Medical devices, 2022
Shortlist up to four to read them side by side.
2,192 medical device recalls FDA’s Enforcement Report published in 2022, 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.
2,192of 2,192 medical device recallsshown with your filters
The list
- Medical device recall SS 4.5MM Pellet Insertion Tray with Large Gloves Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a… Class IIFDA’s classJun 8, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 8, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall SS 4.5MM Pellet Insertion Tray with Medium Gloves Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a… Class IIFDA’s classJun 8, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 8, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall SS 3.5MM Diamond Tip Trocar - Large Gloves Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a… Class IIFDA’s classJun 8, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 8, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall SS 3.5MM Diamond Tip Trocar - Medium Gloves Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a… Class IIFDA’s classJun 8, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 8, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall SS 4.5MM DIAMOND TIP TROCAR WITH LARGE GLOVES Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a… Class IIFDA’s classJun 8, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 8, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall SS 4.5MM DIAMOND TIP TROCAR WITH MEDIUM GLOVES Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a… Class IIFDA’s classJun 8, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 8, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Female SS 3.5MM Pellet Insertion Tray Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a… Class IIFDA’s classJun 8, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 8, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Male SS 4.5MM Pellet Insertion Tray Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a… Class IIFDA’s classJun 8, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 8, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Pellet Insertion Tray Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a… Class IIFDA’s classJun 8, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 8, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 3.2MM Pellet Insertion Tray Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a… Class IIFDA’s classJun 8, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 8, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall SS 3.2MM Pellet Insertion Tray Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a… Class IIFDA’s classJun 8, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 8, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 4.5 MM Pellet Insertion Tray Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a… Class IIFDA’s classJun 8, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 8, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall SS 4.5MM Pellet Insertion Tray Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a… Class IIFDA’s classJun 8, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 8, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Female SS 3.5MM Pellet Insertion Tray Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a… Class IIFDA’s classJun 8, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 8, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Male SS 4.5MM Pellet Insertion Tray Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a… Class IIFDA’s classJun 8, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 8, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 3.2MM Pellet Insertion Tray Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a… Class IIFDA’s classJun 8, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 8, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall SS 4.5MM Pellet Insertion Tray Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a… Class IIFDA’s classJun 8, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 8, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Proteus235- Proton Therapy System: to produce and deliver a proton beam for the treatment of patients with… First layer of Uniform Scanning treatment fields is sometimes irradiated with incorrect Scanning Magnet setpoints resulting in the field size may be smaller… Class IIFDA’s classJun 8, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedJun 8, 2022ClassClass IIStatusOngoingWhereNationwide, and Illinois, Virginia and Washington named
- Medical device recall The C304-HIS device features a guide wire to access the vein, a valve to reduce blood loss during the implant… The firm’s internal processes identified that certain lots may have an improperly sealed barrier that could potentially compromise sterility. Class IIFDA’s classJun 8, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 40 states named PublishedJun 8, 2022ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall Resin UPDATE CD-ROM The problem is with the Bio-Rad VARIANT nbs Sickle Cell Program Resin Update CD-ROM software; Model Number: 250-3020, included in VARIANT nbs Sickle Cell… Class IIFDA’s classJun 8, 2022in FDA’s Enforcement Report24 statesnamed in where it went PublishedJun 8, 2022ClassClass IIStatusOngoingWhereAlabama, Arkansas, Arizona, Colorado, Florida, Georgia, Iowa, Indiana, Kansas, Kentucky, Louisiana, Maryland, Minnesota, Missouri, North Carolina, New Jersey, New York, Ohio, Oregon, Puerto Rico, South Carolina, Tennessee, Utah and Virginia
