Medical devices, 2025
Shortlist up to four to read them side by side.
2,908 medical device recalls FDA’s Enforcement Report published in 2025, 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.
2,908of 2,908 medical device recallsshown with your filters
The list
- Medical device recall CARESCAPE ONE Potential loss of monitoring on affected monitors when powered by certain batteries. Class IIFDA’s classNov 19, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 19, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall B105P, B125P, B105M, B125M, B155M Patient Monitors Potential loss of monitoring on affected monitors when powered by certain batteries. Class IIFDA’s classNov 19, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 19, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Portrait VSM Potential loss of monitoring on affected monitors when powered by certain batteries. Class IIFDA’s classNov 19, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 19, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall BATTERY FLEX-3S2P 10.8V 18650 LI-ION SMBUS used with affected patient monitors Potential loss of monitoring on affected monitors when powered by certain batteries. Class IIFDA’s classNov 19, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 19, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Eterna SCS IPG (Implantable Pulse Generator) There is a potential issue affecting Eterna Spinal Cord Stimulation (SCS) Implantable Pulse Generators (IPGs), Model 32400 and Liberta RC Deep Brain… Class IIFDA’s classNov 19, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 19, 2025ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Liberta RC DBS IPG (Implantable Pulse Generator) There is a potential issue affecting Eterna Spinal Cord Stimulation (SCS) Implantable Pulse Generators (IPGs), Model 32400 and Liberta RC Deep Brain… Class IIFDA’s classNov 19, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 19, 2025ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Brand Name: Sonesta Product Name: 6210 Video fluoroscopy table may contain inadequate weld on backrest bracket resulting in backrest dropping. Class IIFDA’s classNov 19, 2025in FDA’s Enforcement ReportNew Hampshirethe one state its words name PublishedNov 19, 2025ClassClass IIStatusOngoingWhereNew Hampshire
- Medical device recall ProxiDiagnost N90 Philips has identified that some ceiling suspension telescopic carriages manufactured from July 2024 through June 2025 may be difficult to move vertically (i.e. Class IIFDA’s classNov 19, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 19, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall CombiDiagnost R90 Philips has identified that some ceiling suspension telescopic carriages manufactured from July 2024 through June 2025 may be difficult to move vertically (i.e. Class IIFDA’s classNov 19, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 19, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Precision CRF Philips has identified that some ceiling suspension telescopic carriages manufactured from July 2024 through June 2025 may be difficult to move vertically (i.e. Class IIFDA’s classNov 19, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 19, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall DigitalDiagnost 4 Philips has identified that some ceiling suspension telescopic carriages manufactured from July 2024 through June 2025 may be difficult to move vertically (i.e. Class IIFDA’s classNov 19, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 19, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall DigitalDiagnost C90 Philips has identified that some ceiling suspension telescopic carriages manufactured from July 2024 through June 2025 may be difficult to move vertically (i.e. Class IIFDA’s classNov 19, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 19, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Radiography 7300 C Philips has identified that some ceiling suspension telescopic carriages manufactured from July 2024 through June 2025 may be difficult to move vertically (i.e. Class IIFDA’s classNov 19, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 19, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Renewal LigaSure Exact, Dissector without Nano-Coating 21cm FT10 SW Version 4.0.1.15 or lower Medline Renewal has determined that certain areas on the device have the potential to trap residual material, which may remain within the device and, in rare… Class IIFDA’s classNov 19, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 19, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Renewal LigaSure Impact Curved Large Jaw Sealer/Divider, Compatible with FT10 Generator, FT10 SW… Medline Renewal has determined that certain areas on the device have the potential to trap residual material, which may remain within the device and, in rare… Class IIFDA’s classNov 19, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 19, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Renewal Ligasure Impact Sealer/Divider NanoCoated, Compatible with FT10 Generator 18cm FT10 SW… Medline Renewal has determined that certain areas on the device have the potential to trap residual material, which may remain within the device and, in rare… Class IIFDA’s classNov 19, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 19, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Renewal LigaSure Small Jaw Instrument (Purple/White), Compatible with FT10 Generator 18.8 cm FT10 SW… Medline Renewal has determined that certain areas on the device have the potential to trap residual material, which may remain within the device and, in rare… Class IIFDA’s classNov 19, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 19, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Renewal LigaSure Blunt Tip Sealer/Divider, Compatible with FT10 Generator, 5 mm x 37 cm FT10 SW… Medline Renewal has determined that certain areas on the device