Medical devices, 2022
Shortlist up to four to read them side by side.
2,192 medical device recalls FDA’s Enforcement Report published in 2022, newest first; 40,450 in all since 2012.
FDA’s medical device recalls, as its Enforcement Report classifies them, from June 2012. Lists of FDA’s records can’t be saved for alerts: openFDA asks that its data not be used to alert the public (openFDA); FDA’s own emails do that. Copied Nov 5, 2026.
2,192of 2,192 medical device recallsshown with your filters
The list
- Medical device recall Carefusion V BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer’s IFU. Class IIFDA’s classDec 14, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 14, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Carefusion V BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer’s IFU. Class IIFDA’s classDec 14, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 14, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Carefusion V BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer’s IFU. Class IIFDA’s classDec 14, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 14, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Carefusion V BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer’s IFU. Class IIFDA’s classDec 14, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 14, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Carefusion V BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer’s IFU. Class IIFDA’s classDec 14, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 14, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall CareFusion V BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer’s IFU. Class IIFDA’s classDec 14, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 14, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall CareFusion V BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer’s IFU. Class IIFDA’s classDec 14, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 14, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall CareFusion V BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer’s IFU. Class IIFDA’s classDec 14, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 14, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall CareFusion V XXX Class IIFDA’s classDec 14, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 14, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall CareFusion V BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer’s IFU. Class IIFDA’s classDec 14, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 14, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall CareFusion V BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer’s IFU. Class IIFDA’s classDec 14, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 14, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall CareFusion V BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer’s IFU. Class IIFDA’s classDec 14, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 14, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall CareFusion V BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer’s IFU. Class IIFDA’s classDec 14, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 14, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall CareFusion V BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer’s IFU. Class IIFDA’s classDec 14, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 14, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall CareFusion V BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer’s IFU. Class IIFDA’s classDec 14, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 14, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall CareFusion V BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer’s IFU. Class IIFDA’s classDec 14, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 14, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall CareFusion V BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer’s IFU. Class IIFDA’s classDec 14, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 14, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall CareFusion V BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer’s IFU. Class IIFDA’s classDec 14, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 14, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall CareFusion V BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer’s IFU. Class IIFDA’s classDec 14, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 14, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall CareFusion V BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer’s IFU. Class IIFDA’s classDec 14, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 14, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall CareFusion V BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer’s IFU. Class IIFDA’s classDec 14, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 14, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall CareFusion V BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer’s IFU. Class IIFDA’s classDec 14, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 14, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall CareFusion V BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer’s IFU. Class IIFDA’s classDec 14, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 14, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall CareFusion V BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer’s IFU. Class IIFDA’s classDec 14, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 14, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall CareFusion V BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer’s IFU. Class IIFDA’s classDec 14, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 14, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall CareFusion V BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer’s IFU. Class IIFDA’s classDec 14, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 14, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall CareFusion V BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer’s IFU. Class IIFDA’s classDec 14, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 14, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall CareFusion V BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer’s IFU. Class IIFDA’s classDec 14, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 14, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall LineSider Spinal System 5.5/6.0mm, Non-mod Standard 7.1mm - Dual Lead, Non-cannulated Potential for weld separation of the Upper Tulip Head component from the Lower Tulip Head component, which would result in the separation of the Tulip Head… Class IIFDA’s classDec 14, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 16 states named PublishedDec 14, 2022ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Connecticut, District of Columbia, Florida, Illinois, Indiana, Louisiana, Massachusetts, Minnesota, New Jersey, Oklahoma, Puerto Rico, Tennessee, Texas and Virginia named
