Medical Device Recalls
RSS ↗7,493 medical device recalls from federal enforcement feeds.
Showing 101–150 of 7,493
- Class II
Medical Device Recall · March 30, 2026
Brand Name: Disposable Mixing Bowls with Spatula Product Name: Mixing Bowl and Spatula Model/Catalog Number: 00-5049-011-00 Software Version: N/A Product Description: Mixing Bowl and Spatula CompTen complaints have been received identifying issues at the time of use related to the package seal, including incomplete seals, wrinkles in the seals or peeling seals. Compromised sterile barrier may lead to clinically insignificant extension of surgery or infection leading to surgical intervention.
- Class II
Medical Device Recall · March 27, 2026
Edwards EVOQUE tricuspid delivery system REF:9850TDS Sterile EOLabeling update to provide warning if functionality of the valve replacement delivery system is compromised.
- Class II
Medical Device Recall · March 27, 2026
Straumann n!ce PMMA Full-arch Restoration. Screw-retained Bridge. Article 010.0304. Endosseous Dental Implant AbutmentsIncludes an incorrect screw seat interface.
- Class II
Medical Device Recall · March 27, 2026
Straumann n!ce Zr, HT, Full-arch Restoration. Article 010.0158. Endosseous Dental Implant AbutmentsIncludes an incorrect screw seat interface.
- Class II
Medical Device Recall · March 27, 2026
Rover Mobile X-ray System Model/Catalog Number: MXU-RV35 and MXU-RV71X-Ray generator may malfunction resulting in the X-Ray being inoperable.
- Class I
Medical Device Recall · March 27, 2026
AIDBAGs are first aid kits of convenience composed of individually labeled devices designed as specialty first aid kits designed for the appropriate level provider to evaluate and treat patients at thKits contain the McKesson TRUE Metrix PRO Professional Monitoring Blood Glucose System that has been recalled for an issue with the software design of the E-5 Error Code where the meter displays an E-5 error code for a very high blood glucose event (> 600 mg/dL) or when there is a test strip error, which can lead to operator confusion when evaluating patients and a delay in appropriate treatment. This is a downstream recall of Trividia Health Class I, Recall Event ID 98317.
- Class II
Medical Device Recall · March 26, 2026
Brand Name: Spacelabs Ultraview SL Command Module Product Name: SL Command Module Model/Catalog Number: 91496 Software Version: N/A Product Description: The Command Module (91496) is the core of tDue to a manufacturing issue (i.e. malfunctioning of electrical Leakage tester).
- Class II
Medical Device Recall · March 26, 2026
Revolution CT ES, X-ray Computed Tomography, Model Number 5590000-15GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used in conjunction with certain Revolution Apex, Revolution Ascend, and Revolution CT systems.
- Class II
Medical Device Recall · March 26, 2026
Revolution Apex Select, X-ray Computed Tomography, Model Number 5590000-27GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used in conjunction with certain Revolution Apex, Revolution Ascend, and Revolution CT systems.
- Class II
Medical Device Recall · March 26, 2026
Revolution Ascend, computed tomography, Model Numbers 6969000-100 and 6969000-300GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used in conjunction with certain Revolution Apex, Revolution Ascend, and Revolution CT systems.
- Class II
Medical Device Recall · March 26, 2026
Revolution Apex, X-ray Computed Tomography, Model Number 5590000-20GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used in conjunction with certain Revolution Apex, Revolution Ascend, and Revolution CT systems.
- Class II
Medical Device Recall · March 26, 2026
Revolution CT, x-ray computed tomography, Model Numbers 5590000 and 5590000-6GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used in conjunction with certain Revolution Apex, Revolution Ascend, and Revolution CT systems.
- Class II
Medical Device Recall · March 26, 2026
Immy, Myco DDR Trident, Bulk Neutralization Buffer B (60 X 30 mL), REF: TBPN67-60 For processing of clinical specimens for Mycobacterium spp. diagnosisNeutralization Buffer may contain contaminants
- Class II
Medical Device Recall · March 26, 2026
Revolution Apex Plus, X-ray Computed Tomography, Model Number 5590000-25GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used in conjunction with certain Revolution Apex, Revolution Ascend, and Revolution CT systems.
