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 Spacelabs Ultraview DM3 Vital Signs Monitor (all variations -M, -MT, -N, -NT) This product labeling does not adequately provide warning about the risks associated with the use of damaged batteries or batteries past the intended use life. 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 Spacelabs Ultraview DM4 Vital Signs Monitor (all variations -M, -N, -MF, -NF, -MW, -NW, -MFW, -NFW) This product labeling does not adequately provide warning about the risks associated with the use of damaged batteries or batteries past the intended use life. 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 Atellica IM CA 19-9 Positive bias for some samples around the CA 19-9 upper limit of normal of 35 U/m as compared to the previous lot. Class IIFDA’s classSep 18, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 18, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Atellica IM CA 19-9 Positive bias for some samples around the CA 19-9 upper limit of normal of 35 U/m as compared to the previous lot. Class IIFDA’s classSep 18, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 18, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Atellica IM CA 19-9 Positive bias for some samples around the CA 19-9 upper limit of normal of 35 U/m as compared to the previous lot. Class IIFDA’s classSep 18, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 18, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ADVIA Centaur CA 19-9 Positive bias for some samples around the CA 19-9 upper limit of normal of 35 U/m as compared to the previous lot. Class IIFDA’s classSep 18, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 18, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ADVIA Centaur CA 19-9 Positive bias for some samples around the CA 19-9 upper limit of normal of 35 U/m as compared to the previous lot. Class IIFDA’s classSep 18, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 18, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Semi-rigid suction liners labeled as follows: a) SEMI RIGID SUCTION LINER Due to reported adverse events, Medline Industries, LP. 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 containing semi-rigid suction liners labeled as follows: a) ANESTHESIA CIRCUIT-LF,… Due to reported adverse events, Medline Industries, LP. 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 containing semi-rigid suction liners labeled as follows: a) OPEN HEART KIT,ALTA… Due to reported adverse events, Medline Industries, LP. 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 containing semi-rigid suction liners labeled as follows: DENTAL, Pack Number… Due to reported adverse events, Medline Industries, LP. 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 containing semi-rigid suction liners labeled as follows: a) BAPTIST FLOYD… Due to reported adverse events, Medline Industries, LP. 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 containing semi-rigid suction liners labeled as follows: a) MINOR PROCEDURE, Pack… Due to reported adverse events, Medline Industries, LP. 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 containing semi-rigid suction liners labeled as follows: a) ENDO BRONCH PACK, Pack… Due to reported adverse events, Medline Industries, LP. 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 containing semi-rigid suction liners labeled as follows: a) ENDO KIT, Pack Number… Due to reported adverse events, Medline Industries, LP. 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 containing semi-rigid suction liners labeled as follows: a) MINOR BREAST, Pack… Due to reported adverse events, Medline Industries, LP. 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 containing semi-rigid suction liners labeled as follows: a) ENDO KIT, Pack Number… Due to reported adverse events, Medline Industries, LP. 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 containing semi-rigid suction liners labeled as follows: NICU ADMIT KIT, Pack Number… Due to reported adverse events, Medline Industries, LP. 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 containing semi-rigid suction liners labeled as follows: ANES TURNOVER KIT-LF, Pack… Due to reported adverse events, Medline Industries, LP. 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 containing semi-rigid suction liners labeled as follows: KIT NEURO SHUNT ST LOUIS… Due to reported adverse events, Medline Industries, LP. 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 containing semi-rigid suction liners labeled as follows: MTHZ GYN LAPAROSCOPY, Pack… Due to reported adverse events, Medline Industries, LP. 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 containing semi-rigid suction liners labeled as follows: MERCY TIFFIN C-SECTION,… Due to reported adverse events, Medline Industries, LP. 