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 5, 2026.
2,303of 2,303 medical device recallsshown with your filters
The list
- Medical device recall Stealthstation System w/ Stealthstation Cranial Software 3.1.1,3.1.2,3.1 Cranial biopsy procedure software can enter a state where the biopsy depth gauge is no longer synchronized with the rest of the navigational information on the… FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 29, 2021in FDA’s Enforcement Report50 statesnamed in where it went PublishedDec 29, 2021ClassClass IStatusOngoingWhereAlaska, Alabama, 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, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall Stryker CLAW II ORTHOLOC 3DSi Plate, Hole Qty: 4, 30mm The incorrect product is contained in the packaging. Class IIFDA’s classDec 29, 2021in FDA’s Enforcement Report7 statesnamed in where it went PublishedDec 29, 2021ClassClass IIStatusOngoingWhereArizona, Iowa, Idaho, North Carolina, New York, Virginia and West Virginia
- Medical device recall Stryker DARCO Screw, Locking, Ti6A14V The incorrect product is contained in the packaging. Class IIFDA’s classDec 29, 2021in FDA’s Enforcement Report7 statesnamed in where it went PublishedDec 29, 2021ClassClass IIStatusOngoingWhereArizona, Iowa, Idaho, North Carolina, New York, Virginia and West Virginia
- Medical device recall WIRION EMBOLIC PROTECTION SYSTEM, Delivery Catheter and Filter and Retrieval Catheter, 6Fr Under certain circumstances, the WIRION filter assembly may become difficult to withdraw. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 29, 2021in FDA’s Enforcement Report38 statesnamed in where it went PublishedDec 29, 2021ClassClass IStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, District of Columbia, Florida, Georgia, Guam, Hawaii, Iowa, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, Mississippi, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall VirtuTRAX Instrument Navigator, Sensor with 14 Ga VirtutTRAX There is potential that the VirtuTRAX device will not tighten onto the instrument to be used. Class IIFDA’s classDec 29, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 29, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall VirtuTRAX Instrument Navigator, 14 Ga VirtuTRAX There is potential that the VirtuTRAX device will not tighten onto the instrument to be used. Class IIFDA’s classDec 29, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 29, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall VirtuTRAX Instrument Navigator, Sensor with 10 17 GA VirtutTRAX There is potential that the VirtuTRAX device will not tighten onto the instrument to be used. Class IIFDA’s classDec 29, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 29, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall VirtuTRAX Instrument Navigator, 10 17 GA VirtuTRAX There is potential that the VirtuTRAX device will not tighten onto the instrument to be used. Class IIFDA’s classDec 29, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 29, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall SYNCHRON Systems Cholesterol (CHOL) Reagent Cholesterol Reagent may fail with Out of Calibration Range Low (OCR Low) and/or Back to Back (B/B) errors. Class IIFDA’s classDec 29, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 39 states named PublishedDec 29, 2021ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Custom Assemblies, Inc., Single Spike Tumescent Set w/o Chamber, Reorder Number CMS-1212NS Bulk This recall has been initiated to address bulk packed, non-sterile Intravascular Administration Sets that were erroneously distributed to fill orders for the… Class IIFDA’s classDec 29, 2021in FDA’s Enforcement Report10 statesnamed in where it went PublishedDec 29, 2021ClassClass IIStatusTerminatedWhereColorado, Connecticut, Massachusetts, Michigan, North Carolina, New Jersey, New York, Ohio, Oregon and Texas
- Medical device recall Wright Medical Technology Inc Incorrect product is contained in the packaging. Class IIFDA’s classDec 29, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedDec 29, 2021ClassClass IIStatusOngoingWhereNationwide, and Arizona, Iowa and South Carolina named
