Browse Device Recalls
2,447 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,447 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 2,447 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Aug 1, 2022 | MicroClave Clear Neutral Connector. A bidirectional connector used as an acce... | Due to a manufacturing defect which results in a visible gap between the connector's top and bott... | Class II | ICU Medical, Inc. |
| Aug 1, 2022 | 6" (15 cm) Appx 0.85 ml, Smallbore Trifuse Ext Set w/3 MicroClave Clear, 2 Ch... | Due to a manufacturing defect which results in a visible gap between the connector's top and bott... | Class II | ICU Medical, Inc. |
| Aug 1, 2022 | MicroClave Clear Neutral Connector; MicroClave Clear Connector; MicroCl... | Due to a manufacturing defect which results in a visible gap between the connector's top and bott... | Class II | ICU Medical, Inc. |
| Aug 1, 2022 | 6.5 IN (17 cm) APPX 0.78 ml, EXT SET w/Clave CLEAR, Clave 4-WAY Stopcock, Spi... | Due to a manufacturing defect which results in a visible gap between the connector's top and bott... | Class II | ICU Medical, Inc. |
| Jun 28, 2022 | HeartWare Ventricular Assist Device (HVAD) System Batteries, Product Number 1... | Battery performance issues. Battery electrical faults render it unable to power the controller, u... | Class I | Heartware, Inc. |
| Jun 27, 2022 | Product Description/Item: ChemoLock Vial Spike, 20mm/011-CL-80S; ChemoLock B... | Ports have a potential for unintended disconnection, inability to connect to or fully engage with... | Class II | ICU Medical, Inc. |
| Jun 27, 2022 | Product Description/Item: ChemoLock Bag Spike, 10 units/CL-10-10; ChemoLock ... | Ports have a potential for unintended disconnection, inability to connect to or fully engage with... | Class II | ICU Medical, Inc. |
| May 25, 2022 | Pressure Monitoring Set, Single-lumen uncoated central venous catheter. RPN C... | The products may contain excess coating material on the outside and/or interior of the needle com... | Class II | Cook Incorporated |
| May 25, 2022 | Drugs of Abuse Tests: a. Wondfo Tdip Drugs of Abuse Test Tdip Single Drug ... | Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to highe... | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| May 5, 2022 | HeartWare Battery, Model #1650DE, a component of the HeartWare Ventricular As... | Batteries for the HVAD system have a weld defect affecting internal components within the HVAD ba... | Class I | Medtronic Inc |
| Mar 30, 2022 | Instructions for Use, Patient Manuals, and Emergency Responder Guides for Hea... | Errors and inconsistencies that were identified in the Instruction for Use (IFU), Emergency Respo... | Class II | Medtronic Inc |
| Mar 30, 2022 | HeartWare Ventricular Assist Device (HVAD) System, Pump Implant Kit, Model Nu... | Finnish and Turkish translation errors in HVAD controller and monitor displays as will as Instruc... | Class II | Heartware, Inc. |
| Mar 30, 2022 | HeartWare Ventricular Assist Device (HVAD) System, individual pamphlets: HV... | Finnish and Turkish translation errors in HVAD controller and monitor displays as will as Instruc... | Class II | Heartware, Inc. |
| Mar 30, 2022 | HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 14... | Finnish and Turkish translation errors in HVAD controller and monitor displays as will as Instruc... | Class II | Heartware, Inc. |
| Mar 30, 2022 | HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1420 | Finnish and Turkish translation errors in HVAD controller and monitor displays as will as Instruc... | Class II | Heartware, Inc. |
| Mar 30, 2022 | HeartWare Ventricular Assist Device (HVAD) System, Model Number 1521DE, MONIT... | Finnish and Turkish translation errors in HVAD controller and monitor displays as will as Instruc... | Class II | Heartware, Inc. |
