Medical devices, 2021
Shortlist up to four to read them side by side.
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 CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 36mm Material Number: 66-236 - Product Usage:… Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision Class IIFDA’s classMar 17, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 17, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 38mm Material Number: 66-238 - Product Usage:… Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision Class IIFDA’s classMar 17, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 17, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 40mm Material Number: 66-240 - Product Usage:… Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision Class IIFDA’s classMar 17, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 17, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 42mm Material Number: 66-242 - Product Usage:… Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision Class IIFDA’s classMar 17, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 17, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall CervAlign Anterior Cervical Plate System-Cervalign, 3 Level, 42mm Material Number: 66-342 - Product Usage:… Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision Class IIFDA’s classMar 17, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 17, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall CervAlign Anterior Cervical Plate System-Cervalign, 3 Level, 45mm Material Number: 66-345 - Product Usage:… Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision Class IIFDA’s classMar 17, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 17, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall CervAlign Anterior Cervical Plate System-Cervalign, 3 Level, 48mm Material Number: 66-348 - Product Usage:… Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision Class IIFDA’s classMar 17, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 17, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall CervAlign Anterior Cervical Plate System-Cervalign, 3Level, 51mm Material Number: 66-351 - Product Usage:… Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision Class IIFDA’s classMar 17, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 17, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall CervAlign Anterior Cervical Plate System-Cervalign, 3Level, 54mm Material Number: 66-354 - Product Usage:… Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision Class IIFDA’s classMar 17, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 17, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall CervAlign Anterior Cervical Plate System-Cervalign, 3Level, 57mm Material Number: 66-357 - Product Usage:… Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision Class IIFDA’s classMar 17, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 17, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall CervAlign Anterior Cervical Plate System-Cervalign, 3Level, 60mm Material Number: 66-360 - Product Usage:… Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision Class IIFDA’s classMar 17, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 17, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall CervAlign Anterior Cervical Plate System-Cervalign, 3Level, 63mm Material Number: 66-363 - Product Usage:… Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision Class IIFDA’s classMar 17, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 17, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall CervAlign Anterior Cervical Plate System-Cervalign, 4Level, 60mm Material Number: 66-460 - Product Usage:… Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision Class IIFDA’s classMar 17, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 17, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall CervAlign Anterior Cervical Plate System-Cervalign, 4Level, 64mm Material Number: 66-464 - Product Usage:… Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision Class IIFDA’s classMar 17, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 17, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall CervAlign Anterior Cervical Plate System-Cervalign, 4Level, 68mm Material Number: 66-468 - Product Usage:… Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision Class IIFDA’s classMar 17, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 17, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall CervAlign Anterior Cervical Plate System-Cervalign, 4Level, 72mm Material Number: 66-472 - Product Usage:… Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision Class IIFDA’s classMar 17, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 17, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall CervAlign Anterior Cervical Plate System-Cervalign, 4Level, 76mm Material Number: 66-476 - Product Usage:… Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision Class IIFDA’s classMar 17, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 17, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall CervAlign Anterior Cervical Plate System-Cervalign, 4Level, 80mm Material Number: 66-480 - Product Usage:… Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision Class IIFDA’s classMar 17, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 17, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall CervAlign Anterior Cervical Plate System-Cervalign, 4Level, 84mm Material Number: 66-484 - Product Usage:… Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision Class IIFDA’s classMar 17, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 17, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall CervAlign Anterior Cervical Plate System-Cervalign, 4Level, 88mm Material Number: 66-488 - Product Usage:… Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision Class IIFDA’s classMar 17, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 17, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall CervAlign Anterior Cervical Plate System-Cervalign, 5 Level, 100mm Material Number: 66-5100 - Product Usage:… Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision Class IIFDA’s classMar 17, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 17, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall CervAlign Anterior Cervical Plate System-Cervalign, 5 Level, 105mm Material Number: 66-5105 - Product Usage:… Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision Class IIFDA’s classMar 17, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 17, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall CervAlign Anterior Cervical Plate System-Cervalign, 5 Level, 75mm Material Number: 66-575 - Product Usage:… Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision Class IIFDA’s classMar 17, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 17, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall CervAlign Anterior Cervical Plate System-Cervalign, 5 Level, 80mm Material Number: 66-580 - Product Usage:… Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision Class IIFDA’s classMar 17, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 17, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall CervAlign Anterior Cervical Plate System-Cervalign, 5 Level, 85mm Material Number: 66-585 - Product Usage:… Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision Class IIFDA’s classMar 17, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 17, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall CervAlign Anterior Cervical Plate System-Cervalign, 5 Level, 90mm Material Number: 66-590 - Product Usage:… Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision Class IIFDA’s classMar 17, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 17, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall CervAlign Anterior Cervical Plate System-Cervalign, 5 Level, 95mm Material Number: 66-595 - Product Usage:… Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision Class IIFDA’s classMar 17, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 17, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall CervAlign Anterior Cervical Plate System-Cervalign, 1 Level, 22mm Material Number: 66-122 - Product Usage:… Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision Class IIFDA’s classMar 17, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 17, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 30mm Material Number: 66-230 - Product Usage:… Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision Class IIFDA’s classMar 17, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 17, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medtronic 6F Launcher Guide Catheter 100 cmJL 3.5 Sterility may be compromised due to an unsealed pouch Class IIFDA’s classMar 17, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 17, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Medtronic 6F Launcher Guide Catheter 100 cm JR 4.0 Sterility may be compromised due to an unsealed pouch Class IIFDA’s classMar 17, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 17, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Medtronic 6F Launcher Guide Catheter 100cm EBU 3.75 Sterility may be compromised due to an unsealed pouch Class IIFDA’s classMar 17, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 17, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Medtronic 6F Launcher Guide Catheter 100 cm EBU 3.0 Sterility may be compromised due to an unsealed pouch Class IIFDA’s classMar 17, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 17, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall The PrisMax System Version II Hemodialysis Delivery System: Automatic Repositioning System Pump Assembly,… Variability in the performance of the tubing in the ARPS (Automatic Repositioning System) Pump Assembly which may lead to alarm situations during system… Class IIFDA’s classMar 10, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 34 states named PublishedMar 10, 2021ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall Milex Gellhorn Flexible under the following labels: 1) Gellhorn Flexible w/Short Stem Pessary The affected Milex Gellhorn pessaries were incorrectly manufactured with a long stem (2.170 ), instead of a short stem (1.670 or 1.960 nominal height) as… Class IIFDA’s classMar 10, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 15 states named PublishedMar 10, 2021ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Arizona, California, Florida, Illinois, Kansas, Massachusetts, Michigan, North Carolina, New York, Pennsylvania, Puerto Rico, Tennessee, Texas and Washington named
- Medical device recall Velocity Disposable Bipolar Ablators - Product Usage: intended to be used for cutting, vaporization, and… There can be a potential breach of the sterile packaging barrier due to the development of pinholes at the crease of the double-folded edge of the current… Class IIFDA’s classMar 10, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedMar 10, 2021ClassClass IIStatusOngoingWhereNationwide, and California and Florida named
- Medical device recall HNM Disposable Bipolar Ablators - Product Usage: intended to be used for cutting, vaporization, and… There can be a potential breach of the sterile packaging barrier due to the development of pinholes at the crease of the double-folded edge of the current… Class IIFDA’s classMar 10, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedMar 10, 2021ClassClass IIStatusOngoingWhereNationwide, and California and Florida named
- Medical device recall ConMed Disposable Bipolar Ablators - Product Usage: intended to be used for cutting, vaporization, and… There can be a potential breach of the sterile packaging barrier due to the development of pinholes at the crease of the double-folded edge of the current… Class IIFDA’s classMar 10, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedMar 10, 2021ClassClass IIStatusOngoingWhereNationwide, and California and Florida named
- Medical device recall HAMILTON HEATER SHAKER, 115 VAC/ 230 VAC, 750 VA, Power Consumption 41V/ 100W (max.), Relative Humidity 15% -… There is a risk that the device can start a fire if flammable liquids contact and enter the device. Class IIFDA’s classMar 10, 2021in FDA’s Enforcement Report44 statesnamed in where it went PublishedMar 10, 2021ClassClass IIStatusOngoingWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming
- Medical device recall Gram-Negative Bacteria And Associated Resistance Markers The firm has identified an increased risk of false positive Pseudomonas aeruginosa when BCID/BCID2 Panels are used with specific BD BACTEC” blood culture vials. Class IIFDA’s classMar 10, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 10, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BioFire BCID2 Panel The firm has identified an increased risk of false positive Pseudomonas aeruginosa when BCID/BCID2 Panels are used with specific BD BACTEC” blood culture vials. Class IIFDA’s classMar 10, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 10, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Various reprocessed products: PROVISION, Reprocessed Smith and Nephew Arthroscopic Shavers, STERILE EO Non-sterile product was shipped to customers labelled as sterile. Class IIFDA’s classMar 10, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedMar 10, 2021ClassClass IIStatusOngoingWhereNationwide, and California, New Jersey and Oregon named
- Medical device recall Digitial Medica X-ray Imagining System There is a potential for the X-Ray tube head (Touch screen interface) to perform an uncommanded motion. Class IIFDA’s classMar 10, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 10, 2021ClassClass IIStatusTerminatedWhereNationwide, and Texas named
- Medical device recall ACIST Kodama Intravascular Ultrasound Catheter The Kodama Intravascular Ultrasound Catheter is a component of… Test results from the manufacturing line found a piece of damaged o-ring in an unexpected section of the catheter. FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 10, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 19 states named PublishedMar 10, 2021ClassClass IStatusTerminatedWhereNationwide, and Alabama, Arkansas, California, Colorado, Florida, Illinois, Kansas, Kentucky, Louisiana, Maryland, Michigan, Missouri, North Carolina, New Jersey, New York, Oklahoma, Pennsylvania, Rhode Island and Tennessee named
- Medical device recall WMTS Telemetry Receiver, Multiple Patient Receiver Incorrect Date Stamp or No Data Transfer on Telemetry Receiver and Transmitter. Class IIFDA’s classMar 10, 2021in FDA’s Enforcement Report46 statesnamed in where it went PublishedMar 10, 2021ClassClass IIStatusOngoingWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall TECNIS Toric 1-Piece IOL Due to the release of nonconforming Intraocular Lenses (IOLs). Class IIFDA’s classMar 10, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 18 states named PublishedMar 10, 2021ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Florida, Georgia, Illinois, Louisiana, Michigan, Minnesota, North Carolina, New York, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Utah and Washington named
- Medical device recall Band, Elastic, Orthodontic - Product Usage: Orthodontic elastics, also referred to as rubber bands, are small… The text on the patient pack is correct and the product itself remains unchanged. Class IIFDA’s classMar 10, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 20 states named PublishedMar 10, 2021ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, California, Connecticut, Florida, Illinois, Kentucky, Michigan, Minnesota, Mississippi, Montana, North Carolina, New Hampshire, New Jersey, New York, Tennessee, Texas, Utah, Vermont, Washington and West Virginia named
- Medical device recall Captivator Single-Use Polypectomy Snares, Captiflex Single-Use Polypectomy Snares Packaging Incomplete Seal. Class IIFDA’s classMar 10, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 10, 2021ClassClass IIStatusOngoingWhereNationwide
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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