Medical devices
Shortlist up to four to read them side by side.
2,589 medical device recalls FDA’s Enforcement Report published in 2026, the newest year, 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 7, 2026.
2,589of 2,589 medical device recallsshown with your filters
The list
- Medical device recall Gelsoft Plus Gelatin sealed woven polyester prostheses devices, designed for vascular repair, were incorrectly labeled with an additional month of shelf life. Class IIFDA’s classMar 11, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedMar 11, 2026ClassClass 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Brand Name: HiResolution Bionic Ear System Product Name: Sky CI M90 Sound Processor Behind-the-ear sound processer packaging label is different then included product. Class IIFDA’s classMar 11, 2026in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 11, 2026ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Brand Name: Olympus ShockPulse-SE Lithotripsy System with Generator Product Name: ShockPulse-SE Lithotripsy… Mis-wired component-the improperly wired component can result in additional noise on the power supply output. Class IIFDA’s classMar 11, 2026in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 11, 2026ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Brand Name: Hitachi Proton Beam Therapy System Software anomaly in the patient positioning system may result in positional discrepancy. Class IIFDA’s classMar 4, 2026in FDA’s Enforcement Report2 statesnamed in where it went PublishedMar 4, 2026ClassClass IIStatusOngoingWhereDistrict of Columbia and Texas
- Medical device recall Brand Name: Hitachi Proton Beam Therapy Software anomaly in the patient positioning system may result in positional discrepancy. Class IIFDA’s classMar 4, 2026in FDA’s Enforcement Report2 statesnamed in where it went PublishedMar 4, 2026ClassClass IIStatusOngoingWhereDistrict of Columbia and Texas
- Medical device recall Medline Sterile Saline Wound Wash, Cleansing & Wound Irrigation, USP Normal Saline Medline has identified that the manufacturer of the sterile saline wound wash may not have manufactured products to meet the minimum required sterility… Class IIFDA’s classMar 4, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 4, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Convenience Kits: 1) NAIL KIT Medline has identified that the manufacturer of the sterile saline wound wash may not have manufactured products to meet the minimum required sterility… Class IIFDA’s classMar 4, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 4, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Convenience Kits: 1) TRUNK KIT W/EXPIRATION Medline has identified that the manufacturer of the sterile saline wound wash may not have manufactured products to meet the minimum required sterility… Class IIFDA’s classMar 4, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 4, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Convenience Kits: 1) NAIL KIT Medline has identified that the manufacturer of the sterile saline wound wash may not have manufactured products to meet the minimum required sterility… Class IIFDA’s classMar 4, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 4, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Meijer STERILE saline wound wash, First Aid Cleansing Spray, 0.9% USP SODIUM CHLORIDE, 7.1FL OZ Medline has identified that the manufacturer of the sterile saline wound wash may not have manufactured products to meet the minimum required sterility… Class IIFDA’s classMar 4, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 4, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MRI LED Mobile Exam Light Battery Due to battery component overheating while charging resulting in melting of internal components and causing smoke. Class IIFDA’s classMar 4, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 35 states named PublishedMar 4, 2026ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Minnesota, Missouri, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Virginia, Washington and Wisconsin named
- Medical device recall Olympus Cystoscope Outer Sheath Product being removed due to incompatibility when used in conjunction with a GreenLight Laser for BPH therapy which could damage the tip of the device. Class IIFDA’s classMar 4, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 4, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Olympus Resection Sheath Complaints of the ceramic tip of the resection sheath breaking have been received. Class IIFDA’s classMar 4, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 4, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Olympus Resection Inner Sheath, for 26 Fr Complaints of the ceramic tip of the resection sheath breaking have been received. Class IIFDA’s classMar 4, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 4, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Olympus Resection Inner Sheath for 26 Fr Complaints of the ceramic tip of the resection sheath breaking have been received. Class IIFDA’s classMar 4, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 4, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Olympus Resection Sheath, 24 Fr Complaints of the ceramic tip of the resection sheath breaking have been received. Class IIFDA’s classMar 4, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 4, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Olympus Resection Sheath, 24 Fr., with Deflecting Obturator Complaints of the ceramic tip of the resection sheath breaking have been received. Class IIFDA’s classMar 4, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 4, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Olympus Resection Sheath, 26 Fr. Complaints of the ceramic tip of the resection sheath breaking have been received. Class IIFDA’s classMar 4, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 4, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Olympus Resection Sheath, 26 Fr Complaints of the ceramic tip of the resection sheath breaking have been received. Class IIFDA’s classMar 4, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 4, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Olympus Resection Sheath, 28 Fr. Complaints of the ceramic tip of the resection sheath breaking have been received. Class IIFDA’s classMar 4, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 4, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Olympus Resection Sheath, 28 Fr Complaints of the ceramic tip of the resection sheath breaking have been received. Class IIFDA’s classMar 4, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 4, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Olympus Inner Sheath Complaints of the ceramic tip of the resection sheath breaking have been received. Class IIFDA’s classMar 4, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 4, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Olympus Resection Sheath, 8 mm Complaints of the ceramic tip of the resection sheath breaking have been received. Class IIFDA’s classMar 4, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 4, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Olympus Inner Sheath Complaints of the ceramic tip of the resection sheath breaking have been received. Class IIFDA’s classMar 4, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 4, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Olympus Inner Sheath, Long Complaints of the ceramic tip of the resection sheath breaking have been received. Class IIFDA’s classMar 4, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 4, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Olympus