Category

Medical Devices Recalls

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

15,654 recalls
RecallFDA
Cook Medical Incorporated
Cook Celect PlatinumVena Cava Filter Set Catalog Number/GPN: IGTCFS-65-1-FEM-CELECT-PT G34502; IGTCFS-65-1-JUG-CELECT-PT G34309; IGT...
Medical Devices·52,590 affected·Feb 14, 2022
High RiskFDA
Biomet, Inc.
BIOMET Sports Medicine JUGGERLOC SLOTTED REAMER: [Item # 110010371, 6MM], [Item #110010372, 7MM], [Item # 110010373, 8MM], [Item #1100182...
Medical Devices·702 affected·Feb 14, 2022
High RiskFDA
Biomet, Inc.
BIOMET TRAUMA Drill Bit, Tap, Guide Pin: [DVR Drill Bit, Item # 212000022, DVR 2.2MM DRILL BIT], [ALPS Drill Bit, Item # 214227160, 2.7X1...
Medical Devices·2,594 affected·Feb 14, 2022
High RiskFDA
Biomet, Inc.
BIOMET Trauma, [Item # 13182-22-26, DVR CROSSLOCK EXTRA LONG PLATE LEFT], [Item # 1318-12-126, DVR CROSSLOCK EXTRA LONG PLATE RIGHT], [It...
Medical Devices·38 affected·Feb 14, 2022
High RiskFDA
Abbott Molecular, Inc.
Alinity m Integrated Reaction Units (IRU)
Medical Devices·3,063 affected·Feb 11, 2022
High RiskFDA
Maquet Cardiovascular, Llc
Ultima Activator II Reusable Drive Mechanism, part # C-UA-5001. Labeled REF UA-5001.
Medical Devices·60 affected·Feb 9, 2022
High RiskFDA
Wright Medical Technology, Inc.
The DARCO¿ Locking Bone Plate System is designed with rhombus (parallelogram) plates of biocompatible titanium. The plates use either 2....
Medical Devices·12 affected·Feb 9, 2022
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica CH Fructosamine (Fruc), Siemens Material Number 11097637
Medical Devices·199 affected·Feb 9, 2022
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica CH Lithium_2 (LITH_2), Siemens Material Number 11097637
Medical Devices·2,158 affected·Feb 9, 2022
High RiskFDA
Biomerieux, Inc.
VIDAS CMV IgM, 30 tests, REF 30205-01, IVD, Rx.
Medical Devices·480 affected·Feb 9, 2022
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica CH Enzymatic Hemoglobin A1c (A1c_E/A1c_H), Siemens Material Number 11097536
Medical Devices·6,606 affected·Feb 9, 2022
High RiskFDA
Philips North America, Llc
The IFU for the Autoclavable Temperature Probes: Part # 453564635891, providing in the packaging for the following product model #s: 2107...
Medical Devices·478,931 affected·Feb 7, 2022
High RiskFDA
Brius Technologies Inc.
Brius Patient Specific Brackets (components in a set of custom metal orthodontic devices); BRIUS , RX Only, Non-Sterile, Custom Made Devi...
Medical Devices·4 affected·Feb 7, 2022
CriticalFDA
Ev3 Inc.
Medtronic TurboHawk Plus Directional Atherectomy System 6F, Small Vessel, Catalog number THP-S. For use in peripheral vasculature.
Medical Devices·245 affected·Feb 4, 2022
RecallFDA
Cytocell Ltd.
TCL1 Breakapart Probe, Fluorescence in situ hybridisation (FISH) is a technique allows the visualisation of DNA sequences upon chromosom...
Medical Devices·1 affected·Feb 4, 2022
High RiskFDA
Ace Surgical Supply Co., Inc.
NuOss Collagen Block Size 8mm x 9mm x 9mm- used in filling periodontal and maxillofacial defects. Catalog Number: 5099250
Medical Devices·31 affected·Feb 2, 2022
High RiskFDA
Mevion Medical Systems, Inc.
Mevion S250 and S250i Proton Therapy Systems hand pendant (P/N 10263 or P/N 37808)
Medical Devices·39 affected·Feb 1, 2022
High RiskFDA
Bsn Medical Inc
(1) JOBST Compri2, REF 76271-01, containing 2 components, one plastic-wrapped padding and one plastic-wrapped compression bandage with co...
Medical Devices·1,677 affected·Feb 1, 2022
High RiskFDA
B. Braun Medical, Inc.
Dispensing Pins for Air Inlet Filter, Product Catalog No. 412005, DP2500 Dispensing Pin W/Valve. A valve for aspiration or injection of...
Medical Devices·15,550 affected·Jan 31, 2022
High RiskFDA
Canon Medical System, Usa, Inc.
INFX-8000V. For radiographic and fluoroscopic studies and intervention.
Medical Devices·16 affected·Jan 31, 2022
High RiskFDA
B Braun Medical Inc
Conductivity Sensors utilized on Dialog and Dialog+ Hemodialysis Systems. Conductivity Sensor (END) - VERSION 2, Article Code Number 345...
Medical Devices·95 affected·Jan 28, 2022
High RiskFDA
Sam Medical Products
SAM CHEST SEAL REF CS203-EN Combo LOT Y060321-09
Medical Devices·2,950 affected·Jan 28, 2022
High RiskFDA
B Braun Medical Inc
