse Shoulder Humeral Liners, 322-38-00 (145-DEG PE 3... Reverse Shoulder humeral liners have an articular surface position outside of the dimensional spe... Class II Exactech, Inc.
Aug 5, 2025 Pinnacle Radiation Therapy Planning System: Multimodality Simulation Works... Due to a software issue, there is a potential image error of the Region of Interest for expansion... Class II Philips Medical Systems (Cleveland) Inc
Jul 25, 2025 One Step Sterile Lancet for Single Use (3 sizes): 06949517008861 30g 0694... Due to incorrect/lack of Unique Device Identifier (UDI) codes. Class III Home Health US, Incorporated
Jul 17, 2025 Pinnacle 3 with TumorLOC, (870258) Radiation Therapy Planning System Software Due to software issue, Radiation Therapy Planning system may provide incorrect dataset calculati... Class II Philips Medical Systems (Cleveland) Inc
Jul 17, 2025 IPC Powerease System REF 2300000 UDI-DI: 00613994448705 00643169406834. ... Due to out of the box wobble of the driver. Class II Medtronic Xomed, Inc.
Jul 17, 2025 Brand Name: ReQuest Measles IgM Product Name: Enzyme Linked Immunoabsorbant ... Measles IgM Test Kit lacks premarket approval or clearance. Class II Quest International, Inc.
Jun 12, 2025 ACUVUE¿ OASYS MAX 1-Day MULTIFOCAL Due to defects (bubbles/voids) identified during standard finished goods testing Class II Johnson & Johnson Vision Care, Inc.
Jun 6, 2025 Akreos, SKU: AO60P0300. Akreos intraocular lenses An off-power error was identified, which resulted in a diopter of 16, rather than the intended 3 ... Class III Bausch & Lomb Surgical, Inc.
Mar 31, 2025 Ultrasonic Cleaning Systems Triton 36 Model Number 6003000804 Triton 72 Mod... During routine preventative maintenance checks, it was revealed that carbon filter sensors were b... Class II Ultra Clean Systems, Inc.
Mar 27, 2025 Intraocular lens. enVista Monofocal IOL, All models starting with EE; enVist... In response to an increased number of reports of toxic anterior segment syndrome (TASS) in conjun... Class I Bausch & Lomb Surgical, Inc.
Mar 27, 2025 Intraocular Lens. enVista Envy IOL, All models starting with EN; enVista Env... In response to an increased number of reports of toxic anterior segment syndrome (TASS) in conjun... Class I Bausch & Lomb Surgical, Inc.
Mar 10, 2025 NIM Vital Nerve Monitoring System: CONSOLE NIM4CM01 NIM 4.0, REF: NIM4CM01; ... Nerve Monitoring System with certain software versions has potential for increased stimulus artif... Class II Medtronic Xomed, Inc.
Mar 4, 2025 Cordis, REF: C09060ML, Smart Control Vascular Stent System ILIAC, 9mm X 60mm ... product mix-up; Vascular stent labeled as one size but contains a different size. Class II Cordis US Corp
Mar 4, 2025 Cordis, REF C10040ML, Smart Control Vascular Stent System ILIAC, 10mm X 40mm ... product mix-up; Vascular stent labeled as one size but contains a different size. Class II Cordis US Corp
Feb 7, 2025 Vista Brite Tip, Judkins Right 4, REF SM7504, JR3 VBT (Special) 110 cm 6F. G... Catheter manufactured at the incorrect length. Class II Cordis US Corp
Jan 27, 2025 TISSUE APPROXIMATION SYSTEM (TAS), Models T-4000, T-5000, T-LAP Tissue approximation straps (zip-ties) have broken before or during implantation so firm develope... Class II TAS Medical Inc
Dec 31, 2024 Alteon XLE Item Number / Product Description: 140-22-70 NV EHXL NTL LNR G... Due to the lack of the Ethylene Vinyl Alcohol (EVOH) barrier layer. Class II Exactech, Inc.
Dec 31, 2024 Novation XLE Item Number / Product Description: 140-22-70 NV EHXL NTL LNR G... Due to the lack of the Ethylene Vinyl Alcohol (EVOH) barrier layer. Class II Exactech, 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.