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 OUTLOOK PUMP IV SET, 134 IN.-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 PUMP SET, 15 DR, 3 CARESITE, 127 in.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 OUTLOOK PUMP SET, 3 CARESITE LADS, 115 IN-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 OUTLOOK PUMP SET 3 CARESITE LADS 133 IN.-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 Outlook Pump Add-On Set-single use, for use with the Outlook Safety Infusion System and/or Horizon NXT Pump… 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 Primary Administration Set w/ micro Tubing for Epidural Administration-single use, for use with… 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 Blood Administration Set with SAFELINE Injection Site-single use, for use with the Outlook… 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 Covidien HysteroLux Fluid Management System Control Unit When the display of inflow volume to the uterus reaches 32450 ml, the fluid management system control unit display will freeze because the internal software… Class IIFDA’s classOct 6, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 6, 2021ClassClass IIStatusOngoingWhereNationwide, and Connecticut named
- Medical device recall LYMOL Medical Elite X Class Rigid Bronchoscope System Reprocessing instructions were revised November 15, 2020, to reflect new processes and equipment used at consignee user facilities. Class IIFDA’s classOct 6, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 6, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Elekta Monaco - Product Usage: used to make treatment plans for patients with prescriptions for external beam… Contour changes can be saved on an unintended image set. Class IIFDA’s classOct 6, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedOct 6, 2021ClassClass IIStatusOngoingWhereNationwide, and Iowa, Michigan, New Jersey, New York, Pennsylvania, Tennessee, Texas and Wisconsin named
- Medical device recall BF-N20 OES Bronchofiberscope The firm is issuing validated, new reprocessing instructions according to the FDA 2015 guidance, “Reprocessing Medical Devices in Health Care Settings:… Class IIFDA’s classOct 6, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 6, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BF-3C40 OES Bronchofiberscope The firm is issuing validated, new reprocessing instructions according to the FDA 2015 guidance, “Reprocessing Medical Devices in Health Care Settings:… Class IIFDA’s classOct 6, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 6, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BF-XP60 OES Bronchofiberscope The firm is issuing validated, new reprocessing instructions according to the FDA 2015 guidance, “Reprocessing Medical Devices in Health Care Settings:… Class IIFDA’s classOct 6, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 6, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BF-1T60 OES Bronchofiberscope The firm is issuing validated, new reprocessing instructions according to the FDA 2015 guidance, “Reprocessing Medical Devices in Health Care Settings:… Class IIFDA’s classOct 6, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 6, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BF-P60 OES Bronchofiberscope The firm is issuing validated, new reprocessing instructions according to the FDA 2015 guidance, “Reprocessing Medical Devices in Health Care Settings:… Class IIFDA’s classOct 6, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 6, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BF-XP160F EVIS EXERA Bronchovideoscope The firm is issuing validated, new reprocessing instructions according to the FDA 2015 guidance, “Reprocessing Medical Devices in Health Care Settings:… Class IIFDA’s classOct 6, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 6, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BF-XT160 EVIS EXERA Bronchovideoscope The firm is issuing validated, new reprocessing instructions according to the FDA 2015 guidance, “Reprocessing Medical Devices in Health Care Settings:… Class IIFDA’s classOct 6, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 6, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BF-P180 EVIS EXERA II Bronchovideoscope The firm is issuing validated, new reprocessing instructions according to the FDA 2015 guidance, “Reprocessing Medical Devices in Health Care Settings:… Class IIFDA’s classOct 6, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 6, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BF-1T180 EVIS EXERA II Bronchovideoscope The firm is issuing validated, new reprocessing instructions according to the FDA 2015 guidance, “Reprocessing Medical Devices in Health Care Settings:… Class IIFDA’s classOct 6, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 6, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BF-Q180-AC EVIS EXERA II Bronchovideoscope The firm is issuing validated, new reprocessing instructions according to the FDA 2015 guidance, “Reprocessing Medical Devices in Health Care Settings:… Class IIFDA’s classOct 6, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 6, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall NAMIC Manifolds. Potential for sterile barrier breach. Class IIFDA’s classOct 6, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 6, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall NAMIC Stopcocks Potential for sterile barrier breach. Class IIFDA’s classOct 6, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 6, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Vysis CLL FISH Probe Kit with the following components: Vysis LSI p53 SpectrumOrange/ATM, SpectrumGreen and… Potential for Vysis CLL FISH Probe Kits not detecting 13q deletions in known positive patient samples. Class IIFDA’s classOct 6, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 23 states named PublishedOct 6, 2021ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Florida, Georgia, Illinois, Indiana, Kentucky, Massachusetts, Michigan, Minnesota, North Carolina, New Jersey, New Mexico, New York, Ohio, Pennsylvania, Tennessee, Texas, Utah, Virginia, Vermont, Washington and Wisconsin named
