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 BIOTRONIK INTICA NEO 7 HF-T DF-1 IS-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 Smart Port CT-Implantable Port Catalogue #: CT96STSD-VI, CT96STSA-VI - Product Usage: indicated for any… AngioDynamics, Inc. Class IIFDA’s classApr 28, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 22 states named PublishedApr 28, 2021ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, California, Colorado, Florida, Hawaii, Illinois, Indiana, Kansas, Michigan, Missouri, North Carolina, North Dakota, New Mexico, New York, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Virginia and Washington named
- Medical device recall AngioDynamics Safe Sheath Ultralite - Vascular Introducer/Catheter Introducer Catalogue #: VI10 - Product… AngioDynamics, Inc. Class IIFDA’s classApr 28, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 22 states named PublishedApr 28, 2021ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, California, Colorado, Florida, Hawaii, Illinois, Indiana, Kansas, Michigan, Missouri, North Carolina, North Dakota, New Mexico, New York, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Virginia and Washington named
- Medical device recall Midline Catheter Dressing Change Kit with Statlock - Product Usage: Intended to provide ongoing vascular… Evidence of face masks or other material in the seal in several kits, causing improper seals and compromised sterility Class IIFDA’s classApr 28, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedApr 28, 2021ClassClass IIStatusTerminatedWhereNationwide, and Iowa, Illinois, Minnesota, Missouri, Mississippi, Nebraska, New York, Ohio, Oklahoma, Texas and Virginia named
- Medical device recall Instructions for Use and Patient Manual for HeartWare HVAD System IFU and Patient Manual updated to describe Expected Alarm Duration. Class IIFDA’s classApr 28, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 28, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall LogiCal Monitoring Set Specific lots of Medex High Pressure Adaptors, Rotators, Manifolds, Stopcocks and Tubing and Medex LogiCal Kits may have been manufactured with insufficient or… Class IIFDA’s classApr 28, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 28, 2021ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Mark 910 LogiCal Specific lots of Medex High Pressure Adaptors, Rotators, Manifolds, Stopcocks and Tubing and Medex LogiCal Kits may have been manufactured with insufficient or… Class IIFDA’s classApr 28, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 28, 2021ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Left Heart Kit Specific lots of Medex High Pressure Adaptors, Rotators, Manifolds, Stopcocks and Tubing and Medex LogiCal Kits may have been manufactured with insufficient or… Class IIFDA’s classApr 28, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 28, 2021ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall LogiCal Left Heart Kit Specific lots of Medex High Pressure Adaptors, Rotators, Manifolds, Stopcocks and Tubing and Medex LogiCal Kits may have been manufactured with insufficient or… Class IIFDA’s classApr 28, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 28, 2021ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Gang Cath Lab Set Specific lots of Medex High Pressure Adaptors, Rotators, Manifolds, Stopcocks and Tubing and Medex LogiCal Kits may have been manufactured with insufficient or… Class IIFDA’s classApr 28, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 28, 2021ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall ANGIOGRAPHIC KIT W/MX123-3MR MANIFOLD Specific lots of Medex High Pressure Adaptors, Rotators, Manifolds, Stopcocks and Tubing and Medex LogiCal Kits may have been manufactured with insufficient or… Class IIFDA’s classApr 28, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 28, 2021ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Manifold rotator (Component): a. 250 2 GANG MANIFOLD ROTATOR, OFF HANDLE Specific lots of Medex High Pressure Adaptors, Rotators, Manifolds, Stopcocks and Tubing and Medex LogiCal Kits may have been manufactured with insufficient or… Class IIFDA’s classApr 28, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 28, 2021ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Stopcock rotator (Component): a. 1050 STOPCOCK ROTATOR, OFF HANDLE Specific lots of Medex High Pressure Adaptors, Rotators, Manifolds, Stopcocks and Tubing and Medex LogiCal Kits may have been manufactured with insufficient or… Class IIFDA’s classApr 28, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 28, 2021ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall HIGH PRESSURE TUBING, 72IN Specific lots of Medex High Pressure Adaptors, Rotators, Manifolds, Stopcocks and Tubing and Medex LogiCal Kits may have been manufactured with insufficient or… Class IIFDA’s classApr 28, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 28, 2021ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall HIGH PRESSURE ROTATOR (Component) a Specific lots of Medex High Pressure Adaptors, Rotators, Manifolds, Stopcocks and Tubing and Medex LogiCal Kits may have been manufactured with insufficient or… Class IIFDA’s classApr 28, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 28, 2021ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Tubing with male luer lock adapter (Component) a. 76 cm Specific lots of Medex High Pressure Adaptors, Rotators, Manifolds, Stopcocks and Tubing and Medex LogiCal Kits may have been