- Medical device recall These are communication systems, labeled as: a An unrecoverable error may occur where a component will fail to complete the reboot cycle, become non-functional and must be replaced. Class IIFDA’s classDec 29, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 29, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Hemashield Gold Knitted Bifurcated, 18 mm x 9 mm There is a probable mislabeling of product. Class IIFDA’s classDec 29, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedDec 29, 2021ClassClass IIStatusTerminatedWhereNationwide, and Illinois and North Carolina named
- Medical device recall Stanbio TDM/B-Hydroxybutyrate Tri-Level Controls, Ref Affected product was shipped from the warehouse at room temperature instead of the required refrigerated environment. Class IIFDA’s classDec 29, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedDec 29, 2021ClassClass IIStatusTerminatedWhereNationwide, and Illinois, Mississippi, Ohio and Pennsylvania named
- Medical device recall Malosa Core LASIK Pack 2-Medical Refractive Kit- intended to be used to aid in cataract, corneal, or… Kit packaging may have small holes compromising product sterility Class IIFDA’s classDec 29, 2021in FDA’s Enforcement Report9 statesnamed in where it went PublishedDec 29, 2021ClassClass IIStatusOngoingWhereCalifornia, Colorado, Louisiana, Massachusetts, Maryland, North Dakota, Pennsylvania, Tennessee and Utah
- Medical device recall Malosa Core Suface Treatment Pack -Medical Corneal Kit intended to be used to aid in cataract, corneal, or… Kit packaging may have small holes compromising product sterility Class IIFDA’s classDec 29, 2021in FDA’s Enforcement Report9 statesnamed in where it went PublishedDec 29, 2021ClassClass IIStatusOngoingWhereCalifornia, Colorado, Louisiana, Massachusetts, Maryland, North Dakota, Pennsylvania, Tennessee and Utah
- Medical device recall Malosa Core Phaco Pack 1-Medical Cataract Kit intended to be used to aid in cataract, corneal, or refractive… Kit packaging may have small holes compromising product sterility Class IIFDA’s classDec 29, 2021in FDA’s Enforcement Report9 statesnamed in where it went PublishedDec 29, 2021ClassClass IIStatusOngoingWhereCalifornia, Colorado, Louisiana, Massachusetts, Maryland, North Dakota, Pennsylvania, Tennessee and Utah
- Medical device recall Malosa Core Phaco Pack 2- Medical Refractive Kit intended to be used to aid in cataract, corneal, or… Kit packaging may have small holes compromising product sterility Class IIFDA’s classDec 29, 2021in FDA’s Enforcement Report9 statesnamed in where it went PublishedDec 29, 2021ClassClass IIStatusOngoingWhereCalifornia, Colorado, Louisiana, Massachusetts, Maryland, North Dakota, Pennsylvania, Tennessee and Utah
- Medical device recall Malosa Core SMILE Pack 1-Medical Refractive Kit intended to be used to aid in cataract, corneal, or… Kit packaging may have small holes compromising product sterility Class IIFDA’s classDec 29, 2021in FDA’s Enforcement Report9 statesnamed in where it went PublishedDec 29, 2021ClassClass IIStatusOngoingWhereCalifornia, Colorado, Louisiana, Massachusetts, Maryland, North Dakota, Pennsylvania, Tennessee and Utah
- Medical device recall Malosa Core SMILE Pack 2-Beaver-Visitec- A Medical Refractive Kit intended to be used to aid in cataract,… Kit packaging may have small holes compromising product sterility Class IIFDA’s classDec 29, 2021in FDA’s Enforcement Report9 statesnamed in where it went PublishedDec 29, 2021ClassClass IIStatusOngoingWhereCalifornia, Colorado, Louisiana, Massachusetts, Maryland, North Dakota, Pennsylvania, Tennessee and Utah
- Medical device recall regard Clinical Packaging Solutions The kit contains a non-sterile needle. Class IIFDA’s classDec 29, 2021in FDA’s Enforcement ReportMissourithe one state its words name PublishedDec 29, 2021ClassClass IIStatusTerminatedWhereMissouri
- Medical device recall Leica Microsystems M220 F12 Microscope Systems In May 2021, Leica Microsystems received one (1) complaint pertaining to the M220 F12 Surgical Microscope system. Class IIFDA’s classDec 29, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 18 states named PublishedDec 29, 2021ClassClass IIStatusTerminatedWhereNationwide, and California, District of Columbia, Florida, Georgia, Illinois, Indiana, Massachusetts, Maryland, Michigan, New York, Ohio, Oregon, Pennsylvania, Puerto Rico, Tennessee, Texas, Virginia and Wisconsin named
