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15,654 recalls
High RiskFDA
Icu Medical, Inc.
ICU Medical 31" (79 cm) Appx 3.4 ml, Admin Set w/20 Drop Integrated ChemoLock Drip Chamber, Spiros", Purple Cap, Hanger REF: CL3951
Medical Devices·11,000 affected·Sep 8, 2025
High RiskFDA
Icu Medical, Inc.
ICU Medical ChemoLock 13mm Closed Vial Spike REF: CL-82
Medical Devices·3,350 affected·Sep 8, 2025
High RiskFDA
Icu Medical, Inc.
ICU Medical 6" (15 cm) Ext Set w/MicroClave" Clear, ChemoLock" Port, Y-Connector, Rotating Luer REF: CL4118
Medical Devices·1,600 affected·Sep 8, 2025
RecallFDA
Philips Ultrasound, Inc
Philips S5-2 Ultrasound Transducer
Medical Devices·1 affected·Sep 5, 2025
High RiskFDA
Ge Medical Systems, Scs
AW Server 2.0, AW Server 3.0, AW Server 3.1, AW Server 3.2
Medical Devices·7,302 affected·Sep 5, 2025
High RiskFDA
Wipro Ge Healthcare Private Ltd.
GE Healthcare Carescape Central Station (CSCS) V3 MAS800 Desktop with software version V3.0.5, Part Number 5867474-03; Medical Display, c...
Medical Devices·2,306 affected·Sep 5, 2025
RecallFDA
Philips Ultrasound, Inc
Philips S4-1 Ultrasound Transducer
Medical Devices·41 affected·Sep 5, 2025
High RiskFDA
Exactech, Inc.
Brand Name: Equinoxe Ergo Product Name: Adjustable Angle rTSA Reamer, 46mm Model/Catalog Number: 321-59-46 Software Version: N/A Prod...
Medical Devices·1 affected·Sep 5, 2025
RecallFDA
Philips Ultrasound, Inc
Philips X3-1 Ultrasound Transducer
Medical Devices·17 affected·Sep 5, 2025
RecallFDA
Philips Ultrasound, Inc
Philips OMNI II TEE Ultrasound Transducer
Medical Devices·2 affected·Sep 5, 2025
High RiskFDA
Spacelabs Healthcare, Inc.
Brand Name: Branding is not applied to this product. Product Name: DVI display cables Model/Catalog Number: 012-0893-01 Software Versi...
Medical Devices·16,898 affected·Sep 5, 2025
RecallFDA
Philips Ultrasound, Inc
Philips L17-5 Ultrasound Transducer
Medical Devices·2 affected·Sep 5, 2025
High RiskFDA
Wipro Ge Healthcare Private Ltd.
GE Healthcare Carescape Central Station (CSCS) V3 MAS800 Desktop with software version V3.0.5; Part Number 5867474-04; Medical Display, c...
Medical Devices·173 affected·Sep 5, 2025
High RiskFDA
Spacelabs Healthcare, Inc.
Brand Name: Branding is not applied to this product. Product Name: DVI display cables Model/Catalog Number: 012-0895-12 Software Versi...
Medical Devices·820 affected·Sep 5, 2025
High RiskFDA
American Contract Systems Inc.
Medical convenience kits Item Number/Description HSAN63N ANGIO PACK IHAN02W ANGIOGRAPHY PACK MHCA98AK CORONARY ANGIO PACK- 205991 ...
Medical Devices·32,433 affected·Sep 4, 2025
High RiskFDA
American Contract Systems Inc.
Medical convenience kits Item Number/Description BFCT04X CATARACT PACK - 205986 CMEY17AI EYE PACK - 213187 CMEY17AI EYE PACK - 213...
Medical Devices·32,433 affected·Sep 4, 2025
High RiskFDA
American Contract Systems Inc.
Medical convenience kits Item Number/Description BUCY78E CYSTO PACK CMCP10X CYSTO PACK - 205972 IHCY10Y CYSTO PACK MHCY35AE CYSTO...
Medical Devices·32,433 affected·Sep 4, 2025
High RiskFDA
American Contract Systems Inc.
Medical convenience kits Item number/ Product description AHLD15X LABOR DELIVERY PACK - 213387 AKDV96B VAGINAL DELIVERY AKDV96B VA...
Medical Devices·32,433 affected·Sep 4, 2025
High RiskFDA
American Contract Systems Inc.
Medical convenience kits IHDC30R D AND C PACK
Medical Devices·32,433 affected·Sep 4, 2025
High RiskFDA
American Contract Systems Inc.
