Medical devices, 2021
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2,303 medical device recalls FDA’s Enforcement Report published in 2021, newest first; 40,450 in all since 2012.
FDA’s medical device recalls, as its Enforcement Report classifies them, from June 2012. Lists of FDA’s records can’t be saved for alerts: openFDA asks that its data not be used to alert the public (openFDA); FDA’s own emails do that. Copied Nov 6, 2026.
2,303of 2,303 medical device recallsshown with your filters
The list
- Medical device recall Cardiosave Rescue IABP - Product Usage: used to inflate and deflate intra-aortic balloons There are cybersecurity vulnerabilities in a widely used low-level TCP/IP software library that may result in a loss of communication to the Hospital… Class IIIFDA’s classMay 5, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 5, 2021ClassClass IIIStatusOngoingWhereNationwide
- Medical device recall Change Healthcare Enterprise Viewer Change Healthcare has identified an intermittent software defect which may result in an anchor study failing to display. Class IIFDA’s classMay 5, 2021in FDA’s Enforcement Report18 statesnamed in where it went PublishedMay 5, 2021ClassClass IIStatusOngoingWhereAlaska, Arizona, California, Florida, Hawaii, Iowa, Illinois, Indiana, Kentucky, Michigan, Nebraska, New York, Ohio, Pennsylvania, Texas, Washington, Wisconsin and Wyoming
- Medical device recall Filtered Triple-Leg Extension Set - Intravascular administration set BBMI has identified through complaints the potential for the extension set to become occluded or unable to prime. Class IIFDA’s classMay 5, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedMay 5, 2021ClassClass IIStatusTerminatedWhereNationwide, and California and North Carolina named
- Medical device recall CANNU-Flex SILK Interference Screws 6 mmx 30 mm - Product Usage: used for interference fixation of… Mislabeled box contained a 6mm x 20mm screw instead of 6mm x 30mm screw Class IIFDA’s classMay 5, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 5, 2021ClassClass IIStatusTerminatedWhereNationwide, and Florida named
- Medical device recall DONJOY REF:11-0447-9-ULTRASLING PRO, UNIVERSAL, Rx ONLY, UDI:(01)00190446673552 - Product Usage: intended for… failed rivet at the chafe tab of arm sling. Class IIFDA’s classMay 5, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 5, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall DONJOY REF:11-0471-9 ULTRASLING PRO ER/IR 15, UNIVERSAL, Rx ONLY, UDI: (01) 00190446683667 - Product Usage:… failed rivet at the chafe tab of arm sling. Class IIFDA’s classMay 5, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 5, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall DONJOY REF:11-0472-9 ULTRASLING PRO ER/IR 30, UNIVERSAL, Rx ONLY, UDI: (01)00190446683674 - Product Usage:… failed rivet at the chafe tab of arm sling. Class IIFDA’s classMay 5, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 5, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall DONJOY REF:11-0473-9 ULTRASLING PRO AB, UNIVERSAL, Rx ONLY, UDI: (01)00190446683681 - Product Usage: intended… failed rivet at the chafe tab of arm sling. Class IIFDA’s classMay 5, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 5, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Palm Cups - Product Usage: intended to be used to percuss the chest wall to mobilize the secretions within… The firm became aware via complaints that one lot of ACE MDI Spacers with Small Masks and one lot of Palm Cups (Large) may have incorrect shipping box labels. Class IIFDA’s classMay 5, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedMay 5, 2021ClassClass IIStatusTerminatedWhereNationwide, and Minnesota and Pennsylvania named
- Medical device recall ACE MDI Spacer with Small Mask - Product Usage: designed to assist with the delivery of aerosolized… The firm became aware via complaints that one lot of ACE MDI Spacers with Small Masks and one lot of Palm Cups (Large) may have incorrect shipping box labels. Class IIFDA’s classMay 5, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedMay 5, 2021ClassClass IIStatusTerminatedWhereNationwide, and Minnesota and Pennsylvania named
- Medical device recall Philips Xper Flex Cardio (FC2010, Procedure Room and FC2020, Bedside Monitor) devices - intended for use by… Performance issues with the Xper Flex Cardio Physio Monitoring System include: potential delay of up to 10 seconds in displaying ECG, invasive blood pressure… Class IIFDA’s classMay 5, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 5, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Omnia Soft Tissue Punch is a dental instrument designed to remove with precision a circular section of oral… Omnia SRL received a notification from the contract manufacturer informing them of inadequate sterilization processes which have been taking place at their… Class IIFDA’s classMay 5, 2021in FDA’s Enforcement Report8 statesnamed in where it went PublishedMay 5, 2021ClassClass IIStatusTerminatedWhereAlaska, California, Illinois, New York, Oklahoma, Pennsylvania, Texas and Utah
- Medical device recall Aftermarket Alaris Infusion Pump Module Aftermarket front bezel components were installed during service/repair, not by the original manufacturer, within infusion pump modules. FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 28, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 28, 2021ClassClass IStatusOngoingWhereNationwide