manufactured with insufficient or… Class IIFDA’s classApr 28, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 28, 2021ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Medex 10 IN Pressure Injector Line w/Rot Specific lots of Medex High Pressure Adaptors, Rotators, Manifolds, Stopcocks and Tubing and Medex LogiCal Kits may have been manufactured with insufficient or… Class IIFDA’s classApr 28, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 28, 2021ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall ELI 280 Electrocardiograph, with AM12M Acquisition Module accessory Devices do not meet IEC 60601-2-27 requirements as labeled. Class IIFDA’s classApr 28, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 15 states named PublishedApr 28, 2021ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, Florida, Georgia, Indiana, Louisiana, North Carolina, New Jersey, Nevada, New York, Ohio, Oklahoma, Texas, Utah and Virginia named
- Medical device recall ELI 380 Electrocardiograph, with AM12M Acquisition Module accessory Devices do not meet IEC 60601-2-27 requirements as labeled. Class IIFDA’s classApr 28, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 15 states named PublishedApr 28, 2021ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, Florida, Georgia, Indiana, Louisiana, North Carolina, New Jersey, Nevada, New York, Ohio, Oklahoma, Texas, Utah and Virginia named
- Medical device recall Surveyor S12/S19 Bedside Patient Monitor, with AM12M Acquisition Module accessory Devices do not meet IEC 60601-2-27 requirements as labeled. Class IIFDA’s classApr 28, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 15 states named PublishedApr 28, 2021ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, Florida, Georgia, Indiana, Louisiana, North Carolina, New Jersey, Nevada, New York, Ohio, Oklahoma, Texas, Utah and Virginia named
- Medical device recall AM12M Acquisition Module accessory Devices do not meet IEC 60601-2-27 requirements as labeled. Class IIFDA’s classApr 28, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 15 states named PublishedApr 28, 2021ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, Florida, Georgia, Indiana, Louisiana, North Carolina, New Jersey, Nevada, New York, Ohio, Oklahoma, Texas, Utah and Virginia named
- Medical device recall Tibial Opening Wedge Osteotomy Plate, Titanium, 15.0 mm - Product Usage: use in treatment of non-union,… It was discovered that five AR-13200ST-15.0 parts were processed as AR-13200T-15.0 parts. Class IIFDA’s classApr 21, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedApr 21, 2021ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Georgia, Louisiana, Oregon and Texas named
- Medical device recall VGlove NITRILE *** Protect Your Life 100 Patient examination gloves Package labeled as nitrile gloves, contains latex gloves. Class IIFDA’s classApr 21, 2021in FDA’s Enforcement ReportCaliforniathe one state its words name PublishedApr 21, 2021ClassClass IIStatusOngoingWhereCalifornia
- Medical device recall SUNSTAR Butler Clear Dip, 16 FL OZ Product may be contaminated with Burkholderia contaminans. Class IIFDA’s classApr 21, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 21, 2021ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Covidien Signia Small Diameter Curved Tip Intelligent Reload 45 mm Vascular/Thin 8 mm - Long Potential for the device safety interlock to fail. Class IIFDA’s classApr 21, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 21, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Covidien Signia Grey Small Diameter Curved Tip Intelligent Reload 30 mm Vascular 8 mm - Short Potential for the device safety interlock to fail. Class IIFDA’s classApr 21, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 21, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Covidien Signia Small Diameter Curved Tip Intelligent Reload 30 mm Vascular/Thin 8 mm - Short Potential for the device safety interlock to fail. Class IIFDA’s classApr 21, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 21, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ADVIA 2120 with Single Aspirate Autosampler (SMN 10316162) - US, automated hematology analyzer Software… Potential Sample Identification (SID) Mismatch with14-Character Barcodes Class IIFDA’s classApr 21, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 21, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ADVIA 2120 Dual Aspirate Autosampler (SMN 10313419) - US, automated hematology analyzer -automated hematology… Potential Sample Identification (SID) Mismatch with14-Character Barcodes Class IIFDA’s classApr 21, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 21, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ADVIA 2120 REFURB SAA AUTOSAMPLER (SMN 10374453) - US, automated hematology analyzer -automated hematology… Potential Sample Identification (SID) Mismatch with14-Character Barcodes Class IIFDA’s classApr 21, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 21, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ADVIA 2120 REFURB DAA AUTOSAMPLER (SMN 10374454) - US, automated hematology analyzer Software Versions 6.10… Potential Sample Identification (SID) Mismatch with14-Character Barcodes Class IIFDA’s classApr 21, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 21, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ADVIA 2120i with Single Aspirate Autosampler (SMN 10488923) - US, automated hematology analyzer Software… Potential Sample Identification (SID) Mismatch with14-Character Barcodes