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 5, 2026.
3,394of 3,394 medical device recallsshown with your filters
The list
- Medical device recall Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp There has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set. Class IIFDA’s classDec 4, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 4, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp There has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set. Class IIFDA’s classDec 4, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 4, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp There has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set. Class IIFDA’s classDec 4, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 4, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp There has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set. Class IIFDA’s classDec 4, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 4, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Baxter MiniCap Extended Life PD Transfer Set (long) with Titanium Spike There has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set. Class IIFDA’s classDec 4, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 4, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Baxter MiniCap Extended Life PD Transfer Set (short) with Titanium Spike There has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set. Class IIFDA’s classDec 4, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 4, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Arial Server Software Versions 11.1.4 through 11.1.6 Certain software versions will not notify end users of calls initiated by call points with the Arial Emergency and Nurse Call System. Class IIFDA’s classDec 4, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 4, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Essenz HLM (Heart-Lung Machine) Heart-Lung Machine GUI touchscreen may go dark for 10-15 seconds, safety/performance functions remain operational before reset, control maintained through… Class IIFDA’s classDec 4, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedDec 4, 2024ClassClass IIStatusOngoingWhereNationwide, and California, Colorado, Florida, Georgia, Indiana, Mississippi, New Jersey, Nevada and Virginia named
- Medical device recall TriALTIS TORQUE LIMITER, RATCHET, 11.3 Nm An out of specification component may result in the device exhibiting torque output higher than the design specification. Class IIFDA’s classDec 4, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 4, 2024ClassClass IIStatusOngoingWhereNationwide, and Massachusetts named
- Medical device recall MICRO-X Rover Mobile X-ray System, # MXU-RV35 Mobile x-ray system receiving/storage(operation) requirements to be followed: Temp:14 to 131(50 to 86) degrees F, RH:10% to 86%(30% to 60%) allow condensation… Class IIFDA’s classDec 4, 2024in FDA’s Enforcement Report4 statesnamed in where it went PublishedDec 4, 2024ClassClass IIStatusOngoingWhereCalifornia, Maryland, Puerto Rico and Texas
- Medical device recall Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp Baxter is aware of several recalls by other manufacturers related to the potential risk of exposure to non-dioxin-like (NDL) polychlorinated biphenyl acids… FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 27, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 27, 2024ClassClass IStatusOngoingWhereNationwide
- Medical device recall Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp Baxter is aware of several recalls by other manufacturers related to the potential risk of exposure to non-dioxin-like (NDL) polychlorinated biphenyl acids… FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 27, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 27, 2024ClassClass IStatusOngoingWhereNationwide
- Medical device recall Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp Baxter is aware of several recalls by other manufacturers related to the potential risk of exposure to non-dioxin-like (NDL) polychlorinated biphenyl acids… FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 27, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 27, 2024ClassClass IStatusOngoingWhereNationwide
- Medical device recall Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp Baxter is aware of several recalls by other manufacturers related to the potential risk of exposure to non-dioxin-like (NDL) polychlorinated biphenyl acids… FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 27, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 27, 2024ClassClass IStatusOngoingWhereNationwide
- Medical device recall Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp Baxter is aware of several recalls by other manufacturers related to the potential risk of exposure to non-dioxin-like (NDL) polychlorinated biphenyl acids… FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 27, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 27, 2024ClassClass IStatusOngoingWhereNationwide
- Medical device recall Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp Baxter is aware of several recalls by other manufacturers related to the potential risk of exposure to non-dioxin-like (NDL) polychlorinated biphenyl acids… FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 27, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 27, 2024ClassClass IStatusOngoingWhereNationwide
- Medical device recall Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp Baxter is aware of several recalls by other manufacturers related to the potential risk of exposure to non-dioxin-like (NDL) polychlorinated biphenyl acids… FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 27, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 27, 2024ClassClass IStatusOngoingWhereNationwide
- Medical device recall Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp Baxter is aware of several recalls by other manufacturers related to the potential risk of exposure to non-dioxin-like (NDL) polychlorinated biphenyl acids… FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 27, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 27, 2024ClassClass IStatusOngoingWhereNationwide
