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 GE Healthcare Centricity Universal Viewer Zero Footprint Client Footprint Client (ZFP) versions v6.0 SP9.x and SP10.x where the latest addended report is not shown by default to the user. Class IIFDA’s classSep 25, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 25, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall BiomarC EX Fiducial Marker System This recall has been initiated due to a failure to provide an MRI Insert that is to be provided to the patient. Class IIIFDA’s classSep 25, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 25, 2024ClassClass IIIStatusOngoingWhereNationwide, and Tennessee named
- Medical device recall Marodyne-LiV Some power supply units in Austria and Germany had a voltage drop in the millisecond range, which led to a cancellation of the treatment and subsequent restart… Class IIFDA’s classSep 25, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 25, 2024ClassClass IIStatusOngoingWhereNationwide, and Florida named
- Medical device recall TxHA PEEK IBF/TxTiHA IBF System Due to interfacing issues between the implant trial and inserter of the lumbar intervertebral fusion device. Class IIFDA’s classSep 25, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedSep 25, 2024ClassClass IIStatusOngoingWhereNationwide, and Alabama, California, Colorado, Florida, Idaho, Michigan, South Dakota, Texas and Wisconsin named
- Medical device recall 1. Tech Medical Services Inc. Detachable Endo Retrieval Pouch, REF TM2001, 3” x 6”, sterile; 2. Tech Medical… The tube may fall into the surgical site during the grasping process. Class IIFDA’s classSep 25, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedSep 25, 2024ClassClass IIStatusOngoingWhereNationwide, and Georgia, Missouri and Pennsylvania named
- Medical device recall System Code Name: 722282 Azurion 7 M20 722281 Azurion 5 M20 722236 Azurion 7 B20 722235 Azurion 7 B12 722234… Potential Detachment of the Cable Hose Carrier (due to broken plastic and/or bolts) which May Result in Parts Falling and/or Part of the Cable Hose Dropping,… Class IIFDA’s classSep 25, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedSep 25, 2024ClassClass IIStatusOngoingWhereNationwide, and Georgia and US Virgin Islands named
- Medical device recall System Name: 722059 Allura Xper FD20/15 OR Table 722058 Allura Xper FD20/15 722039 Allura Xper FD20/20 OR… Potential Detachment of the Cable Hose Carrier (due to broken plastic and/or bolts) which May Result in Parts Falling and/or Part of the Cable Hose Dropping,… Class IIFDA’s classSep 25, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedSep 25, 2024ClassClass IIStatusOngoingWhereNationwide, and Georgia and US Virgin Islands named
- Medical device recall System Name: 722044 INTEGRIS Allura 15-12 (biplane) 722030 Integris CV Cesar-Powerpack-Visub-Nicol 722021… Potential Detachment of the Cable Hose Carrier (due to broken plastic and/or bolts) which May Result in Parts Falling and/or Part of the Cable Hose Dropping,… Class IIFDA’s classSep 25, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedSep 25, 2024ClassClass IIStatusOngoingWhereNationwide, and Georgia and US Virgin Islands named
- Medical device recall System Name: 708038 MultiDiagnost Eleva with Flat Detector 708037 MultiDiagnost Eleva with Flat Detector… Potential Detachment of the Cable Hose Carrier (due to broken plastic and/or bolts) which May Result in Parts Falling and/or Part of the Cable Hose Dropping,… Class IIFDA’s classSep 25, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedSep 25, 2024ClassClass IIStatusOngoingWhereNationwide, and Georgia and US Virgin Islands named
- Medical device recall Atellica CH Microalbumin_2 (¿ALB_2)-For in vitro diagnostic use in the quantitative measurement of… Atellica CH Microalbumin_2 (¿ALB_2) and the ADVIA Chemistry Microalbumin_2 (¿ALB_2) are not meeting the High-Dose Hook Effect claim/Prozone Effect claim as… Class IIFDA’s classSep 25, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 25, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ADVIA Chemistry Microalbumin_2 (¿ALB_2) -For in vitro diagnostic use in the quantitative measurement of… Atellica CH Microalbumin_2 (¿ALB_2) and the ADVIA Chemistry Microalbumin_2 (¿ALB_2) are not meeting the High-Dose Hook Effect claim/Prozone Effect claim as… Class IIFDA’s classSep 25, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 25, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall DIAMOND POINT, BOTH ENDS K-WIRE Smith & Nephew, Inc., has initiated a field action to voluntarily remove two batches of K-Wires due to a packaging error. Class IIFDA’s classSep 25, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 25, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall DIAMOND POINT, BOTH ENDS K-WIRE Smith & Nephew, Inc., has initiated a field action to voluntarily remove two batches of K-Wires due to a packaging error. Class IIFDA’s classSep 25, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 25, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall SL BLOODLINE FOR FMC 2008 SERIES-Tubing to be used to transfer blood between a patient and a haemodialyser… Incomplete insertion of the patient connector of the Streamline Airless System Hemodialysis Bloodline to the Locksite may result in the potential for occlusion… Class IIFDA’s classSep 25, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 25, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall STREAMLINE FRESENIUS FOR DAVITA-Tubing to be used to transfer blood between a patient and a haemodialyser… Incomplete insertion of the patient connector of the Streamline Airless System Hemodialysis Bloodline to the Locksite may