Class IIFDA’s classApr 21, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 21, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ADVIA 2120i Dual Aspirate Autosampler (SMN 10285573) - US, automated hematology analyzer Software Versions… Potential Sample Identification (SID) Mismatch with14-Character Barcodes Class IIFDA’s classApr 21, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 21, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ADVIA 2120i Refurb Single Aspirate (SMN 11314044) - US, automated hematology analyzer Software Versions 6.10… Potential Sample Identification (SID) Mismatch with14-Character Barcodes Class IIFDA’s classApr 21, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 21, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ADVIA 2120i Refurb Dual Aspirate (SMN 11314045) - US, automated hematology analyzer Software Versions 6.10… Potential Sample Identification (SID) Mismatch with14-Character Barcodes Class IIFDA’s classApr 21, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 21, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ADVIA 2120i (RoHS) with Single Aspirate Autosampler (SMN 11219529) - US, automated hematology analyzer… Potential Sample Identification (SID) Mismatch with14-Character Barcodes Class IIFDA’s classApr 21, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 21, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ADVIA 2120i (RoHS) Dual Aspirate Autosampler (SMN 11219530) - US, automated hematology analyzer Software… Potential Sample Identification (SID) Mismatch with14-Character Barcodes Class IIFDA’s classApr 21, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 21, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ADVIA 2120 with Single Aspirate Autosampler (SMN 10316162) - OUS, automated hematology analyzer Software… Potential Sample Identification (SID) Mismatch with14-Character Barcodes Class IIFDA’s classApr 21, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 21, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ADVIA 2120 Dual Aspirate Autosampler (SMN 10313419) - OUS, automated hematology analyzer Software Versions… Potential Sample Identification (SID) Mismatch with14-Character Barcodes Class IIFDA’s classApr 21, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 21, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ADVIA 2120 REFURB SAA AUTOSAMPLER (SMN 10374453) - OUS, automated hematology analyzer Software Versions 6.10… Potential Sample Identification (SID) Mismatch with14-Character Barcodes Class IIFDA’s classApr 21, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 21, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ADVIA 2120 REFURB DAA AUTOSAMPLER (SMN 10374454) - OUS, automated hematology analyzer Software Versions 6.10… Potential Sample Identification (SID) Mismatch with14-Character Barcodes Class IIFDA’s classApr 21, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 21, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ADVIA 2120i with Single Aspirate Autosampler (SMN 10488923) - OUS, automated hematology analyzer Software… Potential Sample Identification (SID) Mismatch with14-Character Barcodes Class IIFDA’s classApr 21, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 21, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ADVIA 2120i Dual Aspirate Autosampler (SMN 10285573) - OUS, automated hematology analyzer Software Versions… Potential Sample Identification (SID) Mismatch with14-Character Barcodes Class IIFDA’s classApr 21, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 21, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ADVIA 2120i Refurb Single Aspirate (SMN 11314044) - OUS, automated hematology analyzer Software Versions 6.10… Potential Sample Identification (SID) Mismatch with14-Character Barcodes Class IIFDA’s classApr 21, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 21, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ADVIA 2120i Refurb Dual Aspirate (SMN 11314045) - OUS, automated hematology analyzer Software Versions 6.10… Potential Sample Identification (SID) Mismatch with14-Character Barcodes Class IIFDA’s classApr 21, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 21, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ADVIA 2120i (RoHS) with Single Aspirate Autosampler (SMN 11219529) - OUS, automated hematology analyzer… Potential Sample Identification (SID) Mismatch with14-Character Barcodes Class IIFDA’s classApr 21, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 21, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ADVIA 2120i (RoHS) Dual Aspirate Autosampler (SMN 11219530) - OUS, automated hematology analyzer Software… Potential Sample Identification (SID) Mismatch with14-Character Barcodes Class IIFDA’s classApr 21, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 21, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Prodisc C - prosthesis, intervertebral disc - Product Usage: indicated in skeletally mature patients for… Centinel Spine learned through five customer complaints that the product was missing the “UP” etching on the superior plate of the prodisc C device. Class IIFDA’s classApr 21, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 14 states named PublishedApr 21, 2021ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Colorado, District of Columbia, Florida, Georgia, Kentucky, Maryland, Michigan, North Carolina, New York, Ohio, Pennsylvania and Tennessee named
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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