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 |
|---|---|---|---|---|
| Nov 29, 2023 | Procedural convenience kits and trays, cardiac, labeled as: a) EP LAB BI V... | During an internal investigation, ACS identified that several components were "piggybacked" to AC... | Class II | American Contract Systems, Inc. |
| Nov 28, 2023 | MYNXGRIP 6F/7F, REF MX6721, Vascular Closure Device (VCD). Used to seal femor... | Cordis became aware that the label for the carton box containing 10 units is incorrect for some b... | Class II | Cordis US Corp |
| Nov 28, 2023 | MYNXGRIP 5F, REF MX5021, Vascular Closure Device (VCD). Used to seal femoral ... | Cordis became aware that the label for the carton box containing 10 units is incorrect for some b... | Class II | Cordis US Corp |
| Nov 21, 2023 | Exactech Vantage Ankle System, Catalog Numbers: a) 350-21-04, b) 350-22-03 | Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most va... | Class II | Exactech, Inc. |
| Nov 21, 2023 | Exactech Optetrak Logic Knee System, Catalog Numbers: a) 02-012-47-3011, ... | Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most va... | Class II | Exactech, Inc. |
| Nov 21, 2023 | Exactech Vantage Mobile Bearing Tibial Inserts, Catalog Numbers: a) 350-41... | Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most va... | Class II | Exactech, Inc. |
| Nov 21, 2023 | Exactech Truliant, Activit-E Knee Insert, Catalog Numbers: a) 02-023-02-00... | Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most va... | Class II | Exactech, Inc. |
| Nov 21, 2023 | Exactech Truliant Knee System, Catalog Numbers: a) 02-012-35-3509, b) 02... | Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most va... | Class II | Exactech, Inc. |
| Nov 21, 2023 | Exactech Optetrak Knee System, Catalog Numbers: a) 200-02-26, b) 200-02-... | Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most va... | Class II | Exactech, Inc. |
| Nov 21, 2023 | Exactech Alteon Hip XLE Liner, Catalog Numbers: a) 01-030-40-0636, b) 01... | Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most va... | Class II | Exactech, Inc. |
| Nov 21, 2023 | Exactech Novation Hip System, Catalog Numbers: 134-36-45 | Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most va... | Class II | Exactech, Inc. |
| Nov 21, 2023 | Exactech Optetrak Logic PS Knee System, Catalog Numbers: 02-012-35-5009 | Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most va... | Class II | Exactech, Inc. |
| Nov 21, 2023 | Exactech Equinoxe Reverse Shoulder System, Catalog Numbers: a) 320-36-00, ... | Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most va... | Class II | Exactech, Inc. |
| Nov 21, 2023 | Exactech Equinoxe Shoulder System, Catalog Numbers: a) 314-23-02, b) 314... | Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most va... | Class II | Exactech, Inc. |
| Nov 21, 2023 | AcuMatch Hip System, Catalog Number 142-32-27 | Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most va... | Class II | Exactech, Inc. |
| Nov 7, 2023 | NIM TriVantage EMG Endotracheal Tubes, Model (REF) Numbers and sizes: a) 822... | Firm received reports of customers experiencing noise from the NIM System, lead-off or high imped... | Class II | Medtronic Xomed, Inc. |
| Nov 3, 2023 | Multi-Mode Stimulator, Transcutaneous Electrical Nerve Stimulation | The instruction manuals that were included with the Multi-Mode Stimulators distributed from 2018 ... | Class II | Liberty Medical Solutions, LLC |
| Oct 31, 2023 | 1104CA-CLIN - HVAD (HeartWare Ventricular Assist Device) PUMP, Model Number 1... | Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. T... | Class II | Heartware, Inc. |
| Oct 31, 2023 | HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT, Model Number ... | Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. T... | Class II | Heartware, Inc. |
| Oct 31, 2023 | STERILE HVAD (HeartWare Ventricular Assist Device) PUMP (US), Model Number 1101 | Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. T... | Class II | Heartware, Inc. |
| Oct 31, 2023 | PUMP MCS1705PU HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT US, Mod... | Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. T... | Class II | Heartware, Inc. |
| Oct 31, 2023 | PUMP 1104 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT, Model Numbe... | Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. T... | Class II | Heartware, Inc. |
| Oct 31, 2023 | HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT, Model Number ... | Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. T... | Class II | Heartware, Inc. |
| Oct 31, 2023 | PUMP 1104 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT EN JA, Model... | Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. T... | Class II | Heartware, Inc. |
| Oct 31, 2023 | HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT/IMPLANT KIT OU... | Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. T... | Class II | Heartware, Inc. |
| Oct 31, 2023 | PUMP 1103 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT, Model Numb... | Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. T... | Class II | Heartware, Inc. |
