Medical devices, 2023
Shortlist up to four to read them side by side.
2,477 medical device recalls FDA’s Enforcement Report published in 2023, 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.
2,477of 2,477 medical device recallsshown with your filters
The list
- Medical device recall LIFEPAK 15, REF: 99577-000055, Part Number V15-2-000061 Their is a potential for battery pins to become loose within the defibrillator resulting in power issues. Class IIFDA’s classNov 22, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedNov 22, 2023ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, North Carolina, New Jersey and New York named
- Medical device recall LIFEPAK 15, REF: 99577-000061, Part Number V15-2-000067 Their is a potential for battery pins to become loose within the defibrillator resulting in power issues. Class IIFDA’s classNov 22, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedNov 22, 2023ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, North Carolina, New Jersey and New York named
- Medical device recall LIFEPAK 15, REF: 99577-001255, Part Number V15-2-001602 Their is a potential for battery pins to become loose within the defibrillator resulting in power issues. Class IIFDA’s classNov 22, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedNov 22, 2023ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, North Carolina, New Jersey and New York named
- Medical device recall LIFEPAK 15, REF: 99577-001373, Part Number V15-7-000002 Their is a potential for battery pins to become loose within the defibrillator resulting in power issues. Class IIFDA’s classNov 22, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedNov 22, 2023ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, North Carolina, New Jersey and New York named
- Medical device recall LIFEPAK 15, REF: 99577-001955, Part Number V15-5-000584 and V15-7-000020 Their is a potential for battery pins to become loose within the defibrillator resulting in power issues. Class IIFDA’s classNov 22, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedNov 22, 2023ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, North Carolina, New Jersey and New York named
- Medical device recall LIFEPAK 15, REF: 99577-001956, Part Number V15-7-000021 Their is a potential for battery pins to become loose within the defibrillator resulting in power issues. Class IIFDA’s classNov 22, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedNov 22, 2023ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, North Carolina, New Jersey and New York named
- Medical device recall LIFEPAK 15, REF: 99577-001957, Part Number V15-5-000586 and V15-7-000022 Their is a potential for battery pins to become loose within the defibrillator resulting in power issues. Class IIFDA’s classNov 22, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedNov 22, 2023ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, North Carolina, New Jersey and New York named
- Medical device recall LIFEPAK 15, REF: 99577-001958, Part Number: V15-7-000023 Their is a potential for battery pins to become loose within the defibrillator resulting in power issues. Class IIFDA’s classNov 22, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedNov 22, 2023ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, North Carolina, New Jersey and New York named
- Medical device recall LIFEPAK 15, REF: 99577-001960, Part Number: V15-7-000026 Their is a potential for battery pins to become loose within the defibrillator resulting in power issues. Class IIFDA’s classNov 22, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedNov 22, 2023ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, North Carolina, New Jersey and New York named
- Medical device recall Spectral CT on Rails, Software Version 5.1.0 When preparing for CCT Fluoroscopy mode and activating the CCT foot pedal simultaneously, the operator may experience a software crash. Class IIFDA’s classNov 22, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedNov 22, 2023ClassClass IIStatusOngoingWhereNationwide, and Minnesota named
- Medical device recall KWIKSTIK, P. venetum, Catalog numbers: a) 0794P (2-pack), b) 0794K (6-pack) A complaint investigation showed that the bulk pellets (lot 794-142) were contaminated with Aspergillus flavus. Class IIFDA’s classNov 22, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 22, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall LYFO-DISK, P A complaint investigation showed that the bulk pellets (lot 794-142) were contaminated with Aspergillus flavus. Class IIFDA’s classNov 22, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 22, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall AU/DxC AU Chemistry Transferrin The firm has identified that the Transferrin reagent does not meet the Instructions for Use (IFU) reagent on-board stability claims, which may cause control… Class IIFDA’s classNov 22, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 42 states named PublishedNov 22, 2023ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Guam, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall ADLT BLOOD CULTURE COLLECT KIT This recall is being issued due to items within the kit have expired prior to the overall kit expiration date listed on the insert. Class IIFDA’s classNov 22, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedNov 22, 2023ClassClass IIStatusOngoingWhereNationwide, and California named
- Medical device recall PERIPHERAL BLOOD CULTURE DRAW This recall is being issued due to items within the kit have expired prior to the overall kit expiration date listed on the insert. Class IIFDA’s classNov 22, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedNov 22, 2023ClassClass IIStatusOngoingWhereNationwide, and California named
