Medical Device Recalls
RSS ↗8,234 medical device recalls from federal enforcement feeds.
Showing 1–50 of 8,234
- Class II
Medical Device Recall · July 17, 2026
Thermo Fisher Diagnostics Neisseria meningitidis Gp C 2ml/VL, Product Number R30166901; invitro diagnosticsCertain lots of Neisseria meningitidis Gp C 2ml/VL, R30166901, are not performing to IFU criteria not positive to ATCC13102 within 60 Seconds.
- Class II
Medical Device Recall · July 16, 2026
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Philips Azurion Rystem, Model Numbers: 722063, 722064, 722067, 722068, 722078, 722079, 722221, 722222,722223, 722224, 722225, 722226, 722227, 722228, 722280*, 722281*, and 722282* (*These models arTwo software related issues affecting Azurion R2.2.10 Systems: 1) Potential image quality degradation that may lead to delay of therapy, procedural complications and/or inappropriate treatment and 2) Potential loss of geometry movements that may lead to delay of therapy and procedural complications
- Class II
Medical Device Recall · July 16, 2026
FilmArray NGDS Warrior Panel REF NGDS-ASY-0007 UDI-DI code: (01)00851458005136 The FilmArray NGDS Warrior Panel is a qualitative, multiplexed, nucleic acid-based in vitro diagnostic test intendedFirm has identified mismatches between the outbreak strain and the reference strain used in the development of its qualitative, multiplexed, nucleic acid-based in vitro diagnostic panel test.
- Class II
Medical Device Recall · July 16, 2026
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Philips Azurion, Model Numbers: 722229, 722230, 722231, 722232, 722233, 722234, 722235, and 722236, with Software Version Numbers: R3.0 and R3.1; Interventional fluoroscopic x-ray systemTwo software related issues: 1) Potential image quality degradation that may lead to delay of therapy, procedural complications and/or inappropriate treatment and 2) Potential loss of geometry movements that may lead to delay of therapy and procedural complications
- Class II
Medical Device Recall · July 16, 2026
Straumann Bone Level Tapered (BLT) Implant, D 4.1mm RC, SLActive 14mm, Roxolid, Loxim (Article 021.5314); implant, endosseous, root-formBone Level Tapered (BLT) Implant, D 4.1mm RC, SLActive 14mm, Roxolid, Loxim may inadvertently contain implants that are 12mm in length instead of 14mm as the labeling would suggest.
- Class II
Medical Device Recall · July 14, 2026
Cardinal Health Presource Kits: 1) NEWNAN SMR PACK, Catalog Number: SEN21SPPMBProcedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels.
- Class II
Medical Device Recall · July 14, 2026
Cardinal Health Presource Kits: 1) ENT TRAY , Catalog Number: 24-0726A; 2) KIT,SINUS , Catalog Number: PE13SPAJA; 3) KIT,SINUS , CatalogProcedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels.
- Class II
Medical Device Recall · July 14, 2026
Cardinal Health Presource Kits: 1) HARMONIZED SPINE VCH PHC PACK , Catalog Number: SOP30SPBCCProcedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels.
- Class II
Medical Device Recall · July 14, 2026
Cardinal Health Presource Kits: 1) KIT, MER NEURO BACK , Catalog Number: PN33NBMYD; 2) KIT,CHP BASIC NEURO , Catalog Number: PN36NBCH4; 3) KIT,CHP BASIC NEURO , CataProcedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels.
- Class II
Medical Device Recall · July 14, 2026
Cardinal Health Presource Kits: 1) SEPTO RHINO PACK , Catalog Number: SEN73NSKCF; 2) PACK NEURO MINOR CRANIOTOMY , Catalog Number: SNE30CNOHE; 3) NEURO MAJOR 2 PACK , CatalProcedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels.
- Class II
Medical Device Recall · July 14, 2026
Cardinal Health Presource Kits: 1) FAT GRAFT ADD KIT , Catalog Number: 21-4720B; 2) TRAY FAT GRAFT ADD , Catalog Number: 21-4720C; 3) KIT,BOSC MICROLARYNGOSCOPY , Catalog NProcedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels.
- Class II
Medical Device Recall · July 14, 2026
Cardinal Health Presource Kits: 1) CHI STD NEURO CRANI OPT 2 , Catalog Number: CHIP99NC27; 2) CHI STD NEURO CRANI OPT 2 , Catalog Number: CHIP99NC28; 3) CHI STD NEURO CRANI OPT 2 , CatalProcedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels.