have the potential to trap residual material, which may remain within the device and, in rare… Class IIFDA’s classNov 19, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 19, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline RenewalLigasure Blunt Tip Sealer/Divider, NanoCoated Compatible with FT10 Generator 23 cm FT10 SW… Medline Renewal has determined that certain areas on the device have the potential to trap residual material, which may remain within the device and, in rare… Class IIFDA’s classNov 19, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 19, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Renewal Ligasure Blunt Tip Sealer/Divider NanoCoated, Compatible with FT10 Generator 37 cm FT10 SW… Medline Renewal has determined that certain areas on the device have the potential to trap residual material, which may remain within the device and, in rare… Class IIFDA’s classNov 19, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 19, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Renewal Ligasure Blunt Tip Sealer/Divider NanoCoated, Compatible with FT10 Generator 44cm FT10 SW… Medline Renewal has determined that certain areas on the device have the potential to trap residual material, which may remain within the device and, in rare… Class IIFDA’s classNov 19, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 19, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Renewal LigaSure Maryland Jaw Sealer/Divider Nano Coated, Compatible with FT10 Generator 23 cm FT10… Medline Renewal has determined that certain areas on the device have the potential to trap residual material, which may remain within the device and, in rare… Class IIFDA’s classNov 19, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 19, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Renewal LigaSure Maryland Jaw Sealer/Divider NanoCoated, Compatible w/FT10 37 cm FT10 SW Version… Medline Renewal has determined that certain areas on the device have the potential to trap residual material, which may remain within the device and, in rare… Class IIFDA’s classNov 19, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 19, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Renewal Ligasure Maryland Jaw Sealer/Divider NanoCoated, Compatible with FT10 Generator 44 cm FT10 SW… Medline Renewal has determined that certain areas on the device have the potential to trap residual material, which may remain within the device and, in rare… Class IIFDA’s classNov 19, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 19, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Virata Preassembled Polyaxial Screw, utilized in the Virata Spinal Fixation System Polyaxial screws do not meet performance standards. Class IIFDA’s classNov 19, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedNov 19, 2025ClassClass IIStatusOngoingWhereNationwide, and California, North Carolina and Texas named
- Medical device recall BEAR Implant (Bridge-Enhanced ACL Restoration) The field action was initiated in February of 2023 and was limited to the affected lot from sales force trunk stock only. Class IIFDA’s classNov 19, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 19, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall GM85 Digital Mobile X-ray imaging System The four (4) M5 bolts that secure the Tube Head Unit to the end of the arm may loosen or fracture due to metal fatigue. Class IIFDA’s classNov 19, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 19, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall SimplyGo Mini, Standard Battery Kit Certain serial numbers of the SimplyGo Mini standard battery kit contain a defective chip which can lead the battery to either fail to charge or lose voltage… Class IIFDA’s classNov 19, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedNov 19, 2025ClassClass IIStatusOngoingWhereNationwide, and Georgia, Idaho, Kentucky, New Jersey and New York named
- Medical device recall Brand Name: Olympus Single Use Electrosurgical Snare SD-400 Product Name: Single Use Electrosurgical Snare Sterility compromised from small holes that may occur during packaging of the device pouches into the shelf carton and/or during transportation of the shelf… Class IIFDA’s classNov 19, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 19, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Brand Name: Olympus Single Use Single Use Electrosurgical Snare SD-400 Product Name: Single Use Single Use… Sterility compromised from small holes that may occur during packaging of the device pouches into the shelf carton and/or during transportation of the shelf… Class IIFDA’s classNov 19, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 19, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall BD Kiestra” Isolate Suspension Cuvette Array The 2D barcodes on these cuvettes contain formatting errors that prevent the analyzing system from correctly reading the expiration date. Class IIFDA’s classNov 19, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedNov 19, 2025ClassClass IIStatusOngoingWhereNationwide, and Colorado, Connecticut, Kentucky, New Jersey, Tennessee, Texas and Utah named
- Medical device recall Covidien Signia” Small Diameter Curved Tip Intelligent Reload A manufacturing issue could lead to a malformed cover tube press which can lead to internal components’ movement during firing - leading to the potential for… Class IIFDA’s classNov 19, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 19, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Covidien Signia” Small Diameter Curved Tip Intelligent Reload A manufacturing issue could lead to a malformed cover tube press which can lead to internal components’ movement during firing - leading to the potential for… Class IIFDA’s classNov 19, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 19, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Affinity NT Oxygenator, Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir, Product… Medtronic identified an Affinity NT Oxygenator unit with decreased CO2 gas transfer rates that did not meet performance requirements. Class IIFDA’s classNov 19, 2025in FDA’s Enforcement Report3 statesnamed in where it went PublishedNov 19, 2025ClassClass IIStatusOngoingWhereArizona, California and Tennessee
