Category
Medical Devices Recalls
15,654 medical devices recalls on record from CPSC, FDA, and USDA.
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 Devices706 affectedMar 3, 2025
High RiskFDA
Medline Industries, Lp - Northfield
Medline Convenience kits used for various procedures: 1) SKIN LESION SET, Model Number: MNS6270
Medical Devices48 affectedMar 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 Devices8 affectedMar 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 Devices222 affectedMar 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 Devices2,118 affectedMar 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 Devices3,808 affectedMar 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 Devices4,094 affectedMar 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 Devices9,216 affectedMar 3, 2025
High RiskFDA
Reichert, Inc.
Phoroptor VRx Digital Refraction System Model Numbers: 16241
Medical Devices122 affectedFeb 28, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
Spectral CT on Rails, Software Version Number 5.1.0, Model number: 728334;
Medical Devices1 affectedFeb 28, 2025
High RiskFDA
Reichert, Inc.
Phoroptor VRx Digital Refraction System Model Numbers: 16242
Medical Devices1,876 affectedFeb 28, 2025
High RiskFDA
Biofire Diagnostics, Llc
FilmArra Pneumonia Panel plus (Pneumoplus), REF: RFIT-LBL-0374
Medical Devices29 affectedFeb 27, 2025
High RiskFDA
Premier Dental Products Co
Premier Solo Diamond - Large Invented Cone; SKU: 807016C.
Medical Devices77 affectedFeb 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 Devices439 affectedFeb 26, 2025
CriticalFDA
Covidien
Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff Reusable Inner Cannula, REF: 7CN80R
Medical Devices780 affectedFeb 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 Devices182,344 affectedFeb 25, 2025
High RiskFDA
Stryker Corporation
Nasopore FD fragmentable nasal dressing, Catalog Numbers 5400-020-108 and 5400-020-108ITL
Medical Devices182,344 affectedFeb 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 Devices182,344 affectedFeb 25, 2025
High RiskFDA
Stryker Corporation
Hemopore 8cm nasal/sinus temporary wound dressing, Catalog Numbers 5400-020-208 and 5400-020-208ITL (OUS)
Medical Devices182,344 affectedFeb 25, 2025
High RiskFDA
Baxter Healthcare Corporation
Baxter TruSystem 7500 Hybrid Plus (FC), Product Code 1854087
Medical Devices93 affectedFeb 25, 2025
High RiskFDA
Stryker Corporation
Hemopore 2PK nasal/sinus temporary wound dressing, Catalog Number 5400-222-208S
Medical Devices182,344 affectedFeb 25, 2025
High RiskFDA
Baxter Healthcare Corporation
Baxter Mobile column TruSystem 7500 U, Product Code 1730720
Medical Devices40 affectedFeb 25, 2025
High RiskFDA
Stryker Corporation
Nasopore Standard 8cm fragmentable nasal dressing, Catalog Numbers 5400-010-008 and 5400-010-008ITL
Medical Devices182,344 affectedFeb 25, 2025
High RiskFDA
Baxter Healthcare Corporation
Baxter TruSystem 7500, Product Code 4091000
Medical Devices1,709 affectedFeb 25, 2025
High RiskFDA
Baxter Healthcare Corporation
Baxter Stationary column TruSystem 7500, Product Code 1717020
Medical Devices462 affectedFeb 25, 2025
High RiskFDA
Baxter Healthcare Corporation
Baxter TruSystem 7500 Hybrid (MC), Product Code 1773204
Medical Devices2 affectedFeb 25, 2025
High RiskFDA
Baxter Healthcare Corporation
Baxter TruSystem 7500 Hybrid (SC), Product Code 1854086
Medical Devices8 affectedFeb 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 Devices182,344 affectedFeb 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 Devices182,344 affectedFeb 25, 2025
High RiskFDA
Stryker Corporation
Nasopore Standard 4cm fragmentable nasal dressing, Catalog Numbers 5400-010-004 and 5400-010-004ITL
Medical Devices182,344 affectedFeb 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 Devices182,344 affectedFeb 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 Devices182,344 affectedFeb 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 Devices0 affectedFeb 25, 2025
High RiskFDA
Pyrames Inc
Boppli: Bedside Device Kit, REF: 54-0002; Sensor Band, REF: 51-0007
Medical Devices35 affectedFeb 24, 2025
CriticalFDA
Medline Industries, Lp - Northfield
Medline medical procedure kits, containing Medtronic Aortic Root Cannula, labeled as follows: TOL DR R PACK
Medical Devices468 affectedFeb 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 Devices3 affectedFeb 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 Devices4 affectedFeb 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 Devices2 affectedFeb 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 Devices11 affectedFeb 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 Devices253 affectedFeb 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 Devices37 affectedFeb 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 Devices1,563 affectedFeb 19, 2025
High RiskFDA
Mim Software Inc
MIM software; System, Image Processing, Radiological
Medical Devices352 affectedFeb 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 Devices82 affectedFeb 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 Devices1,894,488 affectedFeb 19, 2025
High RiskFDA
Flux Technology Inc.
Lazervida 10W diode laser cutter and engraver with Lazervida shield.
Medical Devices91 affectedFeb 19, 2025
CriticalFDA
Carefusion 303, Inc.
BD Alaris Systems Manager , REF 9601 Infusion Safety Management Software
Medical Devices0 affectedFeb 18, 2025
High RiskFDA
Ge Medical Systems, Llc
GE Healthcare Revolution Apex, System, X-ray, Tomography, Computed
Medical Devices56 affectedFeb 18, 2025