- Class II
Medical Device Recall · July 14, 2026
Cardinal Health Presource Kits: 1) BASIC PACK , Catalog Number: SBA73BPGCA; 2) SPINE PACK , Catalog Number: SNE11SPHKC; 3) SPINE PACK , CaProcedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels.
- Class II
Medical Device Recall · July 13, 2026
GM Helix Implant, Endosseous Dental Implant Article No. 109.984There may be a mismatch between the implant contained inside the packaging and the information described on the outer carton label. If the the incorrect implant is installed, the issue could cause bone compression or difficulty during installation in situations where there is sufficient bone volume
- Class II
Medical Device Recall · July 13, 2026
OBP Medical , ER-Spec Single-Use Vaginal Speculum with LED Light Source, X-Small REF: C020130-1There is a potential for vaginal speculums to contain a burr on the proximal plastic blade, which may introduce a sharp edge in the contact regions for both the patient and the healthcare provider.
- Class II
Medical Device Recall · July 10, 2026
GE Medical Systems Information Technologies Inc
GE Healthcare Portrait Core Services SW V 1.2.0, REF 5700592. patient monitoring systemA software vulnerability may allow unauthorized persons to gain privileged access to the device, which could result in loss of patient monitoring, missed patient alarms, and/or access to Protected Health Information (PHI).
- Class II
Medical Device Recall · July 7, 2026
FORWARD Oral Airway Kit (OPA Sizes 5, 6.5, 7, 8, 9, 10, 12). REF Number: 1011-40002. Containing the affected One-piece Guedel airway components: 1. Size 00, ISO 5.0, blue. Product Code: 1100050.Devices could potentially contain an occluded or partially occluded Guedel Airway tip.
- Class II
Medical Device Recall · July 7, 2026
Kingfisher Compact Individual First Aid Kit. REF Number: 76656. Containing the affected One-piece Guedel airway components: 1. Size 00, ISO 5.0, blue. Product Code: 1100050. 2. Size 000, ISDevices could potentially contain an occluded or partially occluded Guedel Airway tip.
- Class II
Medical Device Recall · July 7, 2026
Olympus Corporation of the Americas
Olympus 4K UHD LCD Monitor. Model Number: OEV321UH. An electrically powered visual display unit designed for displaying graphical information in color.Potential for the HDMI and DisplayPort (DP) connectors can become faulty resulting in image loss or image abnormalities.
- Class II
Medical Device Recall · July 6, 2026
Waldemar Link GmbH & Co. KG (Mfg Site)
Endo-Model, Replacement Set, Tibial Plateau, right/left, L, UHMWPE, CoCrMo, Rotating Hinge Item Number 15-0027/16The affected Endo-Model replacement set for a Rotating Hinge tibial plateau incorrectly contains a Pure Hinge plateau. The incorrect plateau could lead to a prolonged or modified surgery as the plateau cannot be inserted and an alternative product would be needed. If the incorrect plateau were to be implanted, this is associated with increased risk of wear, which could result in a reduced standing time of the implant.
- Class I
Medical Device Recall · July 6, 2026
Brand Name: Elevaris/Spectra Medical Devices Product Name: Sodium Chloride Injection, 0.9%, USP 10mL Ampule Model/Catalog Number: AMPUL10MLK. Sodium Chloride Flush for IV tubing systems and indManufacturing firm, Huons, was cited for issues regarding product quality and sterility assurance. If the product sterility is compromised, patients may be exposed to microorganisms, endotoxins, or foreign matter. This may trigger inflammatory responses, infections, micro-clots, and organ failure.
- Class II
Medical Device Recall · July 6, 2026
Siemens Healthcare Diagnostics, Inc.
Atellica CH Urine Albumin REF: 11537225, in vitro diagnosticProcessing of urine albumin assay on the CI analyzers may lead to the following issues: Falsely depressed Atellica CH Urea Nitrogen (UN_c) results; Falsely depressed Atellica CH Enzymatic Hemoglobin A1c (A1c_E) results; Increased rate of reaction cuvette QC failures and Delayed results due to QC failures.