- Medical device recall Brand Name: Alinity hq Analyzer Product Name: Alinity hq Analyzer Software issue for hq analyzer results in system not visibly applying appropriate flagging to results when saturation is present which may result in incorrect… Class IIFDA’s classNov 19, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedNov 19, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, California, Colorado, Florida, Indiana, Minnesota, North Carolina, New York and Oklahoma named
- Medical device recall HARMONIC FOCUS Shears + Adaptive Tissue Technology, 9 cm Length Due to manufacturing issue, reprocessed shears, may become stuck in the “on position” resulting in continuous activation. Class IIFDA’s classNov 19, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 19, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall IMMULITE 2000 Oak Mix Specific Allergen The barcode orientation on affected devices causes incorrect scanning order of tubes within the allergen holder wedge. Class IIFDA’s classNov 19, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedNov 19, 2025ClassClass IIStatusOngoingWhereNationwide, and California named
- Medical device recall 3gAllergy Specific IgE Universal Kit The barcode orientation on affected devices causes incorrect scanning order of tubes within the allergen holder wedge. Class IIFDA’s classNov 19, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedNov 19, 2025ClassClass IIStatusOngoingWhereNationwide, and California named
- Medical device recall Food Panel 3 Specific Allergen The barcode orientation on affected devices causes incorrect scanning order of tubes within the allergen holder wedge. Class IIFDA’s classNov 19, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedNov 19, 2025ClassClass IIStatusOngoingWhereNationwide, and California named
- Medical device recall Applied Medical Technology, Inc., NutraGlide, 5 f - 6F x 55 Nasal Feeding Tube with Stylet and ENfit The nasal feeding tube may be occluded Class IIFDA’s classNov 19, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedNov 19, 2025ClassClass IIStatusCompletedWhereNationwide, and Massachusetts, North Carolina, Ohio and Rhode Island named
- Medical device recall Applied Medical Technology, Inc., NutraGlide, 5 F- 6 F x 55 Nasal Feeding Tube with Stylet and ENfit The nasal feeding tube may be occluded Class IIFDA’s classNov 19, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedNov 19, 2025ClassClass IIStatusCompletedWhereNationwide, and Massachusetts, North Carolina, Ohio and Rhode Island named
- Medical device recall Applied Medical Technology, Inc., NutraGlide, 5 F- 6 F x 90 Nasal Feeding Tube with Stylet and ENfit The nasal feeding tube may be occluded Class IIFDA’s classNov 19, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedNov 19, 2025ClassClass IIStatusCompletedWhereNationwide, and Massachusetts, North Carolina, Ohio and Rhode Island named
- Medical device recall Applied Medical Technology, Inc., NutraGlide, 6 F- 8 F x 55 Nasal Feeding Tube with Stylet and ENfit The nasal feeding tube may be occluded Class IIFDA’s classNov 19, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedNov 19, 2025ClassClass IIStatusCompletedWhereNationwide, and Massachusetts, North Carolina, Ohio and Rhode Island named
- Medical device recall Applied Medical Technology, Inc., NutraGlide, 6 F- 8 F x 90 Nasal Feeding Tube with Stylet and ENfit The nasal feeding tube may be occluded Class IIFDA’s classNov 19, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedNov 19, 2025ClassClass IIStatusCompletedWhereNationwide, and Massachusetts, North Carolina, Ohio and Rhode Island named
- Medical device recall Ceiling Type X-Ray Tube Support Models CH-200 and CH-200M used with RADspeed, SonialVision and FLUOROspeed… Due to an issue (potential breakage) with the shaft for the mounting of the X-ray tube assembly that could potentially result assembly coming off the rotating… Class IIFDA’s classNov 19, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 46 states named PublishedNov 19, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington and Wisconsin named
- Medical device recall VerifyNow PRUTest Platelet Reactivity Test Due to an device without a premarket clearance being incorrectly package and distributed. Class IIIFDA’s classNov 19, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedNov 19, 2025ClassClass IIIStatusOngoingWhereNationwide, and Alaska, California, Florida, Iowa, Illinois, Maryland, Michigan, New York, South Dakota and Texas named
- Medical device recall Multichem ID-B Potential of negative recovery of the HBsAg analyte across two (2) lots of Multichem ID-B Positive Control when tested on the Alinity i platform. Class IIFDA’s classNov 19, 2025in FDA’s Enforcement Report17 statesnamed in where it went PublishedNov 19, 2025ClassClass IIStatusOngoingWhereCalifornia, Colorado, Connecticut, Florida, Hawaii, Illinois, Louisiana, Michigan, Minnesota, Nevada, New York, Oregon, South Carolina, Tennessee, Texas, Wisconsin and Wyoming
- Medical device recall Multichem ID-B Potential of negative recovery of the HBsAg analyte across two (2) lots of Multichem ID-B Positive Control when tested on the Alinity i platform. Class IIFDA’s classNov 19, 2025in FDA’s Enforcement Report17 statesnamed in where it went PublishedNov 19, 2025ClassClass IIStatusOngoingWhereCalifornia, Colorado, Connecticut, Florida, Hawaii, Illinois, Louisiana, Michigan, Minnesota, Nevada, New York, Oregon, South Carolina, Tennessee, Texas, Wisconsin and Wyoming
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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