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 Chesapeake Anterior Lumbar (AL) Removal Tool Units may arrive with missing pins and/or in a state in disassembly. Class IIFDA’s classOct 20, 2021in FDA’s Enforcement Report9 statesnamed in where it went PublishedOct 20, 2021ClassClass IIStatusTerminatedWhereColorado, Illinois, Louisiana, Massachusetts, Mississippi, Oklahoma, Pennsylvania, Tennessee and Texas
- Medical device recall Thoraguard Chest Tube Kit, 20 Fr An adhesive joint in the SmartValve component of the device can become compromised resulting in a leak. Class IIFDA’s classOct 20, 2021in FDA’s Enforcement ReportCaliforniathe one state its words name PublishedOct 20, 2021ClassClass IIStatusTerminatedWhereCalifornia
- Medical device recall Ion Flexison Biopsy Needle, 19G, Extension Range : 0-3 cm Potential for the sheath tip on the biopsy needle to separate from the sheath shaft. Class IIFDA’s classOct 20, 2021in FDA’s Enforcement Report26 statesnamed in where it went PublishedOct 20, 2021ClassClass IIStatusTerminatedWhereArkansas, Arizona, California, Colorado, District of Columbia, Florida, Georgia, Illinois, Indiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, New Jersey, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Tennessee, Texas, Utah, Virginia and Washington
- Medical device recall Evita V500 Ventilator with Installed CO2 Measurement Option-Intended for the ventilation of adult,pediatric… Software 2.51 and Lower with Installed CO2 Measurement Option, may result in Restart of the Ventilator, brief cessation of ventilation can occur and loss of… Class IIFDA’s classOct 20, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 20, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Babylog VN500 Ventilator with Installed CO2 Measurement Option-intended for the ventilation of neonatal… Software 2.51 and Lower with Installed CO2 Measurement Option, may result in Restart of the Ventilator, brief cessation of ventilation can occur and loss of… Class IIFDA’s classOct 20, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 20, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall United Orthopedics USTAR II Knee System USTAR II Knee System Segment Part, RHS, 25 mm Length Due to product not meeting specification for concentricity and failing to meet requirements of dynamic fatigue testing. Class IIFDA’s classOct 20, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedOct 20, 2021ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado and Nevada named
- Medical device recall Flower Drill Bit Kit 2.0 mm - intended to be used with solid 2.0mm screws and can be used with any plate that… Drill bits packaged in kits are missing the AO connect feature and may result in delay of procedure Class IIFDA’s classOct 20, 2021in FDA’s Enforcement Report10 statesnamed in where it went PublishedOct 20, 2021ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Florida, Illinois, Indiana, Nevada, Ohio, Texas and Virginia
- Medical device recall Flower Drill Bit Kit 2.4 mm-intended to be used with solid 2.4mm screws and can be used with any plate as… Drill bits packaged in kits are missing the AO connect feature and may result in delay of procedure Class IIFDA’s classOct 20, 2021in FDA’s Enforcement Report10 statesnamed in where it went PublishedOct 20, 2021ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Florida, Illinois, Indiana, Nevada, Ohio, Texas and Virginia
- Medical device recall Flower Drill Bit Kit 2.7mm- The Drill Bit Kit, 2.7mm (DBK 027) is intended to be used with solid 2.7mm screws… Drill bits packaged in kits are missing the AO connect feature and may result in delay of procedure Class IIFDA’s classOct 20, 2021in FDA’s Enforcement Report10 statesnamed in where it went PublishedOct 20, 2021ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Florida, Illinois, Indiana, Nevada, Ohio, Texas and Virginia
- Medical device recall Flower Lag Screw Kit 2.7 mm-intended to be used with 2.7mm lag screws and can be used with any plate that as… Drill bits packaged in kits are missing the AO connect feature and may result in delay of procedure Class IIFDA’s classOct 20, 2021in FDA’s Enforcement Report10 statesnamed in where it went PublishedOct 20, 2021ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Florida, Illinois, Indiana, Nevada, Ohio, Texas and Virginia
- Medical device recall Elekta Medical Linear Accelerator (EMLA): Elekta Harmony Pro There is a risk that the Diode D1 in the Modulator can fail in a destructive manner when removed from the machine, and that the protective tube surrounding the… Class IIFDA’s classOct 20, 2021in FDA’s Enforcement Report2 statesnamed in where it went PublishedOct 20, 2021ClassClass IIStatusTerminatedWhereNorth Carolina and North Dakota
- Medical device recall Elekta Medical Linear Accelerator (EMLA), configured as follows: a There is a risk that the Diode D1 in the Modulator can fail in a destructive manner when removed from the machine, and that the protective tube surrounding the… Class IIFDA’s classOct 20, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedOct 20, 2021ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Power Processor 3K, 3K High Speed Stockyards Module Nameplate: PP 3K Stockyard (Refrig) 9707 Missing splash guard which may expose users to hazardous materials. Class IIFDA’s classOct 20, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 21 states named PublishedOct 20, 2021ClassClass IIStatusOngoingWhereNationwide, and California, Georgia, Iowa, Idaho, Illinois, Indiana, Louisiana, Massachusetts, Michigan, Mississippi, New Jersey, New York, Ohio, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Washington and West Virginia named
