Medical devices, 2024
Shortlist up to four to read them side by side.
3,394 medical device recalls FDA’s Enforcement Report published in 2024, newest first; 40,450 in all since 2012.
FDA’s medical device recalls, as its Enforcement Report classifies them, from June 2012. Lists of FDA’s records can’t be saved for alerts: openFDA asks that its data not be used to alert the public (openFDA); FDA’s own emails do that. Copied Nov 6, 2026.
3,394of 3,394 medical device recallsshown with your filters
The list
- Medical device recall MNA-420 ENC HDMI, Material Number K9303311 We have identified a potential issue with the SFP+ module supplied by Molex (Part Number: B620050) when connected to the ETH0 slot of either the MNA-6x0 ENC… Class IIFDA’s classJul 17, 2024in FDA’s Enforcement ReportFloridathe one state its words name PublishedJul 17, 2024ClassClass IIStatusCompletedWhereFlorida
- Medical device recall Synergetics I Pack Injection Kit- Tray for use with Ophthalmic injections Could not confirm products were exposed to the proper sterilization cycle can potentially cause post operative wound infection or injection site infection. Class IIFDA’s classJul 17, 2024in FDA’s Enforcement ReportMissourithe one state its words name PublishedJul 17, 2024ClassClass IIStatusOngoingWhereMissouri
- Medical device recall Synergetics I-Pack Injection Kit with Drape -For use with Ophthalmic injections Could not confirm products were exposed to the proper sterilization cycle can potentially cause post operative wound infection or injection site infection. Class IIFDA’s classJul 17, 2024in FDA’s Enforcement ReportMissourithe one state its words name PublishedJul 17, 2024ClassClass IIStatusOngoingWhereMissouri
- Medical device recall Synergetics I Pack Injection Kit Custom-Tray for use with Ophthalmic injections Could not confirm products were exposed to the proper sterilization cycle can potentially cause post operative wound infection or injection site infection. Class IIFDA’s classJul 17, 2024in FDA’s Enforcement ReportMissourithe one state its words name PublishedJul 17, 2024ClassClass IIStatusOngoingWhereMissouri
- Medical device recall Synergetics I Pack Injection Kit with Wire Speculum- Tray for use in Opthalmic Injection Could not confirm products were exposed to the proper sterilization cycle can potentially cause post operative wound infection or injection site infection. Class IIFDA’s classJul 17, 2024in FDA’s Enforcement ReportMissourithe one state its words name PublishedJul 17, 2024ClassClass IIStatusOngoingWhereMissouri
- Medical device recall The VASOVIEW HEMOPRO Endoscopic Vessel Harvesting Systems is designed for use in conjunction with the 7 mm… There were 27 complaints between March 22, 2024, and April 30, 2024, related to VH-3500 and VH-4000, reporting that the C-Ring wire was straightened (due to… Class IIFDA’s classJul 17, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 17, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall The VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System is designed for use in conjunction with the 7 mm… There were 27 complaints between March 22, 2024, and April 30, 2024, related to VH-3500 and VH-4000, reporting that the C-Ring wire was straightened (due to… Class IIFDA’s classJul 17, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 17, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Braun Thermoscan¿ PRO 6000 Ear Thermometer The Braun Thermoscan PRO 6000 ear thermometers may have been shipped with a compact disc (CD) containing an outdated version of the Instructions for Use (IFU). Class IIFDA’s classJul 17, 2024in FDA’s Enforcement Report2 statesnamed in where it went PublishedJul 17, 2024ClassClass IIStatusOngoingWhereGuam and Puerto Rico
- Medical device recall 190904 2008K@HOME HEMODIALYSIS SYSTEM W/ BIBAG - Blood Pump Rotor spare part An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide… Class IIFDA’s classJul 17, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 17, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall 190828: 2008K@HOME HEMODIALYSIS SYSTEM - Blood Pump Rotor spare part An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide… Class IIFDA’s classJul 17, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 17, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall 191014: 2008K@HOME HD SYSTEM W/BIBAG (CANADA) - Blood Pump Rotor spare part An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide… Class IIFDA’s classJul 17, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 17, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall 190395: 2008K@HOME MACHINE, SHORT CAB,OLC/DP,HP - Blood Pump Rotor spare part An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide… Class IIFDA’s classJul 17, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 17, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall RTL190395: 2008K@HOME MACHINE, SHORT CAB,OLC/DP,HP - Blood Pump Rotor spare part An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide… Class IIFDA’s classJul 17, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 17, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall RTL190828: 2008K@HOME HEMODIALYSIS SYSTEM - Blood Pump Rotor spare part An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide… Class IIFDA’s classJul 17, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 17, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall RTL190904: 2008K@HOME HEMODIALYSIS SYSTEM W/ BIBAG - Blood Pump