- Medical device recall Imperative Care, ZOOM 71 Reperfusion Catheter There is a potential for distal end of catheters to fracture and become detached. 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 IStatusCompletedWhereNationwide
- Medical device recall PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM Malfuncton-Implant did not deploy successfully may necessitate the need for an additional medical intervention for patients which would result in a potential… Class IIFDA’s classOct 6, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedOct 6, 2021ClassClass IIStatusTerminatedWhereNationwide, and Florida, Michigan, New York, Texas and Wisconsin named
- Medical device recall PAS-PORT PROXIMAL ANASTOMOSIS DEVICE US Malfuncton-Implant did not deploy successfully may necessitate the need for an additional medical intervention for patients which would result in a potential… Class IIFDA’s classOct 6, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedOct 6, 2021ClassClass IIStatusTerminatedWhereNationwide, and Florida, Michigan, New York, Texas and Wisconsin named
- Medical device recall Atomlab 500 Dose Calibrator Software 2.0.00 through Revision 2.0.08, inclusive When deleting a previously entered custom isotope, the software deletes the isotope, but not the associated dial setting. Class IIFDA’s classOct 6, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 6, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall AtomLab 500Plus Dose CalibratorSoftware 2.0.00 through Revision 2.0.08, inclusive When deleting a previously entered custom isotope, the software deletes the isotope, but not the associated dial setting. Class IIFDA’s classOct 6, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 6, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Norco Ultrasound Gel, Item/Description: NC70479/Norco Ultrasound Gel, 250 mL 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 EcoLotion Transmission Lotion, used in ultrasound procedures 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 Operating room table - Product Usage: intended for use during diagnostic examinations, radiologic procedures… ORT200/300 rotational lock may fail to function such that it cannot change states between locked and unlocked, due to a mechanical hardware issue. Class IIFDA’s classOct 6, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedOct 6, 2021ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, North Carolina, New Hampshire, Ohio, Oregon, Tennessee, Texas and Utah named
- Medical device recall Operating room table - Product Usage: intended for use during diagnostic examinations, radiologic procedures… ORT200/300 rotational lock may fail to function such that it cannot change states between locked and unlocked, due to a mechanical hardware issue. Class IIFDA’s classOct 6, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedOct 6, 2021ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, North Carolina, New Hampshire, Ohio, Oregon, Tennessee, Texas and Utah named
- Medical device recall Operating room table - Product Usage: intended for use during diagnostic examinations, radiologic procedures… ORT200/300 rotational lock may fail to function such that it cannot change states between locked and unlocked, due to a mechanical hardware issue. Class IIFDA’s classOct 6, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedOct 6, 2021ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, North Carolina, New Hampshire, Ohio, Oregon, Tennessee, Texas and Utah named
- Medical device recall GENOSYL DS (Delivery System) console, for use as a vasodilator. Manufacturing defect involving reversal of the inlet and outlet gas lines, resulting in delivery of nitrogen dioxide (NO2) instead of nitric oxide (NO). 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 IStatusCompletedWhereIllinois and Texas
- Medical device recall Arjo Citadel beds originally assembled with the IndiGo modules during manufcturing The IndiGo power cord might wear during use which could lead to its damage, resulting in the cord being cut, burnt or short circuit with limited emission of… Class IIFDA’s classOct 6, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedOct 6, 2021ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Illinois, Kentucky, Maryland, Nevada, New York, Pennsylvania and South Dakota named
- Medical device recall Atrium ADVANTA VXT Vascular Graft The product package may potentially contain a mismatched graft that does not contain the radial support ring (helix) identified in the labeling. Class IIFDA’s classOct 6, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 6, 2021ClassClass IIStatusTerminatedWhereNationwide, and Florida named