- Medical device recall VESSEL SEALER EXTEND, Single-Use Instrument EndoWrist Instruments 8mm, da Vinci X’ da Vinci Xi’ Placing excessive tissue in the instrument jaws of the devices prior to sealing and transection can result in an insufficient seal. Class IIFDA’s classJun 8, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 8, 2022ClassClass IIStatusCompletedWhereNationwide
- Medical device recall DAVINCI | Energy SynchroSeal da Vinci X’ da Vinci Xi’, Single Use Instrument 8mm Placing excessive tissue in the instrument jaws of the devices prior to sealing and transection can result in an insufficient seal. Class IIFDA’s classJun 8, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 8, 2022ClassClass IIStatusCompletedWhereNationwide
- Medical device recall XVIVO Organ Chamber The weld seal of the primary pouch was incomplete, and the sterility of the product cannot be ensured/guaranteed. Class IIFDA’s classJun 8, 2022in FDA’s Enforcement Report8 statesnamed in where it went PublishedJun 8, 2022ClassClass IIStatusTerminatedWhereCalifornia, Florida, Massachusetts, North Carolina, New York, Ohio, Pennsylvania and Texas
- Medical device recall FIRMap” Catheter, 60mm Basket Incorrect product labeling. Class IIFDA’s classJun 8, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedJun 8, 2022ClassClass IIStatusTerminatedWhereNationwide, and California, Missouri, Ohio and Washington named
- Medical device recall BD Anti-Kappa APC (Cat Anti-Kappa APC & Anti-Kappa PE analyte reagents may exhibit uncharacteristic flow profiles. Class IIFDA’s classJun 8, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 29 states named PublishedJun 8, 2022ClassClass IIStatusOngoingWhereNationwide, and Alabama, California, Colorado, District of Columbia, Delaware, Florida, Iowa, Illinois, Indiana, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, North Carolina, North Dakota, New York, Ohio, Oklahoma, Pennsylvania, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall BD Anti-Kappa PE (Cat Anti-Kappa APC & Anti-Kappa PE analyte reagents may exhibit uncharacteristic flow profiles. Class IIFDA’s classJun 8, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 29 states named PublishedJun 8, 2022ClassClass IIStatusOngoingWhereNationwide, and Alabama, California, Colorado, District of Columbia, Delaware, Florida, Iowa, Illinois, Indiana, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, North Carolina, North Dakota, New York, Ohio, Oklahoma, Pennsylvania, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Ratcheting Screwdriver Handle, provided in the Aequalis Perform Reversed kit The device is unable to meet sterilization requirements when sterilized per instructions in an Aesculap container. Class IIFDA’s classJun 8, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 8, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MEDLINE Polyurethane Foam Enzymatic Cleaning Sponge Sporadic reports were received of discoloration on the foam sponge on certain lots of the product, which has been identified as microbial contamination. Class IIFDA’s classJun 8, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 8, 2022ClassClass IIStatusOngoingWhereNo state named
- Medical device recall MEDLINE Polyurethane Foam Bedside Cleaning Kit Sporadic reports were received of discoloration on the foam sponge on certain lots of the product, which has been identified as microbial contamination. Class IIFDA’s classJun 8, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 8, 2022ClassClass IIStatusOngoingWhereNo state named
- Medical device recall MEDLINE Polyurethane Bedside Cleaning Kit Sporadic reports were received of discoloration on the foam sponge on certain lots of the product, which has been identified as microbial contamination. Class IIFDA’s classJun 8, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 8, 2022ClassClass IIStatusOngoingWhereNo state named
- Medical device recall MEDLINE Polyurethane Foam Bedside Cleaning Kit Sporadic reports were received of discoloration on the foam sponge on certain lots of the product, which has been identified as microbial contamination. Class IIFDA’s classJun 8, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 8, 2022ClassClass IIStatusOngoingWhereNo state named
- Medical device recall MEDLINE Polyurethane Foam Bedside Cleaning Kit Sporadic reports were received of discoloration on the foam sponge on certain lots of the product, which has been identified as microbial contamination. Class IIFDA’s classJun 8, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 8, 2022ClassClass IIStatusOngoingWhereNo state named
- Medical device recall DYNEX Agility, Agility Analyzer Control samples aspirated from wrong SmartKit on the Agility. Class IIFDA’s classJun 8, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 22 states named PublishedJun 8, 2022ClassClass IIStatusOngoingWhereNationwide, and Alabama, California, District of Columbia, Florida, Georgia, Illinois, Indiana, Massachusetts, Maryland, Michigan, Nebraska, New Jersey, New York, Ohio, Pennsylvania, Puerto Rico, Tennessee, Texas, Utah, Virginia, Wisconsin and West Virginia named
