Medical Device Recalls
RSS ↗7,870 medical device recalls from federal enforcement feeds.
Showing 451–500 of 7,870
- 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, 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
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
ZENBONE, REF: ORB-0320C-Z, ORB-0310C-Z, ORB-0304C-ZResorbable 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-2111Potential 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-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, 25ga DEX Stiff Serrated Forceps, Model/Catalog Number: DVF4016-25-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-2138.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 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
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
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
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
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
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-2112Potential 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 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
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-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 Maculorhexis Forceps, Model/Catalog Number: DVF4019-25-SField Safety Corrective Action for IFU in DEX Forceps and Scissors.
- 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
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-2115.XXX
- 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
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
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 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
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 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 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 I
Medical Device Recall · March 24, 2026
1. 3 VALVE MAN KIT, Medline Kit SKU Number: 65101544; 2. 3V MANIFOLD KIT, Medline Kit SKU Number: 65110351; 3. HEART CATH PACK-LF, Medline Kit SKU Number: DYNJ0373285M; 4. ANGIO DRAPE CARDIACMedline has identified the presence of particulate within the fluid path of the Manifolds.
- 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 II
Medical Device Recall · March 24, 2026
Hintermann Series Talar Implant, Left, Size 2 REF 302112Through customer complaints, the ankle replacement system was found to contain incorrect devices: Left implant packaging and labeling bears a right implant device.
- Class I
Medical Device Recall · March 24, 2026
Namic Preceptor Manifold, custom, Medline Product Number/SKU 64039307; Extravascular blood pressure transducerMedline has identified the presence of particulate within the fluid path of the Manifolds.
- Class II
Medical Device Recall · March 24, 2026
Oncology Kit w/60" (152 cm) Appx 2.2 ml, Smallbore Ext Set w/ChemoLock Port, Clamp, Anti-Siphon Valve, Spiros; ChemoLock; Syringe Transfer Set w/MicroClave, ChemoLock Port, REF: CL3960Oncology sets/closed system transfer devices with extension sets may leak resulting in therapy delayed if noticed and corrected during setup, but if the leak occurs during therapy this may result in therapy interruption with the potential for the patient to receive less infusion solution than intended. Exposure of hazardous substances to the patient, caregiver, or pharmacy technician is possible.
- Class I
Medical Device Recall · March 24, 2026
Medline medical convenience kits, containing Namic Manifold, Labeled as: HEART CATH PACK-LF, Medline Kit Number/SKU DYNJ36478BMedline has identified the presence of particulate within the fluid path of the Manifolds.
- Class I
Medical Device Recall · March 24, 2026
Medline medical convenience kits, containing Namic Manifold, Labeled as: 1. ANGIOGRAPHY CATH LAB, Medline Kit Number/SKUDYNJ23532C; 2. CATH LAB PACK, Medline Kit Number/SKUDYNJ65185; 3. ANGIO KMedline has identified the presence of particulate within the fluid path of the Manifolds.
- Class I
Medical Device Recall · March 24, 2026
Namic Angiographic Manifold, custom, Medline Product Number/SKU 64038301; Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting.Medline has identified the presence of particulate within the fluid path of the Manifolds.
- Class II
Medical Device Recall · March 24, 2026
Yeastone Broth, 11ML, 10/BOX YY3462Products may report incorrect AST results during quality control. Health consequences may include delayed response or the need to change to another antifungal agent if laboratory ignores Quality Control test result.
- Class I
Medical Device Recall · March 24, 2026
Namic Preceptor Manifold, custom, Medline Product Number/SKU 64037107; Extravascular blood pressure transducerMedline has identified the presence of particulate within the fluid path of the Manifolds.
- Class I
Medical Device Recall · March 24, 2026
Medline medical convenience kits, containing Namic Manifold, Labeled as: TAVI, Medline Kit Number/SKU DYNJ904981CMedline has identified the presence of particulate within the fluid path of the Manifolds.
- 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.
- Class I
Medical Device Recall · March 24, 2026
Namic Angiographic Manifold, custom, Medline Product Number/SKU 64038200; Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting.Medline has identified the presence of particulate within the fluid path of the Manifolds.
- Class I
Medical Device Recall · March 24, 2026
Medline medical convenience kits, containing Namic Manifold, Labeled as: 1. MTS,RT,HANDED/LFT,HRT,KIT, Medline Kit Number/SKU 60010508; 2. DBD-MTS,LEFT HEART,KIT, Medline Kit Number/SKU 60160075;Medline has identified the presence of particulate within the fluid path of the Manifolds.
- Class II
Medical Device Recall · March 23, 2026
Olympus Corporation of the Americas
Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 20cm. Model Number: TB2-0520FC.Potential for detachment of a distal tip component of the device during use.
- Class II
Medical Device Recall · March 23, 2026
Olympus Corporation of the Americas
Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 35cm. Model Number: TB2-0535FC.Potential for detachment of a distal tip component of the device during use.
- Class II
Medical Device Recall · March 23, 2026
Olympus Corporation of the Americas
Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 25cm. Model Number: TB2-0525FC.Potential for detachment of a distal tip component of the device during use.
- Class II
Medical Device Recall · March 23, 2026
Tangent Endoscopy, Tangent Single Use Digital Catheter. Model Numbers: (1) TNG4002-IND. (2) TNG-4007-6pk.Affected devices exhibited fractures at the distal shaft tip without complete detachment.
- Class II
Medical Device Recall · March 23, 2026
Brand Name: HiResolution" Bionic Ear System Product Name: M Zn-Air Battery Pak Model/Catalog Number: CI-5501-110; CI-5501-120; CI-5501-130; CI-5501-140; CI-5501-150; CI-5501-190; CI-5501-240; CI-550The non-tamperproof battery door supplied with the sound processor fails to conform to IEC 60601-1-11:2015 by not requiring the use of a tool to replace the button/coin cell battery.
- Class II
Medical Device Recall · March 23, 2026
Olympus Corporation of the Americas
Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 45cm. Model Number: TB2-0545FC.Potential for detachment of a distal tip component of the device during use.