- Medical device recall AMX Navigate Mobile X-Ray System An unexpected column motion while attempting to park the column on the AMX Navigate mobile X-ray system. Class IIFDA’s classOct 6, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 6, 2021ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall MOSAIQ Oncology Information System A drug strength in MOSAIQ can be changed during the ordering process and approved, but the saved drug strength reverts to the original value. Class IIFDA’s classOct 6, 2021in FDA’s Enforcement Report17 statesnamed in where it went PublishedOct 6, 2021ClassClass IIStatusOngoingWhereCalifornia, Colorado, Florida, Idaho, Louisiana, Missouri, Mississippi, North Carolina, New Hampshire, New Mexico, Nevada, New York, Ohio, Oklahoma, Pennsylvania, South Dakota and Washington
- Medical device recall Atrium Pneumostat Chest Drain Valve The firm is revising the Indication for Use, Contraindications, Warnings, and Precautions, after the device was involved in the treatment of a preterm infant… Class IIFDA’s classOct 6, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 6, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall uMI 550 System - Product Usage: intended to be operated by qualified healthcare professionals to assist in… The EXAM acquisition workflow could occasionally freeze after canceling the PET scan. Class IIFDA’s classOct 6, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedOct 6, 2021ClassClass IIStatusOngoingWhereNationwide, and California, Illinois, Indiana, Texas and Wisconsin named
- Medical device recall uEXPLORER PET/CT System - Product Usage: intended to be operated by qualified healthcare professionals to… The EXAM acquisition workflow could occasionally freeze after canceling the PET scan. Class IIFDA’s classOct 6, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedOct 6, 2021ClassClass IIStatusOngoingWhereNationwide, and California, Illinois, Indiana, Texas and Wisconsin named
- Medical device recall Flow sensors kept as stand-alone user replaceable spare parts for the GEHC anethesia machines: 2089610-001… The flow sensors built prior to June 2021 could have damaged tubes with small punctures or cuts that could cause leaks resulting in incorrect anesthesia… Class IIFDA’s classOct 6, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 6, 2021ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Flow sensors that may be installed in the following GEHC anesthesia machines The flow sensors built prior to June 2021 could have damaged tubes with small punctures or cuts that could cause leaks resulting in incorrect anesthesia… Class IIFDA’s classOct 6, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 6, 2021ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall OctoStretch with Stretch Leveller - The combination of this products allows the user to easily adjust/control… Stretch Leveller has the potential to lose the function of maintaining a patient in the horizontal position when lifting and in motion. Class IIFDA’s classOct 6, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 14 states named PublishedOct 6, 2021ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Colorado, Delaware, Illinois, Maine, Michigan, Missouri, Mississippi, New Jersey, Ohio, Pennsylvania, Virginia and Washington named
- Medical device recall FlexoStretch Stretch Leveller has the potential to lose the function of maintaining a patient in the horizontal position when lifting and in motion. Class IIFDA’s classOct 6, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 14 states named PublishedOct 6, 2021ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Colorado, Delaware, Illinois, Maine, Michigan, Missouri, Mississippi, New Jersey, Ohio, Pennsylvania, Virginia and Washington named
- Medical device recall Stretch Leveller Stretch Leveller has the potential to lose the function of maintaining a patient in the horizontal position when lifting and in motion. Class IIFDA’s classOct 6, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 14 states named PublishedOct 6, 2021ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Colorado, Delaware, Illinois, Maine, Michigan, Missouri, Mississippi, New Jersey, Ohio, Pennsylvania, Virginia and Washington named
- Medical device recall LikoStretch 1900 Stretch Leveller has the potential to lose the function of maintaining a patient in the horizontal position when lifting and in motion. Class IIFDA’s classOct 6, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 14 states named PublishedOct 6, 2021ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Colorado, Delaware, Illinois, Maine, Michigan, Missouri, Mississippi, New Jersey, Ohio, Pennsylvania, Virginia and Washington named
- Medical device recall LikoStretch Mod 600 IC Stretch Leveller has the potential to lose the function of maintaining a patient in the horizontal position when lifting and in motion. Class IIFDA’s classOct 6, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 14 states named PublishedOct 6, 2021ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Colorado, Delaware, Illinois, Maine, Michigan, Missouri, Mississippi, New Jersey, Ohio, Pennsylvania, Virginia and Washington 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.”
Your shortlist0 of 4
Add one more to compare.