- Class II
Medical Device Recall · March 26, 2026
Revolution Apex Elite, X-ray Computed Tomography, Model Number 5590000-23GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used in conjunction with certain Revolution Apex, Revolution Ascend, and Revolution CT systems.
- Class II
Medical Device Recall · March 25, 2026
Olympus Corporation of the Americas
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2119.Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
- Class II
Medical Device Recall · March 25, 2026
DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Maculorhexis Forceps, Model/Catalog Number: DVF4019-25-SField Safety Corrective Action for IFU in DEX Forceps and Scissors.
- Class II
Medical Device Recall · March 25, 2026
Oxoid Agglutinating Sera, Salmonella 9-0 R30957301Affected lots are not performing to IFU criteria showing cross reactions with 2-0 within 60 seconds. Cross-reactivity may result in the misidentification of a Salmonella 9-O serotype as a 2-O serotype.
- Class I
Medical Device Recall · March 25, 2026
Rolls of label stock used with the Omnicell i.v.Station. 1. Part Number 258920028, LABEL, STERILE, IVSTATION SYRINGE (40MMX40MM). 2. Part Number 258900029, LABEL, STERILE, IVSTATION SYRINGEPotential for mislabeled syringe produced by the i.v.STATION device.
- Class II
Medical Device Recall · March 25, 2026
BioCera Fibers, Bioresorbable Bone Void Filler, REF: ORB-0320C-KC, ORB-0310C-KC, ORB-0304C-KC, ORB-0302C-KC, ORB-0305D-KCResorbable bone void filler falls outside standard specifications.
- Class II
Medical Device Recall · March 25, 2026
Olympus Corporation of the Americas
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2118.Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
- Class II
Medical Device Recall · March 25, 2026
Olympus Corporation of the Americas
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2115.XXX
- Class II
Medical Device Recall · March 25, 2026
Olympus Corporation of the Americas
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2330.Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
- Class II
Medical Device Recall · March 25, 2026
DEX Ophthalmic Tissue Forceps, 27ga DEX Stiff Maculorhexis Forceps, Model/Catalog Number: DVF4019-27Field Safety Corrective Action for IFU in DEX Forceps and Scissors.
- Class II
Medical Device Recall · March 25, 2026
DEX Ophthalmic Tissue Forceps, 23ga DEX NanoTapered AWH Forceps, Model/Catalog Number: DVF4005-23Field Safety Corrective Action for IFU in DEX Forceps and Scissors.
- Class II
Medical Device Recall · March 25, 2026
DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff End Grasping Forceps, Model/Catalog Number: DVF4022-25-SField Safety Corrective Action for IFU in DEX Forceps and Scissors.
- Class II
Medical Device Recall · March 25, 2026
Avitene Ultrafoam Microfibrillar Collagen Hemostat - 8cm x 6.25cm x 1cm. Catalog Number: 1050030.Potential for product to contain foreign matter, confirmed to be inspect fragments.
- Class II
Medical Device Recall · March 25, 2026
DEX Ophthalmic Tissue Forceps, 27ga DEX Stiff Super Grip Forceps, Model/Catalog Number: DVF4034-27Ophthalmic Tissue Forceps (DEX") are sterile, hand-held ophthalmic surgical instruments designed for grasping, manipulating, compressing, pulling, or joining eye and/or surrounding tissues during surgical procedures. These devices fall under the GMDN code 62478 entitled Ophthalmic soft-tissue surgical forceps, probe-like, single use . Double pouched in tyvek pouches, sold in boxes of 5 with an inner and outer box.
- Class II
Medical Device Recall · March 25, 2026
Olympus Corporation of the Americas
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2112Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
- Class III
Medical Device Recall · March 25, 2026
Heraeus Medical GmbH (Dental Division)
Heraeus, PALAMIX uno. Material Number: 66057893.Based on long-term stability testing, it was determined that in units older than 1.5 years (17 months) the mixing rod may, in rare cases, come loose from its lock during the mixing process. Notification is to reduce the shelf life from 3 years to 1.5 years (17 months).
- Class II
Medical Device Recall · March 25, 2026
Olympus Corporation of the Americas
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2117.Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
- Class II
Medical Device Recall · March 25, 2026
DEX Ophthalmic Tissue Forceps, 23ga DEX Maculorhexis Forceps, Model/Catalog Number: DVF4019-23Field Safety Corrective Action for IFU in DEX Forceps and Scissors.