| Mar 30, 2022 | HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 14... | Finnish and Turkish translation errors in HVAD controller and monitor displays as will as Instruc... | Class II | Heartware, Inc. |
| Mar 1, 2022 | Access-9 Large Bore Hemostasis Valves, Catalog Code: 580775001, IN8112/C, K05... | A design change made to a hemostasis valve to improve manufacturability caused an internal gap be... | Class II | Merit Medical Systems, Inc. |
| Mar 1, 2022 | AccessPLUS Large Bore Hemostasis Valves, Catalog Code: 580758001, 580774001, ... | A design change made to a hemostasis valve to improve manufacturability caused an internal gap be... | Class II | Merit Medical Systems, Inc. |
| Feb 17, 2022 | Trumpf Mount Clamp Assembly (table adapter component), part #118704-000, a co... | Reports have been received that after normal or routine lateral forces are applied to the head fi... | Class II | Deerfield Imaging, Inc. |
| Feb 10, 2022 | Nextra Hammertoe Correction System 4.5 Middle and 3.2 Proximal Saw Cut SKU:... | Proximal end of the driver is oversized in varying degrees, making it difficult to fully connect ... | Class II | Nextremity Solutions |
| Feb 10, 2022 | Nextra Hammertoe Correction System 4.5 Middle 3.2 Proximal Kit SKU: NX-4532... | Proximal end of the driver is oversized in varying degrees, making it difficult to fully connect ... | Class II | Nextremity Solutions |
| Feb 10, 2022 | Nextra Hammertoe Correction System 3.5 Middle 3.2 Proximal Kit SKU: NX-3532... | Proximal end of the driver is oversized in varying degrees, making it difficult to fully connect ... | Class II | Nextremity Solutions |
| Feb 10, 2022 | Nextra Hammertoe Correction System Driver SKU: NX-DR Orthopedic surgical ... | Proximal end of the driver is oversized in varying degrees, making it difficult to fully connect ... | Class II | Nextremity Solutions |
| Feb 10, 2022 | Nextra Hammertoe Correction System 3.5 Middle and 3.2 Proximal Saw Cut SKU:... | Proximal end of the driver is oversized in varying degrees, making it difficult to fully connect ... | Class II | Nextremity Solutions |
| Jan 27, 2022 | HeartWare Ventricular Assist Device (HVAD) System | Updated cleaning instructions are being provided for the Controller AC Adapter, DC Adapter, and B... | Class II | Heartware, Inc. |
| Dec 17, 2021 | Chameleon PTA Balloon Dilation Catheter 8 mm x 40 mm, Chameleon PTA Balloon C... | The firm has received six (6) complaint reports from customers indicating difficulty removing the... | Class II | Covidien Llc |
| Dec 6, 2021 | LigaSure Blunt Tip Laparoscopic Sealer/Divider, Nano-Coated, Product Number L... | Customers reported that the device jaws were difficult to open or would not open following applic... | Class II | Covidien Llc |
| Nov 22, 2021 | WIRION EMBOLIC PROTECTION SYSTEM, Delivery Catheter and Filter and Retrieval ... | Under certain circumstances, the WIRION filter assembly may become difficult to withdraw. Under s... | Class I | Cardiovascular Systems Inc |
| Nov 19, 2021 | Distractor Rack, REF 5598007, which may be packaged in Modular Distractor Set... | Two lots of the 5598007 Distractor Rack which were not manufactured to specification. The crest w... | Class II | Medtronic Sofamor Danek USA Inc |
| Nov 10, 2021 | SYNCHRON Systems Cholesterol (CHOL) Reagent, REF: 467825 | Cholesterol Reagent may fail with Out of Calibration Range Low (OCR Low) and/or Back to Back (B/B... | Class II | Beckman Coulter Inc. |
| Nov 9, 2021 | Torosa Saline-Filled Testicular Prosthesis (Size Small) | Product is mislabeled for size. | Class II | Coloplast Manufacturing US, LLC |
| Nov 4, 2021 | Puritan Bennett 980 Series Ventilator, 980S1ENDICU | Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, w... | Class I | Covidien Llc |