- Medical device recall LineSider Spinal System 5.5/6.0mm, Non-mod Standard 7.1mm - Dual Lead, Cannulated Potential for weld separation of the Upper Tulip Head component from the Lower Tulip Head component, which would result in the separation of the Tulip Head… Class IIFDA’s classDec 14, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 16 states named PublishedDec 14, 2022ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Connecticut, District of Columbia, Florida, Illinois, Indiana, Louisiana, Massachusetts, Minnesota, New Jersey, Oklahoma, Puerto Rico, Tennessee, Texas and Virginia named
- Medical device recall LineSider Spinal System 5.5/6.0mm, Non-mod MIS 7.1mm - Dual Lead, Cannulated Potential for weld separation of the Upper Tulip Head component from the Lower Tulip Head component, which would result in the separation of the Tulip Head… Class IIFDA’s classDec 14, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 16 states named PublishedDec 14, 2022ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Connecticut, District of Columbia, Florida, Illinois, Indiana, Louisiana, Massachusetts, Minnesota, New Jersey, Oklahoma, Puerto Rico, Tennessee, Texas and Virginia named
- Medical device recall LineSider Spinal System pedicle screws, 5.5/6.0mm, Non-mod Standard 7.1mm - Dual Lead, Non-cannulated Potential for intraoperative screw head separation at weld location. Class IIFDA’s classDec 14, 2022in FDA’s Enforcement Report5 statesnamed in where it went PublishedDec 14, 2022ClassClass IIStatusTerminatedWhereCalifornia, District of Columbia, Indiana, New York and Oklahoma
- Medical device recall Flow-c Anesthesia System (Product Code 6887700) Flow-e Anesthesia System (Product Code 6887900) The power backup battery, under certain conditions, may exhibit reduced battery run-time while in use, and there is a potential that the battery may fail to… Class IIFDA’s classDec 14, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedDec 14, 2022ClassClass IIStatusOngoingWhereNationwide, and Colorado, Florida, Indiana, Massachusetts, Missouri and Virginia named
- Medical device recall Omnipod 5 Automated Insulin Delivery System Product The firm has become aware of an issue with the Omnipod 5 Controller where the Controller charging port and charging cable are melting, deforming, or… Class IIFDA’s classDec 14, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 14, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall HF Resection Electrodes An incompatible HF cable may be packaged with the HF Resection Electrodes. Class IIFDA’s classDec 14, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 14, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall The FAST System and the FAST PBC Prep Cartridge together are a closed, rapid and automated sample preparation… Device exceeds the limitations of a Class I 510(k)-exempt device so the user manual, instructions for use, and promotional materials are being corrected to… Class IIFDA’s classDec 14, 2022in FDA’s Enforcement Report4 statesnamed in where it went PublishedDec 14, 2022ClassClass IIStatusOngoingWhereAlabama, California, New York and Utah
- Medical device recall Propel Mini Mometasone Furoate Sinus Implant, with Straight Delivery System Sinus Implant product label displays incorrect product information including: “Straight Delivery System”, with incorrect reference number and UDI-DI. Class IIFDA’s classDec 14, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 31 states named PublishedDec 14, 2022ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Kansas, Louisiana, Massachusetts, Maryland, Minnesota, Missouri, Montana, North Carolina, North Dakota, New Jersey, Nevada, New York, Oklahoma, Oregon, South Carolina, South Dakota, Tennessee, Texas, Utah, Washington, Wisconsin and Wyoming named
- Medical device recall Philips Ingenia Elition S MR System Gradient Coil may act as a heat source with a potential to produce smoke and/or fire. Class IIFDA’s classDec 14, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 14, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Philips Ingenia Elition X MR System Gradient Coil may act as a heat source with a potential to produce smoke and/or fire. Class IIFDA’s classDec 14, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 14, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Philips SmartPath to Ingenia Elition X MR System Gradient Coil may act as a heat source with a potential to produce smoke and/or fire. Class IIFDA’s classDec 14, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 14, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Philips MR 7700 System Gradient Coil may act as a heat source with a potential to produce smoke and/or fire. Class IIFDA’s classDec 14, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 14, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Philips Upgrade to MR 7700 System Gradient Coil may act as a heat source with a potential to produce smoke and/or fire. Class IIFDA’s classDec 14, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 14, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medical Action Industries Inc The Port Access Kits were incorrectly labeled as IV Start Kits on the kit label. Class IIFDA’s classDec 14, 2022in FDA’s Enforcement ReportMinnesotathe one state its words name PublishedDec 14, 2022ClassClass IIStatusTerminatedWhereMinnesota
- Medical device recall Small Joint OATS Set The devices may be packaged with the wrong reamer size. Class IIFDA’s classDec 14, 2022in FDA’s Enforcement Report20 statesnamed in where it went PublishedDec 14, 2022ClassClass IIStatusOngoingWhereAlabama, Arkansas, California, Colorado, Florida, Iowa, Illinois, Louisiana, Massachusetts, Maryland, Michigan, North Carolina, New Jersey, New York, Ohio, Pennsylvania, South Carolina, Texas, Utah and Virginia
- Medical device recall CoViPoint COVID test kit (MultiPLEX/Direct) Kit Distribution of COVID Test Kits without FDA Approval, Clearance or Authorization. Class IIFDA’s classDec 7, 2022in FDA’s Enforcement Report11 statesnamed in where it went PublishedDec 7, 2022ClassClass IIStatusOngoingWhereCalifornia, District of Columbia, Georgia, Indiana, Maryland, New Jersey, New York, Oregon, Pennsylvania, Texas and Washington
- Medical device recall Busse JOINT INJECTION TRAY -Intended as a nerve block Kits containing 3M Steri-Drape Surgical Drapes recalled by 3M due to liner on the adhesive component is difficult to remove without damaging the product and… Class IIFDA’s classDec 7, 2022in FDA’s Enforcement ReportTexasthe one state its words name PublishedDec 7, 2022ClassClass IIStatusOngoingWhereTexas
- Medical device recall Busse SPINE INJECTION TRAY-Intended as a nerve block Kits containing 3M Steri-Drape Surgical Drapes recalled by 3M due to liner on the adhesive component is difficult to remove without damaging the product and… Class IIFDA’s classDec 7, 2022in FDA’s Enforcement ReportTexasthe one state its words name PublishedDec 7, 2022ClassClass IIStatusOngoingWhereTexas
- Medical device recall INTUITIVE Da Vinci Xi 8mm SureForm 30 Curved-Tip Stapler Da Vinci Xi|X Potential staple deployment failure and device fragment generation Class IIFDA’s classDec 7, 2022in FDA’s Enforcement Report24 statesnamed in where it went PublishedDec 7, 2022ClassClass IIStatusOngoingWhereArizona, California, Colorado, Florida, Illinois, Indiana, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, North Carolina, Nevada, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin
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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