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 ZOLL, REF 8700-0793-01 (SL-2593) Premium Access Kit SOLEX 7, Intravascular Heat Exchange catheter Kit, with… 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 8700-0793-40 (SL-2593AE) SOLEX 7, Intravascular Heat Exchange Catheter Kit with central venous… 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 8700-0781-14 (CL-2295CO), COOL LINE Intravascular Heat Exchange Catheter kit with central venous… 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 8700-0781-40 (CL-2295AE), COOL LINE Intravascular Heat Exchange Catheter Kit with central venous… 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 8700-0787-40 (IC-3893AE), 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: 8700-0782-40 (IC-3893AE), 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: 8700-0783-01 (IC-4593), QUATTRO Intravascular Heat Exchange Catheter Kit Custom Luer Applause… 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: 8700-0783-40 (IC-4593AE), QUATTRO Intravascular Heat Exchange Catheter Kit with central venous… 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: 8700-0782-14 (IC-3893CO), 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: 8700-0783-14 (IC-4593CO), QUATTRO Intravascular Heat Exchange Catheter Kit with central venous… 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: 8700-0793-14 (SL-2593CO), SOLEX 7 Intravascular Heat Exchange Catheter Kit with central venous… 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: 8700-0783-03 (IC-4593AE) QUATTRO Intravascular Heat Exchange Catheter Kit, with central venous… 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 8700-0781-03 (CL-2295AE), COOLINE Intravascular Heat Intravascular Heat Exchange Catheter Kit, with… 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 8700-0782-03 (IC-3893AE), ICY Intravascular Heat Intravascular Heat Exchange Catheter Kit, with… 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 8700-0695-40 (IC-3893AE), ICY Intravascular Heat Intravascular Heat Exchange Catheter Kit, with… 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 8700-0657-40 (IC-3893AE), ICY Intravascular Heat Intravascular Heat Exchange Catheter Kit, with… 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 8700-000766-01, Quattro IVTM Premium Disposable Pack and Start UP Kit (6 ft.) 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 8700-000865-01, Cool Line IVTM Disposable Pack and Start UP Kit (6 ft.) 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 8700-000866-01, ICY IVTM Disposable Pack and Start UP Kit (6 ft.) 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 8700-000867-01, Quattro IVTM Disposable Pack and Start UP Kit (6 ft.) 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 8700-000868-01, Solex 7 IVTM Disposable Pack and Start UP Kit (6 ft.) 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 8700-000869-40, Cool Line (Heparin) IVTM Disposable Pack and Start UP Kit (6 ft.), EU, New 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
- Medical device recall Zoll, REF 8700-000870-40, ICY (Heparin) IVTM Disposable Pack and Start UP Kit (6 ft.), EU, New 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
- Medical device recall Zoll, REF 8700-000871-40, Quattro (Heparin) IVTM Disposable Pack and Start UP Kit (6 ft.), EU, New 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
- Medical device recall Zoll, REF 8700-000872-40, SOLEX 7(Heparin) IVTM Disposable Pack and Start UP Kit (6 ft.), EU, New 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
- Medical device recall CardioQuip, Modular Cooler-Heater 1000(i), Refrigeration Module There is the potential bacterial including Nontuberculous mycobacterial (NTM) to grow in the water system of heater-cooler devices which could result in… Class IIFDA’s classOct 13, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 37 states named PublishedOct 13, 2021ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Wisconsin and West Virginia named
- Medical device recall Philips Ultrasound, Inc Battery system data issue with the ultrasound system can intermittently cause a system shutdown, regardless of actual battery state or application of… Class IIFDA’s classOct 13, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedOct 13, 2021ClassClass IIStatusTerminatedWhereNationwide, and California, Massachusetts, Maryland, Michigan, Mississippi, North Carolina, New York, Ohio, Virginia and Washington named
- Medical device recall Philips Ultrasound, Inc Battery system data issue with the ultrasound system can intermittently cause a system shutdown, regardless of actual battery state or application of… Class IIFDA’s classOct 13, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedOct 13, 2021ClassClass IIStatusTerminatedWhereNationwide, and California, Massachusetts, Maryland, Michigan, Mississippi, North Carolina, New York, Ohio, Virginia and Washington named
- Medical device recall ARCH Leg Positioning System Due to the holes not being bored to the specific diameter, the locking pins are unable to engage under a load. Class IIFDA’s classOct 13, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedOct 13, 2021ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, Florida, Michigan, Minnesota, Oklahoma, South Dakota and Texas named
- Medical device recall AngioDynamics NanoKnife Disposable Single Electrode Probes, Irreversible Electroporation (IRE) Device, 15 cm… Programming issue affected RFID function of a single lot and did not allow the NanoKnife probes to be recognized by the NanoKnife generator. Class IIFDA’s classOct 13, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 13, 2021ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall ATTUNE Revision Tibial Augment Size 7/8 5mm- intended for knee joint replacement Part Code:152307001 Packaging may include screws that are not intended to be used with the 5mm augments, may cause delay in surgery Class IIFDA’s classOct 13, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedOct 13, 2021ClassClass IIStatusTerminatedWhereNationwide, and California, Louisiana, Minnesota, Missouri, North Carolina, Nebraska, Oregon, Pennsylvania, Washington and Wisconsin named