Rotor spare part An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide… Class IIFDA’s classJul 17, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 17, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall RTLR190395: 2008K@HOME MACHINE, SHORT CAB,OLC/DP,HP - Blood Pump Rotor spare part An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide… Class IIFDA’s classJul 17, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 17, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall HORIBA custom configured fluorescence instrument, modular Fluorolog-QM HORIBA custom configured fluorescence instrument has a laser safety defect. Class IIFDA’s classJul 10, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 10, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Sterile surgical convenience kits: a Surgical convenience kits containing Pure Pouch component that has weak seals which may result in a breach in sterility of the contents if the seal fails. Class IIFDA’s classJul 10, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 23 states named PublishedJul 10, 2024ClassClass IIStatusOngoingWhereNationwide, and Alabama, California, Colorado, Connecticut, Florida, Illinois, Indiana, Maryland, Minnesota, Montana, North Carolina, New Jersey, Nevada, New York, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington, Wisconsin and Wyoming named
- Medical device recall Sterile surgical convenience kit: Medline Retrograde PK-22025203-LF, Pack #DYNJ47873L, containing a Pure… Surgical convenience kits containing Pure Pouch component that has weak seals which may result in a breach in sterility of the contents if the seal fails. Class IIFDA’s classJul 10, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 23 states named PublishedJul 10, 2024ClassClass IIStatusOngoingWhereNationwide, and Alabama, California, Colorado, Connecticut, Florida, Illinois, Indiana, Maryland, Minnesota, Montana, North Carolina, New Jersey, Nevada, New York, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington, Wisconsin and Wyoming named
- Medical device recall Sterile surgical convenience kit: Medline Neuro IR Pack, Pack #DYNJ56073C, containing a Pure Pouch with… Surgical convenience kits containing Pure Pouch component that has weak seals which may result in a breach in sterility of the contents if the seal fails. Class IIFDA’s classJul 10, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 23 states named PublishedJul 10, 2024ClassClass IIStatusOngoingWhereNationwide, and Alabama, California, Colorado, Connecticut, Florida, Illinois, Indiana, Maryland, Minnesota, Montana, North Carolina, New Jersey, Nevada, New York, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington, Wisconsin and Wyoming named
- Medical device recall Sterile convenience kit: Medline Birthing Room Pack, Pack #DYNJ38429D, containing a Pure Pouch component… Surgical convenience kits containing Pure Pouch component that has weak seals which may result in a breach in sterility of the contents if the seal fails. Class IIFDA’s classJul 10, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 23 states named PublishedJul 10, 2024ClassClass IIStatusOngoingWhereNationwide, and Alabama, California, Colorado, Connecticut, Florida, Illinois, Indiana, Maryland, Minnesota, Montana, North Carolina, New Jersey, Nevada, New York, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington, Wisconsin and Wyoming named
- Medical device recall Sterile convenience kits: a Surgical convenience kits containing Pure Pouch component that has weak seals which may result in a breach in sterility of the contents if the seal fails. Class IIFDA’s classJul 10, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 23 states named PublishedJul 10, 2024ClassClass IIStatusOngoingWhereNationwide, and Alabama, California, Colorado, Connecticut, Florida, Illinois, Indiana, Maryland, Minnesota, Montana, North Carolina, New Jersey, Nevada, New York, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington, Wisconsin and Wyoming named
- Medical device recall Nonsterile convenience kits: a Surgical convenience kits containing Pure Pouch component that has weak seals which may result in a breach in sterility of the contents if the seal fails. Class IIFDA’s classJul 10, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 23 states named PublishedJul 10, 2024ClassClass IIStatusOngoingWhereNationwide, and Alabama, California, Colorado, Connecticut, Florida, Illinois, Indiana, Maryland, Minnesota, Montana, North Carolina, New Jersey, Nevada, New York, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington, Wisconsin and Wyoming named
- Medical device recall Non-sterile convenience kits: a Surgical convenience kits containing Pure Pouch component that has weak seals which may result in a breach in sterility of the contents if the seal fails. Class IIFDA’s classJul 10, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 23 states named PublishedJul 10, 2024ClassClass IIStatusOngoingWhereNationwide, and Alabama, California, Colorado, Connecticut, Florida, Illinois, Indiana, Maryland, Minnesota, Montana, North Carolina, New Jersey, Nevada, New York, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington, Wisconsin and Wyoming named