- Medical device recall Torosa Saline-Filled Testicular Prosthesis (Size Small) Product is mislabeled for size. Class IIFDA’s classDec 29, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 29, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Skinny Needle with Chiba Tip Specific lots may contain black debris on the exterior of the inner stylet and/or on the interior of the outer cannula. Class IIFDA’s classDec 29, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedDec 29, 2021ClassClass IIStatusOngoingWhereNationwide, and Alabama, California, Indiana, Louisiana, Mississippi, Montana, North Carolina, New York, Oregon, Pennsylvania and Washington named
- Medical device recall TruDi NAV Suction Instruments: 0-Degree Suction Instruments were incorrectly calibrated so they may not meet the system accuracy specification for visual verification of device location in the… Class IIFDA’s classDec 29, 2021in FDA’s Enforcement Report39 statesnamed in where it went PublishedDec 29, 2021ClassClass IIStatusOngoingWhereAlabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Wisconsin, West Virginia and Wyoming
- Medical device recall Philips Allura Xper FD series with Software Version Number: 2.1.x- intended for Vascular, cardiovascular and… Set screws securing the two gliding rods of the Extra Monitors (called 7th and 8th monitor) mounted on the Monitor Ceiling Suspension (MCS) can come loose, the… Class IIFDA’s classDec 29, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedDec 29, 2021ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia, Georgia, Massachusetts, Texas and Virginia named
- Medical device recall Stealth Autoguide Tracker A tracker that holds and guides neurosurgical surgical instruments may be subject to separation/weld failure, where the tracker connects to the instrument tube. Class IIFDA’s classDec 29, 2021in FDA’s Enforcement Report21 statesnamed in where it went PublishedDec 29, 2021ClassClass IIStatusOngoingWhereArizona, California, Florida, Illinois, Indiana, Kansas, Kentucky, Michigan, Minnesota, Missouri, Mississippi, Nebraska, Nevada, Ohio, Oklahoma, Oregon, South Carolina, Texas, Utah, Virginia and Washington
- Medical device recall Cardiosave Hybrid IntraAortic Balloon Pump Firm is initiating a correction due to the possibility of fluid ingress. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 22, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 22, 2021ClassClass IStatusOngoingWhereNationwide
- Medical device recall Cardiosave Rescue IntraAortic Balloon Pump Firm is initiating a correction due to the possibility of fluid ingress. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 22, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 22, 2021ClassClass IStatusOngoingWhereNationwide
- Medical device recall EVLP Convenience Pack/Kit NaCl 250 mL Bag Inj expired 04/2020 while the kit expiration date was after 04/2020. Class IIFDA’s classDec 22, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 22, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Neuro Convenience Kit NaCl 250 mL Bag Inj expired 04/2020 while the kit expiration date was after 04/2020. Class IIFDA’s classDec 22, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 22, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Major Vascular CDS Convenience Kit NaCl 250 mL Bag Inj expired 04/2020 while the kit expiration date was after 04/2020. Class IIFDA’s classDec 22, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 22, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Venous Access Pack-LF Convenience Kit NaCl 250 mL Bag Inj expired 04/2020 while the kit expiration date was after 04/2020. Class IIFDA’s classDec 22, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 22, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Bedside PICC CDS Convenience Kit NaCl 250 mL Bag Inj expired 04/2020 while the kit expiration date was after 04/2020. Class IIFDA’s classDec 22, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 22, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall smith&Nephew EVOS MEDIAL DISTAL FEMUR PLATE, L, 5H, 90MM Testing vendor notified Smith & Nephew that previous MRI scanning conditions provided in Exponents reports were erroneous. Class IIFDA’s classDec 22, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 16 states named PublishedDec 22, 2021ClassClass IIStatusTerminatedWhereNationwide, and Colorado, Florida, Georgia, Massachusetts, Minnesota, Missouri, North Carolina, New Jersey, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Tennessee, Texas and Washington named
