Category

Medical Devices Recalls

15,654 medical devices recalls on record from CPSC, FDA, and USDA.

15,654 recalls
CriticalFDA
Teleflex Medical Inc
HUDSON RCI COMFORT FLO Corrugated Humidification System, REF 2415, humidifier nebulizer kit
Medical Devices·30,566 affected·Dec 13, 2019
RecallFDA
Randox Laboratories Ltd.
Liquid Clinical Chemistry Control, Catalogue Number: LAE4217, Size: 12 x 5 ml
Medical Devices·2 affected·Dec 13, 2019
High RiskFDA
Beckman Coulter Inc.
Beckman Coulter MicroScan PROMPT Inoculation System-D, Catalog Number B1026-10D, UDI: 15099590659561 - Product Usage: The Prompt Inoculat...
Medical Devices·3,472 affected·Dec 13, 2019
High RiskFDA
Baxter Healthcare Corporation
Clearlink System Continu-Flo Administration Sets, Product Codes: 2C8519, 2C8537, and 2C8541 - Product Usage:For the administration of fl...
Medical Devices·271,014,984 affected·Dec 12, 2019
High RiskFDA
Centurion Medical Products Corporation
Centurion- ENT SNUF3 SNUFFER KIT Y
Medical Devices·146 affected·Dec 11, 2019
High RiskFDA
Centurion Medical Products Corporation
Centurion- HT5555A HYPERALIMENTATION & DRSG CHG TRAY
Medical Devices·0 affected·Dec 11, 2019
High RiskFDA
Centurion Medical Products Corporation
Centurion- Skin Prep Kits SB1280 SKIN SCRUB KIT SB1525 VAGINAL PREP TRAY
Medical Devices·108 affected·Dec 11, 2019
High RiskFDA
Centurion Medical Products Corporation
Centurion- Biopsy Tray TRIBT170 BIOPSY TRAY
Medical Devices·60 affected·Dec 11, 2019
High RiskFDA
Centurion Medical Products Corporation
Centurion Chest Tube Trays: Kit Code Product CHT1170 CHEST TUBE TRAY CHT1700 CHEST TUBE INSERTION TRAY C...
Medical Devices·448 affected·Dec 11, 2019
High RiskFDA
Centurion Medical Products Corporation
Centurion- Driveline System Kit TRIDM250 OUTPATIENT DRIVELINE MGMT SYSTEM
Medical Devices·100 affected·Dec 11, 2019
High RiskFDA
Centurion Medical Products Corporation
Centurion- Umbilical Vessel UPC175 UMBILICAL VESSEL CATH. INSERTION UPC175 UMBILICAL VESSEL CATH. INSERTION
Medical Devices·0 affected·Dec 11, 2019
High RiskFDA
Centurion Medical Products Corporation
Centurion- OR2020 BASIN SET
Medical Devices·188 affected·Dec 11, 2019
High RiskFDA
Centurion Medical Products Corporation
Centurion-Vaginal Speculum VS2000LST STERILE ER VAGINAL SPECULUM W/LIGHT
Medical Devices·1,100 affected·Dec 11, 2019
High RiskFDA
Centurion Medical Products Corporation
Centurion- Port Draw Kit KNV30 PORT DRAW KIT
Medical Devices·75 affected·Dec 11, 2019
High RiskFDA
Centurion Medical Products Corporation
Centurion- LC145 STERILE NICU LINE CHANGE KIT
Medical Devices·160 affected·Dec 11, 2019
High RiskFDA
Abaxis Inc
Piccolo Xpress chemistry analyzer, Model No. 1100-1001, Software version 2.1.55 (NGA)/3.1.35(Jen II)
Medical Devices·15 affected·Dec 11, 2019
High RiskFDA
Centurion Medical Products Corporation
Centurion-Pelvic PE120 LARGE/MEDIUM PELVIC TRAY PE2200 PELVIC EXAM TRAY PE2200 PELVIC EXAM TRAY PE2400 PELVIC EXAM TRAY PE2515 SMALL...