- Class II
Medical Device Recall · July 2, 2026
OsteoBallast, 45 x 17.5 mm (SeaSpine Brand), REF: 56800095. Ballast, 45 x 17.5 mm (IsoTis Brand), REF: 02-8000-095Demineralized bone matrix (DBM) in resorbable mesh indicated for use with autograft as a bone graft extender in the posterolateral spine and pelvis, were filled with approx. 4.5 cc DBM (fill for 45 ¿ 11 mm configuration) instead of approx. 7.5 cc DBM (fill for 45 ¿ 17.5 mm configuration), which may lead to delayed fusion, incomplete fusion, pseudarthrosis, or lack of bone ingrowth.
- Class II
Medical Device Recall · July 1, 2026
Stryker Hoffmann II Connecting Rod Micro 3 x 60mm. Catalog Number: 50796060.Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization.
- Class II
Medical Device Recall · July 1, 2026
5-PLASMA Bivalirudin Control, Model Number 5D-44905Stability issues with the reconstituted lyophilized human plasma and bivalirudin matrix have been identified. These stability issues lead to a degradation of measurable bivalirudin in the controls, calibrators, and linearity values.
- Class II
Medical Device Recall · July 1, 2026
Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475630 Product Description: Intramedullary Bone Saw Blade Assembly 14mmZimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedullary Bone Saw Blade Assembly due to potential sterile barrier packaging damage caused by an exposed saw blade.
- Class II
Medical Device Recall · July 1, 2026
5-PLASMA Bivalirudin Calibrator, Model Number 5D-46905Stability issues with the reconstituted lyophilized human plasma and bivalirudin matrix have been identified. These stability issues lead to a degradation of measurable bivalirudin in the controls, calibrators, and linearity values.
- Class II
Medical Device Recall · July 1, 2026
Stryker Hoffmann II Connecting Rod Micro 3 x 40mm. Catalog Number: 50796040.Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization.
- Class II
Medical Device Recall · July 1, 2026
Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475625 Product Description: Intramedullary Bone Saw Blade Assembly 13mmZimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedullary Bone Saw Blade Assembly due to potential sterile barrier packaging damage caused by an exposed saw blade.
- Class II
Medical Device Recall · July 1, 2026
Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475620 Product Description: Intramedullary Bone Saw Blade Assembly 12mmZimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedullary Bone Saw Blade Assembly due to potential sterile barrier packaging damage caused by an exposed saw blade.
- Class II
Medical Device Recall · July 1, 2026
Stryker Hoffmann II Connecting Rod Micro 3 x 30mm. Catalog Number: 50796030.Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization.
- Class II
Medical Device Recall · July 1, 2026
Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475640 Product Description: Intramedullary Bone Saw Blade Assembly 16mmZimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedullary Bone Saw Blade Assembly due to potential sterile barrier packaging damage caused by an exposed saw blade.
- Class II
Medical Device Recall · July 1, 2026
Stryker Hoffmann II Connecting Rod Micro 3 x 50mm. Catalog Number: 50796050.Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization.
- Class II
Medical Device Recall · July 1, 2026
Stryker Hoffmann II Connecting Rod Micro 3 x 120mm. Catalog Number: 50796120.Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization.
- Class II
Medical Device Recall · July 1, 2026
5-PLASMA Bivalirudin AMR Verification Kit, Model Number 5D-45905Stability issues with the reconstituted lyophilized human plasma and bivalirudin matrix have been identified. These stability issues lead to a degradation of measurable bivalirudin in the controls, calibrators, and linearity values.
- Class II
Medical Device Recall · July 1, 2026
Stryker Hoffmann II Connecting Rod Micro 3 x 150mm. Catalog Number: 50796150.Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization.
- Class II
Medical Device Recall · July 1, 2026
Stryker Hoffmann II Connecting Rod Micro 3 x 90mm. Catalog Number: 50796090.Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization.
- Class II
Medical Device Recall · July 1, 2026
Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475635 Product Description: Intramedullary Bone Saw Blade Assembly 15mmZimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedullary Bone Saw Blade Assembly due to potential sterile barrier packaging damage caused by an exposed saw blade.
- Class II
Medical Device Recall · June 30, 2026
Medline Micro-Kill Bleach Germicidal Bleach Wipes, 12" x 12", 110 Count Bag, Product Number MSC351450BG4Medline Micro-Kill Bleach Germicidal Bleach Wipes may exhibit a reduction in bleach concentration to levels below specification prior to the end of the labeled 12-month shelf life. Reduced bleach concentration may compromise the effectiveness of disinfection, potentially allowing for the survival and persistence of pathogenic microorganisms.