- Medical device recall smith&nephew EVOS MEDIAL DISTAL FEMUR PLATE, R, 5H, 90MM Testing vendor notified Smith & Nephew that previous MRI scanning conditions provided in Exponents reports were erroneous. Class IIFDA’s classDec 22, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 16 states named PublishedDec 22, 2021ClassClass IIStatusTerminatedWhereNationwide, and Colorado, Florida, Georgia, Massachusetts, Minnesota, Missouri, North Carolina, New Jersey, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Tennessee, Texas and Washington named
- Medical device recall smith&nephew EVOS CONDYLAR MEDIAL DISTAL FEMUR PLATE, L, 5H, 115MM Testing vendor notified Smith & Nephew that previous MRI scanning conditions provided in Exponents reports were erroneous. Class IIFDA’s classDec 22, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 16 states named PublishedDec 22, 2021ClassClass IIStatusTerminatedWhereNationwide, and Colorado, Florida, Georgia, Massachusetts, Minnesota, Missouri, North Carolina, New Jersey, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Tennessee, Texas and Washington named
- Medical device recall smith&nephew EVOS CONDYLAR MEDIAL DISTAL FEMUR PLATE, R, 5H, 115MM Testing vendor notified Smith & Nephew that previous MRI scanning conditions provided in Exponents reports were erroneous. Class IIFDA’s classDec 22, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 16 states named PublishedDec 22, 2021ClassClass IIStatusTerminatedWhereNationwide, and Colorado, Florida, Georgia, Massachusetts, Minnesota, Missouri, North Carolina, New Jersey, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Tennessee, Texas and Washington named
- Medical device recall MENTOR Saline-Filled Breast Implants are constructed from room temperature vulcanized silicone elastomer,… Due to a manufacturing issue, Implant may have a potentially weakened area on the base patch portion of the implant which may cause leakage/deflation of the… Class IIFDA’s classDec 22, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedDec 22, 2021ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, 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, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall SmartGown Breathable Surgical Gowns with raglan sleeves X-large, X-long, A-line Potential for open packaging seals compromising the sterility of the surgical gowns Class IIFDA’s classDec 22, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 22, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns-Large Potential for open packaging seals compromising the sterility of the surgical gowns Class IIFDA’s classDec 22, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 22, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns-X-Large Potential for open packaging seals compromising the sterility of the surgical gowns Class IIFDA’s classDec 22, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 22, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns X-large, X-long Potential for open packaging seals compromising the sterility of the surgical gowns Class IIFDA’s classDec 22, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 22, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Cardinal Health Poly-Reinforced Surgical Gowns Large Potential for open packaging seals compromising the sterility of the surgical gowns Class IIFDA’s classDec 22, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 22, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Cardinal Health Poly-Reinforced Surgical Gowns X-large Potential for open packaging seals compromising the sterility of the surgical gowns Class IIFDA’s classDec 22, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 22, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Cardinal Health Poly-Reinforced Surgical Gowns XX-large Potential for open packaging seals compromising the sterility of the surgical gowns Class IIFDA’s classDec 22, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 22, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall RoyalSilk Non-Reinforced Surgical Gowns Large Potential for open packaging seals compromising the sterility of the surgical gowns Class IIFDA’s classDec 22, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 22, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall RoyalSilk Non-Reinforced Surgical Gowns X-large Potential for open packaging seals compromising the sterility of the surgical gowns Class IIFDA’s classDec 22, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 22, 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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