| Oct 9, 2023 | MED-810A Zemits NDPrime Laser products | Advance-Esthetic LLC failed to comply with the applicable standards regarding Electronic Product ... | Class II | Advance-Esthetic LLC |
| Sep 26, 2023 | Cordis ANGIOGRAPHIC CATHETERIZATION SETS, INFINITI THRULEMEN, 5F, REF CO0208,... | Non-sterile product labeled as sterile was distributed. | Class I | Cordis US Corp |
| Sep 8, 2023 | Omega Medical Imaging Elevating Monitor Suspension Systems, Part Number 1000-... | An actuator separated from the pivot mechanism on a lower monitor boom system column. The lower b... | Class II | Omega Medical Imaging, Inc. |
| Sep 1, 2023 | General Pack, REF BBGP31C | During an internal investigation, ACS identified that the components, I.V. Cath (part number 4252... | Class II | American Contract Systems, Inc. |
| Sep 1, 2023 | Pediatric Urology Wolson Pack, REF BPPU55A | During an internal investigation, ACS identified that the components, I.V. Cath (part number 4252... | Class II | American Contract Systems, Inc. |
| Sep 1, 2023 | Breast Plastics Pack, REF BBPL20D | During an internal investigation, ACS identified that the components, I.V. Cath (part number 4252... | Class II | American Contract Systems, Inc. |
| Sep 1, 2023 | Sub Q Recorder Pack, REF BPRC87A | During an internal investigation, ACS identified that the components, I.V. Cath (part number 4252... | Class II | American Contract Systems, Inc. |
| Sep 1, 2023 | Robotics Pack, REF SSRO22D | During an internal investigation, ACS identified that the components, I.V. Cath (part number 4252... | Class II | American Contract Systems, Inc. |
| Sep 1, 2023 | Cath Cardiac Pack, REF IHCC03V | During an internal investigation, ACS identified that the components, I.V. Cath (part number 4252... | Class II | American Contract Systems, Inc. |
| Sep 1, 2023 | Pediatric Heart SJH, REF SJPH34K | During an internal investigation, ACS identified that the components, I.V. Cath (part number 4252... | Class II | American Contract Systems, Inc. |
| Sep 1, 2023 | CVS PCSU SJH, REF SJCV48J | During an internal investigation, ACS identified that the components, I.V. Cath (part number 4252... | Class II | American Contract Systems, Inc. |
| Sep 1, 2023 | Vasc. Open CVOR SJH, REF SJVO56B | During an internal investigation, ACS identified that the components, I.V. Cath (part number 4252... | Class II | American Contract Systems, Inc. |
| Sep 1, 2023 | Robotics Pack, REF SJVO56B | During an internal investigation, ACS identified that the components, I.V. Cath (part number 4252... | Class II | American Contract Systems, Inc. |
| Sep 1, 2023 | Robotics Pack SAH, REF SAR530M | During an internal investigation, ACS identified that the components, I.V. Cath (part number 4252... | Class II | American Contract Systems, Inc. |
| Sep 1, 2023 | LAVH, REF BBLV21C | During an internal investigation, ACS identified that the components, I.V. Cath (part number 4252... | Class II | American Contract Systems, Inc. |
| Jun 5, 2023 | Exactech Shoulder GPS Impactor Handle, Catalog #531-07-05. | The ball and spring housed within the locking mechanism of the handle can dislodge during disasse... | Class II | Exactech, Inc. |
| Jun 5, 2023 | Exactech Ergo Impactor Handle, Catalog #321-09-05. | The ball and spring housed within the locking mechanism of the handle can dislodge during disasse... | Class II | Exactech, Inc. |
| May 31, 2023 | COULTER DxH Diluent, REF 628017; diluent used for counting and sizing blood c... | Specific diluent lot numbers showed that conductivity, osmolality, and pH were out of manufacturi... | Class II | Beckman Coulter, Inc. |
| May 16, 2023 | HeartWare Ventricular Assist Device System. a) Monitor 1521US Explore Tech,... | Medtronic has identified that the logfiles downloaded from the recently updated Model 1521 monito... | Class II | Heartware, Inc. |
| May 3, 2023 | The TREO ABDOMINAL STENT-GRAFT SYSTEM (TREO) consists of four types of implan... | Potential for the incorrect size stent-graft than the printed carton label. | Class II | Bolton Medical Inc. |
| Apr 5, 2023 | DxU 850m Iris Urine Microscopy Analyzer Catalog Number C49513, in-vitro diagn... | Beckman Coulter has become aware of an intermittent issue in which the optional flag "Previous Sa... | Class II | Beckman Coulter, Inc. |
| Apr 5, 2023 | UA WIN 10 Kit, Catalog Number C52900, in-vitro diagnostic device, urine analysis | Beckman Coulter has become aware of an intermittent issue in which the optional flag "Previous Sa... | Class II | Beckman Coulter, Inc. |
| Apr 5, 2023 | iQ200 Series Urine Microscopy Analyzer: a) iQ 200 Select, Part Numbers C1068... | Beckman Coulter has become aware of an intermittent issue in which the optional flag Previous Sa... | Class II | Beckman Coulter, Inc. |
| Apr 5, 2023 | DxU 840m Iris Urine Microscopy Analyzer, Catalog Number C76947, in-vitro diag... | Beckman Coulter has become aware of an intermittent issue in which the optional flag "Previous Sa... | Class II | Beckman Coulter, 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.