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 BioGX SARS-CoV-2 Reagents for BD MAX System Some N1 and N2 master mix pouches packaged within the lots of BioGX SARS-CoV-2 Reagents for BD MAX System may be mislabeled. Class IIFDA’s classFeb 17, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 17, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 60 IN (152cm) APPX 1.5 ml, PUR YELLOW SMALLBORE SET, FILTER REF B2209 - Product Usage: The intravascular… Due to the incorrect filter assembly. Class IIFDA’s classFeb 17, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 18 states named PublishedFeb 17, 2021ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Colorado, Connecticut, Florida, Idaho, Illinois, Louisiana, Massachusetts, Minnesota, North Carolina, New Jersey, New York, Tennessee, Texas, Virginia, Washington and West Virginia named
- Medical device recall 60” (152 cm) Appx 1.9 ml, Smallbore Ext Set w/MicroClave¿ Clear, 1.2 Micron Filter, 2 Clamps, Luer Lock REF… Due to the incorrect filter assembly. Class IIFDA’s classFeb 17, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 18 states named PublishedFeb 17, 2021ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Colorado, Connecticut, Florida, Idaho, Illinois, Louisiana, Massachusetts, Minnesota, North Carolina, New Jersey, New York, Tennessee, Texas, Virginia, Washington and West Virginia named
- Medical device recall 7 IN (18cm) APPX 0.43ml, SMALLBORE SET, MicroCLAVE, FILTER SetSource - Product Usage: The intravascular… Due to the incorrect filter assembly. Class IIFDA’s classFeb 17, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 18 states named PublishedFeb 17, 2021ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Colorado, Connecticut, Florida, Idaho, Illinois, Louisiana, Massachusetts, Minnesota, North Carolina, New Jersey, New York, Tennessee, Texas, Virginia, Washington and West Virginia named
- Medical device recall 154 cm (61 IN) APPX 1.5ml, PUR YELLOW EXT, 1.2 MICRON FILTER - Product Usage: The intravascular… Due to the incorrect filter assembly. Class IIFDA’s classFeb 17, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 18 states named PublishedFeb 17, 2021ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Colorado, Connecticut, Florida, Idaho, Illinois, Louisiana, Massachusetts, Minnesota, North Carolina, New Jersey, New York, Tennessee, Texas, Virginia, Washington and West Virginia named
- Medical device recall PRYTIME MEDICAL REBOA Catheter Introducer Kit There is a potential that a catheter convenience set contains a 21G access needle instead of the correct 18G needle. Class IIFDA’s classFeb 17, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 25 states named PublishedFeb 17, 2021ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Indiana, Massachusetts, Maine, Michigan, Missouri, Montana, New Jersey, New York, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall Cook Medical Kwart Retro-Inject Ureteral Stent Set 7.0Fr. 22-32cm -Used for retrograde injection during… Manufactured with incorrect material, which may result in the stent being stiffer and potentially susceptible to degradation could potentially lead to… Class IIFDA’s classFeb 17, 2021in FDA’s Enforcement Report6 statesnamed in where it went PublishedFeb 17, 2021ClassClass IIStatusTerminatedWhereFlorida, Kentucky, Maryland, New York, Pennsylvania and Texas
- Medical device recall B5-2Q BALLOON CATHETER Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Class IIFDA’s classFeb 17, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 17, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall B5-2C BALLOON CATHETER 11MM DIA 2.0 Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Class IIFDA’s classFeb 17, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 17, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall B7-2C BALLOON CATHETER 13mm dia 2.8 Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Class IIFDA’s classFeb 17, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 17, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall B7-2LA BALLOON CATHETER 13MM DIA 3.2 Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Class IIFDA’s classFeb 17, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 17, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall B7-2Q BALLOON CATHETER 13MM DIA 3.2 Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Class IIFDA’s classFeb 17, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 17, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall B-V233P-A 3-LUMEN EXTRACTION BALLOON V Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Class IIFDA’s classFeb 17, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 17, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall B-V243Q-A 3-LUMEN EXTRACTION BALLOON V Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Class IIFDA’s classFeb 17, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 17, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall B-V443Q-A 3-LUMEN EXTRACTION BALLOON V Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Class IIFDA’s classFeb 17, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 17, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall PR-V614M 2-LUMEN CANNULA Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Class IIFDA’s classFeb 17, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 17, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall K-201 GUIDE SHEATH Kit 2.0MM Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Class IIFDA’s classFeb 17, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 17, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall K-202 GUIDE SHEATH Kit 2.0MM Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Class IIFDA’s classFeb 17, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 17, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall K-203 GUIDE SHEATH Kit 2.6MM Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Class IIFDA’s classFeb 17, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 17, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall K-204 GUIDE SHEATH Kit 2.6MM Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Class IIFDA’s classFeb 17, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 17, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall KD-611L ELECTROSURGICAL KNIFE Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Class