Browse Device Recalls
39,969 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 39,969 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 39,969 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Nov 1, 2023 | 24 BLOOD CULTURE KIT, REF DYNDH1632 | This recall is being issued due to items within the kit have expired prior to the overall kit exp... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 1, 2023 | Brand Name: Guardian 2 System Product Name: Guardian System 2 Controller Mo... | A software issue where "low" and "terminal" battery alerts did not display on the screen to the u... | Class II | Turncare, Inc |
| Nov 1, 2023 | BLOOD CULTURE KIT, REF DYNDH1647B | This recall is being issued due to items within the kit have expired prior to the overall kit exp... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 1, 2023 | PERIPHERAL BLOOD CULTURE DRAW, REF DYNDH1561 | This recall is being issued due to items within the kit have expired prior to the overall kit exp... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 1, 2023 | ADLT BLOOD CULTURE COLLECT KIT, REF DYNDH1245 | This recall is being issued due to items within the kit have expired prior to the overall kit exp... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 1, 2023 | Infusomat Administration Sets as listed below: 362031 Infusomat Space Pu... | In affected products, the tubing outer diameter may vary in size or the length of tubing may be t... | Class I | B. Braun Medical, Inc. |
| Nov 1, 2023 | Change Healthcare Stratus Imaging PACS 1.4 and Stratus Imaging Share 1.4, a c... | Under certain circumstances, information from HL7 messages received by Stratus PACS/Imaging Share... | Class II | CHANGE HEALTHCARE CANADA COMPANY |
| Nov 1, 2023 | Atrium Oasis Drain Single W / AC, Part No. 3600-100 | A sterilization nonconformance prematurely aged the product by 48.3 days, resulting in the expira... | Class II | Atrium Medical Corporation |
| Oct 31, 2023 | Acrobat-i Vacuum Positioner System, Model Number XP-5000Z | The Positioner Arm may not tighten or lock during normal use. | Class II | Maquet Cardiovascular, 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 | ZEUS ELISA Parvovirus B19 IgG Test System, Product Number SM9Z7701M | The organization completed a product improvement process to the conjugate found within the certai... | Class II | Zeus Scientific, 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 | ZEUS ELISA Parvovirus B19 IgM Test System, Product Number SM9Z7701G | The organization completed a product improvement process to the conjugate found within the certai... | Class II | Zeus Scientific, Inc. |
| Oct 31, 2023 | The 4Kscore Test, an in vitro serum or plasma test that combines the results ... | Mathematical modeling of the 4Kscore with and without DRE information was recently performed on o... | Class II | BioReference Health, LLC |
| 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 30, 2023 | Snapshot NIR, REF: KD204 | Tissue oxygenation measurement system touchscreens may be unresponsive, which may prevent the vie... | Class II | KENT IMAGING, INC. |
| Oct 30, 2023 | Small DKS Disposable Kerrison System, Catalog Number DKS-63030, instrument se... | Units were not intended for commercial distribution and inadvertently distributed. | Class II | Folsom Metal Products, Inc. |
| Oct 30, 2023 | DKS Disposable Kerrison System, Catalog Number DKS-63030, instrument sets tha... | Units were not intended for commercial distribution and inadvertently distributed. | Class II | Folsom Metal Products, Inc. |
| Oct 30, 2023 | Alinity m HCV AMP kit, List (REF) Numbers: a) 08N50-095 and b) 08N50-090. Th... | Abbott has received reports of an increase in reactive negative controls and false positive resul... | Class II | Abbott Molecular, Inc. |
| Oct 27, 2023 | vyaire Flexible Patient Circuit, 3100A, REF 29028-003, intended to be used wi... | Two patient circuits, 29028-003 and 29028-004, for the 3100 High Frequency Oscillatory ventilator... | Class II | Vyaire Medical |
| Oct 27, 2023 | PHYSICA HPS Tibial Liner #6 H10 REF 6539.54.610 | Due to incorrect product labeling | Class II | Limacorporate S.p.A |
| Oct 27, 2023 | vyaire Flexible Patient Circuit, 3100A, REF 29028-004, intended to be used wi... | Two patient circuits, 29028-003 and 29028-004, for the 3100 High Frequency Oscillatory ventilator... | Class II | Vyaire Medical |
| Oct 26, 2023 | RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 100 -Intended fo... | RAPIDPoint 500 Systems Measurement Cartridges (with lactate) has the potential to affect the Sodi... | Class II | Siemens Healthcare Diagnostics Inc |