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 containing semi-rigid suction liners labeled as follows: a) AMB VITRECTOMY, Pack… XXX 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 containing semi-rigid suction liners labeled as follows: a) LAMINECTOMY CDS, Pack… Due to reported adverse events, Medline Industries, LP. Class IIFDA’s classSep 18, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 18, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall FILMARRAY 2.0 INSTRUMENT Some automated in vitro diagnostic modules and instruments manufactured or serviced between May 2022 and May 2024 were calibrated with internal equipment that… Class IIFDA’s classSep 18, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedSep 18, 2024ClassClass IIStatusOngoingWhereNationwide, 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, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall FILMARRAY TORCH MODULE BOX, HTFA-ASY-0003, HTFA-ASY-0003-W, HTFA-ASY-0003U Some automated in vitro diagnostic modules and instruments manufactured or serviced between May 2022 and May 2024 were calibrated with internal equipment that… Class IIFDA’s classSep 18, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedSep 18, 2024ClassClass IIStatusOngoingWhereNationwide, 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, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Blood Pressure Module BPM3 TM-2917B (Spare Machines equipped with BPM3 Blood Pressure Modules (Blood pressure monitor TM-2917B with firmware version S005) will not record Blood Pressure measurements and… Class IIFDA’s classSep 18, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 18, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Brand Name: PROBEAT Product Name: PROBEAT-FR During positioning within the system’s 3D to 3D matching mode while transferring CBCT images, when the Float Image Selection button is pressed, it may display… Class IIFDA’s classSep 18, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedSep 18, 2024ClassClass IIStatusOngoingWhereNationwide, and Tennessee, Texas and Washington named
- Medical device recall Brand Name: PROBEAT Product Name: PROBEAT-CR During positioning within the system’s 3D to 3D matching mode while transferring CBCT images, when the Float Image Selection button is pressed, it may display… Class IIFDA’s classSep 18, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedSep 18, 2024ClassClass IIStatusOngoingWhereNationwide, and Tennessee, Texas and Washington named
- Medical device recall Brand Name: PROBEAT Product Name: PROBEAT-V During positioning within the system’s 3D to 3D matching mode while transferring CBCT images, when the Float Image Selection button is pressed, it may display… Class IIFDA’s classSep 18, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedSep 18, 2024ClassClass IIStatusOngoingWhereNationwide, and Tennessee, Texas and Washington named
- Medical device recall Medtronic DLP Single Stage Venous Cannulae with right angle metal tip During manufacturing, DLP Single Stage Venous Cannulae - straight tip (Model 66118) was incorrectly placed into a product labeled as DLP Single Stage Venous… Class IIFDA’s classSep 18, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 18, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Foam Protective Pouches The protective pouches were identified to have been improperly labeled with UDI that is associated with an incorrect GMDN (Global Medical Device Nomenclature)… Class IIFDA’s classSep 18, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 18, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medtronic ENT Ultra Round Steel Cutting Bur Product was distributed past expiration date. 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 NEUROSIGN Disposable Stimulating Dissector Product has have presence of brown discoloration or substance on the hinge area of the device Class IIFDA’s classSep 18, 2024in FDA’s Enforcement Report7 statesnamed in where it went PublishedSep 18, 2024ClassClass IIStatusOngoingWhereCalifornia, Florida, Illinois, Massachusetts, New York, Pennsylvania and Texas
- Medical device recall Biolox Option Taper Sleeve, Type 1 Taper, Standard Neck - Indicated for use in total hip replacement with… Mislabeled: Incorrect sleeve in the packaging. Class IIFDA’s classSep 18, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 18, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Biolox Option Taper Sleeve, Type 1 Taper, -6mm Neck - Indicated for use in total hip replacement with… Mislabeled: Incorrect sleeve in the packaging. Class IIFDA’s classSep 18, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 18, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall DxI 9000 Access Immunoassay Analyzer Beckman Coulter manufacturing discovered cracks around a threaded insert on the bottom of the Internal Wash Buffer Tank that is used within the Wash Buffer… Class IIFDA’s classSep 11, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 11, 2024ClassClass IIStatusOngoingWhereNationwide, and New Hampshire named