- Medical device recall Non-sterile convenience kits: Medline Open Heart CDS, Pack #CDS981759C, containing a Pure Pouch with… Surgical convenience kits containing Pure Pouch component that has weak seals which may result in a breach in sterility of the contents if the seal fails. Class IIFDA’s classJul 10, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 23 states named PublishedJul 10, 2024ClassClass IIStatusOngoingWhereNationwide, and Alabama, California, Colorado, Connecticut, Florida, Illinois, Indiana, Maryland, Minnesota, Montana, North Carolina, New Jersey, Nevada, New York, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington, Wisconsin and Wyoming named
- Medical device recall Non-sterile convenience kits: a Surgical convenience kits containing Pure Pouch component that has weak seals which may result in a breach in sterility of the contents if the seal fails. Class IIFDA’s classJul 10, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 23 states named PublishedJul 10, 2024ClassClass IIStatusOngoingWhereNationwide, and Alabama, California, Colorado, Connecticut, Florida, Illinois, Indiana, Maryland, Minnesota, Montana, North Carolina, New Jersey, Nevada, New York, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington, Wisconsin and Wyoming named
- Medical device recall EasySuite 4K Integrated Operating Room System A subset of the ES4K systems do not have complete records for earth leakage testing. Class IIFDA’s classJul 10, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 10, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Brand Name: Fathom Pedicle-Based Retractor Product Name: C/C Blade, 35-55mm Cranial Caudal Blades manufactured incorrectly could result in fracture and/or damage to the bone structure Class IIFDA’s classJul 10, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedJul 10, 2024ClassClass IIStatusOngoingWhereNationwide, and California, Michigan, Minnesota, Nevada, New York, Oklahoma, Oregon, Rhode Island and Texas named
- Medical device recall Brand Name: Fathom Pedicle-Based Retractor Product Name: C/C Blade, 50-80mm Cranial Caudal Blades manufactured incorrectly could result in fracture and/or damage to the bone structure Class IIFDA’s classJul 10, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedJul 10, 2024ClassClass IIStatusOngoingWhereNationwide, and California, Michigan, Minnesota, Nevada, New York, Oklahoma, Oregon, Rhode Island and Texas named
- Medical device recall Acumatch L-Series BIPOLAR LINER, 22mm (BIPOLAR ENDOPROSTHESIS-Hip) The AcuMatch L-Series 22mm Inner Diameter Bipolar Hip Liner lots were packaged without the specified ethylene vinyl alcohol (EVOH) layer. Class IIFDA’s classJul 10, 2024in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedJul 10, 2024ClassClass IIStatusOngoingWherePuerto Rico
- Medical device recall Beckman Coulter DxI 9000 Access Immunoassay Analyzer is a discrete photometric chemistry analyzer for… The reason for the recall is the pneumatic tubing used in the analytical pick-and-place (PnP) assembly cable may fully or partially disconnect from the flex… Class IIFDA’s classJul 10, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 10, 2024ClassClass IIStatusOngoingWhereNationwide, and Indiana named
- Medical device recall AMT Initial Placement Dilator Set Devices were labelled with the incorrect guidewire labelling. Class IIFDA’s classJul 10, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedJul 10, 2024ClassClass IIStatusCompletedWhereNationwide, and Georgia, Illinois, Indiana, Louisiana, North Carolina, Nebraska, South Carolina, Tennessee, Texas, Utah, Virginia, Washington and West Virginia named
- Medical device recall Avalon Ultrasound Transducer Potential for inaccurate fetal heart rate measurements when monitoring multiples. Class IIFDA’s classJul 10, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 10, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ARTIS is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and… A potential issue with ARTIS icono systems equipped with a small detector and a corresponding collimator (model # 10843101) was identified. Class IIFDA’s classJul 10, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedJul 10, 2024ClassClass IIStatusOngoingWhereNationwide, and Illinois, Massachusetts, Michigan, Minnesota, Missouri, North Carolina, New Hampshire, New Jersey, New York, Oklahoma, South Carolina and Texas named
- Medical device recall ARTIS is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and… A potential issue with ARTIS icono systems equipped with a small detector and a corresponding collimator (model # 10843101) was identified. Class IIFDA’s classJul 10, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedJul 10, 2024ClassClass IIStatusOngoingWhereNationwide, and Illinois, Massachusetts, Michigan, Minnesota, Missouri, North Carolina, New Hampshire, New Jersey, New York, Oklahoma, South Carolina and Texas named
- Medical device recall ARTIS is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and… A potential issue with ARTIS icono systems equipped with a small detector and a corresponding collimator (model # 10843101) was identified. Class IIFDA’s classJul 10, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedJul 10, 2024ClassClass IIStatusOngoingWhereNationwide, and Illinois, Massachusetts, Michigan, Minnesota, Missouri, North Carolina, New Hampshire, New Jersey, New York, Oklahoma, South Carolina and Texas named