Conductivity Sensors utilized on Dialog and Dialog+ Hemodialysis Systems. Conductivity Sensor (BIC) - VERSION 2, Article Code Number 345...
Medical Devices·80 affected·Jan 28, 2022
CriticalFDA
E25bio, Inc.
E25Bio COVID-19 Direct Antigen Rapid Test ; E25Bio COVID-19 DART Kit
Medical Devices·73,300 affected·Jan 27, 2022
High RiskFDA
Integrity Implants Inc.
LineSider Spinal System 5.5/6.0mm, Non-mod Standard 7.1mm - Dual Lead, Cannulated. Thoracolumbosacral pedicle screw system; Spinal inter...
Medical Devices·1,702 affected·Jan 27, 2022
High RiskFDA
Integrity Implants Inc.
LineSider Spinal System 5.5/6.0mm, Non-mod MIS 7.1mm - Dual Lead, Cannulated. Thoracolumbosacral pedicle screw system; Spinal interlamin...
Medical Devices·1,369 affected·Jan 27, 2022
High RiskFDA
Bolder Surgical, Llc
CoolSeal Generator, REF: CSL-200-50
Medical Devices·10 affected·Jan 25, 2022
High RiskFDA
Argon Medical Devices, Inc
1. Arterial Line Kit 20ga x 6" 2. Arterial Line Kit /1 20ga x 6"
Medical Devices·600 affected·Jan 24, 2022
High RiskFDA
Matrix Medical Network
Matrix Clinical Solution At-Home COVID-19 Test
Medical Devices·3,226 affected·Jan 24, 2022
High RiskFDA
Integra Lifesciences Corp.
Codman Cranial Access Kits- indicated when a craniotomy is required for placement of an intracranial pressure (ICP) monitoring device and...
Medical Devices·1,160 affected·Jan 21, 2022
High RiskFDA
Nrt X-ray A/s
1. Footrest ( use exclusively in combination with Intelli-C devices) 2. Shoulder support ( use exclusively in combination with Intelli-C...
Medical Devices·72 affected·Jan 21, 2022
High RiskFDA
Surgical Innovations Ltd
Product/Part: YelloPort Plus 5x70 Cannula + Luer/YC0507001. For use in laparoscopic procedures.
Medical Devices·1 affected·Jan 20, 2022
High RiskFDA
Envisiontec Us Llc
PCA 4000 Curing Units, SKU number ACC-06-1000 The PCA 4000 is used for curing industrial resins as well and this recall will not impac...
Medical Devices·172 affected·Jan 20, 2022
High RiskFDA
Bard Peripheral Vascular Inc
LUMBAR PUNCTURE TRAY PEDIATRIC 21G 2.5
Medical Devices·11,970 affected·Jan 20, 2022
High RiskFDA
Bard Peripheral Vascular Inc
SAFE-T PLUS ATRAUMATIC ADULT LP TRAY
Medical Devices·3,240 affected·Jan 20, 2022
High RiskFDA
Bard Peripheral Vascular Inc
SAFE-T PLUS LUMBAR PUNCTURE TRAY ADULT
Medical Devices·49,760 affected·Jan 20, 2022
CriticalFDA
Ventana Medical Systems Inc
BenchMark ULTRA and DISCOVERY ULTRA Instruments
Medical Devices·9,214 affected·Jan 20, 2022
High RiskFDA
Surgical Innovations Ltd
Product/Part: YelloPort Elite 12x75 Pencil Point Trocar/ET1207503; YelloPort Elite Hasson Adaptor 10mm/EA10NH. For use in laparosc...
Medical Devices·19 affected·Jan 20, 2022
High RiskFDA
Bard Peripheral Vascular Inc
LUMBAR PUNCTURE DRUG FREE TRAY 22G
Medical Devices·2,880 affected·Jan 20, 2022
High RiskFDA
Bard Peripheral Vascular Inc
LUMBAR PUNCTURE TRAY ADULT 18G X 3.5
Medical Devices·8,630 affected·Jan 20, 2022
High RiskFDA
Bard Peripheral Vascular Inc
ADULT LUMBAR PUNCTURE DRUG FREE TRAY 20G
Medical Devices·1,260 affected·Jan 20, 2022
High RiskFDA
Volcano Corporation
SyncVision Systems, Model: 400-0100.10, PN: 30000485688x, with software version 4.2.x
Medical Devices·3,216 affected·Jan 19, 2022
High RiskFDA
Merete Medical Gmbh
Merete PediatrOS RigidTack, REF CP20120, Size 20 mm, Sterile, Rx Only
Medical Devices·26 affected·Jan 18, 2022
High RiskFDA
Lacrimedics Inc
Collagen Plugs, CP3, 0.3mm, CP4, 0.4mm, CP5, 0.5 mm, Sterile, EO, Rx Only, CE Dry eye treatment
Medical Devices·4,780 affected·Jan 17, 2022
High RiskFDA
Howmedica Osteonics Corp.
Biolox delta Ceramic V40 Femoral Head 32/ +4.0mm Catalog Number: 6570-0-232
Medical Devices·39 affected·Jan 14, 2022
High RiskFDA
Sunstar Americas, Inc.
BUTLER Clear Dip, 12 bottles/case
Medical Devices·22,514 affected·Jan 14, 2022
High RiskFDA
Hill-rom, Inc.
(1)Traverse Rail Carrier E-System, wide 31017XX component to Liko overhead lift, (2)Traverse Rail Carrier 31025XX component to Liko o...
Medical Devices·0 affected·Jan 14, 2022
High RiskFDA
Stryker Corporation
1688 Camera Control Unit (CCU), Catalog number:1688010000. Used in general laparoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy, and...
Medical Devices·11,955 affected·Jan 14, 2022