- Class II
Medical Device Recall · March 25, 2026
DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Super Grip Forceps, Model/Catalog Number: DVF4034-25-SField Safety Corrective Action for IFU in DEX Forceps and Scissors.
- Class II
Medical Device Recall · March 25, 2026
Olympus Corporation of the Americas
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2114.Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
- Class II
Medical Device Recall · March 25, 2026
Olympus Corporation of the Americas
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2111Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
- Class II
Medical Device Recall · March 25, 2026
DEX Ophthalmic Tissue Forceps, 25ga DEX Nano Tapered AWH Forceps, Model/Catalog Number: DVF4005-25Field Safety Corrective Action for IFU in DEX Forceps and Scissors.
- Class II
Medical Device Recall · March 25, 2026
DEX Ophthalmic Tissue Forceps, 25ga DEX Super Grip Forceps, Model/Catalog Number: DVF4034-25Field Safety Corrective Action for IFU in DEX Forceps and Scissors.
- Class II
Medical Device Recall · March 25, 2026
Olympus Corporation of the Americas
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2110. May be included with the Olympus OER-ELITE.Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
- Class II
Medical Device Recall · March 25, 2026
DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Asymmetrical Tano Forceps, Model/Catalog Number: DVF4014-25-SField Safety Corrective Action for IFU in DEX Forceps and Scissors.
- Class II
Medical Device Recall · March 25, 2026
Olympus Corporation of the Americas
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2113.Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
- Class II
Medical Device Recall · March 25, 2026
ZENBONE, REF: ORB-0320C-Z, ORB-0310C-Z, ORB-0304C-ZResorbable bone void filler falls outside standard specifications.
- Class III
Medical Device Recall · March 25, 2026
Heraeus Medical GmbH (Dental Division)
Heraeus, PALAMIX duo. Material Number: 66057897.Based on long-term stability testing, it was determined that in units older than 1.5 years (17 months) the mixing rod may, in rare cases, come loose from its lock during the mixing process. Notification is to reduce the shelf life from 3 years to 1.5 years (17 months).
- Class II
Medical Device Recall · March 25, 2026
DEX Ophthalmic Tissue Forceps, 25ga DEX Maculorhexis Forceps, Model/Catalog Number: DVF4019-25Field Safety Corrective Action for IFU in DEX Forceps and Scissors.
- Class II
Medical Device Recall · March 25, 2026
Olympus Corporation of the Americas
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2138.Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
- Class I
Medical Device Recall · March 25, 2026
VOCSN V+Pro package, REF: PRT-01198-000; VOCSN V+Pro unit, REF: PRT-01185-000Respiratory system intended to provide continuous/intermittent ventilator support, may not have been evaluated under all intended high-pressure conditions during production testing, so an oxygen leak condition could occur that may lead to reduced below intended levels of fraction of inspired oxygen delivery prior to and during ventilation and this oxygen-enriched environment may increase fire risk
- Class II
Medical Device Recall · March 25, 2026
Olympus Corporation of the Americas
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2116.Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
- Class II
Medical Device Recall · March 25, 2026
DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Serrated Forceps, Model/Catalog Number: DVF4016-25-SField Safety Corrective Action for IFU in DEX Forceps and Scissors.
- Class I
Medical Device Recall · March 24, 2026
1. DBD-MTS,3V,MAN,KIT, Medline Kit Number/SKU 60010195; 2. MTS-LEFT HEART,KIT, Medline Kit Number/SKU 60033123; 3. MTS,3 VALVE,KIT, Medline Kit Number/SKU 60050183; 4. MTS,LEFT HEART,KIT, MedlinMedline has identified the presence of particulate within the fluid path of the Manifolds.
- Class II
Medical Device Recall · March 24, 2026
Protocol Configuration Tool (PCT) software v1.3.0 for Hamilton AutoLys STAR used within FoundationOneCDx (F1CDx) installed on Research Triangle Park laboratory Equipment IDs 01342, 01591, 01989, 01990Potential for spontaneous closures of Hamilton HxRunControl software during execution of Autolys protocols after deployment of the PCT software for AutoLys Hamilton STAR.
- Class I
Medical Device Recall · March 24, 2026
Namic Angiographic Manifold, custom, Medline Product Number/SKU 64038402; Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting.Medline has identified the presence of particulate within the fluid path of the Manifolds.