- Medical device recall WOM Tube Set for lrrlgatlon, single-use- Intended to transport irrigation fluid to the patient in endoscopic… Incorrect transponder data was written on the RFID tags triggers the error message E03, Tube Set lnvalid, may result in a delay of surgery Class IIFDA’s classJul 10, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 10, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall EVOLUTION¿ MP Femoral CS/CR Non-Porous Non-porous MicroPort total knee replacement implants are for cemented… One confirmed incident has been received that EFSRN4PR, lot number MP1982170, Size 4 Evolution MP Non-Porous Femoral Right was opened during surgery and… Class IIFDA’s classJul 10, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 10, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall VITROS Chemistry Products Calibrator Kit 29- In-Vitor used to calibrate the VITROS 5,1 FS/4600 Chemistry… Kit assigned an extended expiration date of 24-Jul-2025 during release. Class IIIFDA’s classJul 10, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 10, 2024ClassClass IIIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall First Source Vision M Potential for the bolt that secures the positioning arm to the gas spring to come loose and fall onto patient. Class IIFDA’s classJul 10, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 19 states named PublishedJul 10, 2024ClassClass IIStatusOngoingWhereNationwide, and Arkansas, California, Florida, Georgia, Illinois, Indiana, Louisiana, Massachusetts, Maryland, Michigan, Missouri, Mississippi, North Carolina, New York, Oklahoma, Pennsylvania, Tennessee, Texas and Virginia named
- Medical device recall First Source iQ Flex M Potential for the bolt that secures the positioning arm to the gas spring to come loose and fall onto patient. Class IIFDA’s classJul 10, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 19 states named PublishedJul 10, 2024ClassClass IIStatusOngoingWhereNationwide, and Arkansas, California, Florida, Georgia, Illinois, Indiana, Louisiana, Massachusetts, Maryland, Michigan, Missouri, Mississippi, North Carolina, New York, Oklahoma, Pennsylvania, Tennessee, Texas and Virginia named
- Medical device recall Brand Name: MEGADYNE” MEGA 2000” Patient Return Electrode Product Name: MEGADYNE” MEGA 2000” Patient Return… To limit the use of the Mega Soft Pads to patients aged 12 or older to mitigate the potential risk of patient burns identified with use of Mega Soft pads. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 10, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 10, 2024ClassClass IStatusOngoingWhereNationwide
- Medical device recall Brand Name: MEGADYNE” MEGA SOFT” Reusable Patient Return Electrode Product Name: MEGADYNE” MEGA SOFT”… To limit the use of the Mega Soft Pads to patients aged 12 or older to mitigate the potential risk of patient burns identified with use of Mega Soft pads. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 10, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 10, 2024ClassClass IStatusOngoingWhereNationwide
- Medical device recall Brand Name: MEGADYNE” MEGA SOFT” Dual Reusable Patient Return Electrode Product Name: MEGADYNE” MEGA SOFT”… To limit the use of the Mega Soft Pads to patients aged 12 or older to mitigate the potential risk of patient burns identified with use of Mega Soft pads. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 10, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 10, 2024ClassClass IStatusOngoingWhereNationwide
- Medical device recall BD Pyxis, Name/REF: MEDBANK MINI 1FH-1FM/ 169-137, MEDBANK MINI 1FH-2HH MEDPASS/ 169-151, MEDBANK MINI… Multiple socket-outlet power strips that shipped with automated dispensing cabinet devices have not been certified to International Electrotechnical Commission… Class IIFDA’s classJul 10, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 47 states named PublishedJul 10, 2024ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, 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, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall BD Pyxis, Name/REF: BD PYXIS MB TOWER MAIN/ 169-153, BD PYXIS MB TOWER MAIN CR/ 169-154, BD PYXIS MB TOWER… Multiple socket-outlet power strips that shipped with automated dispensing cabinet devices have not been certified to International Electrotechnical Commission… Class IIFDA’s classJul 10, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 47 states named PublishedJul 10, 2024ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, 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, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Neurostimulation Kit (Ported, Dual 8, 40 cm) Neurostimulation Systems have a manufacturing non-conformance that may reduce the efficiency of the radiofrequency signals between the Implantable Pulse… Class IIFDA’s classJul 10, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedJul 10, 2024ClassClass IIStatusOngoingWhereNationwide, and Arkansas, Arizona, California, Illinois, Missouri, Oklahoma, Tennessee and Texas named
- Medical device recall Prucka 3 Amplifier Capacitors in certain Prucka 3 Amplifiers used with CardioLab / ComboLab systems could fail resulting in transient oscillations on the display and inability to… Class IIFDA’s classJul 10, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 21 states named PublishedJul 10, 2024ClassClass IIStatusOngoingWhereNationwide, and Alaska, Arizona, California, Colorado, Florida, Georgia, Illinois, Kentucky, Massachusetts, Maine, Minnesota, Missouri, North Carolina, New Jersey, New York, Ohio, Oregon, Pennsylvania, Tennessee, Texas 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.”
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