Category

Medical Devices Recalls

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

15,654 recalls
High RiskFDA
Maquet Cardiovascular, Llc
HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-1 Branch, Product Code: M00202175826P0 - Product Usage: for use in the replacement...
Medical Devices·0 affected·Apr 7, 2020
High RiskFDA
Maquet Cardiovascular, Llc
HEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 1 Branch, Product Code: M00202175822P0 - Product Usage: for use in the replacemen...
Medical Devices·0 affected·Apr 7, 2020
High RiskFDA
Maquet Cardiovascular, Llc
Hemashield Gold Knitted Microvel Double Velour Vascular Graft Axillo-bifemoral, Product Code: M002020955890 - Product Usage: for use in t...
Medical Devices·0 affected·Apr 7, 2020
High RiskFDA
Inpeco S.a.
Inpeco FlexLab, ARCHITECT cSystem c8000/c16000 Interface Module, Part Numbers: FLX-208-00, FLX-208-10 - Product Usage: The FlexLab (aka A...
Medical Devices·82 affected·Apr 7, 2020
High RiskFDA
Inpeco S.a.
Accelerator a3600 Automation System with Advia2120LAS Interface Module (P/N FLX-219-00, FLX-219-10), ImmunoCAP 1000 Interface Module (P/N...
Medical Devices·3 affected·Apr 7, 2020
High RiskFDA
Baxter Healthcare Corporation
Prismaflex Control Unit
Medical Devices·5 affected·Apr 7, 2020
High RiskFDA
Maquet Cardiovascular, Llc
HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-Angled 4 Branch, Product Code: M00202175730AP0 - Product Usage: for use in the rep...
Medical Devices·0 affected·Apr 7, 2020
High RiskFDA
Maquet Cardiovascular, Llc
HEMASHIELD PLATINUM Woven Double Velour Vascular Graft01 Branch, Product Code: M00202175834P0 - Product Usage: for use in the replacement...
Medical Devices·0 affected·Apr 7, 2020
High RiskFDA
Maquet Cardiovascular, Llc
HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-1 Branch, Product Code: M00202175832P0 - Product Usage: for use in the replacement...
Medical Devices·0 affected·Apr 7, 2020
High RiskFDA
Maquet Cardiovascular, Llc
HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-4 Branch, Product Code: M00202175732P0 - Product Usage: for use in the replacement...
Medical Devices·0 affected·Apr 7, 2020
High RiskFDA
Inpeco S.a.
Accelerator a3600 Automation System using the Aliquoter Module (Inpeco P/N FLX-212) - Product Usage: The systems consolidate multiple Ana...
Medical Devices·97 affected·Apr 7, 2020
High RiskFDA
Inpeco S.a.
Siemens Aptio Automation Centrifuge Module, tube loading algorithm, Inpeco SA P/N: FLX-202, with Firmware Versions: CM_1-7-0.H86 or xCMd_...
Medical Devices·313 affected·Apr 7, 2020
High RiskFDA
Maquet Cardiovascular, Llc
HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-4 Branch, Product Code: M00202175924P0 - Product Usage: for use in the replacement...
Medical Devices·0 affected·Apr 7, 2020
High RiskFDA
Maquet Cardiovascular, Llc
HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-Thoracoabdominal, Product Code: M00202175428T0 - Product Usage: for use in the rep...
Medical Devices·0 affected·Apr 7, 2020
High RiskFDA
Inpeco S.a.
FlexLab Automation System with Advia2120LAS Interface Module (P/N FLX-219-00, FLX-219-10), ImmunoCAP 1000 Interface Module (P/N FLX-226-0...
Medical Devices·37 affected·Apr 7, 2020
High RiskFDA
Inpeco S.a.
Aptio Automation System using the Aliquoter Module (Inpeco P/N FLX-212) - Product Usage: The systems consolidate multiple Analytical inst...
Medical Devices·61 affected·Apr 7, 2020
High RiskFDA
Maquet Cardiovascular, Llc
HEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 4 Branch, Product Code: M00202175928P0 - Product Usage: for use in the replacemen...
