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 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. |
| Jun 3, 2021 | HeartWare HVAD Driveline Extension Cable, REF 100 | 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 Accessories, REF MCS1753AK | 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 Outflow Graft, REF MCS1725OG | 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 1153 | 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 1125 | Medtronic is stopping the distribution and sale of the HVAD System due to a growing body of obser... | Class I | Heartware, Inc. |
| May 28, 2021 | HeartWare, HVAD Pump Implant Kit, REF MCS1705PU - Product Usage: indicated fo... | The pump has an impeller with a shroud height that did not meet the lower control limit. | Class II | Heartware, Inc. |
| May 12, 2021 | Prime TC-transport chair intended for medical purposes to assist a person in... | Medical devices intended for use in a healthcare facility were distributed to residential custom... | Class II | Stryker Medical Division of Stryker Corporation |
| May 7, 2021 | DePuy Synthes Articul/eze Femoral Head: Hip joint metal/polymer semi-constrai... | Fifty (50) individual units from Lot D20111130 were distributed with the incorrect part number an... | Class II | DePuy Orthopaedics, Inc. |
| Apr 6, 2021 | Implantable cardiac resynchronization therapy pacemakers (CRT-P) - Product Us... | A longevity estimation error may occur in the early years of device life when a unipolar pacing ... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Apr 6, 2021 | LeverEdge Contrast Injector: 35 cc syringe with ISO 594 female luer lock - Pr... | The firm received a complaint regarding particulate found in the packaging foam that could contam... | Class II | LeMaitre Vascular, Inc. |
| Apr 6, 2021 | Programmers - Product Usage: used to treat arrhythmias related to bradycardia... | A longevity estimation error may occur in the early years of device life when a unipolar pacing ... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Apr 6, 2021 | Implantable Pulse Generators - Product Usage: used to treat arrhythmias relat... | A longevity estimation error may occur in the early years of device life when a unipolar pacing ... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Apr 6, 2021 | CareLink SmartSync Device Manager - Product Usage: used to treat arrhythmias ... | A longevity estimation error may occur in the early years of device life when a unipolar pacing ... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Mar 26, 2021 | PIC070 Arterial Blood Sampler PICO70 - Product Usage: Preheparinized, electro... | Radiometer has become aware of an issue with PICO70 Arterial Blood Sampler. The issue relates to ... | Class II | Radiometer Medical ApS |
| Mar 25, 2021 | ZVplasty, Direct Bipedicular, Bone Access Kit with Coxaial Cannula, REF VCF-D... | Products distributed as sterile may not have been adequately sterilized | Class II | Zavation |
| Mar 25, 2021 | ZVplasty Direct Bipedicular Bone Access Kit with Drill, 11 Gauge, REF VCF-DDB... | Products distributed as sterile may not have been adequately sterilized | Class II | Zavation |
| Mar 25, 2021 | PowerPort duo M.R.I. Implantable Port, with attachable 9.5F Polurethane Open-... | Catheters may experience difficulty in flushing, infusion, and/or aspiration, and septum dislodge... | Class II | Bard Peripheral Vascular Inc |
| Mar 25, 2021 | ZVplasty Direct Unipedicular Bone Access Kit with Drill, 10 Gauge, REF VCF-DS... | Products distributed as sterile may not have been adequately sterilized | Class II | Zavation |
| Mar 25, 2021 | ZVplasty 10G, 20mm, Traditional Unipedicular Kit, REF VCF-1020-1. For use in... | Products distributed as sterile may not have been adequately sterilized | Class II | Zavation |
| Mar 25, 2021 | ZVPlasty, 11G, 15mm Traditional Bipedicular Kit, REF VCF-1115-2. For use in ... | Products distributed as sterile may not have been adequately sterilized | Class II | Zavation |
| Mar 25, 2021 | ZVplasty, Bipedicular Cement Delivery Cannula Kit, 10 Gauge, REF VCF-DCDK. F... | Products distributed as sterile may not have been adequately sterilized | Class II | Zavation |
| Mar 25, 2021 | ZVplasty Unipedicular Cement Delivery Cannula Kit, 10 Gauge, REF VCG-SCDK. F... | Products distributed as sterile may not have been adequately sterilized | Class II | Zavation |
| Mar 25, 2021 | ZVplasty Direct Bipedicular Bone Access Kit with Drill, 11 Gauge, REF VCF-DDB... | Products distributed as sterile may not have been adequately sterilized | Class II | Zavation |
| Mar 25, 2021 | PowerPort duo M.R.I. Implantable Port, with attachable 9.5F Polurethane Open-... | Catheters may experience difficulty in flushing, infusion, and/or aspiration, and septum dislodge... | Class II | Bard Peripheral Vascular Inc |
| Mar 25, 2021 | ZVplasty Bipedicular Cement Delivery Cannula, 11 Gauge, REF VCF-DCDK-11. For... | Products distributed as sterile may not have been adequately sterilized | Class II | Zavation |
| Mar 25, 2021 | ZVplasty Direct Bipedicular Bone Access Kit with Drill, 10 Gauge, VCF-DDBAK. ... | Products distributed as sterile may not have been adequately sterilized | Class II | Zavation |
| Mar 25, 2021 | PowerPort duo M.R.I. Implantable Port, with attachable 9.5F Polurethane Open-... | Catheters may experience difficulty in flushing, infusion, and/or aspiration, and septum dislodge... | Class II | Bard Peripheral Vascular Inc |
| Mar 25, 2021 | ZVplasty Unipedicular Cement Delivery Cannula Kit, 10 Gauge, REF VCF-SCDK. F... | Products distributed as sterile may not have been adequately sterilized | Class II | Zavation |
| Mar 18, 2021 | VERIGENE Processor SP - Product Usage: intended for processing and identifyin... | Potential for a false-negative result for Vibrio parahaemolyticus, Salmonella, and/or Shigella sp... | Class II | Luminex Corporation |
| Mar 16, 2021 | REF CH2020 20mL Syringe w/Spinning Spiros, Red Cap - Product Usage: provides ... | Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios... | Class II | ICU Medical, Inc. |
| Mar 16, 2021 | REF 011-CH3967 Admin Set w/ClaveTM, SpirosTM - Product Usage: provides access... | Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios... | Class II | ICU Medical, Inc. |
| Mar 16, 2021 | REF CH3034 5" (13 cm) Bag Spike Adapter w/Spiros" w/Red Cap, Vented Cap - Pr... | Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios... | Class II | ICU Medical, 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.