Inner Sheath, Long Complaints of the ceramic tip of the resection sheath breaking have been received. Class IIFDA’s classMar 4, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 4, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Olympus Resection Sheath Complaints of the ceramic tip of the resection sheath breaking have been received. Class IIFDA’s classMar 4, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 4, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Olympus Inner Sheath 21 Fr Complaints of the ceramic tip of the resection sheath breaking have been received. Class IIFDA’s classMar 4, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 4, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Olympus Sheath, 10 Fr Complaints of the ceramic tip of the resection sheath breaking have been received. Class IIFDA’s classMar 4, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 4, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Olympus Inner Sheath Complaints of the ceramic tip of the resection sheath breaking have been received. Class IIFDA’s classMar 4, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 4, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Olympus Inner Sheath Complaints of the ceramic tip of the resection sheath breaking have been received. Class IIFDA’s classMar 4, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 4, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Olympus Resection Sheath Complaints of the ceramic tip of the resection sheath breaking have been received. Class IIFDA’s classMar 4, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 4, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Brand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP HUMERAL SOCKET INSERT, 32MM +4MM, STANDARD… Knee and Humeral socket implants contain incorrect labeling. Class IIFDA’s classMar 4, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 17 states named PublishedMar 4, 2026ClassClass IIStatusOngoingWhereNationwide, and California, Colorado, Florida, Illinois, Indiana, Louisiana, Massachusetts, Michigan, Missouri, Montana, New Jersey, Oklahoma, Pennsylvania, Rhode Island, Tennessee, Virginia and Wyoming named
- Medical device recall Brand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 7L 16MM, VE Knee and Humeral socket implants contain incorrect labeling. Class IIFDA’s classMar 4, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 17 states named PublishedMar 4, 2026ClassClass IIStatusOngoingWhereNationwide, and California, Colorado, Florida, Illinois, Indiana, Louisiana, Massachusetts, Michigan, Missouri, Montana, New Jersey, Oklahoma, Pennsylvania, Rhode Island, Tennessee, Virginia and Wyoming named
- Medical device recall Brand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP STANDARD HUMERAL SOCKET INSERT, 36MM, HXe-plus Knee and Humeral socket implants contain incorrect labeling. Class IIFDA’s classMar 4, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 17 states named PublishedMar 4, 2026ClassClass IIStatusOngoingWhereNationwide, and California, Colorado, Florida, Illinois, Indiana, Louisiana, Massachusetts, Michigan, Missouri, Montana, New Jersey, Oklahoma, Pennsylvania, Rhode Island, Tennessee, Virginia and Wyoming named
- Medical device recall PIE Trolley System Lack of 510K clearance Class IIFDA’s classMar 4, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 18 states named PublishedMar 4, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Colorado, Florida, Illinois, Indiana, Massachusetts, Minnesota, Missouri, North Carolina, New York, Ohio, Pennsylvania, South Carolina, Tennessee, Texas and Virginia named
- Medical device recall PIE PAK Models: P2HC-A, P2HC-S, P2HC Lack of 510K clearance Class IIFDA’s classMar 4, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 18 states named PublishedMar 4, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Colorado, Florida, Illinois, Indiana, Massachusetts, Minnesota, Missouri, North Carolina, New York, Ohio, Pennsylvania, South Carolina, Tennessee, Texas and Virginia named
- Medical device recall Medline Kits containing Tego Connectors: Medline IR Pack Affected lots may exhibit issues with the silicone seal on Tego Connectors included in kits. Class IIFDA’s classMar 4, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 4, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Kits containing Tego Connectors Medline DIALYSIS ON/OFF KIT Affected lots may exhibit issues with the silicone seal on Tego Connectors included in kits. Class IIFDA’s classMar 4, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 4, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Convenience kits used for dialysis maintenance Medline ADD A CATH DIALYSIS KIT Affected lots may exhibit issues with the silicone seal on Tego Connectors included in kits. Class IIFDA’s classMar 4, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 4, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline kits containing Tego Connectors Medline APHERESIS SUBQPORT ACCESS KIT Affected lots may exhibit issues with the silicone seal on Tego Connectors included in kits. Class IIFDA’s classMar 4, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 4, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Convenience kits containing Tego Connectors: Medline DIALYSIS DRESSING CHANGE Affected lots may exhibit issues with the silicone seal on Tego Connectors included in kits. Class IIFDA’s classMar 4, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 4, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Convenience kits containing Tego Connectors Medline DIALYSIS DRSNG CHNG Affected lots may exhibit issues with the silicone seal on Tego Connectors included in kits. Class IIFDA’s classMar 4, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 4, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Adapt Pump, Model/Catalog Number: 61600200-Adapt Pump, component of Adapt support surfaces (Adapt Air, Adapt… Agiliti identified an issue where the Adapt Pump (61600200-Adapt Pump) supplied with all Adapt Line support surfaces does not re-engage the Microclimate… Class IIFDA’s classMar 4, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 4, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Octopus Nuvo Tissue Stabilizer, disposable tissue stabilization system, Product Number TSMICS1 During the manufacturing, Medtronic personnel identified an assembly issue where the tubing was incorrectly positioned. Class IIFDA’s classMar 4, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 4, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Campy CVA Medium 100/PK, R01272 Customer complaints report low to no recovery of Campylobacter Jejuni ATCC 33291 on identified lot of medium. Class IIFDA’s classMar 4, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedMar 4, 2026ClassClass IIStatusOngoingWhereNationwide, and Arizona, Colorado, Illinois, New Jersey, Ohio, Tennessee and Washington named
- Medical device recall Olympus High Flow Insufflation Unit Issue with software algorithm which may lead to overpressure events. FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 25, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 25, 2026ClassClass IStatusOngoingWhereNationwide
- Medical device recall Olympus High Flow Insufflation Unit Issue with software algorithm which may lead to overpressure events. FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 25, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 25, 2026ClassClass IStatusOngoingWhereNationwide
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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