Browse Device Recalls
35,226 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 35,226 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 35,226 FDA device recalls, Class II.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 | Hintermann Series Talar Implant, Left, Size 2 REF 302112 | Through customer complaints, the ankle replacement system was found to contain incorrect devices:... | Class II | DT MedTech, LLC |
| 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 | Nerivio Infinity. Model/Catalog Number: FGD000100. Software Version: FW Ver... | Potential for the batter to have a thermal-runway event during charging, resulting in smoke and o... | Class II | THERANICA BIOELECTRONICS LTD |
| 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 |
| Mar 23, 2026 | Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 35cm. Model Number: TB2... | Potential for detachment of a distal tip component of the device during use. | Class II | Olympus Corporation of the Americas |
| Mar 23, 2026 | Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 20cm. Model Number: TB2... | Potential for detachment of a distal tip component of the device during use. | Class II | Olympus Corporation of the Americas |
| Mar 23, 2026 | Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 45cm. Model Number: TB2... | Potential for detachment of a distal tip component of the device during use. | Class II | Olympus Corporation of the Americas |
| Mar 23, 2026 | Gentuity HF-OCT Imaging System Model G10-01; Software version 23.2.13; | The potential for repeated frames during HF-OCT pullback when using the Gentuity HF-OCT Console (... | Class II | Gentuity, LLC |
| Mar 20, 2026 | Prodisc C SK U.S. IMPLANT EXTRA LARGE 6MM. Model Number: PDSXL6. Total cer... | Product labeling mix up. The prodisc C SK U.S. Implant Extra Large 6mm product was labeled as a 5... | Class II | Centinel Spine, Inc. |
| Mar 20, 2026 | Prodisc C SK U.S. IMPLANT EXTRA LARGE 5MM. Model: PDSXL5 Total cervical di... | Product labeling mix up. The prodisc C SK U.S. Implant Extra Large 6mm product was labeled as a 5... | Class II | Centinel Spine, Inc. |
| Mar 20, 2026 | Sequencing Agent SEQ0067, component of FoundationOne CDx (F1CDx) | Possible increase in phasing, potentially resulting in false-positive BARD1 splice site indel art... | Class II | Foundation Medicine, Inc. |
| Mar 19, 2026 | Brand Name: U2 Total Knee System Product Name: Femoral offset bushing, 2mm a... | Due to a design issue causing the incorrect engraved numbering on implant that could result in th... | Class II | United Orthopedic Corp. |
| Mar 19, 2026 | Brand Name: U2 Total Knee System Product Name: Femoral offset bushing, 0mm a... | Due to a design issue causing the incorrect engraved numbering on implant that could result in th... | Class II | United Orthopedic Corp. |
| Mar 19, 2026 | Brand Name: DONJOY Product Name: ICEMAN, W/COLDPAD, NS, RH Model/Catalog Nu... | Due to broken connector which may result in a temporary interruption of prescribed cold therapy. | Class II | DJO, LLC |
| Mar 19, 2026 | Brand Name: DONJOY Product Name: ICEMAN W/,UNIV,LOOP,NS,RH Model/Catalog Nu... | Due to broken connector which may result in a temporary interruption of prescribed cold therapy. | Class II | DJO, LLC |
| Mar 19, 2026 | Brand Name: DONJOY Product Name: ICEMAN CLASSIC CUBE Model/Catalog Number: ... | Due to broken connector which may result in a temporary interruption of prescribed cold therapy. | Class II | DJO, LLC |
| Mar 19, 2026 | Brand Name: DONJOY Product Name: ICEMAN W/,UNIV,LOOP,NS,EH Model/Catalog Nu... | Due to broken connector which may result in a temporary interruption of prescribed cold therapy. | Class II | DJO, LLC |
| Mar 19, 2026 | Medline and Centurion medical procedure kits, containing Medline Neuro Sponge... | During an internal review, Medline identified higher-than-expected endotoxin levels on a represen... | Class II | Medline Industries, LP |
| Mar 19, 2026 | Medline medical procedure kits, containing Medline Neuro Sponges, labeled as ... | During an internal review, Medline identified higher-than-expected endotoxin levels on a represen... | Class II | Medline Industries, LP |
| Mar 19, 2026 | Medline medical procedure kits, containing Medline Neuro Sponges (102 in total) | During an internal review, Medline identified higher-than-expected endotoxin levels on a represen... | Class II | Medline Industries, LP |
| Mar 19, 2026 | Centurion medical procedure kits, containing Medline Neuro Sponges, labeled a... | During an internal review, Medline identified higher-than-expected endotoxin levels on a represen... | Class II | Medline Industries, LP |
| Mar 19, 2026 | Medline medical procedure kits, containing Medline Neuro Sponges, labeled as ... | During an internal review, Medline identified higher-than-expected endotoxin levels on a represen... | Class II | Medline Industries, LP |
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.