- Medical device recall REF TIN3015, 15G x 79 mm Bone Marrow Aspiration/Intraosseous Infusion Needle, For Single Use Only, Sterile… Potential for needle protector to become fully dislodge exposing infusion needle which could result in needle stick. Class IIFDA’s classOct 13, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 39 states named PublishedOct 13, 2021ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington and West Virginia named
- Medical device recall Medtronic Bio-Medicus Insertion Kits There was a label mix-up between two model numbers resulting in the incorrect guidewire being contained in the kits for both model numbers. Class IIFDA’s classOct 13, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 13, 2021ClassClass IIStatusOngoingWhereNationwide, and Massachusetts named
- Medical device recall GEL CONDUCTOR, Description/REF: 5 LITER W/DISP/4238, 24-8.5OZ BOTTLES/4248, 5 LITER/4266 Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 13, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 53 states named PublishedOct 13, 2021ClassClass IStatusOngoingWhereNationwide, 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, US Virgin Islands, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Ultra-Myossage Lotion 1-gallon bottle Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 13, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 53 states named PublishedOct 13, 2021ClassClass IStatusOngoingWhereNationwide, 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, US Virgin Islands, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall ELI, Burdick and McKesson brand 280 Resting Electrocardiographs (ELI 280, MLBUR280 and BUR280) The devices malfunction under specific operator workflows. Class IIFDA’s classOct 13, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 13, 2021ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Centricity Universal Viewer 7.0 A software anomaly exists in the Centricity Universal Viewer study management feature in which study changes are not propagated to either the Centricity… Class IIFDA’s classOct 13, 2021in FDA’s Enforcement Report8 statesnamed in where it went PublishedOct 13, 2021ClassClass IIStatusTerminatedWhereArkansas, Illinois, Maine, Mississippi, Nebraska, New Jersey, New York and Tennessee
- Medical device recall Scan Abutment SP Some devices are outside tolerances and showed a maximal deviation of 2 degrees in the orientation between the peek head and titanium base, and an incongruence… Class IIFDA’s classOct 13, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 13, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Scan Abutment NP Some devices are outside tolerances and showed a maximal deviation of 2 degrees in the orientation between the peek head and titanium base, and an incongruence… Class IIFDA’s classOct 13, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 13, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Scan Abutment MU Some devices are outside tolerances and showed a maximal deviation of 2 degrees in the orientation between the peek head and titanium base, and an incongruence… Class IIFDA’s classOct 13, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 13, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Scan Abutment SU Some devices are outside tolerances and showed a maximal deviation of 2 degrees in the orientation between the peek head and titanium base, and an incongruence… Class IIFDA’s classOct 13, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 13, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Scan Abutment PCA Some devices are outside tolerances and showed a maximal deviation of 2 degrees in the orientation between the peek head and titanium base, and an incongruence… Class IIFDA’s classOct 13, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 13, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Scan Abutment WP Some devices are outside tolerances and showed a maximal deviation of 2 degrees in the orientation between the peek head and titanium base, and an incongruence… Class IIFDA’s classOct 13, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 13, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall OPTETRAK Comprehensive Knee System, labeled as the following: a Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer. Class IIFDA’s classOct 13, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 13, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall OPTETRAK Comprehensive Knee System including OPTETRAK All-polyethylene UNI Tibial Components, Product Lines,… Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer. Class IIFDA’s classOct 13, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 13, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall OPTETRAK LOGIC Polyethylene Tibial Inserts, labeled as the following: a Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer. Class IIFDA’s classOct 13, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 13, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall OPTETRAK Comprehensive Knee System custom devices labeled as the following: a Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer. Class IIFDA’s classOct 13, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 13, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall TRULIANT Knee System including TRULIANT Tibial Inserts, also labeled as the following: a Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer. Class IIFDA’s classOct 13, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 13, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Vantage Total Ankle System including a Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer. Class IIFDA’s classOct 13, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 13, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer. Class IIFDA’s classOct 13, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 13, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line:… Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer. Class IIFDA’s classOct 13, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 13, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ARTHROFOCUS Polyethylene Tibial Inserts (Product Line: 256-12-XX, 256-13-XX) Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer. Class IIFDA’s classOct 13, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 13, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall TECNIS Eyhance IOLs are permanent intraocular implants intended for implantation in the capsular bag Nonconforming product was distributed in error. Class IIFDA’s classOct 13, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 13, 2021ClassClass IIStatusTerminatedWhereNationwide, and Illinois named
