Medical devices, 2020
Shortlist up to four to read them side by side.
3,055 medical device recalls FDA’s Enforcement Report published in 2020, 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.
3,055of 3,055 medical device recallsshown with your filters
The list
- Medical device recall Alaris Pump Module LED display, which provides infusion or patient monitoring values, on the module may have segments that appear dim. Class IIFDA’s classAug 26, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 55 states named PublishedAug 26, 2020ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, American Samoa, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Northern Mariana Islands, 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
- Medical device recall Alaris Syringe Module LED display, which provides infusion or patient monitoring values, on the module may have segments that appear dim. Class IIFDA’s classAug 26, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 55 states named PublishedAug 26, 2020ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, American Samoa, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Northern Mariana Islands, 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
- Medical device recall Alaris PCA Module LED display, which provides infusion or patient monitoring values, on the module may have segments that appear dim. Class IIFDA’s classAug 26, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 55 states named PublishedAug 26, 2020ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, American Samoa, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Northern Mariana Islands, 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
- Medical device recall Alaris EtCO2 Module LED display, which provides infusion or patient monitoring values, on the module may have segments that appear dim. Class IIFDA’s classAug 26, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 55 states named PublishedAug 26, 2020ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, American Samoa, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Northern Mariana Islands, 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
- Medical device recall Alaris SpO2 Module LED display, which provides infusion or patient monitoring values, on the module may have segments that appear dim. Class IIFDA’s classAug 26, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 55 states named PublishedAug 26, 2020ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, American Samoa, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Northern Mariana Islands, 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
- Medical device recall POLARSTEM COLLAR Reamer Guide Multiple lots being recalled due to a product design issue Class IIFDA’s classAug 26, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 26, 2020ClassClass IIStatusTerminatedWhereNationwide, and Tennessee named
- Medical device recall NobelReplace Conical Connection (CC) PMC RP 4.3x10mm Dental implant cap label may incorrectly indicate implant measurements 5.0x8mm. Class IIFDA’s classAug 26, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedAug 26, 2020ClassClass IIStatusTerminatedWhereNationwide, and Florida and New York named
- Medical device recall Cytocell LPH533-A NUP98 Distal Probe Green - Product Usage:The NUP98 Distal probe, labelled in green,… A low risk of a false positive result being issued with a laboratory developed test (LDT) that utilizes the LPH533-A NUP98 Distal Probe Green. Class IIFDA’s classAug 26, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 26, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Ultra/Phonic Focus BP Conforming Gel Pads, UDI 00300361301021 (Primary) The firm registered the product as a Class I device, but has since been informed by FDA that the device is not Class I and requires a 510(k) submission. Class IIFDA’s classAug 26, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 26, 2020ClassClass IIStatusTerminatedWhereNationwide, and Nevada named
- Medical device recall VITROS Anti-SARS-CoV-2 Total Reagent, COV2TOT, VITROS CoV2T The reagent bottles may be swapped within the reagent pack, which may lead to false negative results or delayed results due to calibration failures, or quality… Class IIFDA’s classAug 19, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 19, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall VITROS Anti-SARS-CoV-2 IgG Reagent Pack, COV2IgG, VITROS CoV2G The reagent bottles may be swapped within the reagent pack, which may lead to false negative results or delayed results due to calibration failures, or quality… Class IIFDA’s classAug 19, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 19, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall OmniTom Computed tomography x-ray system There are potential issues related to the operational state of the scanner, specifically for transport and inadvertent system shutdowns. Class IIFDA’s classAug 19, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 19, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Proteus 235 The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) is a medical… Signature from the user is necessary to proceed with specific actions in the Proton Therapy System (PTS). Class IIFDA’s classAug 19, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedAug 19, 2020ClassClass IIStatusTerminatedWhereNationwide, and Florida and Virginia named