- Medical device recall Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp Baxter is aware of several recalls by other manufacturers related to the potential risk of exposure to non-dioxin-like (NDL) polychlorinated biphenyl acids… FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 27, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 27, 2024ClassClass IStatusOngoingWhereNationwide
- Medical device recall Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp EX Short Baxter is aware of several recalls by other manufacturers related to the potential risk of exposure to non-dioxin-like (NDL) polychlorinated biphenyl acids… FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 27, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 27, 2024ClassClass IStatusOngoingWhereNationwide
- Medical device recall smiths medical CADD-Solis Li-ion Rechargeable Battery Packs AC adapter The adapter input plug can become damaged or broken. Class IIFDA’s classNov 27, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 27, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Bard Marquee Disposable Core Biopsy Instrument Kit: BARD MARQUEE KIT 12G X 10 CM Disposable biopsy instruments were potentially manufactured missing the backend notch retention feature on the needle that results in inadequate securing of… Class IIFDA’s classNov 27, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 46 states named PublishedNov 27, 2024ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, 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 and Wyoming named
- Medical device recall Posi-Stop Injection Needle, 23 Gauge Injection solutions would not flow as intended through the tip of 25ga-sized needles. Class IIFDA’s classNov 27, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 15 states named PublishedNov 27, 2024ClassClass IIStatusOngoingWhereNationwide, and Connecticut, Georgia, Indiana, Michigan, Minnesota, Mississippi, New Hampshire, New Jersey, New York, Ohio, Tennessee, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall Posi-Stop Injection Needle, 23 Gauge Injection solutions would not flow as intended through the tip of 25ga-sized needles. Class IIFDA’s classNov 27, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 15 states named PublishedNov 27, 2024ClassClass IIStatusOngoingWhereNationwide, and Connecticut, Georgia, Indiana, Michigan, Minnesota, Mississippi, New Hampshire, New Jersey, New York, Ohio, Tennessee, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall Posi-Stop Injection Needle, 23 Gauge Injection solutions would not flow as intended through the tip of 25ga-sized needles. Class IIFDA’s classNov 27, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 15 states named PublishedNov 27, 2024ClassClass IIStatusOngoingWhereNationwide, and Connecticut, Georgia, Indiana, Michigan, Minnesota, Mississippi, New Hampshire, New Jersey, New York, Ohio, Tennessee, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall Posi-Stop Injection Needle, 23 Gauge Injection solutions would not flow as intended through the tip of 25ga-sized needles. Class IIFDA’s classNov 27, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 15 states named PublishedNov 27, 2024ClassClass IIStatusOngoingWhereNationwide, and Connecticut, Georgia, Indiana, Michigan, Minnesota, Mississippi, New Hampshire, New Jersey, New York, Ohio, Tennessee, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall Posi-Stop Injection Needle, 23 Gauge Injection solutions would not flow as intended through the tip of 25ga-sized needles. Class IIFDA’s classNov 27, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 15 states named PublishedNov 27, 2024ClassClass IIStatusOngoingWhereNationwide, and Connecticut, Georgia, Indiana, Michigan, Minnesota, Mississippi, New Hampshire, New Jersey, New York, Ohio, Tennessee, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall Posi-Stop Injection Needle, 25 Gauge Injection solutions would not flow as intended through the tip of 25ga-sized needles. Class IIFDA’s classNov 27, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 15 states named PublishedNov 27, 2024ClassClass IIStatusOngoingWhereNationwide, and Connecticut, Georgia, Indiana, Michigan, Minnesota, Mississippi, New Hampshire, New Jersey, New York, Ohio, Tennessee, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall Posi-Stop Injection Needle, 25 Gauge Injection solutions would not flow as intended through the tip of 25ga-sized needles. Class IIFDA’s classNov 27, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 15 states named PublishedNov 27, 2024ClassClass IIStatusOngoingWhereNationwide, and Connecticut, Georgia, Indiana, Michigan, Minnesota, Mississippi, New Hampshire, New Jersey, New York, Ohio, Tennessee, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall Posi-Stop Injection Needle, 25 Gauge Injection solutions would not flow as intended through the tip of 25ga-sized needles. Class IIFDA’s classNov 27, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 15 states named PublishedNov 27, 2024ClassClass IIStatusOngoingWhereNationwide, and Connecticut, Georgia, Indiana, Michigan, Minnesota, Mississippi, New Hampshire, New Jersey, New York, Ohio, Tennessee, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall Posi-Stop Injection Needle, 25 Gauge Injection solutions would not flow as intended through the tip of 25ga-sized needles. Class IIFDA’s classNov 27, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 15 states named PublishedNov 27, 2024ClassClass IIStatusOngoingWhereNationwide, and Connecticut, Georgia, Indiana, Michigan, Minnesota, Mississippi, New Hampshire, New Jersey, New York, Ohio, Tennessee, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall JuggerLoc/ToggleLoc 2.9mm Drill Guide Firm received complaints reporting that guides were warped when pulled out of packaging. Class IIFDA’s classNov 27, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 27, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall CAIRE FreeStyle Comfort portable oxygen concentrator Potential failure of affected units to recharge the battery of the oxygen concentrators. Class IIFDA’s classNov 27, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedNov 27, 2024ClassClass IIStatusCompletedWhereNationwide, and Puerto Rico named
