Browse Device Recalls
1,503 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 1,503 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 1,503 FDA device recalls in FL.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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. |
| 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. |
| Dec 31, 2024 | AcuMatch XLE Item Number / Product Description: 140-28-27 AM EHXL 0¿ LNR G ... | Due to the lack of the Ethylene Vinyl Alcohol (EVOH) barrier layer. | Class II | Exactech, Inc. |
| Dec 20, 2024 | Brand Name: N/A Product Name: Repeater Bone Tamp Model/Catalog Number: ASY-... | Due to incompatibility of bone tamp (Rev A) and bone funnels (Rev C). | Class II | Integrity Implants Inc. |
| Dec 10, 2024 | Neo-Tee T-Piece Resuscitator, for pediatric emergency respiratory support, Pa... | Gas powered emergency resuscitator has a circuit flow controller manufactured with an undersized ... | Class I | Mercury Enterprises, Inc. dba Mercury Medical |
| Dec 6, 2024 | Temporary Titanium Abutments | Certain definitive dental implant restoration cases may have included a temporary titanium abutme... | Class II | DDS Lab |
| Nov 27, 2024 | Brand Name: 3B Medical, Inc. Product Name: Ultrasoft Oxygen Cannula, 12 Foot... | The devices were inadvertently shipped after their expiration date. | Class II | 3B Medical, Inc. |
| Aug 30, 2024 | Neo-Tee T-Piece Resuscitator. Part Numbers 1050805, 1050832. For pediatric em... | Manual resuscitator circuit flow controller may come apart due to a missing manufacturing step. | Class I | Mercury Enterprises, Inc. dba Mercury Medical |
| Jul 16, 2024 | Beckman Coulter IRISPEC CA/CB/CC Urine Chemistry Controls, Catalog Number REF... | Beckman Coulter has become aware of an increase in customer complaints for intermittent IRISpec C... | Class III | Beckman Coulter, Inc. |
| Jul 12, 2024 | NavaClick Syringe and Needle, Model Number LIN02 | Incorrect GTIN number on carton. | Class III | LINEAGE BIOMEDICAL, INC |
| Jul 5, 2024 | Medtronic ENT Ultra Round Steel Cutting Bur, Model Number REF 31313069 | Product was distributed past expiration date. | Class II | Medtronic Xomed, Inc. |
| Jun 24, 2024 | NIM Vital Nerve Monitoring systems (all serial numbers manufactured) with NIM... | Potential for false negative response on the NIM Vital Nerve Monitoring System | Class I | Medtronic Xomed, Inc. |
| Jun 2, 2024 | Nanoplasty 3D Bunion Correction System Implant, Model Number: SK57. System co... | Potential issue causing a higher frequency of interference with locking screws and/or inserter ro... | Class II | Treace Medical Concepts, Inc. |
| May 20, 2024 | Pink Luminous Breast, Breast transilluminator | Firm is marketing and distributing the Pink Luminous Breast device without premarket approval | Class II | Silkprousa LLC |
| Apr 26, 2024 | Acumatch L-Series BIPOLAR LINER, 22mm (BIPOLAR ENDOPROSTHESIS-Hip), Item Numb... | The AcuMatch L-Series 22mm Inner Diameter Bipolar Hip Liner lots were packaged without the specif... | 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.