result in the potential for occlusion… Class IIFDA’s classSep 25, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 25, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall STREAMLINE FRESENIUS FOR DAVITA-Tubing to be used to transfer blood between a patient and a haemodialyser… Incomplete insertion of the patient connector of the Streamline Airless System Hemodialysis Bloodline to the Locksite may result in the potential for occlusion… Class IIFDA’s classSep 25, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 25, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall STREAMLINE BLOODLINE LONG VERSION, FMC-Tubing to be used to transfer blood between a patient and a… Incomplete insertion of the patient connector of the Streamline Airless System Hemodialysis Bloodline to the Locksite may result in the potential for occlusion… Class IIFDA’s classSep 25, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 25, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall STREAMLINE LONG-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodialysis Incomplete insertion of the patient connector of the Streamline Airless System Hemodialysis Bloodline to the Locksite may result in the potential for occlusion… Class IIFDA’s classSep 25, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 25, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall STREAMLINE BLOODLINE SET FOR DIALOG-Tubing to be used to transfer blood between a patient and a haemodialyser… Incomplete insertion of the patient connector of the Streamline Airless System Hemodialysis Bloodline to the Locksite may result in the potential for occlusion… Class IIFDA’s classSep 25, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 25, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall STREAMLINE BLOODLINE SET FOR DIALOG DR-Tubing to be used to transfer blood between a patient and a… Incomplete insertion of the patient connector of the Streamline Airless System Hemodialysis Bloodline to the Locksite may result in the potential for occlusion… Class IIFDA’s classSep 25, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 25, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Beckman Coulter DxI 9000 Access Immunoassay Analyzer Beckman Coulter is recalling the DxI 9000 Access Immunoassay Analyzer due to undersized Pneumatics Tubing in the reagent storage module causing air leaks,… Class IIFDA’s classSep 25, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 25, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall HAWK Warming Grid Incorrect expiration date. Class IIFDA’s classSep 25, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 16 states named PublishedSep 25, 2024ClassClass IIStatusOngoingWhereNationwide, and Alaska, California, Colorado, District of Columbia, Georgia, Illinois, North Carolina, New Mexico, New York, Oklahoma, Oregon, Rhode Island, Texas, Virginia, Washington and Wisconsin named
- Medical device recall HAWK Advanced Hypothermia Management Set Incorrect expiration date. Class IIFDA’s classSep 25, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 16 states named PublishedSep 25, 2024ClassClass IIStatusOngoingWhereNationwide, and Alaska, California, Colorado, District of Columbia, Georgia, Illinois, North Carolina, New Mexico, New York, Oklahoma, Oregon, Rhode Island, Texas, Virginia, Washington and Wisconsin named
- Medical device recall Kits of Convenience containing 1 of the 2 Incorrect expiration date. Class IIFDA’s classSep 25, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 16 states named PublishedSep 25, 2024ClassClass IIStatusOngoingWhereNationwide, and Alaska, California, Colorado, District of Columbia, Georgia, Illinois, North Carolina, New Mexico, New York, Oklahoma, Oregon, Rhode Island, Texas, Virginia, Washington and Wisconsin named
- Medical device recall BinaxNOW Respiratory Strep A Test Kit, CLIA Waived Due to a classification error in our inventory management system, these medical devices were shipped to customers that did not have the requisite license to… Class IIFDA’s classSep 25, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 25, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Acceava Respiratory Strep A, CLIA Waived Due to a classification error in our inventory management system, these medical devices were shipped to customers that did not have the requisite license to… Class IIFDA’s classSep 25, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 25, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall VariSoft Infusion Set, Single Use. Specific VariSoftTM Infusion Sets were packaged using incorrect secondary packaging (boxes) branded “Trusteel Infusion Set”. Class IIFDA’s classSep 25, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 25, 2024ClassClass IIStatusOngoingWhereNationwide, and California named
- Medical device recall Olympus Triangle Tip Electrosurgical Knives- to be used with Olympus endoscopes and electrosurgical units to… Due to increase in complaints for the KD-640L and KD-645L Triangle Tip Electrosurgical Knives breaking off during use -issuing reminder to users to utilize the… Class IIFDA’s classSep 18, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 18, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Olympus Triangle Tip Electrosurgical Knives- to be used with Olympus endoscopes and electrosurgical units to… Due to increase in complaints for the KD-640L and KD-645L Triangle Tip Electrosurgical Knives breaking off during use -issuing reminder to users to utilize the… Class IIFDA’s classSep 18, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 18, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Infusomat Space Infusion System/ Large Volume Pump Extension of previous recall RES 92978. FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 18, 2024in FDA’s Enforcement Report6 statesnamed in where it went PublishedSep 18, 2024ClassClass IStatusOngoingWhereAlabama, California, Georgia, Illinois, Michigan and Texas