Medical Devices·0 affected·Dec 11, 2019
High RiskFDA
Centurion Medical Products Corporation
Centurion- Circumcision Tray Kits DYNDF1078C CIRCUMCISION TRAY DYNDF1082 CIRCUMCISION TRAY DYNDF1082 CIRCUMCISION TRAY DYNDF109...
Medical Devices·0 affected·Dec 11, 2019
High RiskFDA
Centurion Medical Products Corporation
Centurion-BLOOD CULTURE COLLECTION KIT BP115 BLOOD CULTURE COLLECTION KIT
Medical Devices·0 affected·Dec 11, 2019
High RiskFDA
Centurion Medical Products Corporation
Centurion- Uterine Sound 67465 STERILE SIMS UTERINE SOUND (83360) Y 2019032790
Medical Devices·0 affected·Dec 11, 2019
High RiskFDA
Brasseler Usa I Lp
Brasseler USA KM169-39-76 Steinmann Pin Single Diamond Smooth, Diameter 2.8 mm, Length 228 mm Product Usage: A Steinmann Pin is used ...
Medical Devices·56 affected·Dec 11, 2019
High RiskFDA
Centurion Medical Products Corporation
Centurion- Trach Kits TC6282G TRACHEOSTOMY CARE TRAY TC7170 LATEX FREE TRACHEOSTOMY CARE TRAY TC7370 TRACHEOSTOMY KIT TC7450 DISPO...
Medical Devices·0 affected·Dec 11, 2019
High RiskFDA
Centurion Medical Products Corporation
Centurion- Dressing Tray M101156A DRESSING TRAY M101167A DRESSING TRAY M101168A DRESSING TRAY M101170A MAJOR DRESSING TRAY M101170A ...
Medical Devices·0 affected·Dec 11, 2019
High RiskFDA
Centurion Medical Products Corporation
Centurion- Nasal Speculum NSP500ST STERILE NASAL SPECULUM
Medical Devices·1,820 affected·Dec 11, 2019
High RiskFDA
Centurion Medical Products Corporation
Centurion IVS3505 ULTRASOUND GUIDED PIV KIT
Medical Devices·350 affected·Dec 11, 2019
High RiskFDA
Centurion Medical Products Corporation
Centurion-Pitcher Kit GR100150ST GRADUATED PITCHER STERILE 1000 CC Y 2018121090 GR1200ST STERILE 1200CC PITCHER KIT Y 2019031990
Medical Devices·0 affected·Dec 11, 2019
High RiskFDA
Centurion Medical Products Corporation
Centurion- DRESSING CHANGE KIT BSICVC1005A CVC DRESSING CHANGE KIT NICU BSIPICC1002A PICC DRESSING CHANGE KIT NICU BSIPICC1003A PIC...
Medical Devices·0 affected·Dec 11, 2019
High RiskFDA
Mindray Ds Usa, Inc. Dba Mindray North America
ABS800 Chemistry Analyzer Part Number BA81F-PA00001, Containing Gas spring YQ-8/18-90-272-180N (Material Code M6T-010001--- (front spring...
Medical Devices·6 affected·Dec 9, 2019
High RiskFDA
Abbott Medical
Fast-Cath Trio HEMOSTASIS INTRODUCER, 14F, 4.6 mm, REF 406303
Medical Devices·814 affected·Dec 9, 2019
High RiskFDA
Stryker Gmbh
Stryker T2 Alpha Delta Strike Plate IMN Instruments - part of the IMN Instruments System and is used to support insertion and withdrawal ...
Medical Devices·433 affected·Dec 5, 2019
High RiskFDA
Maquet Cardiovascular Us Sales, Llc
Maquet Cardiopulmonary (MCP)/Getinge ROTAFLOW Drive, Model Number 701022161. The device is a component of the ROTAFLOW System Console.
Medical Devices·11 affected·Dec 3, 2019
High RiskFDA
Ge Healthcare, Llc
Lunar iDXA bone densitometer
Medical Devices·123 affected·Dec 3, 2019
High RiskFDA
Ge Healthcare, Llc
Lunar iDXA Advance (iDXA with enCORE v16) bone densitometer
Medical Devices·123 affected·Dec 3, 2019
High RiskFDA
Exactech, Inc.
