Browse Device Recalls
34,608 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 34,608 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.
Medical Device Recalls
Browse 34,608 FDA device recalls — Class II.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Mar 30, 2026 | LUX-DX II, Arrythmia detector and alarm, Model M302, with SERVER SW LATITUDE ... | For some patients upgraded from a LUX-Dx M301 device to a new Model M302 or M312, the new ICM dev... | Class II | Boston Scientific Corporation |
| Mar 30, 2026 | Brand Name: Disposable Mixing Bowls with Spatula Product Name: Mixing Bowl a... | Ten complaints have been received identifying issues at the time of use related to the package se... | Class II | Zimmer, Inc. |
| Mar 27, 2026 | Edwards EVOQUE tricuspid delivery system REF:9850TDS Sterile EO | Labeling update to provide warning if functionality of the valve replacement delivery system is ... | Class II | Edwards Lifesciences, LLC |
| Mar 27, 2026 | Straumann n!ce PMMA Full-arch Restoration. Screw-retained Bridge. Article 010... | Includes an incorrect screw seat interface. | Class II | Straumann USA LLC |
| Mar 27, 2026 | Straumann n!ce Zr, HT, Full-arch Restoration. Article 010.0158. Endosseous... | Includes an incorrect screw seat interface. | Class II | Straumann USA LLC |
| Mar 27, 2026 | Rover Mobile X-ray System Model/Catalog Number: MXU-RV35 and MXU-RV71 | X-Ray generator may malfunction resulting in the X-Ray being inoperable. | Class II | Micro-X Ltd. |
| Mar 26, 2026 | Revolution CT, x-ray computed tomography, Model Numbers 5590000 and 5590000-6 | GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed... | Class II | GE Medical Systems, LLC |
| Mar 26, 2026 | Revolution Apex Plus, X-ray Computed Tomography, Model Number 5590000-25 | GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed... | Class II | GE Medical Systems, LLC |
| Mar 26, 2026 | Revolution Apex, X-ray Computed Tomography, Model Number 5590000-20 | GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed... | Class II | GE Medical Systems, LLC |
| Mar 26, 2026 | Revolution Apex Elite, X-ray Computed Tomography, Model Number 5590000-23 | GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed... | Class II | GE Medical Systems, LLC |
| Mar 26, 2026 | Revolution Apex Select, X-ray Computed Tomography, Model Number 5590000-27 | GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed... | Class II | GE Medical Systems, LLC |
| Mar 26, 2026 | Revolution Ascend, computed tomography, Model Numbers 6969000-100 and 6969000... | GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed... | Class II | GE Medical Systems, LLC |
| Mar 26, 2026 | Revolution CT ES, X-ray Computed Tomography, Model Number 5590000-15 | GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed... | Class II | GE Medical Systems, LLC |
| Mar 26, 2026 | Brand Name: Spacelabs Ultraview SL Command Module Product Name: SL Command M... | Due to a manufacturing issue (i.e. malfunctioning of electrical Leakage tester). | Class II | Spacelabs Healthcare, Inc. |
| Mar 26, 2026 | Immy, Myco DDR Trident, Bulk Neutralization Buffer B (60 X 30 mL), REF: TBPN6... | Neutralization Buffer may contain contaminants | Class II | Immuno-Mycologics, Inc |
| Mar 25, 2026 | DEX Ophthalmic Tissue Forceps, 27ga DEX Stiff Maculorhexis Forceps, Model/Cat... | Field Safety Corrective Action for IFU in DEX Forceps and Scissors. | Class II | Katalyst Surgical, LLC |
| Mar 25, 2026 | DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Serrated Forceps, Model/Catalog... | Field Safety Corrective Action for IFU in DEX Forceps and Scissors. | Class II | Katalyst Surgical, LLC |
| Mar 25, 2026 | DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Maculorhexis Forceps, Model/Cat... | Field Safety Corrective Action for IFU in DEX Forceps and Scissors. | Class II | Katalyst Surgical, LLC |
| Mar 25, 2026 | DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff End Grasping Forceps, Model/Cat... | Field Safety Corrective Action for IFU in DEX Forceps and Scissors. | Class II | Katalyst Surgical, LLC |
| Mar 25, 2026 | DEX Ophthalmic Tissue Forceps, 25ga DEX Super Grip Forceps, Model/Catalog Num... | Field Safety Corrective Action for IFU in DEX Forceps and Scissors. | Class II | Katalyst Surgical, LLC |
| Mar 25, 2026 | DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Super Grip Forceps, Model/Catal... | Field Safety Corrective Action for IFU in DEX Forceps and Scissors. | Class II | Katalyst Surgical, LLC |
| Mar 25, 2026 | DEX Ophthalmic Tissue Forceps, 27ga DEX Stiff Super Grip Forceps, Model/Catal... | Ophthalmic Tissue Forceps (DEX") are sterile, hand-held ophthalmic surgical instruments designed ... | Class II | Katalyst Surgical, LLC |
| Mar 25, 2026 | DEX Ophthalmic Tissue Forceps, 23ga DEX NanoTapered AWH Forceps, Model/Catalo... | Field Safety Corrective Action for IFU in DEX Forceps and Scissors. | Class II | Katalyst Surgical, LLC |
| Mar 25, 2026 | BioCera Fibers, Bioresorbable Bone Void Filler, REF: ORB-0320C-KC, ORB-0310C-... | Resorbable bone void filler falls outside standard specifications. | Class II | Orthorebirth Co Ltd |