- Medical device recall Pneupac paraPAC plus 300 ventilator kit There is a potential for inadvertent tidal volume knob movement from the original setting when set at high (1000-1500 mL) and low (70-150 mL) settings. FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 18, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 18, 2024ClassClass IStatusOngoingWhereNo state named
- Medical device recall Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP There is a potential for inadvertent tidal volume knob movement from the original setting when set at high (1000-1500 mL) and low (70-150 mL) settings. FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 18, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 18, 2024ClassClass IStatusOngoingWhereNo state named
- Medical device recall 25-LHP-828, HeNe Laser System, 35 mW These laser products fail to comply with 21 CFR 1040.10(f)(4) Key control which requires, Each laser system classified as a Class IIIb or IV laser product… Class IIFDA’s classSep 18, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 18, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall 25-LHP-928, HeNe Laser System, 25 mW These laser products fail to comply with 21 CFR 1040.10(f)(4) Key control which requires, Each laser system classified as a Class IIIb or IV laser product… Class IIFDA’s classSep 18, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 18, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall N-LHP-928, HeNe Laser System, 35 mW These laser products fail to comply with 21 CFR 1040.10(f)(4) Key control which requires, Each laser system classified as a Class IIIb or IV laser product… Class IIFDA’s classSep 18, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 18, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Convenience kits, labeled as: 1) TRACHEOTOMY TRAY, Pack Number DYNDA1894 Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Class IIFDA’s classSep 18, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 18, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Medline Convenience kits, labeled as: 1) TRACH CDS-LF , Pack Number CDS983142B Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Class IIFDA’s classSep 18, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 18, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Medline Convenience kits, labeled as: 1) GAS SAM LINE .06ID 10FT MM FLT, Pack Number 35772 Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Class IIFDA’s classSep 18, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 18, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Medline Convenience kits, labeled as: 1) TRACHEOTOMY TRAY, Pack Number DYNDA1894 Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Class IIFDA’s classSep 18, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 18, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Medline Convenience kits, labeled as: 1) DYNJ39451D , Pack Number HOOD PACK Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Class IIFDA’s classSep 18, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 18, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Medline Convenience kits labeled as: 1) STERILE LIDOCAINE SYRINGE PACK, Pack Number DYNDM1076A Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Class IIFDA’s classSep 18, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 18, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Medline Convenience kits, labeled as: 1) SINGLE SHOT EPIDURAL PACK-LF, Pack Number DYNJ0708470K Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Class IIFDA’s classSep 18, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 18, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Medline Convenience kits, labeled as: 1) NERVE BLOCK TRAY-LF, Pack Number DYNJRA0377B Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Class IIFDA’s classSep 18, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 18, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Medline Convenience kits, labeled as: SPINAL BLOCK 22G QUINCKE 5S BU, Pack Number DYNJRA9026 Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Class IIFDA’s classSep 18, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 18, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Medline Convenience kits labeled as: 1) KIT MANIFOLD CSTM-NORTHRIDGE, Pack Number 129736 Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Class IIFDA’s classSep 18, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 18, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Medline Convenience kits labeled as: CARDIAC PACING PACK, Pack Number DYNJ41223 Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Class IIFDA’s classSep 18, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 18, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Medline convenience kits labeled as: 1) ANGIOGRAPHY DRAPE PACK, Pack Number 00-398281J Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Class IIFDA’s classSep 18, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 18, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Medline Convenience kits labeled as: 1) CATH LAB SPECIAL PROCEDURE, Pack Number 00-RDF036O Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Class IIFDA’s classSep 18, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 18, 2024ClassClass IIStatusOngoingWhereNo state 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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