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.

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DateProductReasonClassFirm
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.