- Medical device recall NIM Vital Console 4.0 (P/N: NIM4CM01) NIM with Software version 1.3.2 Software anomaly was identified. Class IIFDA’s classJun 8, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedJun 8, 2022ClassClass IIStatusOngoingWhereNationwide, and Colorado, New Jersey and Texas named
- Medical device recall NIM Vital Patient Interface 4.0 (P/N: NIM4CPB1) NIM with Software version 1.3.2 Software anomaly was identified. Class IIFDA’s classJun 8, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedJun 8, 2022ClassClass IIStatusOngoingWhereNationwide, and Colorado, New Jersey and Texas named
- Medical device recall PROFEMUR PLASMA Z CLASSIC STEM SIZE 7 STANDARD SHORT NECK One manufacturing lot is missing the plasma-spray coating in the proximal region of the stem body. Class IIFDA’s classJun 8, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedJun 8, 2022ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Indiana and Missouri named
- Medical device recall Sara Plus Active Floor Lift The device may emit smoke or ignite. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 1, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 1, 2022ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Ultra Pure Non-Woven Sponges Non-Sterile 4-Ply 5,000 per case 25 sleeves of 200 2 in x 2 in / 5.1 cm x 5.1 cm Product not approved for release for US distribution Class IIFDA’s classJun 1, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 1, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Ultra Pure Non-Woven Sponges Non-Sterile 4-Ply 2,000 per case 10 sleeves of 200 4 in x 4 in / 10.2 cm x 10.2… Product not approved for release for US distribution Class IIFDA’s classJun 1, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 1, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Outer Packaging Label: Protekt Sharps Safety Knives Surgical knives may contain incorrect description printed on handles. Class IIFDA’s classJun 1, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJun 1, 2022ClassClass IIStatusCompletedWhereNationwide, and Minnesota and Texas named
- Medical device recall The VerifyNow P2Y12 Test is designed to measure platelet P2Y12 receptor blockade Two whole blood Platelet Reactivity tests exist that share the same reagent formulation and are used to obtain P2Y12 Reactivity Unit results. Class IIFDA’s classJun 1, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 1, 2022ClassClass IIStatusTerminatedWhereNationwide, and California named
- Medical device recall Olympus DISPOSABLE GRASPING FORCEPS, FG-51D Forceps do not comply with Olympus standards for the amount of force required to open and close the forceps Class IIFDA’s classJun 1, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 1, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Vanta INS Implantable Neurostimulator The Implantable Neurostimulator Model may be susceptible to not communicating with the clinical programmer and/or patient programmer system. Class IIFDA’s classJun 1, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedJun 1, 2022ClassClass IIStatusOngoingWhereNationwide, and 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 named
- Medical device recall HydroMARK Breast Biopsy Marker Small patient labels do not match the primary device label. Class IIFDA’s classJun 1, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedJun 1, 2022ClassClass IIStatusTerminatedWhereNationwide, and Delaware, Kentucky, New York, Ohio and West Virginia named
- Medical device recall KWIK-STIK” plus: Clostridium perfringens Labeling error. Class IIIFDA’s classJun 1, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJun 1, 2022ClassClass IIIStatusTerminatedWhereNationwide, and Iowa and Tennessee named
- Medical device recall (1) Gibeck Humid-Vent 2S Flex DC, Product #17731, sterile Reports received of torn corrugated breathing tubes. Class IIFDA’s classJun 1, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 35 states named PublishedJun 1, 2022ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Jersey, Nevada, New York, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall (1) Teleflex Flex tube, Product #20011, sterile Reports received of torn corrugated breathing tubes. Class IIFDA’s classJun 1, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 35 states named PublishedJun 1, 2022ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Jersey, Nevada, New York, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Percept BrainSense Implantable Neurostimulator (INS) The Implantable Neurostimulator (INS) cannot communicate with the clinical programmer and/or the patient programmer system. Class IIFDA’s classJun 1, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedJun 1, 2022ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, 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, West Virginia and Wyoming 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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