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15,654 recalls
High RiskFDA
Medline Industries, Lp - Northfield
Medline Convenience kits used for various procedures: 1) STANDARD D&C, Model Number: DYNJ69733; 2) NHS - LAP BOWEL GNG, Model Number: ...
Medical Devices·706 affected·Mar 3, 2025
High RiskFDA
Medline Industries, Lp - Northfield
Medline Convenience kits used for various procedures: 1) SKIN LESION SET, Model Number: MNS6270
Medical Devices·48 affected·Mar 3, 2025
High RiskFDA
Medline Industries, Lp - Northfield
Medline Convenience kits used for various procedures: 1) CUSTOM BLOCK KEMP PACK-LF, Model Number: DYNJ0371999G;
Medical Devices·8 affected·Mar 3, 2025
High RiskFDA
Medline Industries, Lp - Northfield
Medline Convenience kits used for various procedures: 1) ARTHROSCOPIE DU GENOU-LF, Model Number: DYNJ40229A; 2) ARTHROSCOPY PACK-LF, M...
Medical Devices·222 affected·Mar 3, 2025
High RiskFDA
Medline Industries, Lp - Northfield
Medline Convenience kits used for various procedures: 1) ANGIO CONSOLIDATED PACK, Model Number: DYNJHTCAD1; 2) ANGIOGRAPHY TRAY-LF, Mo...
Medical Devices·2,118 affected·Mar 3, 2025
High RiskFDA
Medline Industries, Lp - Northfield
Medline Convenience kits used for various procedures: 1) LINE INSERTION PACK, Model Number: DYNJ44949C; 2) PICC LINE INSERTION BJC-LF,...
Medical Devices·3,808 affected·Mar 3, 2025
High RiskFDA
Medline Industries, Lp - Northfield
Medline Convenience kits used for various procedures: 1) OCULOPLASTIC PICK PACK, Model Number: DYNJ43914B; 2) PLASTIC PACK, Model Numb...
Medical Devices·4,094 affected·Mar 3, 2025
High RiskFDA
Medline Industries, Lp - Northfield
Medline Convenience kits used for various procedures: 1) T A PACK, Model Number: DYNJ67791A; 2) NASAL PACK, Model Number: DYNJ66514;...
Medical Devices·9,216 affected·Mar 3, 2025
High RiskFDA
Reichert, Inc.
Phoroptor VRx Digital Refraction System Model Numbers: 16241
Medical Devices·122 affected·Feb 28, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
Spectral CT on Rails, Software Version Number 5.1.0, Model number: 728334;
Medical Devices·1 affected·Feb 28, 2025
High RiskFDA
Reichert, Inc.
Phoroptor VRx Digital Refraction System Model Numbers: 16242
Medical Devices·1,876 affected·Feb 28, 2025
High RiskFDA
Biofire Diagnostics, Llc
FilmArra Pneumonia Panel plus (Pneumoplus), REF: RFIT-LBL-0374
Medical Devices·29 affected·Feb 27, 2025
High RiskFDA
Premier Dental Products Co
Premier Solo Diamond - Large Invented Cone; SKU: 807016C.
Medical Devices·77 affected·Feb 27, 2025
High RiskFDA
Intuitive Surgical, Inc.
Brand Name: Da Vinci 5 Product Name: ASSY,DV5 CONSOLE,IS5000 Foot Tray Pedals Model/Catalog Number: 380730 Software Version: N/A . ...
Medical Devices·439 affected·Feb 26, 2025
CriticalFDA
Covidien
Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff Reusable Inner Cannula, REF: 7CN80R
Medical Devices·780 affected·Feb 26, 2025
High RiskFDA
Stryker Corporation
Otopore Cylinder outer ear wound dressing, Firm Catalog Number 5400-020-000 and Forte Catalog Number 5400-020-000TL
Medical Devices·182,344 affected·Feb 25, 2025
High RiskFDA
Stryker Corporation
Nasopore FD fragmentable nasal dressing, Catalog Numbers 5400-020-108 and 5400-020-108ITL
Medical Devices·182,344 affected·Feb 25, 2025
High RiskFDA
Stryker Corporation
Otopore Square outer ear wound dressing, Firm Catalog Number 5400-020-100 and Forte Catalog Number 5400-020-100ITL
Medical Devices·182,344 affected·Feb 25, 2025
High RiskFDA
Stryker Corporation
Hemopore 8cm nasal/sinus temporary wound dressing, Catalog Numbers 5400-020-208 and 5400-020-208ITL (OUS)
Medical Devices·182,344 affected·Feb 25, 2025
High RiskFDA
Baxter Healthcare Corporation
Baxter TruSystem 7500 Hybrid Plus (FC), Product Code 1854087
Medical Devices·93 affected·Feb 25, 2025
High RiskFDA
Stryker Corporation
Hemopore 2PK nasal/sinus temporary wound dressing, Catalog Number 5400-222-208S
Medical Devices·182,344 affected·Feb 25, 2025
High RiskFDA
Baxter Healthcare Corporation
Baxter Mobile column TruSystem 7500 U, Product Code 1730720
Medical Devices·40 affected·Feb 25, 2025
High RiskFDA
Stryker Corporation
Nasopore Standard 8cm fragmentable nasal dressing, Catalog Numbers 5400-010-008 and 5400-010-008ITL
Medical Devices·182,344 affected·Feb 25, 2025
High RiskFDA
Baxter Healthcare Corporation
Baxter TruSystem 7500, Product Code 4091000
Medical Devices·1,709 affected·Feb 25, 2025
High RiskFDA