| Mar 25, 2026 | DEX Ophthalmic Tissue Forceps, 25ga DEX Maculorhexis Forceps, Model/Catalog N... | Field Safety Corrective Action for IFU in DEX Forceps and Scissors. | Class II | Katalyst Surgical, LLC |
| Mar 25, 2026 | ZENBONE, REF: ORB-0320C-Z, ORB-0310C-Z, ORB-0304C-Z | Resorbable bone void filler falls outside standard specifications. | Class II | Orthorebirth Co Ltd |
| Mar 25, 2026 | DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Asymmetrical Tano Forceps, Mode... | Field Safety Corrective Action for IFU in DEX Forceps and Scissors. | Class II | Katalyst Surgical, LLC |
| Mar 25, 2026 | DEX Ophthalmic Tissue Forceps, 23ga DEX Maculorhexis Forceps, Model/Catalog N... | Field Safety Corrective Action for IFU in DEX Forceps and Scissors. | Class II | Katalyst Surgical, LLC |
| Mar 25, 2026 | DEX Ophthalmic Tissue Forceps, 25ga DEX Nano Tapered AWH Forceps, Model/Catal... | Field Safety Corrective Action for IFU in DEX Forceps and Scissors. | Class II | Katalyst Surgical, LLC |
| Mar 25, 2026 | OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2... | Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely. | Class II | Olympus Corporation of the Americas |
| Mar 25, 2026 | Oxoid Agglutinating Sera, Salmonella 9-0 R30957301 | Affected lots are not performing to IFU criteria showing cross reactions with 2-0 within 60 secon... | Class II | Remel Europe Ltd. |
| Mar 25, 2026 | OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2... | Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely. | Class II | Olympus Corporation of the Americas |
| Mar 25, 2026 | OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2111 | Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely. | Class II | Olympus Corporation of the Americas |
| Mar 25, 2026 | OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2... | Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely. | Class II | Olympus Corporation of the Americas |
| Mar 25, 2026 | OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2... | Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely. | Class II | Olympus Corporation of the Americas |
| Mar 25, 2026 | OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2112 | Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely. | Class II | Olympus Corporation of the Americas |
| Mar 25, 2026 | Avitene Ultrafoam Microfibrillar Collagen Hemostat - 8cm x 6.25cm x 1cm. Cata... | Potential for product to contain foreign matter, confirmed to be inspect fragments. | Class II | Davol, Inc. |
| Mar 25, 2026 | OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2... | Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely. | Class II | Olympus Corporation of the Americas |
| Mar 25, 2026 | OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2... | Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely. | Class II | Olympus Corporation of the Americas |
| Mar 25, 2026 | OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2... | Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely. | Class II | Olympus Corporation of the Americas |
| Mar 25, 2026 | OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2... | Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely. | Class II | Olympus Corporation of the Americas |
| Mar 25, 2026 | OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2... | Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely. | Class II | Olympus Corporation of the Americas |
| Mar 25, 2026 | OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2... | XXX | Class II | Olympus Corporation of the Americas |
| Mar 24, 2026 | Oncology Kit w/60" (152 cm) Appx 2.2 ml, Smallbore Ext Set w/ChemoLock Port, ... | Oncology sets/closed system transfer devices with extension sets may leak resulting in therapy de... | Class II | ICU Medical, Inc. |
| Mar 24, 2026 | Protocol Configuration Tool (PCT) software v1.3.0 for Hamilton AutoLys STAR u... | Potential for spontaneous closures of Hamilton HxRunControl software during execution of Autolys ... | Class II | Foundation Medicine, Inc. |
| Mar 24, 2026 | Yeastone Broth, 11ML, 10/BOX YY3462 | Products may report incorrect AST results during quality control. Health consequences may include... | Class II | Remel, Inc |
| Mar 23, 2026 | Tangent Endoscopy, Tangent Single Use Digital Catheter. Model Numbers: (1... | Affected devices exhibited fractures at the distal shaft tip without complete detachment. | Class II | TANGENT ENDOSCOPY, LLC |
| Mar 23, 2026 | Brand Name: HiResolution" Bionic Ear System Product Name: M Zn-Air Battery P... | The non-tamperproof battery door supplied with the sound processor fails to conform to IEC 60601-... | Class II | Advanced Bionics, LLC |
| Mar 23, 2026 | Brand Name: Genius" Review Station Product Name: Genius" Review Station Disp... | It was identified that certain devices were being operated outside the validated and FDA-cleared ... | Class II | Hologic, Inc |
| Mar 23, 2026 | Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 25cm. Model Number: TB2... | Potential for detachment of a distal tip component of the device during use. | Class II | Olympus Corporation of the Americas |
Frequently Asked Questions
When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.
All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.
Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.