- Medical device recall Tibial knee prosthesis Due to an inconsistency in the raw material process, specific lots may contain units with internal non-homogenous material defects. Class IIFDA’s classAug 19, 2020in FDA’s Enforcement Report25 statesnamed in where it went PublishedAug 19, 2020ClassClass IIStatusOngoingWhereAlabama, Arkansas, Arizona, Connecticut, Florida, Georgia, Iowa, Indiana, Kentucky, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, North Carolina, New Jersey, Nevada, New York, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Wisconsin and West Virginia
- Medical device recall Verigene Processor SP with assay: Luminex, VERIGENE Gram-Positive Blood Culture Nucleic Acid Test,BC-GP, IVD… An instrument failure mode that may result in a Blood Culture Gram Positive (BC-GP) or Gram Negative (BC-GN) false negative call. Class IIFDA’s classAug 19, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedAug 19, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Verigene Processor SP with assay Luminex, VERIGENE Gram-Negative Blood Culture Nucleic Acid Test, BC-GN, IVD… An instrument failure mode that may result in a Blood Culture Gram Positive (BC-GP) or Gram Negative (BC-GN) false negative call. Class IIFDA’s classAug 19, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedAug 19, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall PERI-LOC TARGETER 4.5MM DISTAL FEMUR, HANDLE, LEFT, NON-STERILE - Product Usage: used for adult and pediatric… The 4.5MM PeriLoc Targeter right hand part was anodized green and was marked as a left-hand part. Class IIFDA’s classAug 19, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedAug 19, 2020ClassClass IIStatusTerminatedWhereNationwide, and Indiana and Tennessee named
- Medical device recall Anjon Bremer Molded Crown High rate of galling of one threaded component. Class IIFDA’s classAug 19, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 19, 2020ClassClass IIStatusTerminatedWhereNationwide, and Michigan named
- Medical device recall STAT KIT Z-1000 emergency medical kit HealthFirst - Product Usage: is intended to prepare physicians with… A missing component (hand suction pump) in the emergency medical kits. Class IIFDA’s classAug 19, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedAug 19, 2020ClassClass IIStatusTerminatedWhereNationwide, and Tennessee and Utah named
- Medical device recall Holder HKHZ 19 for use with Quadrox-i and Quadrox-iD Neonatal / Pediatric Oxygenators Removal for a specific lot, lot number 70128207, of Holder HKHZ 19 for use with QUADROX iD Pediatric Oxygenator. Class IIFDA’s classAug 19, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedAug 19, 2020ClassClass IIStatusTerminatedWhereNationwide, and Connecticut, Ohio, Pennsylvania and South Carolina named
- Medical device recall AVE 2 Birthing Bed - Product Usage: is designated to be used by mothers ready for spontaneous vaginal… The UDI on the device label indicates incorrect manufacturer. Class IIIFDA’s classAug 19, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 18 states named PublishedAug 19, 2020ClassClass IIIStatusOngoingWhereNationwide, and Arkansas, California, Delaware, Florida, Georgia, Indiana, Louisiana, Massachusetts, Minnesota, Missouri, Mississippi, New Jersey, Oklahoma, Pennsylvania, Puerto Rico, Tennessee, Texas and West Virginia named
- Medical device recall Calcaneus Plate, Extensile, Small, Left The contract manufacturer of the calcaneus plate inadvertently used the incorrect material to manufacture the plates (a titanium alloy rather than pure… Class IIFDA’s classAug 19, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedAug 19, 2020ClassClass IIStatusTerminatedWhereNationwide, and Arizona, Florida and Ohio named
- Medical device recall Calcaneus Plate, Extensile, Medium, Left The contract manufacturer of the calcaneus plate inadvertently used the incorrect material to manufacture the plates (a titanium alloy rather than pure… Class IIFDA’s classAug 19, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedAug 19, 2020ClassClass IIStatusTerminatedWhereNationwide, and Arizona, Florida and Ohio named