Medical Devices·0 affected·Apr 7, 2020
High RiskFDA
Inpeco S.a.
FlexLab Augomation System using the Aliquoter Module (Inpeco P/N FLX-212) The systems consolidate multiple Analytical instruments into a ...
Medical Devices·71 affected·Apr 7, 2020
High RiskFDA
Inpeco S.a.
Abbott Accelerator a3600, ARCHITECT cSystem c8000/c16000 Interface Module, Part Numbers: ACP-208-00 - Product Usage: The FlexLab (aka Acc...
Medical Devices·273 affected·Apr 7, 2020
High RiskFDA
Maquet Cardiovascular, Llc
HEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 4 Branch, Product Code: M00202175734P0 - Product Usage: for use in the replacemen...
Medical Devices·0 affected·Apr 7, 2020
High RiskFDA
Maquet Cardiovascular, Llc
HEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 1 Branch, Product Code: M00202175828P0 - Product Usage: for use in the replacemen...
Medical Devices·0 affected·Apr 7, 2020
High RiskFDA
Philips North America, Llc
Philips Brilliance iCT SP Computed Tomography X-Ray System; Model # 728311
Medical Devices·2 affected·Apr 6, 2020
High RiskFDA
Philips North America, Llc
Philips Brilliance iCT Computed Tomography X-Ray System; Model # 728306; UDI #s (01)00884838059474(21)100783, (01)00884838059474(21)100848
Medical Devices·19 affected·Apr 6, 2020
High RiskFDA
Siemens Medical Solutions Usa, Inc
System AXIOM Aristos FX - Product Usage: A dedicated x-ray system with a flat panel detector which allows the acquisition of x-ray exposu...
Medical Devices·314 affected·Apr 6, 2020
High RiskFDA
Philips North America, Llc
Philips Azurion 7 M20 -XperGuide Software hosted in Interventional Workspot 1.5 when used with the Azurion R2.0 system Intervent...
Medical Devices·22 affected·Apr 3, 2020
High RiskFDA
C.a. Greiner & Sohne Gesellschaftmbh
VACUETTE Blood Transfer Unit. Lot no. A19024NX. Expiration date: 2022-02-07 - Product Usage: The Blood Transfer Unit is used to transfer ...
Medical Devices·90,400 affected·Apr 3, 2020
High RiskFDA
Osteomed, Llc
OSTEOVATIONEX 3CC INJECT FORMULA. REF/UDI: 390-0003/00813845020016 - Product Usage: The product provides a bone void filler that is repla...
Medical Devices·270 affected·Apr 2, 2020
High RiskFDA
Osteomed, Llc
OSTEOVATION 5CC IMPACTFORMULA. REF/UDI: 390-2105/00813845020085 - Product Usage: The product provides a bone void filler that is replaced...
Medical Devices·1,724 affected·Apr 2, 2020
High RiskFDA
Osteomed, Llc
OSTEOVATION RMX Injectable BVF 5CC . REF/UDI: 390-6001/ /00813845021082 - Product Usage: The product provides a bone void filler that is ...
Medical Devices·278 affected·Apr 2, 2020
High RiskFDA
Osteomed, Llc
OSTEOVATIONEX 5CC INJECT FORMULA. REF/UDI: 390-0005/00813845020023 - Product Usage: The product provides a bone void filler that is repla...
Medical Devices·647 affected·Apr 2, 2020
High RiskFDA
Osteomed, Llc
OSTEOVATION 10CC INJECT FORMULA. REF/UDI: 390-2010/00813845020061 - Product Usage: The product provides a bone void filler that is replac...
Medical Devices·436 affected·Apr 2, 2020
High RiskFDA
Ge Healthcare, Llc
Giraffe Shuttle. Upgrade Kits with part number 2109672-001 and 2109673-001 GTIN: 00840682110808.
Medical Devices·204 affected·Apr 2, 2020
High RiskFDA
Osteomed, Llc
OSTEOVATION 5CC INJECT FORMULA. REF/UDI: 390-2005/00813845020054 - Product Usage: The product provides a bone void filler that is replace...