Baxter Healthcare Corporation
Baxter Stationary column TruSystem 7500, Product Code 1717020
Medical Devices·462 affected·Feb 25, 2025
High RiskFDA
Baxter Healthcare Corporation
Baxter TruSystem 7500 Hybrid (MC), Product Code 1773204
Medical Devices·2 affected·Feb 25, 2025
High RiskFDA
Baxter Healthcare Corporation
Baxter TruSystem 7500 Hybrid (SC), Product Code 1854086
Medical Devices·8 affected·Feb 25, 2025
High RiskFDA
Stryker Corporation
Nasopore 4cm Standard 2PK fragmentable nasal dressing, Catalog Number 5400-212-004S and Nasopore 4cm Firm 2PK Catalog Number 5400-222-004S
Medical Devices·182,344 affected·Feb 25, 2025
High RiskFDA
Stryker Corporation
Nasopore 8cm fragmentable nasal dressing, Firm Catalog Number 5400-020-008 and Forte Catalog Number 5400-020-008ITL
Medical Devices·182,344 affected·Feb 25, 2025
High RiskFDA
Stryker Corporation
Nasopore Standard 4cm fragmentable nasal dressing, Catalog Numbers 5400-010-004 and 5400-010-004ITL
Medical Devices·182,344 affected·Feb 25, 2025
High RiskFDA
Stryker Corporation
Nasopore Ex Firm 4cm fragmentable nasal dressing, Catalog Number 5400-030-004 and Nasopore Forte plus 4cm Catalog Number 5400-030-004ITL
Medical Devices·182,344 affected·Feb 25, 2025
High RiskFDA
Stryker Corporation
Nasopore Ex Firm 8cm fragmentable nasal dressing, Catalog Number 5400-030-008 and Nasopore Forte plus 8cm Catalog Number 5400-030-008ITL
Medical Devices·182,344 affected·Feb 25, 2025
High RiskFDA
Stryker Corporation
Nasopore 4cm fragmentable nasal dressing, Firm Catalog Number 5400-020-004 and Forte Catalog Number 5400-020-004ITL
Medical Devices·0 affected·Feb 25, 2025
High RiskFDA
Pyrames Inc
Boppli: Bedside Device Kit, REF: 54-0002; Sensor Band, REF: 51-0007
Medical Devices·35 affected·Feb 24, 2025
CriticalFDA
Medline Industries, Lp - Northfield
Medline medical procedure kits, containing Medtronic Aortic Root Cannula, labeled as follows: TOL DR R PACK
Medical Devices·468 affected·Feb 21, 2025
High RiskFDA
Omnicell, Inc.
IVX Station Reconstitution Transfer Set. Model Number: 298921215. Packaging: 1 set per White Tyvek Pouch, 5 Tyvek Pouches per shelf box, ...
Medical Devices·3 affected·Feb 20, 2025
High RiskFDA
Ge Healthcare
GE Healthcare Centricity Centricity PACS-IW with Universal Viewer, Model Numbers: 1) 2049587-015; 2) 2066908-086; 3) 2066908-136; ...
Medical Devices·4 affected·Feb 19, 2025
High RiskFDA
Merge Healthcare, Inc.
VERICIS, Merge Cardio, Model/Catalog Number: Version 9.x, Software Version: 9.0.6 and 9.0.8; VERICIS is an integrated cardiovascular info...
Medical Devices·2 affected·Feb 19, 2025
High RiskFDA
Merge Healthcare, Inc.
VERICIS, Merge Cardio, Model/Catalog Number: Version 10.x, Software Version: 10.0, 10.1.1.1, 10.1.2, 10.2.0, 10.2 P2 , 10.3; The VERICIS ...
Medical Devices·11 affected·Feb 19, 2025
High RiskFDA
Merge Healthcare, Inc.
Merge Cardio, Model/Catalog Number: Version 12.X, Software Version: 12.1, 12.1.1, 12.2, 12.3, 12.3.1, 12.3.2, 12.3.3, 12.4, 12.4.1, 12.4....
Medical Devices·253 affected·Feb 19, 2025
High RiskFDA
Merge Healthcare, Inc.
VERICIS, Merge Cardio, Model/Catalog Number: Version 12.X, Software Version: 12.0.1, 12.0.2; The VERICIS is an integrated cardiovascular ...
Medical Devices·37 affected·Feb 19, 2025
High RiskFDA
Ge Healthcare
GE Healthcare Centricity Radiology RA600 (RA600), Model Numbers: 1) 2022296-001; 2) 2033901-001; 3) 2038437-001; 4) 2038437-011;...
Medical Devices·1,563 affected·Feb 19, 2025
High RiskFDA
Mim Software Inc
MIM software; System, Image Processing, Radiological
Medical Devices·352 affected·Feb 19, 2025
High RiskFDA
Ge Healthcare
GE Healthcare Centricity PACS-IW (PACS-IW), Model Numbers: 1) 2042988-001; 2) 2049587-009; 3) 2049587-011; 4) 2049587-012; 5) ...
Medical Devices·82 affected·Feb 19, 2025
High RiskFDA
Medline Industries, Lp - Northfield
Wayson Hydrocolloid Models: 1) MJ BANDAGE HYDROCOLLOID HEEL OVAL 6CT, Model Number: MJ18004V2; 2) MJ BANDAGE HYDROCOLLOID ALL PURP 10C...
Medical Devices·1,894,488 affected·Feb 19, 2025
High RiskFDA
Flux Technology Inc.
Lazervida 10W diode laser cutter and engraver with Lazervida shield.
Medical Devices·91 affected·Feb 19, 2025
CriticalFDA
Carefusion 303, Inc.
BD Alaris Systems Manager , REF 9601 Infusion Safety Management Software
Medical Devices·0 affected·Feb 18, 2025
High RiskFDA
Ge Medical Systems, Llc
GE Healthcare Revolution Apex, System, X-ray, Tomography, Computed
Medical Devices·56 affected·Feb 18, 2025