- Medical device recall CAIRE FreeStyle Comfort portable oxygen concentrator Potential failure of affected units to recharge the battery of the oxygen concentrators. Class IIFDA’s classNov 27, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedNov 27, 2024ClassClass IIStatusCompletedWhereNationwide, and Puerto Rico named
- Medical device recall CAIRE FreeStyle Comfort portable oxygen concentrator Potential failure of affected units to recharge the battery of the oxygen concentrators. Class IIFDA’s classNov 27, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedNov 27, 2024ClassClass IIStatusCompletedWhereNationwide, and Puerto Rico named
- Medical device recall CAIRE FreeStyle Comfort portable oxygen concentrator Potential failure of affected units to recharge the battery of the oxygen concentrators. Class IIFDA’s classNov 27, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedNov 27, 2024ClassClass IIStatusCompletedWhereNationwide, and Puerto Rico named
- Medical device recall Allegedly counterfeit batteries ICU Medical has received reports of allegedly counterfeit CSB batteries being used with Plum Infusion Systems. FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 27, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedNov 27, 2024ClassClass IStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall NovoHip Biolox Ball Head 32mmL Mislabeled: Packaged in a box labeled as 32 long but containing a 28 long head by physical marking, may result in joint instability if implanted Class IIFDA’s classNov 27, 2024in FDA’s Enforcement Report2 statesnamed in where it went PublishedNov 27, 2024ClassClass IIStatusOngoingWhereFlorida and West Virginia
- Medical device recall Acrobat-i Positioner Deviations in the manufacturing process created a compromise in the sterile barrier, in which sterility cannot be assured during the duration of the product’s… Class IIFDA’s classNov 27, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 27, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Acrobat SUV Vacuum Stabilizer System, ST Deviations in the manufacturing process created a compromise in the sterile barrier, in which sterility cannot be assured during the duration of the product’s… Class IIFDA’s classNov 27, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 27, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Acrobat-i Vacuum Stabilizer System Deviations in the manufacturing process created a compromise in the sterile barrier, in which sterility cannot be assured during the duration of the product’s… Class IIFDA’s classNov 27, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 27, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MONOCRYL” (poliglecaprone 25) Suture Due a component mix-up in manufacturing, the affected products may contain incorrect needle type/size and suture length. Class IIFDA’s classNov 27, 2024in FDA’s Enforcement Report45 statesnamed in where it went PublishedNov 27, 2024ClassClass IIStatusOngoingWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, 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
- Medical device recall EnChroma Safety Glasses with Rx Indoor Universal Lenses: Martinez Cx1 Indoor Rx Safety glasses with Rx indoor universal lenses fail to meet high impact safety specifications, which may not provide adequate protection against impact, posing… Class IIFDA’s classNov 27, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedNov 27, 2024ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Colorado, Florida, Iowa, Illinois, Kentucky, Massachusetts, Michigan, Montana, North Carolina, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oregon, Pennsylvania, South Carolina, Texas, Virginia, Wisconsin and West Virginia named
- Medical device recall cobas HCYS, Homocysteine Enzymatic Assay, Material Number Abnormal calibration signals and control recovery issues on the Homocysteine Enzymatic (HCYS) Assay can produce erroneous patient results (positive or negative… Class IIFDA’s classNov 27, 2024in FDA’s Enforcement Report8 statesnamed in where it went PublishedNov 27, 2024ClassClass IIStatusOngoingWhereFlorida, Iowa, Indiana, New Jersey, New York, Oklahoma, South Carolina and Texas
- Medical device recall a) Alcon Custom-Pak CONSTELLATION 25G PLUS CHRISTIANA CARE HLTH SERV, # 15340-11, containing TUBING, SALEM… Reported breakage in the tubing Anti-Reflux Valve (ARV) due to improper use. Class IIIFDA’s classNov 27, 2024in FDA’s Enforcement Report3 statesnamed in where it went PublishedNov 27, 2024ClassClass IIIStatusOngoingWhereDelaware, Illinois and Oklahoma
- Medical device recall Abbott Navitor Titan, Vision Technology, Transcatheter Aortic Heart Valve, 35 mm, NVRO-35, Sterile A manufacturing error resulting in acceptance of valves with a leaflet deflection value that was outside of established specifications. Class IIFDA’s classNov 27, 2024in FDA’s Enforcement ReportNew Yorkthe one state its words name PublishedNov 27, 2024ClassClass IIStatusOngoingWhereNew York
- Medical device recall Abbott Navitor Transcatheter Aortic Heart Valve, 29 mm, NVTR-29, Sterile A manufacturing error resulting in acceptance of valves with a leaflet deflection value that was outside of established specifications. Class IIFDA’s classNov 27, 2024in FDA’s Enforcement ReportNew Yorkthe one state its words name PublishedNov 27, 2024ClassClass IIStatusOngoingWhereNew York
- Medical device recall Abbot Navitor, Vision Technology, Transcatheter Aortic Heart Valve, 29 mm, NVRO-29, Sterile A manufacturing error resulting in acceptance of valves with a leaflet deflection value that was outside of established specifications. Class IIFDA’s classNov 27, 2024in FDA’s Enforcement ReportNew Yorkthe one state its words name PublishedNov 27, 2024ClassClass IIStatusOngoingWhereNew York
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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