- Medical device recall Vivo 45 LS, pressure and volume ventilator capable of delivering continuous or intermittent ventilatory… There is a potential for short term (<7 days) elevated levels of formaldehyde emitted from the device into the patient breathing airpath in specific conditions. FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 11, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 11, 2024ClassClass IStatusOngoingWhereNationwide
- Medical device recall LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site (Qty 25) A defect may cause an uncontrolled medication flow condition which may result in a dose greater than prescribed for the patient (i.e., medication overdose). FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 11, 2024in FDA’s Enforcement Report4 statesnamed in where it went PublishedSep 11, 2024ClassClass IStatusOngoingWhereColorado, Idaho, New Jersey and Utah
- Medical device recall Trilogy Evo EV300 Firm has released a mandatory software update Version 1.05.10.00 and a User Manual addendum for affected ventilators. FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 11, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 11, 2024ClassClass IStatusOngoingWhereNationwide
- Medical device recall Trilogy Evo Universal Ventilator Firm has released a mandatory software update Version 1.05.10.00 and a User Manual addendum for affected ventilators. FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 11, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 11, 2024ClassClass IStatusOngoingWhereNationwide
- Medical device recall Trilogy Evo; Model No./Model Description -- AU2110X15B Trilogy Evo, Australia BL2110X15B Trilogy Evo, Benelux… Firm has released a mandatory software update Version 1.05.10.00 and a User Manual addendum for affected ventilators. FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 11, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 11, 2024ClassClass IStatusOngoingWhereNationwide
- Medical device recall Heparin, Gore Viabahn VBX, Balloon Expandable Endoprosthesis, for the following Reference numbers: United… Due to packaging defects, sterility assurance and heparin activity may be compromised. Class IIFDA’s classSep 11, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedSep 11, 2024ClassClass IIStatusOngoingWhereNationwide, 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 Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Heparin, Gore Viabahn VBX, Balloon Expandable Endoprosthesis, for the following Reference numbers: United… Due to packaging defects, sterility assurance and heparin activity may be compromised. Class IIFDA’s classSep 11, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedSep 11, 2024ClassClass IIStatusOngoingWhereNationwide, 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 Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall BD Pyxis QFill Replenishment Station Due to software issue, there is a potential when a restock label is printed for a medication stored in a non-CUBIE location, that the incorrect bin for the… Class IIFDA’s classSep 11, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedSep 11, 2024ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Kansas, Minnesota, New Jersey, New York and Pennsylvania named
- Medical device recall BKIT BD Pyxis QFill Replenishment Station Due to software issue, there is a potential when a restock label is printed for a medication stored in a non-CUBIE location, that the incorrect bin for the… Class IIFDA’s classSep 11, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedSep 11, 2024ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Kansas, Minnesota, New Jersey, New York and Pennsylvania named
- Medical device recall Sevoflurane E_Vap.(Quik-Fil):used with the A9 Anesthesia System-Used to provide the vapor of an anesthetic… V90 electronic vaporizer anesthetic agent output may be higher than the set amount due to a component within the vaporizer causing an incomplete seal in some… Class IIFDA’s classSep 11, 2024in FDA’s Enforcement Report8 statesnamed in where it went PublishedSep 11, 2024ClassClass IIStatusOngoingWhereCalifornia, Georgia, Kentucky, Mississippi, New Jersey, Puerto Rico, Texas and West Virginia
- Medical device recall Sevoflurane E_Vap.(Safety Filling adapter) used with the A9 Anesthesia System-Used to provide the vapor of an… V90 electronic vaporizer anesthetic agent output may be higher than the set amount due to a component within the vaporizer causing an incomplete seal in some… Class IIFDA’s classSep 11, 2024in FDA’s Enforcement Report8 statesnamed in where it went PublishedSep 11, 2024ClassClass IIStatusOngoingWhereCalifornia, Georgia, Kentucky, Mississippi, New Jersey, Puerto Rico, Texas and West Virginia
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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