| Oct 26, 2023 | RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 750-Intended for ... | RAPIDPoint 500 Systems Measurement Cartridges (with lactate) has the potential to affect the Sodi... | Class II | Siemens Healthcare Diagnostics Inc |
| Oct 26, 2023 | RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 400-Intended for ... | RAPIDPoint 500 Systems Measurement Cartridges (with lactate) has the potential to affect the Sodi... | Class II | Siemens Healthcare Diagnostics Inc |
| Oct 26, 2023 | RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 250-Intended for ... | RAPIDPoint 500 Systems Measurement Cartridges (with lactate) has the potential to affect the Sodi... | Class II | Siemens Healthcare Diagnostics Inc |
| Oct 25, 2023 | INDICAID COVID-19 Rapid Antigen At-Home Test, REF: P0040 | COVID-19 rapid antigen at home tests were released with an incorrect expiration date of 05 April ... | Class II | PHASE SCIENTIFIC INTERNATIONAL LIMITED |
| Oct 25, 2023 | VITROS Chemistry Products ECO2 Slides-For in vitro diagnostic use only. VITR... | Ortho Clinical Diagnostics (QuidelOrtho) confirmed during routine testing that some lots from Coa... | Class II | Ortho-Clinical Diagnostics, INc. |
| Oct 25, 2023 | ELEKTA LIMITED Precise Digital Accelerator, REF MRT 6001, MRT 6011; Medical C... | Elekta has identified that if the microswitch within the middle arm is incorrectly setup, there i... | Class II | Elekta, Inc. |
| Oct 25, 2023 | ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Partic... | Elekta has identified that if the microswitch within the middle arm is incorrectly setup, there i... | Class II | Elekta, Inc. |
| Oct 25, 2023 | CD11b APC: ASR, REF: 340936, and CE, REF: 333143 | In vitro diagnostics product that impacts the quality of cell staining can cause low or dim fluor... | Class II | Becton, Dickinson and Company, BD Biosciences |
| Oct 25, 2023 | ELEKTA AXESSE, REF XRT 2181, XRT 27891; Medical Charged-Particle Radiation T... | Elekta has identified that if the microswitch within the middle arm is incorrectly setup, there i... | Class II | Elekta, Inc. |
| Oct 25, 2023 | Iconix Knotless 1.4mm Anchor with XBraid S (Blue/Black) REF 3911-714-520 ... | Use of a 1.4 drill in hard bone conditions caused increased insertion forces leading to subsequen... | Class II | Riverpoint Medical, LLC |
| Oct 25, 2023 | ELEKTA LIMITED Versa HD, REF XRT 2121, 2131; Medical Charged-Particle Radiati... | Elekta has identified that if the microswitch within the middle arm is incorrectly setup, there i... | Class II | Elekta, Inc. |
| Oct 25, 2023 | ELEKTA LIMITED Elekta Synergy Platform, REF MRT 8501, MRT 8511; Medical Charg... | Elekta has identified that if the microswitch within the middle arm is incorrectly setup, there i... | Class II | Elekta, Inc. |
| Oct 25, 2023 | ELEKTA LIMITED Elekta Infinity, REF XRT 0511, XRT 0521, XRT 0531, XRT 0541; M... | Elekta has identified that if the microswitch within the middle arm is incorrectly setup, there i... | Class II | Elekta, Inc. |
| Oct 24, 2023 | Liberty Select Cycler, Model numbers RTLR180343 and RTLR180111 | Affected Liberty Select cyclers may display an incorrect time stamp on the treatment data report ... | Class III | Fresenius Medical Care Holdings, Inc. |
| Oct 24, 2023 | Injection Needle, REF: 25207 | The efficacy of the manual cleaning process cannot be assured for the affected injection needles ... | Class II | Karl Storz Endoscopy |
| Oct 24, 2023 | Injection Needle, LUER-lock,0.8mm, REF: 26175PD | The efficacy of the manual cleaning process cannot be assured for the affected injection needles ... | Class II | Karl Storz Endoscopy |
| Oct 24, 2023 | Injection Needle, single cvd. 70 degrees, REF: 738750; Injection Needle, sing... | The efficacy of the manual cleaning process cannot be assured for the affected injection needles ... | Class II | Karl Storz Endoscopy |
| Oct 24, 2023 | Injection Needle, curved 23 cm, REF: 8598A; Injection Needle, straight, 23 cm... | The efficacy of the manual cleaning process cannot be assured for the affected injection needles ... | Class II | Karl Storz Endoscopy |
| Oct 24, 2023 | CardioQuip Modular Cooler-Heater, Model: MCH-1000(i), Power: 115V-60Hz, 16A | There is the potential that cooler-heater devices may contain bacterial contamination which could... | Class II | CardioQuip, LLC |
| Oct 24, 2023 | Injection Needle, 3 Fr., REF: 27030N; Injection Cannula, 6 Fr., REF: 27182A | The efficacy of the manual cleaning process cannot be assured for the affected injection needles ... | Class II | Karl Storz Endoscopy |
| Oct 24, 2023 | GRAPHENANO DENTAL G-CAM, Product Codes: a) 95 Multichroma 14LB2, REF GC00089... | Machining error on cams renders the device unusable. | Class II | GRAPHENANO DENTAL SL |
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.