Basic Biopsy Tray, Item Number NMBP44L
Medical Devices·32,433 affected·Sep 4, 2025
High RiskFDA
American Contract Systems Inc.
Medical convenience kits Item Number/Description ANSH14AF SHOULDER PACK - 205962 EVAH76H ANTERIOR HIP PACK FDSA15M SHOULDER ARTHRO...
Medical Devices·32,433 affected·Sep 4, 2025
High RiskFDA
American Contract Systems Inc.
Basic Biopsy Tray; Item Number/Description: AKRB26D ROBOTIC, AMGL09AA GENERAL LAPAROSCOPY, ANLC35AD LAP CHOLE PACK - 205956, ANLP...
Medical Devices·32,433 affected·Sep 4, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
Allura Xper FD20 Biplane Product Codes: (1)722013, (2) 722008; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K1...
Medical Devices·268 affected·Sep 3, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
Allura Xper FD20/15; Product Code: 722058; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033...
Medical Devices·98 affected·Sep 3, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
Allura Xper FD10/10 Product Codes: (1)722011, (2) 722027, (3) 722005; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141...
Medical Devices·286 affected·Sep 3, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
Allura Xper FD20/15 OR Table; Product Code: 722059; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162...
Medical Devices·1 affected·Sep 3, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
Allura Xper FD10 OR Table Product Codes: (1)722022, (2) 722033; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K...
Medical Devices·2 affected·Sep 3, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
Allura Xper FD10; Model Numbers: (1) 722003, (2) 722010, (3) 722026; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K...
Medical Devices·2,317 affected·Sep 3, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
Allura Xper FD20/15; Model Numbers: 722058; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
Medical Devices·300 affected·Sep 3, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
Allura Xper FD20/10; Model Numbers: 722029; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
Medical Devices·87 affected·Sep 3, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
Allura Xper FD20/20 OR Table; Model Numbers: 722039; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
Medical Devices·5 affected·Sep 3, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
Allura Xper FD10 OR Table; Model Numbers: 722033; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
Medical Devices·2 affected·Sep 3, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
Allura CV20; Product Code: 722031; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K04...
Medical Devices·46 affected·Sep 3, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
Allura Xper FD10C; Model Number: 722001; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
Medical Devices·2 affected·Sep 3, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
Allura Xper FD10 Product Codes: (1)722010, (2) 722026, (3) 722003; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979...
Medical Devices·1,117 affected·Sep 3, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
Allura Xper FD20 Biplane OR Table; Model Numbers: (1) 722020, (2) 722025; Associated 510(k)s: K102005, K130638, K130842, K133292, K1419...
Medical Devices·4 affected·Sep 3, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
Allura Xper CV20; Model Numbers: 722031; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
Medical Devices·53 affected·Sep 3, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
Allura Xper FD20 OR Table Product Codes: (1)722023, (2) 722035, (3) 722015; Associated 510(k) numbers: K102005, K130842, K130638, K133292...
Medical Devices·174 affected·Sep 3, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
Allura Xper FD20 Biplane; Model Numbers: (1) 722008, (2) 722013; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K1628...
Medical Devices·501 affected·Sep 3, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
Allura Xper FD20/20; Model Numbers: 722038; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
Medical Devices·115 affected·Sep 3, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
Allura Xper FD20/20 OR Table; Product Code: 722039; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162...
Medical Devices·3 affected·Sep 3, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
Cardio Vascular-Allura Centron; Model Numbers: 722400; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
Medical Devices·313 affected·Sep 3, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
Allura Xper FD20/15 OR Table; Model Numbers: 722059; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
Medical Devices·8 affected·Sep 3, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
Allura Xper FD20 OR Table; Model Numbers: (1) 722015, (2) 722023, (3) 722035; Associated 510(k)s: K102005, K130638, K130842, K133292, K...
Medical Devices·298 affected·Sep 3, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
Allura Xper FD20 Biplane OR Table Product Codes: (1)722020, (2) 722025; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K1...
Medical Devices·5 affected·Sep 3, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
Allura Xper FD20; Model Numbers: (1) 722006, (2) 722012, (3) 722028; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K...
Medical Devices·5,067 affected·Sep 3, 2025
High RiskFDA
Fresenius Kabi Usa, Llc
Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004.
Medical Devices·6 affected·Sep 3, 2025
High RiskFDA
Lemaitre Vascular, Inc.
Artegraft Collagen Vascular Grafts Model Numbers: (1) AG 616, (2) AG 630, (3) AG 636, (4) AG 640, (5) AG 645, (6) AG 715, (7) AG 730, (8...
Medical Devices·28 affected·Sep 2, 2025