Category
Medical Devices Recalls
15,654 medical devices recalls on record from CPSC, FDA, and USDA.
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 Devices11,000 affectedSep 8, 2025
High RiskFDA
Icu Medical, Inc.
ICU Medical ChemoLock 13mm Closed Vial Spike REF: CL-82
Medical Devices3,350 affectedSep 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 Devices1,600 affectedSep 8, 2025
RecallFDA
Philips Ultrasound, Inc
Philips S5-2 Ultrasound Transducer
Medical Devices1 affectedSep 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 Devices7,302 affectedSep 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 Devices2,306 affectedSep 5, 2025
RecallFDA
Philips Ultrasound, Inc
Philips S4-1 Ultrasound Transducer
Medical Devices41 affectedSep 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 Devices1 affectedSep 5, 2025
RecallFDA
Philips Ultrasound, Inc
Philips X3-1 Ultrasound Transducer
Medical Devices17 affectedSep 5, 2025
RecallFDA
Philips Ultrasound, Inc
Philips OMNI II TEE Ultrasound Transducer
Medical Devices2 affectedSep 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 Devices16,898 affectedSep 5, 2025
RecallFDA
Philips Ultrasound, Inc
Philips L17-5 Ultrasound Transducer
Medical Devices2 affectedSep 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 Devices173 affectedSep 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 Devices820 affectedSep 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 Devices32,433 affectedSep 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 Devices32,433 affectedSep 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 Devices32,433 affectedSep 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 Devices32,433 affectedSep 4, 2025
High RiskFDA
American Contract Systems Inc.
Medical convenience kits IHDC30R D AND C PACK
Medical Devices32,433 affectedSep 4, 2025
High RiskFDA
American Contract Systems Inc.
Basic Biopsy Tray, Item Number NMBP44L
Medical Devices32,433 affectedSep 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 Devices32,433 affectedSep 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 Devices32,433 affectedSep 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 Devices268 affectedSep 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 Devices98 affectedSep 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 Devices286 affectedSep 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 Devices1 affectedSep 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 Devices2 affectedSep 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 Devices2,317 affectedSep 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 Devices300 affectedSep 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 Devices87 affectedSep 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 Devices5 affectedSep 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 Devices2 affectedSep 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 Devices46 affectedSep 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 Devices2 affectedSep 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 Devices1,117 affectedSep 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 Devices4 affectedSep 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 Devices53 affectedSep 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 Devices174 affectedSep 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 Devices501 affectedSep 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 Devices115 affectedSep 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 Devices3 affectedSep 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 Devices313 affectedSep 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 Devices8 affectedSep 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 Devices298 affectedSep 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 Devices5 affectedSep 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 Devices5,067 affectedSep 3, 2025
High RiskFDA
Fresenius Kabi Usa, Llc
Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004.
Medical Devices6 affectedSep 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 Devices28 affectedSep 2, 2025