- Class II
Medical Device Recall · June 30, 2026
Medline Micro-Kill Bleach Germicidal Bleach Wipes, 6" x 5", 150 count, Product Number MSC351410ANMedline Micro-Kill Bleach Germicidal Bleach Wipes may exhibit a reduction in bleach concentration to levels below specification prior to the end of the labeled 12-month shelf life. Reduced bleach concentration may compromise the effectiveness of disinfection, potentially allowing for the survival and persistence of pathogenic microorganisms.
- Class II
Medical Device Recall · June 30, 2026
Medline Micro-Kill Bleach Germicidal Bleach Wipes, 12" x 12", 110 Count, Product Number MSC351450ANMedline Micro-Kill Bleach Germicidal Bleach Wipes may exhibit a reduction in bleach concentration to levels below specification prior to the end of the labeled 12-month shelf life. Reduced bleach concentration may compromise the effectiveness of disinfection, potentially allowing for the survival and persistence of pathogenic microorganisms.
- Class I
Medical Device Recall · June 30, 2026
Baxter Duo-Vent Solution Set and Male Luer Lock Adapter, Product Code 1C8507; Solution Administration SetsBaxter received customer reports of air bubbles in the drip chamber and tubing when a pressure cuff is in use or when the tubing is flushed at the fully open position.
- Class II
Medical Device Recall · June 30, 2026
Radial Jaw 4 Jumbo Biopsy Forceps with the following descriptions and UPN: Radial Jaw 4 Jumbo 240cm Box 5; Outer Box UPN: M00513363; Inner Box UPN: M00513360.Potential for breach in sterile barrier of device packaging.
- Class II
Medical Device Recall · June 30, 2026
Merge OrthoPACS, medical imaging diagnostic workstationThumbnails from a previously opened patient study may be displayed in the Thumbnail Bar while a different patient study is currently open.
- Class II
Medical Device Recall · June 30, 2026
Rapid Refill Continuous Injection System, UPN M00566001Devices contain recalled Medline Namic Angiographic Control Syringe with Rotating Adaptor. There is a risk of syringe loosening or disconnecting from the manifold, resulting in loose connection or complete disconnection. May lead to difficulty connecting syringe, inability to aspirate or inject properly, fluid leakage, or separation of the syringe from the system, potentially requiring device exchange and prolonging the procedure.
- Class II
Medical Device Recall · June 30, 2026
Radial Jaw 4 Large Capacity Biopsy Forceps with the following descriptions and UPN: 1. Radial Jaw 4 LC 240cm Box 20; Outer Box UPN: M00513321; Inner Box UPN: M00513320. 2. Radial Jaw 4 LC 240Potential for breach in sterile barrier of device packaging.
- Class II
Medical Device Recall · June 30, 2026
Medline Micro-Kill Bleach Germicidal Bleach Wipes,7" x 8", 150 count, 150 count, Product Number MSC351400ANMedline Micro-Kill Bleach Germicidal Bleach Wipes may exhibit a reduction in bleach concentration to levels below specification prior to the end of the labeled 12-month shelf life. Reduced bleach concentration may compromise the effectiveness of disinfection, potentially allowing for the survival and persistence of pathogenic microorganisms.
- Class II
Medical Device Recall · June 30, 2026
SnapshotGLO Wound Imaging Device, Model KB100, KB100AA.The software controlling the wound imaging device's battery charging circuit was not designed to recognize and recover a battery that has fully discharged into a low-power "shipping mode." When this occurs, an affected device will not resume charging when reconnected to power and becomes temporarily unusable/ unavailable for wound imaging until corrected.
- Class II
Medical Device Recall · June 30, 2026
Merge PACS, medical imaging diagnostic workstationThumbnails from a previously opened patient study may be displayed in the Thumbnail Bar while a different patient study is currently open.
- Class II
Medical Device Recall · June 30, 2026
Radial Jaw 4 Standard Capacity Biopsy Forceps with the following descriptions and UPN: 1. Radial Jaw 4 SC 240cm Box 20; Outer Box UPN: M00513401; Inner Box UPN: M00513400. 2. Radial Jaw 4 SCPotential for breach in sterile barrier of device packaging.