- Medical device recall Calcaneus Plate, Extensile, Large, Left The contract manufacturer of the calcaneus plate inadvertently used the incorrect material to manufacture the plates (a titanium alloy rather than pure… Class IIFDA’s classAug 19, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedAug 19, 2020ClassClass IIStatusTerminatedWhereNationwide, and Arizona, Florida and Ohio named
- Medical device recall Calcaneus Plate, Extensile, Small, Right The contract manufacturer of the calcaneus plate inadvertently used the incorrect material to manufacture the plates (a titanium alloy rather than pure… Class IIFDA’s classAug 19, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedAug 19, 2020ClassClass IIStatusTerminatedWhereNationwide, and Arizona, Florida and Ohio named
- Medical device recall Calcaneus Plate, Extensile, Medium, Right The contract manufacturer of the calcaneus plate inadvertently used the incorrect material to manufacture the plates (a titanium alloy rather than pure… Class IIFDA’s classAug 19, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedAug 19, 2020ClassClass IIStatusTerminatedWhereNationwide, and Arizona, Florida and Ohio named
- Medical device recall Calcaneus Plate, Extensile, Large, Right The contract manufacturer of the calcaneus plate inadvertently used the incorrect material to manufacture the plates (a titanium alloy rather than pure… Class IIFDA’s classAug 19, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedAug 19, 2020ClassClass IIStatusTerminatedWhereNationwide, and Arizona, Florida and Ohio named
- Medical device recall HealthFirst Emergency Medical Kit Instead of 2 doses, packaged 1 dose of nasal spray in an emergency kits. Class IIFDA’s classAug 19, 2020in FDA’s Enforcement Report39 statesnamed in where it went PublishedAug 19, 2020ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Kansas, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Virginia, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall STAT KIT, Model SM30 ; Emergency Medical Kit P/N: 1008670 containing various products to include Narcan Nasal… Instead of 2 doses, packaged 1 dose of nasal spray in an emergency kits. Class IIFDA’s classAug 19, 2020in FDA’s Enforcement Report39 statesnamed in where it went PublishedAug 19, 2020ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Kansas, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Virginia, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall STAT KIT Model 550 Emergency Medical Kit P/N: 1009580 containing various products to include Narcan Nasal… Instead of 2 doses, packaged 1 dose of nasal spray in an emergency kits. Class IIFDA’s classAug 19, 2020in FDA’s Enforcement Report39 statesnamed in where it went PublishedAug 19, 2020ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Kansas, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Virginia, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall STAT KIT Model 550AI Emergency Medical Kit. P/N: 1010830 containing various products to include Narcan Nasal… Instead of 2 doses, packaged 1 dose of nasal spray in an emergency kits. Class IIFDA’s classAug 19, 2020in FDA’s Enforcement Report39 statesnamed in where it went PublishedAug 19, 2020ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Kansas, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Virginia, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall BRAINLAB Curve Incorrect manufacturer calibration Class IIFDA’s classAug 19, 2020in FDA’s Enforcement Report3 statesnamed in where it went PublishedAug 19, 2020ClassClass IIStatusTerminatedWhereCalifornia, Rhode Island and Texas
- Medical device recall BRAINLAB Kick 2 Incorrect manufacturer calibration Class IIFDA’s classAug 19, 2020in FDA’s Enforcement Report3 statesnamed in where it went PublishedAug 19, 2020ClassClass IIStatusTerminatedWhereCalifornia, Rhode Island and Texas
- Medical device recall Philips HeartStart MRx, Monitor/Defibrillators with The therapy switch may fail, resulting in the device exhibiting the following behaviors: the device may not perform the selected function, the therapy knob may… Class IIFDA’s classAug 19, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 19, 2020ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Bioseal Trachea Extender 1/pl 50pk/Cs The reported stress crack in the port of the swivel elbow where the flip cap is inserted could result in leakage from the breathing system resulting in the… Class IIFDA’s classAug 19, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 19, 2020ClassClass IIStatusTerminatedWhereNationwide, and California named
- Medical device recall Hardware removal kit Hardware removal kit does not include drivers to remove Dart-Fire 2.5 and 3.0mm Headless screws. Class IIFDA’s classAug 19, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedAug 19, 2020ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, California, Colorado, Florida, Illinois, Missouri, North Carolina, New Jersey, Oregon, South Carolina, Texas, Utah and Virginia named