- Medical device recall Instructions for Use and Patient Manual for HeartWare HVAD System Medtronic HeartWare HVAD System Instructions for Use (IFU) and Patient Manual (PM) updates regarding: Carrying Cases, Driveline Cover Orientation, and… FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 28, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 28, 2021ClassClass IStatusOngoingWhereNationwide
- Medical device recall Bard Clean-Cath Intermittent Catheter, 12 French female length (catheter, urological) - Product Usage: for… The device catheter tip was cut off (no tip) and the product packaging was not fully sealed. Class IIFDA’s classApr 28, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 28, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Assure COVID-19 IgG/IgM Rapid Test Device that include: 1) Pouch Label - FaStep Rapid Diagnostic Test ***… Due to Products being incorrect labeling “for diagnostic use” and labelled with an unsupported 24 month expiration dating. Class IIFDA’s classApr 28, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedApr 28, 2021ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Georgia, Illinois, Louisiana, Maryland, Minnesota, North Carolina, Texas, Utah, Virginia and Washington named
- Medical device recall The AMS 700 Inflatable Penile Prosthesis is a closed fluid-filled system containing saline An AMS 700 100 mL Spherical Reservoir with InhibiZone was incorrectly labeled as a 100 mL Conceal Reservoir with InhibiZone. Class IIFDA’s classApr 28, 2021in FDA’s Enforcement Report14 statesnamed in where it went PublishedApr 28, 2021ClassClass IIStatusTerminatedWhereArkansas, Arizona, Colorado, Florida, Georgia, Iowa, Michigan, Missouri, Nebraska, Oregon, Pennsylvania, Tennessee, Texas and Utah
- Medical device recall Sensis/ Sensis Vibe Hemo systems with VD12A software as follows: Dedicated SIS Server- 6648153 Sensis… Due to the configuration of certain Windows Service Permissions within the operating systems of the Sensis/ Sensis Vibe computer, there is a risk for exposure… Class IIFDA’s classApr 28, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 28, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BCS XP System: Multipurpose system for in vitro coagulation studies Siemens Healthcare Diagnostics Products GmbH has confirmed that the BCS XP System may be affected by a potential Emicizumab carryover on patient samples. Class IIFDA’s classApr 28, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 32 states named PublishedApr 28, 2021ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, Nebraska, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall DirectInject consists of a sterile dual paste system which is calcium phosphate based Inability for the user to inject the paste from the syringe into the target location. Class IIFDA’s classApr 28, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 28, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Tritanium X TL Instruments - intervertebral fusion device with bone graft, lumbar Stryker identified non-conforming instruments that are components of the Tritanium X TL sets. Class IIFDA’s classApr 28, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 14 states named PublishedApr 28, 2021ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Colorado, Georgia, Kentucky, Massachusetts, Montana, North Carolina, Nebraska, New Jersey, New York, Ohio, Pennsylvania and Wyoming named
- Medical device recall Instructions for Use and Patient Manual for HeartWare HVAD System IFU and Patient Manual updated to describe HVAD Controller Connection Verification. Class IIFDA’s classApr 28, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 28, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Endoskeleton TC Interbody System with Titan nanoLOCK Surface Technology, 6 Degree, Small, 8 mm, Product… The shelf box identifies a small device actually contains a large device, and the shelf box identifying a large device actually contains a small device. Class IIFDA’s classApr 28, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 28, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Endoskeleton TC Interbody System with Titan nanoLOCK Surface Technology, 6 Degree, Large, 8 mm, Product… The shelf box identifies a small device actually contains a large device, and the shelf box identifying a large device actually contains a small device. Class IIFDA’s classApr 28, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 28, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BIOTRONIK Ilestro 7 DR-T, DF-1, REF383562, UDI: 04035479125189 - Product Usage: intended to provide… There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT’Ds) Class IIFDA’s classApr 28, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 28, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BIOTRONIK Ilestro 7 DR-T, DF-4, REF383564, UDI: 04035479125202 - Product Usage: intended to provide… There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT’Ds) Class IIFDA’s classApr 28, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 28, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BIOTRONIK Ilestro 7 VR-T, DF-1 There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT’Ds) Class IIFDA’s classApr 28, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 28, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BIOTRONIK Ilestro 