| Nov 4, 2021 | Puritan Bennett 980 Series Ventilator, 980S3ENDICU | Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, w... | Class I | Covidien Llc |
| Oct 14, 2021 | Arietta 65 Ultrasound Software Versions: V1.0 through V4.0.0 | When the ultrasound system is used in combination with a Fujifilm (formally Hitachi) transducer, ... | Class II | FujiFilm Healthcare Americas Corporation |
| Oct 11, 2021 | BioFire Blood Culture Identification 2 (BCID2) Panel Part No: RFIT-ASY-0147 U... | Due to an increased risk of false positive Acinetobacter calcoaceticus- baumannii complex results... | Class II | BioFire Diagnostics, LLC |
| Sep 21, 2021 | ASC PneumoLiner device, Part No. WA90500US (US market only) The Pneumoline... | Due to manufacturing error, the Pneumoliner Bag Distal Tab that exits the Introducer shaft is in ... | Class II | Olympus Corporation of the Americas |
| Sep 13, 2021 | Medtronic Bio-Medicus Insertion Kits, Model number 96553, Pediatric Insertion... | There was a label mix-up between two model numbers resulting in the incorrect guidewire being con... | Class II | Medtronic Perfusion Systems |
| Aug 31, 2021 | Medtronic sterile single-use blades that are components of the StraightShot M... | There was an increase in complaints related to tip breaks and wobble/vibration. | Class II | Medtronic Xomed, Inc. |
| Aug 31, 2021 | Medtronic sterile single-use blades that are components of the StraightShot M... | There was an increase in complaints related to tip breaks and wobble/vibration. | Class II | Medtronic Xomed, Inc. |
| Aug 24, 2021 | McKesson PREVENT HT Safety Blood Collection Needles, 21G 1 1/4 inch, MFR # 16... | Potential for difficulty in safety mechanism activation. | Class II | Zhejiang Kindly Medical Devices Co., Ltd. |
| Aug 24, 2021 | McKesson PREVENT HT Safety Blood Collection Needles, 22G 1 1/4 inch, MFR # 16... | Potential for difficulty in safety mechanism activation. | Class II | Zhejiang Kindly Medical Devices Co., Ltd. |
| Aug 24, 2021 | McKesson PREVENT HT Safety Winged Blood Collection Needle with Tube Holder, M... | Potential for difficulty in safety mechanism activation. | Class II | Zhejiang Kindly Medical Devices Co., Ltd. |
| Aug 24, 2021 | HENRY SCHEIN Safety Blood Collection Needle 22Gx 1 1/4 Inch, REF 570-2068, 10... | Potential for difficulty in safety mechanism activation. | Class II | Zhejiang Kindly Medical Devices Co., Ltd. |
| Aug 24, 2021 | McKesson PREVENT HT Safety Winged Blood Collection Needle with Tube Holder, M... | Potential for difficulty in safety mechanism activation. | Class II | Zhejiang Kindly Medical Devices Co., Ltd. |
| Aug 24, 2021 | HENRY SCHEIN Safety Blood Collection Needle 21Gx 1 1/4 Inch, REF 570-2067, 10... | Potential for difficulty in safety mechanism activation. | Class II | Zhejiang Kindly Medical Devices Co., Ltd. |
| Aug 6, 2021 | Medtronic HVAD Pump Implant Kits | There is more force required to slide the driveline cover (boot cover) away from the connector af... | Class II | Heartware, Inc. |
| Aug 2, 2021 | BD ADD-ON Burette Set V/NV Needle-Free Valve, REF: 82113E-0006 | Needle-free connector valves, either standalone or attached to extension sets, may have issues in... | Class II | CAREFUSION |
| Aug 2, 2021 | BD Extension Set SMALLBORE Tubing SmartSite VALVE, REF: 10010511; BD SmartSi... | Needle-free connector valves, either standalone or attached to extension sets, may have issues in... | Class II | CAREFUSION |
| Aug 2, 2021 | BD Alaris Pump Infusion Buerette Set Smallbore Tubing Smartsite Port (Burette... | Needle-free connector valves, either standalone or attached to extension sets, may have issues in... | Class II | CAREFUSION |
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.