- Medical device recall CENTRAL LINE BLOOD CULTURE DRA This recall is being issued due to items within the kit have expired prior to the overall kit expiration date listed on the insert. Class IIFDA’s classNov 22, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedNov 22, 2023ClassClass IIStatusOngoingWhereNationwide, and California named
- Medical device recall 24 BLOOD CULTURE KIT This recall is being issued due to items within the kit have expired prior to the overall kit expiration date listed on the insert. Class IIFDA’s classNov 22, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedNov 22, 2023ClassClass IIStatusOngoingWhereNationwide, and California named
- Medical device recall BLOOD CULTURE KIT This recall is being issued due to items within the kit have expired prior to the overall kit expiration date listed on the insert. Class IIFDA’s classNov 22, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedNov 22, 2023ClassClass IIStatusOngoingWhereNationwide, and California named
- Medical device recall Regard CV PK Specific Regard kits contain the Gentige Chest Drain Products being recalled by Gentige. Class IIFDA’s classNov 22, 2023in FDA’s Enforcement ReportMissourithe one state its words name PublishedNov 22, 2023ClassClass IIStatusOngoingWhereMissouri
- Medical device recall Ocean Water Seal Chest Drains (Ocean): Products Instructions for Use (IFU) for the Atrium Ocean, Oasis, and Express chest drains do not provide sufficient precaution instruction for proper set up of… Class IIFDA’s classNov 22, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 22, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Oasis Dry Suction Water Seal Chest Drains (Oasis) Instructions for Use (IFU) for the Atrium Ocean, Oasis, and Express chest drains do not provide sufficient precaution instruction for proper set up of… Class IIFDA’s classNov 22, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 22, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Express Dry Seal Chest Drains (Express): 4000-100N DRAIN, EXPRESS, SINGLE Instructions for Use (IFU) for the Atrium Ocean, Oasis, and Express chest drains do not provide sufficient precaution instruction for proper set up of… Class IIFDA’s classNov 22, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 22, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Spectral CT on Rails, Software Version 5.1.0 This recall is part of a 2-issue recall for the same system. Class IIFDA’s classNov 22, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedNov 22, 2023ClassClass IIStatusOngoingWhereNationwide, and Minnesota named
- Medical device recall FT1000S FLUID TRANSFER SET Devices may leak as a result of a manufacturing issue. Class IIFDA’s classNov 15, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 15, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall SA3000 VENTED MICRO SPIKE ADAPTER Devices may leak as a result of a manufacturing issue. Class IIFDA’s classNov 15, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 15, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall AMO ADMINISTRATION SET, Article No. 7A3817 Devices may leak as a result of a manufacturing issue. Class IIFDA’s classNov 15, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 15, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall 30 ML 2PORT BURETTE ASSEMBLY, Article No. 7A3950, used in a contrast management system. Devices may leak as a result of a manufacturing issue. Class IIFDA’s classNov 15, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 15, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall TERUMO 60” TUBE SET W/HIGH CRACK CHK VLV, Article No. 7S3070 Devices may leak as a result of a manufacturing issue. Class IIFDA’s classNov 15, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 15, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall THERASPHERE ADMIN SET, Article No. 7M2650 Devices may leak as a result of a manufacturing issue. Class IIFDA’s classNov 15, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 15, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ALLERGAN UNIVERSAL FILL KIT Devices may leak as a result of a manufacturing issue. Class IIFDA’s classNov 15, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 15, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall 30ML BURETTE ASSY WITH STOPCOCK, BNS, Article No. 7A3970 Devices may leak as a result of a manufacturing issue. Class IIFDA’s classNov 15, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 15, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall BULK LARGEBORE MALE LL FITTING, Article No Devices may leak as a result of a manufacturing issue. Class IIFDA’s classNov 15, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 15, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Novum IQ Syringe infusion system Baxter is issuing an Urgent Medical Device Correction for the Novum IQ Syringe Pump. FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 15, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 27 states named PublishedNov 15, 2023ClassClass IStatusOngoingWhereNationwide, and Arkansas, Arizona, California, Florida, Georgia, Hawaii, Iowa, Indiana, Kansas, Louisiana, Maryland, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Hampshire, New Jersey, New York, Pennsylvania, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall BD Alaris PCU Alaris PCA Module 8120, Patient Controlled Analgesia infusion pump: compatible syringes labeling contains syringes that have not been validated. FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 15, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 54 states named PublishedNov 15, 2023ClassClass IStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, American Samoa, Arizona, California, Colorado, District of Columbia, Delaware, Florida, Georgia, Guam, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Northern Mariana Islands, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall BD Alaris Syringe Module Alaris PCA Module 8120, Patient Controlled Analgesia infusion pump: compatible syringes labeling contains syringes that have not been validated. FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 15, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 54 states named PublishedNov 15, 2023ClassClass IStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, American Samoa, Arizona, California, Colorado, District of Columbia, Delaware, Florida, Georgia, Guam, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Northern Mariana Islands, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Alaris PCA Module 8120 Alaris PCA Module 8120, Patient Controlled Analgesia infusion pump: compatible syringes labeling contains syringes that have not been validated. FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 15, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 54 states named PublishedNov 15, 2023ClassClass IStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, American Samoa, Arizona, California, Colorado, District of Columbia, Delaware, Florida, Georgia, Guam, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Northern Mariana Islands, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall StealthStation S8 Application version 2.0 and 2.0.1 (Part 9735762) The StealthStation System, with… Due to a software anomaly which potentially could result in the surgical planning data shifting to an unintended location. FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 15, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedNov 15, 2023ClassClass IStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall BRONCHOVIDEOSCOPE OLYMPUS BF TYPE There is a risk of endobronchial combustion if high-frequency cauterization is performed while supplying oxygen [and/or] the electrode section of the… FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 15, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 15, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE There is a risk of endobronchial combustion if high-frequency cauterization is performed while supplying oxygen [and/or] the electrode section of the… FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 15, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 15, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE There is a risk of endobronchial combustion if high-frequency cauterization is performed while supplying oxygen [and/or] the electrode section of the… FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 15, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 15, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall EVIS EXERA III BRONCHOVIDEOSCOPE There is a risk of endobronchial combustion if high-frequency cauterization is performed while supplying oxygen [and/or] the electrode section of the… FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 15, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 15, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall EVIS EXERA b BRONCHOVIDEOSCOPE OLYMPUS There is a risk of endobronchial combustion if high-frequency cauterization is performed while supplying oxygen [and/or] the electrode section of the… FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 15, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 15, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS There is a risk of endobronchial combustion if high-frequency cauterization is performed while supplying oxygen [and/or] the electrode section of the… FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 15, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 15, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall CardioMEMS Patient Electronic System (PES) Potential for damaged and frayed power connector plug with repeated bending or manipulation beyond 90 degrees. Class IIFDA’s classNov 15, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 15, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall LeadCare II Blood Lead Test Kit-For in vitro diagnostic use only During an internal audit a small percentage (<10%) of plastic caps used to close the treatment reagent tubes were found to not meet the minimum dimensional lip… Class IIFDA’s classNov 15, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 15, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Arial Water Resistant Pendant with Neck Lanyard, Models: 59360 and 2560-59360 Premature battery depletion presents a risk that alarms will not be received by the Arial Wireless Emergency Call System. Class IIFDA’s classNov 15, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 15, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Arial Water Resistant Pendant with Wristband, Models: 59361 and 2560-59361 Premature battery depletion presents a risk that alarms will not be received by the Arial Wireless Emergency Call System. Class IIFDA’s classNov 15, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 15, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Arial Water Resistant Pendant with Long Wristband, Models: 59362 and 2560-59362 Premature battery depletion presents a risk that alarms will not be received by the Arial Wireless Emergency Call System. Class IIFDA’s classNov 15, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 15, 2023ClassClass IIStatusOngoingWhereNationwide
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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