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 MicroScan Neg MIC 56 Due to the likely presence of contamination in well(s). Class IIFDA’s classApr 1, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedApr 1, 2026ClassClass IIStatusOngoingWhereNationwide, and California, Colorado, Indiana, Massachusetts, Maryland, Minnesota, Missouri, North Carolina, New Jersey, Oklahoma, Pennsylvania and Texas named
- Medical device recall Olympus Endoscope Suction Valve - MAJ-1443 The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors. Class IIFDA’s classApr 1, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 1, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Olympus Endoscope Air/Water Valve - MAJ-1444 The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors. Class IIFDA’s classApr 1, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 1, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Olympus Endoscope Reprocessor OER-Elite The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors. Class IIFDA’s classApr 1, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 1, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Olympus Endoscope Reprocessor OER-Pro The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors. Class IIFDA’s classApr 1, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 1, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Philips Respironics Trilogy Evo, Software Version 1.05.15.00 Using non-pneumatic nebulizers with Trilogy Evo Platform ventilators may result in a discrepancy between the set tidal volume and the tidal volume received by… FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 1, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 1, 2026ClassClass IStatusOngoingWhereNationwide
- Medical device recall Philips Respironics Trilogy Evo O2, Software Version 1.05.15.00 Using non-pneumatic nebulizers with Trilogy Evo Platform ventilators may result in a discrepancy between the set tidal volume and the tidal volume received by… FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 1, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 1, 2026ClassClass IStatusOngoingWhereNationwide
- Medical device recall Philips Respironics Trilogy EV300, Software Version 1.05.15.00 Using non-pneumatic nebulizers with Trilogy Evo Platform ventilators may result in a discrepancy between the set tidal volume and the tidal volume received by… FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 1, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 1, 2026ClassClass IStatusOngoingWhereNationwide
- Medical device recall Philips Respironics Trilogy Evo Universal, Software Version 1.05.15.00 Using non-pneumatic nebulizers with Trilogy Evo Platform ventilators may result in a discrepancy between the set tidal volume and the tidal volume received by… FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 1, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 1, 2026ClassClass IStatusOngoingWhereNationwide
- Medical device recall Philips 3D6-2 Ultrasound Transducer To provide clarification and labelling to define the useful life of ultrasound transducers in the field. Class IIIFDA’s classApr 1, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 1, 2026ClassClass IIIStatusOngoingWhereNationwide
- Medical device recall Philips C9-4 Ultrasound Transducer To provide clarification and labelling to define the useful life of ultrasound transducers in the field. Class IIIFDA’s classApr 1, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 1, 2026ClassClass IIIStatusOngoingWhereNationwide
- Medical device recall Philips L12-5 Ultrasound Transducer To provide clarification and labelling to define the useful life of ultrasound transducers in the field. Class IIIFDA’s classApr 1, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 1, 2026ClassClass IIIStatusOngoingWhereNationwide
- Medical device recall Philips L17-5 Ultrasound Transducer To provide clarification and labelling to define the useful life of ultrasound transducers in the field. Class IIIFDA’s classApr 1, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 1, 2026ClassClass IIIStatusOngoingWhereNationwide
- Medical device recall Philips Mini Multi TEE Ultrasound Transducer To provide clarification and labelling to define the useful life of ultrasound transducers in the field. Class IIIFDA’s classApr 1, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 1, 2026ClassClass IIIStatusOngoingWhereNationwide
- Medical device recall Philips OMNI II TEE Ultrasound Transducer To provide clarification and labelling to define the useful life of ultrasound transducers in the field. Class IIIFDA’s classApr 1, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 1, 2026ClassClass IIIStatusOngoingWhereNationwide
- Medical device recall Philips OMNI III TEE Ultrasound Transducer To provide clarification and labelling to define the useful life of ultrasound transducers in the field. Class IIIFDA’s classApr 1, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 1, 2026ClassClass IIIStatusOngoingWhereNationwide
- Medical device recall Philips S4-1 Ultrasound Transducer To provide clarification and labelling to define the useful life of ultrasound transducers in the field. Class IIIFDA’s classApr 1, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 1, 2026ClassClass IIIStatusOngoingWhereNationwide