7 VR-T, DF-4 There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT’Ds) Class IIFDA’s classApr 28, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 28, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BIOTRONIK Ilestro 7 VR-T DX, DF-1 There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT’Ds) Class IIFDA’s classApr 28, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 28, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BIOTRONIK Iperia 7, DR-T, DF-1, ProMRI There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT’Ds) Class IIFDA’s classApr 28, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 28, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BIOTRONIK Iforia 7, vr-T, DX, DF-1,REF 390090, UDI: 04035479127176 - Product Usage: intended to provide… There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT’Ds) Class IIFDA’s classApr 28, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 28, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BIOTRONIK Iforia 7,DR-T, DF-1,REF 390064, UDI: 04035479126926 - Product Usage: intended to provide… There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT’Ds) Class IIFDA’s classApr 28, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 28, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BIOTRONIK IPERIA 7,VR-T, DX, DF-1, ProMRI There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT’Ds) Class IIFDA’s classApr 28, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 28, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BIOTRONIK ITREVIA 7, VR-T DX DF-1 There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT’Ds) Class IIFDA’s classApr 28, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 28, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BIOTRONIK ITREVIA 7, VR-T DF-1 There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT’Ds) Class IIFDA’s classApr 28, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 28, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BIOTRONIK ITREVIA 7, VR-T DF-4 There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT’Ds) Class IIFDA’s classApr 28, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 28, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BIOTRONIK IPERIA 7, DR-T DF4 ProMRI There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT’Ds) Class IIFDA’s classApr 28, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 28, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BIOTRONIK INVENTRA 7, HF-T QP DF4 IS4 There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT’Ds) Class IIFDA’s classApr 28, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 28, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BIOTRONIK ITREVIA 7, DR-T QP DF-1 There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT’Ds) Class IIFDA’s classApr 28, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 28, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BIOTRONIK ILIVIA 7, DR-T DF4 ProMRI There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT’Ds) Class IIFDA’s classApr 28, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 28, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BIOTRONIK ILIVIA 7, VR-T DF-1 ProMRI There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT’Ds) Class IIFDA’s classApr 28, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 28, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BIOTRONIK ILIVIA 7, VR-T DF4 ProMRI There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT’Ds) Class IIFDA’s classApr 28, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 28, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BIOTRONIK INVENTRA 7, VR-T DX DF-1 ProMRI There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT’Ds) Class IIFDA’s classApr 28, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 28, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BIOTRONIK INVENTRA 7, VR-T DX DF-1 There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT’Ds) Class IIFDA’s classApr 28, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 28, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BIOTRONIK ILIVIA 7, DR-T DF-1 PROMRI There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT’Ds) Class IIFDA’s classApr 28, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 28, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BIOTRONIK ILIVIA NEO 7 VR-T DF-1 ProMRI There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT’Ds) Class IIFDA’s classApr 28, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 28, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BIOTRONIK INTICA NEO 7 VR-T DX DF-1 ProMRI There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT’Ds) Class IIFDA’s classApr 28, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 28, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BIOTRONIK ILIVIA NEO 7 DR-T DF-1 ProMRI There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT’Ds) Class IIFDA’s classApr 28, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 28, 2021ClassClass IIStatusTerminatedWhereNationwide
Nothing matches all of these.
Remove a filter to see more. Each one is a fact FDA’s record publishes, so a recall can be left out because its record is silent on it.
Source:
FDA, Device recall enforcement reports. Released Nov 3, 2026. Updated weekly.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.”
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