- Medical device recall Screw Removal Case Assembly Hardware removal kit does not include drivers to remove Dart-Fire 2.5 and 3.0mm Headless screws. Class IIFDA’s classAug 19, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedAug 19, 2020ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, California, Colorado, Florida, Illinois, Missouri, North Carolina, New Jersey, Oregon, South Carolina, Texas, Utah and Virginia named
- Medical device recall Barricaid Annual Closure Device (ACD) BAR-A8-8MM - Product Usage: The Barricaid¿ ACD is indicated for… The catalog ( REF ) number on the peelable inner labels (patient sticker) that is on the inner container (box) is incorrect. Class IIFDA’s classAug 19, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 19, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall uEXPLORER PET/CT Diagnostic Imaging System - Product Usage: This system is intended to be operated by… 1) 1) Potential intermittent issue may cause image data problems, may lead to artifacts; 2) Potential intermittent scout scanning interruption due to angle… Class IIFDA’s classAug 19, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 19, 2020ClassClass IIStatusTerminatedWhereNationwide, and Texas named
- Medical device recall uMI 550 PET/CT Diagnostic Imaging System - Product Usage: This system is intended to be operated by qualified… 1) Service function problem may cause false marking of a bad channel resulting in ring artifacts; 2) Potential intermittent scout scanning interruption due to… Class IIFDA’s classAug 19, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 19, 2020ClassClass IIStatusTerminatedWhereNationwide, and Texas named
- Medical device recall Arrow Single Shot Epidural Anesthesia Kit - Product Usage: The Arrow Blunt Needle Single Shot Epidural Kit… The lidstock states the incorrect expiration date for the product. Class IIFDA’s classAug 19, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 19, 2020ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Cannon II Plus Replacement Hub Set - Product Usage: is indicated for use in the replacement of a Cannon II… The lidstock states the incorrect expiration date for the product. Class IIFDA’s classAug 19, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 19, 2020ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Arrow TheraCath Epidural Catheter - Product Usage: The Arrow Epidural Catheter permits access to the epidural… The lidstock states the incorrect expiration date for the product. Class IIFDA’s classAug 19, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 19, 2020ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall NextStep Retrograde Replacement Hub Set - Product Usage: is indicated for use in the replacement of a… The lidstock states the incorrect expiration date for the product. Class IIFDA’s classAug 19, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 19, 2020ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Alaris System PC Unit Cleaning agents may damage Inter-Unit Interface (IUI) Connectors, which may lead to interruption of communication or power between PC Unit and modules, which… FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 12, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedAug 12, 2020ClassClass IStatusTerminatedWhereNationwide, and American Samoa, Guam and Puerto Rico named
- Medical device recall Alaris System PC Unit Cleaning agents may damage Inter-Unit Interface (IUI) Connectors, which may lead to interruption of communication or power between PC Unit and modules, which… FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 12, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedAug 12, 2020ClassClass IStatusTerminatedWhereNationwide, and American Samoa, Guam and Puerto Rico named
- Medical device recall Alaris Pump Module Cleaning agents may damage Inter-Unit Interface (IUI) Connectors, which may lead to interruption of communication or power between PC Unit and modules, which… FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 12, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedAug 12, 2020ClassClass IStatusTerminatedWhereNationwide, and American Samoa, Guam and Puerto Rico named
- Medical device recall Alaris Syringe Module Cleaning agents may damage Inter-Unit Interface (IUI) Connectors, which may lead to interruption of communication or power between PC Unit and modules, which… FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 12, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedAug 12, 2020ClassClass IStatusTerminatedWhereNationwide, and American Samoa, Guam and Puerto Rico 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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