IIFDA’s classFeb 17, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 17, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall KD-612L ELECTROSURGICAL KNIFE Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Class IIFDA’s classFeb 17, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 17, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall KD-612U ELECTROSURGICAL SNARE Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Class IIFDA’s classFeb 17, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 17, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall KD-620LR ELECTROSURGICAL SNARE Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Class IIFDA’s classFeb 17, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 17, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall KD-620UR ELECTROSURGICAL SNARE Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Class IIFDA’s classFeb 17, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 17, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall KD-640L ELECTROSURGICAL SNARE Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Class IIFDA’s classFeb 17, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 17, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall KD-650L ELECTROSURGICAL SNARE Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Class IIFDA’s classFeb 17, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 17, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall KD-650U ELECTROSURGICAL SNARE Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Class IIFDA’s classFeb 17, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 17, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall KD-655L ELECTROSURGICAL SNARE Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Class IIFDA’s classFeb 17, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 17, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall KD-655U ELECTROSURGICAL SNARE Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Class IIFDA’s classFeb 17, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 17, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall SD-210U-10 ELECTROSURGICAL SNARE Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Class IIFDA’s classFeb 17, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 17, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall SD-210U-15 ELECTROSURGICAL SNARE, SD-210U-15 - Product Usage: Used with endoscopes to electrosurgically… Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Class IIFDA’s classFeb 17, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 17, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall SD-210U-25 ELECTROSURGICAL SNARE, SD-210U-25 - Product Usage: Used with endoscopes to electrosurgically… Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Class IIFDA’s classFeb 17, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 17, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall SD-230U-20 ELECTROSURGICAL SNARE Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Class IIFDA’s classFeb 17, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 17, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall SD-240U-10 ELECTROSURGICAL SNARE Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Class IIFDA’s classFeb 17, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 17, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall SD-240U-15 ELECTROSURGICAL SNARE Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Class IIFDA’s classFeb 17, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 17, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall SD-240U-25 ELECTROSURGICAL SNARE Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Class IIFDA’s classFeb 17, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 17, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall SD-400U-10 SNAREMASTER PLUS Hot/Cold 10m Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Class IIFDA’s classFeb 17, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 17, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall SD-400U-15 SNAREMASTER PLUS Hot/Cold 15m Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Class IIFDA’s classFeb 17, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 17, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall INJECTOR FORCEMAX UP 2.8MMCH 21G 4MM Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Class IIFDA’s classFeb 17, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 17, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall INJECTOR FORCEMAX UP 2.8MMCH 23G 4MM Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Class IIFDA’s classFeb 17, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 17, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall INJECTOR FORCEMAX UP 2.8MMCH 25G 4MM Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Class IIFDA’s classFeb 17, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 17, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall INJECTOR FORCEMAX UP 2.8MMCH 23G 5MM Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Class IIFDA’s classFeb 17, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 17, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall INJECTOR FORCEMAX UP 2.8MMCH 25G 5MM Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Class IIFDA’s classFeb 17, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 17, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall INJECTOR FORCEMAX UP 2.8MMCH 21G 6MM Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Class IIFDA’s classFeb 17, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 17, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall INJECTOR FORCEMAX UP 2.8MMCH 23G 6MM Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Class IIFDA’s classFeb 17, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 17, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall INJECTOR FORCEMAX UP 2.8MMCH 25G 6MM Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Class IIFDA’s classFeb 17, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 17, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall INJECTOR FORCEMAX LOWER 23G 3MM Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Class IIFDA’s classFeb 17, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 17, 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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