Browse Device Recalls
2,479 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,479 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 2,479 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 |
| Aug 2, 2021 | BD SmartSite Bag Access Device Needle-Free Valve, REF: 2300E; BD Bag access D... | Needle-free connector valves, either standalone or attached to extension sets, may have issues in... | Class II | CAREFUSION |
| Aug 2, 2021 | BD Gravity Burette Set 60 DP 3 SmartSite VALVES BALL VALVE DRIP CHAMBER, REF:... | Needle-free connector valves, either standalone or attached to extension sets, may have issues in... | Class II | CAREFUSION |
| Aug 2, 2021 | BD Syringe Set 20 DP MIC TBG 0.2MF CKV Anti-Siphon SmartSite VLV Sensing Disc... | Needle-free connector valves, either standalone or attached to extension sets, may have issues in... | Class II | CAREFUSION |
| Aug 2, 2021 | BD SmartSite, REF: 2000E CHINA; BD SmartSite Connector, REF: 2000E-04; BD Sma... | Needle-free connector valves, either standalone or attached to extension sets, may have issues in... | Class II | CAREFUSION |
| Aug 2, 2021 | BD BURETTE GRAVITY SET 60 DROP 2 Smartsite VALVES VENTED/NONVENTED, REF: 42163E | Needle-free connector valves, either standalone or attached to extension sets, may have issues in... | Class II | CAREFUSION |
| Aug 2, 2021 | BD SmartSite 'Y' Extension Set 2 Needle-Free Valves, REF: 20019E7D | Needle-free connector valves, either standalone or attached to extension sets, may have issues in... | Class II | CAREFUSION |
| Aug 2, 2021 | BD SmartSite Bag Access Device, REF: 2300E-0500; BD BAG ACCESS DEVICE CHECK V... | 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 with 2 SmartSite VALVES, REF: 20019E | 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 0.2 Micron Filter Smallbore Tubing Smart... | Needle-free connector valves, either standalone or attached to extension sets, may have issues in... | Class II | CAREFUSION |
| Aug 2, 2021 | BD SE Burette Set 20 Drops 2 Injection Ports Vented/NonVented, REF: 72103E-0006 | Needle-free connector valves, either standalone or attached to extension sets, may have issues in... | Class II | CAREFUSION |
| Aug 2, 2021 | BD Gravity IV Set 3-port Closed Manifold Back Check Valve 3 Needle-Free Y-sit... | Needle-free connector valves, either standalone or attached to extension sets, may have issues in... | Class II | CAREFUSION |
| Aug 2, 2021 | BD Gravity Burette Set 60 DROP 1.2 MF 2 SmartSite VALVES BALL VALVE DRIP CHAM... | Needle-free connector valves, either standalone or attached to extension sets, may have issues in... | Class II | CAREFUSION |
| Jul 14, 2021 | FLASH Ostial System, Dual Balloon Angioplasty Catheter, REF: OAB6014BA | Angioplasty system has a manufacturing issue that has the potential to result in difficulty defla... | Class II | Ostial Corporation |
| Jun 3, 2021 | HeartWare HVAD Implant Kit, REF MCS1705PU | Medtronic is stopping the distribution and sale of the HVAD System due to a growing body of obser... | Class I | Heartware, Inc. |
| Jun 3, 2021 | HeartWare HVAD Driveline Extension Cable, REF 100US | Medtronic is stopping the distribution and sale of the HVAD System due to a growing body of obser... | Class I | Heartware, Inc. |
| Jun 3, 2021 | HeartWare HVAD Implant Kit, REF 1104JP | Medtronic is stopping the distribution and sale of the HVAD System due to a growing body of obser... | Class I | Heartware, Inc. |
| Jun 3, 2021 | HeartWare HVAD Pump Implant Kit, REF 1104 | Medtronic is stopping the distribution and sale of the HVAD System due to a growing body of obser... | Class I | Heartware, Inc. |
| Jun 3, 2021 | HeartWare HVAD Pump Implant Kit, REF 1103 | Medtronic is stopping the distribution and sale of the HVAD System due to a growing body of obser... | Class I | Heartware, 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.