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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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.