Browse Device Recalls

39,162 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 39,162 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 39,162 FDA device recalls.

DateProductReasonClassFirm
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 Rolls of label stock used with the Omnicell i.v.Station. 1. Part Number ... Potential for mislabeled syringe produced by the i.v.STATION device. Class I Omnicell, 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 VOCSN V+Pro package, REF: PRT-01198-000; VOCSN V+Pro unit, REF: PRT-01185-000 Respiratory system intended to provide continuous/intermittent ventilator support, may not have b... Class I Ventec Life Systems, Inc.
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 Heraeus, PALAMIX duo. Material Number: 66057897. Based on long-term stability testing, it was determined that in units older than 1.5 years (17 mo... Class III Heraeus Medical GmbH (Dental Division)
Mar 25, 2026 Heraeus, PALAMIX uno. Material Number: 66057893. Based on long-term stability testing, it was determined that in units older than 1.5 years (17 mo... Class III Heraeus Medical GmbH (Dental Division)
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 Medline medical convenience kits, containing Namic Manifold, Labeled as: 1... Medline has identified the presence of particulate within the fluid path of the Manifolds. Class I Medline Industries, LP
Mar 24, 2026 Namic Preceptor Manifold, custom, Medline Product Number/SKU 64039307; Extrav... Medline has identified the presence of particulate within the fluid path of the Manifolds. Class I Medline Industries, LP
Mar 24, 2026 Namic Angiographic Manifold, custom, Medline Product Number/SKU 64038402; Car... Medline has identified the presence of particulate within the fluid path of the Manifolds. Class I Medline Industries, LP
Mar 24, 2026 Namic Angiographic Manifold, custom, Medline Product Number/SKU 64038200; Car... Medline has identified the presence of particulate within the fluid path of the Manifolds. Class I Medline Industries, LP
Mar 24, 2026 Namic Angiographic Manifold, custom, Medline Product Number/SKU 64038301; Car... Medline has identified the presence of particulate within the fluid path of the Manifolds. Class I Medline Industries, LP
Mar 24, 2026 1. DBD-MTS,3V,MAN,KIT, Medline Kit Number/SKU 60010195; 2. MTS-LEFT HEART,K... Medline has identified the presence of particulate within the fluid path of the Manifolds. Class I Medline Industries, LP
Mar 24, 2026 1. 3 VALVE MAN KIT, Medline Kit SKU Number: 65101544; 2. 3V MANIFOLD KIT, ... Medline has identified the presence of particulate within the fluid path of the Manifolds. Class I Medline Industries, LP
Mar 24, 2026 Medline medical convenience kits, containing Namic Manifold, Labeled as: 1... Medline has identified the presence of particulate within the fluid path of the Manifolds. Class I Medline Industries, LP
Mar 24, 2026 Medline medical convenience kits, containing Namic Manifold, Labeled as: TAV... Medline has identified the presence of particulate within the fluid path of the Manifolds. Class I Medline Industries, LP
Mar 24, 2026 Namic Preceptor Manifold, custom, Medline Product Number/SKU 64037107; Extrav... Medline has identified the presence of particulate within the fluid path of the Manifolds. Class I Medline Industries, LP
Mar 24, 2026 Medline medical convenience kits, containing Namic Manifold, Labeled as: HEA... Medline has identified the presence of particulate within the fluid path of the Manifolds. Class I Medline Industries, LP
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

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.