- Medical device recall Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP) The Helium Indicator on the Cardiosave display may over represent the amount of helium in unit in the presence of Electromagnetic Interference. Class IIFDA’s classOct 13, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 13, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Cardiosave Rescue Intra-Aortic Balloon Pump (IABP) The Helium Indicator on the Cardiosave display may over represent the amount of helium in unit in the presence of Electromagnetic Interference. Class IIFDA’s classOct 13, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 13, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall VACUETTE TUBE 6 ml K2E K2EDTA 13x100 pink cap-pink ring, non-ridged Blood collection tubes may experience a clotting issue. Class IIFDA’s classOct 6, 2021in FDA’s Enforcement Report15 statesnamed in where it went PublishedOct 6, 2021ClassClass IIStatusTerminatedWhereAlabama, Arizona, Colorado, Connecticut, Florida, Illinois, Massachusetts, Maryland, Michigan, Missouri, North Carolina, New Mexico, Pennsylvania, Texas and Virginia
- Medical device recall DeRoyal Procedure Packs containing Smiths Medical NORMOFLO Irrigation Warming Set DeRoyal manufactured procedure packs containing a Smiths Medical NORMOFLO Irrigation Warming System which is recalled due to the potential for aluminum ions… FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 6, 2021in FDA’s Enforcement Report2 statesnamed in where it went PublishedOct 6, 2021ClassClass IStatusTerminatedWhereFlorida and South Carolina
- Medical device recall Omnisound Gel, 250 ml bottle and 5 L container Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 6, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 6, 2021ClassClass IStatusOngoingWhereNationwide
- Medical device recall The Instructions for Use (IFU) for: Gelsoft Plus Bifurcate, Gelsoft Plus Ax-Fem, GelsoftPlus ERS Ax-Fem,… The devices contained the IFU for distribution to ROW (rest of world) consignees rather than U.S. Class IIFDA’s classOct 6, 2021in FDA’s Enforcement Report2 statesnamed in where it went PublishedOct 6, 2021ClassClass IIStatusTerminatedWhereGuam and Puerto Rico
- Medical device recall The Instructions for Use (IFU) for: Carotid Patch and Gelsoft Patch vascular patches The devices contained the IFU for distribution to ROW (rest of world) consignees rather than U.S. Class IIFDA’s classOct 6, 2021in FDA’s Enforcement Report2 statesnamed in where it went PublishedOct 6, 2021ClassClass IIStatusTerminatedWhereGuam and Puerto Rico
- Medical device recall 15 drops/ml, Priming Volume: 27ml, Length: 129 in Leakage of the pump set within the cassette portion of the pump sets, potential for delays in administration of medications, under-delivery or incomplete… Class IIFDA’s classOct 6, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 6, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Outlook Pump Sets w/3 CARESITE Needle-Free Injection Sites: single-use for use with the Outlook Safety… Leakage of the pump set within the cassette portion of the pump sets, potential for delays in administration of medications, under-delivery or incomplete… Class IIFDA’s classOct 6, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 6, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Outlook¿ Pump 15 Drop 0.2 Micron Filtered IV Set with 2 CARESITE¿ Y-Sites: single-use for use with the… Leakage of the pump set within the cassette portion of the pump sets, potential for delays in administration of medications, under-delivery or incomplete… Class IIFDA’s classOct 6, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 6, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 60 drops/ml, Priming volume: 25 ml, Length: 120 in.in-single-use for use with the Outlook Safety Infusion… Leakage of the pump set within the cassette portion of the pump sets, potential for delays in administration of medications, under-delivery or incomplete… Class IIFDA’s classOct 6, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 6, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 10 drops/ml, Priming volume: 46ml, Length: 130 in.-single-use for use with the Outlook Safety Infusion System… Leakage of the pump set within the cassette portion of the pump sets, potential for delays in administration of medications, under-delivery or incomplete… Class IIFDA’s classOct 6, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 6, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Outlook Pump Measured Volume Solution Set/ w/ Auto Shut-Off Leakage of the pump set within the cassette portion of the pump sets, potential for delays in administration of medications, under-delivery or incomplete… Class IIFDA’s classOct 6, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 6, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ET82HP OUTLOOK PUMP EXTENSION SET-single-use for use with the Outlook Safety Infusion System and/or Horizon… Leakage of the pump set within the cassette portion of the pump sets, potential for delays in administration of medications, under-delivery or incomplete… Class IIFDA’s classOct 6, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 6, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall V1500HP OUTLOOK PUMP SET 118-single-use for use with the Outlook Safety Infusion System and/or Horizon NXT… Leakage of the pump set within the cassette portion of the pump sets, potential for delays in administration of medications, under-delivery or incomplete… Class IIFDA’s classOct 6, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 6, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall OUTLOOK PUMP IV SET W/UNIVERSAL SPIKE-single-use for use with the Outlook Safety Infusion System and/or… Leakage of the pump set within the cassette portion of the pump sets, potential for delays in administration of medications, under-delivery or incomplete… Class IIFDA’s classOct 6, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 6, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Y-Type Blood, Outlook Pump Set, Caresite-single-use for use with the Outlook Safety Infusion System and/or… Leakage of the pump set within the cassette portion of the pump sets, potential for delays in administration of medications, under-delivery or incomplete… Class IIFDA’s classOct 6, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 6, 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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