- Medical device recall Philips S5-2 Ultrasound Transducer To provide clarification and labelling to define the useful life of ultrasound transducers in the field. Class IIIFDA’s classApr 1, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 1, 2026ClassClass IIIStatusOngoingWhereNationwide
- Medical device recall Philips X3-1 Ultrasound Transducer To provide clarification and labelling to define the useful life of ultrasound transducers in the field. Class IIIFDA’s classApr 1, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 1, 2026ClassClass IIIStatusOngoingWhereNationwide
- Medical device recall Philips X7-2 Ultrasound Transducer To provide clarification and labelling to define the useful life of ultrasound transducers in the field. Class IIIFDA’s classApr 1, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 1, 2026ClassClass IIIStatusOngoingWhereNationwide
- Medical device recall Drill Plate, Ortho Dev Drill plates manufactured out of specification can result in a bone cut in excess 00800”(2.8448mm) Class IIFDA’s classApr 1, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 1, 2026ClassClass IIStatusOngoingWhereNationwide, and Utah named
- Medical device recall Drill Plate, Ortho Dev Drill plates manufactured out of specification can result in a bone cut in excess 00800”(2.8448mm) Class IIFDA’s classApr 1, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 1, 2026ClassClass IIStatusOngoingWhereNationwide, and Utah named
- Medical device recall Brand Name: BiDop 3 Product Name: BiDop 3 Pocket Doppler (ES-100V3) with BT2M20S8C fetal probe Product labeling includes a fetal indication for use that is not cleared under its 510(k). Class IIFDA’s classApr 1, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 16 states named PublishedApr 1, 2026ClassClass IIStatusOngoingWhereNationwide, and Arizona, Colorado, Florida, Georgia, Illinois, Indiana, Louisiana, Massachusetts, Missouri, Montana, North Carolina, New York, Oregon, Texas, Washington and Wisconsin named
- Medical device recall Custom Abutment Ti, for Straumann RC, incl A material mix-up had occurred during the manufacturing of Straumann¿ Custom Abutments. Class IIFDA’s classApr 1, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedApr 1, 2026ClassClass IIStatusOngoingWhereNationwide, and California, Colorado, Florida, Iowa, Illinois, Minnesota, Missouri, Montana, Oregon and Washington named
- Medical device recall Custom Abutment AS Ti, for Straumann RC, incl A material mix-up had occurred during the manufacturing of Straumann¿ Custom Abutments. Class IIFDA’s classApr 1, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedApr 1, 2026ClassClass IIStatusOngoingWhereNationwide, and California, Colorado, Florida, Iowa, Illinois, Minnesota, Missouri, Montana, Oregon and Washington named
- Medical device recall Brand Name: TECNIS Eyhance IOL with TECNIS Simplicity” Delivery System Product Name: TECNIS Eyhance IOL with… Due to identifying a limited quantity of intraocular lenses that may have a haptic that sticks to the optic which prevents the lens from unfolding as… Class IIFDA’s classApr 1, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedApr 1, 2026ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Illinois, Maine, Mississippi, New Jersey, New York, Oklahoma, Oregon, Texas and Wisconsin named
- Medical device recall MiniMed” 780G - MMT-1884 MiniMed” 780G - MMT-1886 With Software 6.60 and 6.61 Three software defects (Pump Error 53, BG check, and Critical Pump Error (Open Book Image)) that occurred as a result of software updates (versions 6.60, 6.61,… Class IIFDA’s classApr 1, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedApr 1, 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 Tandem pumps are battery-operated infusion pumps capable of both basal and bolus delivery of insulin The Czech language user guide contained multiple translation errors. Class IIFDA’s classApr 1, 2026in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 1, 2026ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Brand Name: Olympus Everest Bipolar Cutting Forceps, 5 mm 33 cm Product Name: Everest Bipolar Cutting Forceps Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Class IIFDA’s classApr 1, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 1, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Brand Name: Olympus Everest Bipolar Cutting Forceps w/Cord, 5mm 33 cm Product Name: Everest Bipolar Cutting… Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Class IIFDA’s classApr 1, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 1, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Brand Name: Olympus PK Cutting Forceps, 5mm 33cm Product Name: PK Cutting Forceps Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Class IIFDA’s classApr 1, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 1, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Brand Name: Olympus HALO PKS Cutting Forceps, 5mm 33cm Product Name: HALO PKS Cutting Forceps Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Class IIFDA’s classApr 1, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 1, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Brand Name: Olympus PKS Cutting Forceps, 5mm 33cm Product Name: PKS Cutting Forceps Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Class IIFDA’s classApr 1, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 1, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Brand Name: Olympus PKS Cutting Forceps w/Cord, 5mm 24cm Product Name: PKS Cutting Forceps Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Class IIFDA’s classApr 1, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 1, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Brand Name: Olympus PKS Cutting Forceps, 5mm 33cm Product Name: PKS Cutting Forceps Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Class IIFDA’s classApr 1, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 1, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall BD Alaris” System with Guardrails” Suite MX with Point of Care Unit Due to product labeling not indicating which Transport Layer Security (TLS) version that must be enabled on hospital network to ensure secure Wi-Fi… Class IIFDA’s classApr 1, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 53 states named PublishedApr 1, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, 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 Puracol and Puracol Plus Collagen Wound Dressings: MSC8522 DRESSING,COLLAGEN,PURACOL,STRL,2” X 2” MSC8622EP… Elevated endotoxin levels identified in affected lots. Class IIFDA’s classApr 1, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 1, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Embrace Drill Tower, Wedged The surgical technique for the Embrace Shoulder Instruments - Drill Tower has mixed-up article numbers in the overview of the instruments. Class IIFDA’s classApr 1, 2026in FDA’s Enforcement Report15 statesnamed in where it went PublishedApr 1, 2026ClassClass IIStatusOngoingWhereAlabama, Arizona, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Michigan, North Carolina, Ohio, Oklahoma, Texas and Virginia
- Medical device recall Embrace Drill Tower, Standard/Lateral The surgical technique for the Embrace Shoulder Instruments - Drill Tower has mixed-up article numbers in the overview of the instruments. Class IIFDA’s classApr 1, 2026in FDA’s Enforcement Report15 statesnamed in where it went PublishedApr 1, 2026ClassClass IIStatusOngoingWhereAlabama, Arizona, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Michigan, North Carolina, Ohio, Oklahoma, Texas and Virginia
- Medical device recall Product Name: ID NOW” Influenza A & B 2 It was confirmed that the impacted lot has a higher occurrence of invalid rates when compared to the product Instructions for Use. Class IIFDA’s classMar 25, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 25, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Centricity Universal Viewer Software Versions 7.0 through 7.0 Sp2.0.1, a device that displays medical images… There is a potential cybersecurity vulnerability affecting certain versions of Centricity Universal Viewer. Class IIFDA’s classMar 25, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 25, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Centricity Universal Viewer Software Versions 6.0 through 6.0 Sp10.4.1, a device that displays medical images… There is a potential cybersecurity vulnerability affecting certain versions of Centricity Universal Viewer. Class IIFDA’s classMar 25, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 25, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Centricity Universal Viewer Software Versions 5.0 SP6 through UV 5.0 SP7.1, a device that displays medical… There is a potential cybersecurity vulnerability affecting certain versions of Centricity Universal Viewer. Class IIFDA’s classMar 25, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 25, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MICS3 Angled Sagittal Saw Attachment A potential issue was identified with the torque strength on the external screws of the MICS3 Angled Sagittal Saw Attachment. Class IIFDA’s classMar 25, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 25, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Brand Name: Welch Allyn, Inc Display screen may unintentionally flicker due to a software issue. Class IIFDA’s classMar 25, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 14 states named PublishedMar 25, 2026ClassClass IIStatusOngoingWhereNationwide, and Arizona, Colorado, Illinois, Indiana, Kansas, Massachusetts, Nebraska, New Jersey, New Mexico, New York, Pennsylvania, South Carolina, Texas and Virginia named
- Medical device recall Artegraft Vascular Graft Labeling mix-up resulting in the incorrect lot outer packaging of product. Class IIFDA’s classMar 25, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 25, 2026ClassClass IIStatusOngoingWhereNationwide, and Illinois named
- Medical device recall Cub Pediatric Crib Cribs sold in the USA are missing two access door warning labels. Class IIFDA’s classMar 25, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 25, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Brand Name: Leksell Gamma Knife Product Description: Leksell Gamma Knife¿ Perfexion Leksell Gamma Knife¿… Due to adapter not being properly aligned or locked in place. Class IIFDA’s classMar 25, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 37 states named PublishedMar 25, 2026ClassClass IIStatusOngoingWhereNationwide, and Alaska, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
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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