- Medical device recall Action De Gala, FuSion Conductive Gel - Product Usage: Intended for use in acoustic coupling of ultrasound… Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 13, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedOct 13, 2021ClassClass IStatusOngoingWhereNationwide, and Alaska, Arizona, California, Texas and Washington named
- Medical device recall Nutrifill Scleral, Hybrid, and Gas Permeable (GP) Lens Insertion Solution, Physiologic Formula, Preservative… Contact lens solution may contain foreign material Class IIFDA’s classOct 13, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedOct 13, 2021ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, 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, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Nox T3s Recorder - Product Usage: intended for ambulatory recording of physiological signals during sleep. Error in the device firmware results in the inaccurate detection of device position. Class IIFDA’s classOct 13, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedOct 13, 2021ClassClass IIStatusTerminatedWhereNationwide, and California, Georgia, Iowa, Illinois, Michigan, New Mexico, Ohio, Pennsylvania and South Dakota named
- Medical device recall Access hsTnI High Sensitivity Troponin I Through customer feedback, testing a sample with cardiac troponin I concentration that are >270,000 pg/mL may cause carryover into the hsTnl reagent pack. Class IIFDA’s classOct 13, 2021in FDA’s Enforcement Report46 statesnamed in where it went PublishedOct 13, 2021ClassClass IIStatusOngoingWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall Alinity c CRP Vario Cardiac High Sensitivity Calibrator Kit (ref 07P5605) - Product Usage: use in the… Calibrator vials were incorrectly labeled. Class IIIFDA’s classOct 13, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedOct 13, 2021ClassClass IIIStatusTerminatedWhereNationwide, and Louisiana, Maryland, Minnesota, North Dakota, New York, Puerto Rico and West Virginia named
- Medical device recall Flower E-Kit, Advanced-Bone Fixation Fasterner-Fixation of Product kit missing CDG 200 (Cannulated Countersink for 3.0-4.5mm Screws) from EWK 201 (Flower E-Kit, Advanced) Class IIFDA’s classOct 13, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedOct 13, 2021ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Colorado, Connecticut, Florida, Illinois, Indiana, North Carolina, Nevada, New York, Ohio, Texas and West Virginia named
- Medical device recall CardioQuip, Modular Cooler-Heater Labeling does not include guidance for proper water-quality maintenance and device inspection for heater cooler devices. Class IIFDA’s classOct 13, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedOct 13, 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 CardioQuip, Modular Cooler-Heater 1000(i), Standard Unit Labeling does not include guidance for proper water-quality maintenance and device inspection for heater cooler devices. Class IIFDA’s classOct 13, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedOct 13, 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 CardioQuip, Modular Cooler-Heater 1000(m),Compact Unit Labeling does not include guidance for proper water-quality maintenance and device inspection for heater cooler devices. Class IIFDA’s classOct 13, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedOct 13, 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 CardioQuip, Modular Cooler-Heater 1000(m),Thermoelectric Cooling Lid Labeling does not include guidance for proper water-quality maintenance and device inspection for heater cooler devices. Class IIFDA’s classOct 13, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedOct 13, 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 Zoll REF: 8700-0782-01 (IC-3893), ICY Intravascular Heat Exchange Catheter Kit, with central venous infusion… Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing Class IIFDA’s classOct 13, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 37 states named PublishedOct 13, 2021ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Zoll, REF: 8700-0791-01 (IC-4593), Premium Access Kit QUATTRO, Intravascular Heat exchange Catheter Kit… Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing Class IIFDA’s classOct 13, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 37 states named PublishedOct 13, 2021ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall ZOLL, REF: 8700-0781-01 (CL-2295), COOL LINE, Intravascular Heat Exchange Catheter Kit Applause Custom Luer… Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing Class IIFDA’s classOct 13, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 37 states named PublishedOct 13, 2021ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington, Wisconsin and West Virginia 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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