Exactech equinoxe PLATFORM FRACTURE, HUMERAL STEM, CEMENTED, Right, 10.5mm, REF 304-22-11 - Product Usage: The Equinoxe Shoulder System i...
Medical Devices·0 affected·Dec 3, 2019
High RiskFDA
Exactech, Inc.
Exactech equinoxe PLATFORM FRACTURE, HUMERAL STEM, CEMENTED, Right, 6.5mm, REF 304-22-07 - Product Usage: The Equinoxe Shoulder System is...
Medical Devices·2,910 affected·Dec 3, 2019
High RiskFDA
Ge Healthcare, Llc
Lunar iDXA Pro/Lunar iDXA Advance (iDXA with enCORE v18) bone densitometer
Medical Devices·123 affected·Dec 3, 2019
High RiskFDA
Medela Inc
Invia Foam Dressing Kit with FitPad - X-Large (3 pcs) SKU # 0876224. The Invia Foam Dressing Kit with FitPad consists of a foam pad, a...
Medical Devices·331 affected·Dec 2, 2019
High RiskFDA
Medical Action Industries, Inc. 306
Medical convenience trays and kits, labeled as: Medical Action Industries, Inc.: ***CVC*** Clear Sequence Change Kit, REF 77070B ***...
Medical Devices·9,924 affected·Dec 2, 2019
High RiskFDA
Polymer Technology Systems, Inc.
Henry Schein CardioChek Starter Kit, Reference Number 4060 HS, 570-1036
Medical Devices·44,448 affected·Dec 2, 2019
High RiskFDA
Flexicare Medical Ltd.
BriteBlade Pro Single-Use Fiber Optic Handle and Blade Mac 3, CE 0120, Do not Re-use, Rx Only, REF, 040-333U, Sterile EO, Qty 10, (01)150...
Medical Devices·1,024,890 affected·Nov 27, 2019
High RiskFDA
Flexicare Medical Ltd.
BriteBlade Pro Single-se Fiber Optic Miller 2, CE 0120, Do not Re-use, Rx Only, REF, 040-722U, Sterile EO, Qty 10, (01) 15055788722783 ...
Medical Devices·1,024,890 affected·Nov 27, 2019
High RiskFDA
Flexicare Medical Ltd.
BriteBlade Pro Single-Use Fiber Optic Handle and Blade Miller 2, CE 0120, Do not Re-use, Rx Only, REF: 040-342U, Sterile EO, Qty 10, UDI:...
Medical Devices·1,024,890 affected·Nov 27, 2019
High RiskFDA
Edwards Lifesciences, Llc
QuickDraw Venous Cannula, REF: QD22, UDI: 00690103182699; and REF: QD25, UDI: 00690103182705
Medical Devices·27,168 affected·Nov 27, 2019
High RiskFDA
Flexicare Medical Ltd.
BriteBlade Pro Single-Use Fiber Optic Mac 3, CE01120, Do Not Re-use, Rx Only, REF 040-713U, Sterile EO, Qty 10, (01)15055788723001 Th...
Medical Devices·1,024,890 affected·Nov 27, 2019
High RiskFDA
Greiner Bio-one North America, Inc.
VACUETTE TUBE, 3.5mL CAL Serum Sep Clot Activator, REF 454067P - Product Usage: VACUETTE Tubes, Holders, and Needles are use together as ...
Medical Devices·1,002,000 affected·Nov 25, 2019
High RiskFDA
Microvention, Inc.
Terumo AZUR CX Peripheral Coil System, Detachable 35, CX Coil, REF numbers 45-751019, 45-751324, 45-751632, 45-752039, 45-750407, 45-7505...
Medical Devices·1,187 affected·Nov 24, 2019
High RiskFDA
Microvention, Inc.
Terumo AZUR Peripheral Coil System, Detachable 18, Framing Coil, REF numbers 45-681026, 45-681434, 45-682050, and 45-680820, Sterile, Rx....
Medical Devices·107 affected·Nov 24, 2019
High RiskFDA
Microvention, Inc.
MicroVention Terumo HydroSoft 10, HydroCoil Embolic System, Endovascular Embolization Coil, Helical, Sterile, Rx, REF numbers 100101H2HS-...
Medical Devices·2,762 affected·Nov 22, 2019