Medical Devices·417 affected·Apr 2, 2020
High RiskFDA
Osteomed, Llc
OSTEOVATION 10 CC IMPACT FORMULA. REF/UDI: 390-2110/ /00813845021092 - Product Usage: The product provides a bone void filler that is rep...
Medical Devices·995 affected·Apr 2, 2020
High RiskFDA
Aesculap Implant Systems Llc
PRESTIGE RETRACTION GRASPER, W/PORT DUAL ACTION, ROTATING 5mm DIAM., 36cm LENGTH. Product Code 8361-10
Medical Devices·399 affected·Apr 1, 2020
High RiskFDA
Aesculap Implant Systems Llc
PRESTIGE ATRAUMATIC GRASPER W/PORT DUAL ACTION, ROTATING 5mm DIAM., 36cm LENGTH. Product Code 8360-10
Medical Devices·3,392 affected·Apr 1, 2020
High RiskFDA
Ortho-clinical Diagnostics
VITROS Chemistry Products CKMB Slides, Creatine Kinase MB, Product Code 8001133-90 slides, UDI Number 10758750004201 - Product Usage: The...
Medical Devices·0 affected·Apr 1, 2020
High RiskFDA
Ortho-clinical Diagnostics
VITROS Chemistry Products CKMB Slides, Creatine Kinase MB, Product Code 805 8232-300 slides, UDI Number 10758750004294 - Product Usage: T...
Medical Devices·0 affected·Apr 1, 2020
High RiskFDA
Spectranetics Corporation
Bridge Occlusion Balloon, REF 590-001, QTY 1, Sheath Compatibility 12F, Guidewire Compatibility 0.035 in, Working Length 90 cm, Balloon O...
Medical Devices·0 affected·Mar 31, 2020
High RiskFDA
Beckman Coulter Inc.
iChem¿VELOCITY Urine Chemistry System-
Medical Devices·1,557 affected·Mar 30, 2020
High RiskFDA
Elekta Inc
Leksell Vantage Stereotactic System. Instrument Carrier, Part of Leksell Vantage Arc (1053958). Neurological stereotaxic Instrument
Medical Devices·25 affected·Mar 30, 2020
High RiskFDA
Shanghai United Imaging Healthcare Co., Ltd.
Positron Emission Tomography and Computed Tomography System, Model: uMI 550, Material Number: 88000057 - Product Usage: This system is in...
Medical Devices·3 affected·Mar 26, 2020
High RiskFDA
Medtronic Sofamor Danek Usa Inc
VERTEX SELECT MULTI AXIAL SCREW. 4.0 X 38MM MULTI AXIAL SCREW. Lot H5517628
Medical Devices·83 affected·Mar 26, 2020
High RiskFDA
Olympus Corporation Of The Americas
Olympus Pleuravideoscope, Model LTF-160
Medical Devices·265 affected·Mar 23, 2020
High RiskFDA
The Magstim Company Limited
Horizon PSU Stim Interconnecting Cable - Product Usage: Horizon is indicated for the treatment of Major Depressive Disorder in adult pati...
Medical Devices·71 affected·Mar 23, 2020
High RiskFDA
Welch Allyn, Inc/mortara
X12+ and patient cable for the X12+ Telemeter with the following device name: PAT CBL 10WIRE LEADFORM AHA SNAP, PAT CBL 10WIRE LEADFORM I...
Medical Devices·78,521 affected·Mar 18, 2020
High RiskFDA
Welch Allyn, Inc/mortara
Surveyor S12/S19 and patient cable for the S12/S19 Bedside Monitor under the following device names: PAT CBL 10WIRE AHA SNAP JSCREW, PAT ...
Medical Devices·78,521 affected·Mar 18, 2020
High RiskFDA
Welch Allyn, Inc/mortara
Replaceable lead set for the Wireless Acquisition Module (WAM), which is the ECG front-end for various Electrocardiographs. Sold under ...
Medical Devices·78,521 affected·Mar 18, 2020