Medical Devices Recalls
Medical device recalls including implants, diagnostic equipment, and surgical tools
27,372 recalls · Page 160 of 548
FDA Devices Moderate Jan 19, 2022
GLOBAL UNITE STD STEM SZ 10 Part Number: 110010100
DePuy Orthopaedics, Inc.
FDA Devices Moderate Jan 19, 2022
OCT-Camera 211 01 A3; Running software iOCT-Control 3 v1.4
Haag-Streit USA Inc
FDA Devices Moderate Jan 19, 2022
Proteus 235; Version: PTS-8 versions before PTS-8.7.2
Ion Beam Applications S.A.
FDA Devices Moderate Jan 19, 2022
GLOBAL UNITE STD STEM SZ 12 Product Code: 110012100
DePuy Orthopaedics, Inc.
FDA Devices Moderate Jan 19, 2022
SOMATOM Confidence -Computed tomography systems Model 10590100
Siemens Medical Solutions USA, Inc
FDA Devices Moderate Jan 19, 2022
Flat Panel Detector, Model Number: TFP-800A, used with the Alphenix Systems, Item Numbers: INFX-8000V, INFX-8000C, INFX-8000F, and INFX-8000H.
Canon Medical System, USA, INC.
FDA Devices Moderate Jan 19, 2022
Software BeamAdjust version 2.2, Catalog No: S070009 Software VeriSoft version 8.0, Catalog No: S080032
PTW NORTH AMERICA CORPORATION
FDA Devices Moderate Jan 12, 2022
QIAstat-Dx Respiratory SARS-CoV-2 Panel (US IVD under FDA EUA 200075); REF 691223
Qiagen Sciences LLC
FDA Devices Moderate Jan 12, 2022
Invacare AVIVA FX with LiNX Gyro Power Wheelchair (with LiNX Gyro Module Model Numbers DLX-GRY100-A and DLX-GRY101-A) Models: IFX-20R, IFX-20SP, IF…
Invacare Corporation
FDA Devices Moderate Jan 12, 2022
DYNANAIL MINI, Endcap +6mm, REF 2600-05-006, Rx Only, Sterile
Medshape, INC.
FDA Devices Moderate Jan 12, 2022
DBB-06 Hemodialysis Delivery System
Nikkiso Ltd - Shizuoka Plant
FDA Devices Moderate Jan 12, 2022
UROMEDICA Implantation Instrument Set (Sheath and Sharp Trocar), REF 750041, nonsterile.
Uromedica Inc.
FDA Devices Moderate Jan 12, 2022
Triathlon Pro Tibial Preparation Tray, Revision AC- for organization, storage, and transport in preparation for sterilization of re-usable instrument…
Howmedica Osteonics Corp.
FDA Devices Moderate Jan 12, 2022
Biomeme SARS-CoV-2- Real Time RT-PCR Test, Instructions for Use, Part number 100002824 Subcomponent of: SARS-CoV-2 Go-Strips, 3000555; SARS-CoV-2 Go…
Biomeme, Inc.
FDA Devices Moderate Jan 12, 2022
Alinity m System, Part No. 08N53-002
Abbott Molecular, Inc.
FDA Devices Low Jan 12, 2022
iontoPATCH On-the-Go Patch Therapy, Transdermal Iontophoretic Drug Delivery System, Extra Strength, 8-HOUR Average Wear Time, 6/1-patch pouches/box.…
Tapemark Company
FDA Devices Moderate Jan 5, 2022
iDesign, Model - G300: System AWS (International), System AWS (China), Advanced WaveScan Studio (United States); iDesign Refractive Studio Aberromete…
AMO Manufacturing USA, LLC
FDA Devices Moderate Jan 5, 2022
ARTISTE with syngo RT Therapist-linear accelerator systems to deliver X-Ray photon and electron radiation for the therapeutic treatment of cancer. M…
Siemens Medical Solutions USA, Inc
FDA Devices Moderate Jan 5, 2022
VIDAS RUB IgG (RBG), REF 30226
bioMerieux, Inc.
FDA Devices Moderate Jan 5, 2022
VIDAS FSH, REF 30407-01
bioMerieux, Inc.
FDA Devices Moderate Jan 5, 2022
Ultimum HEMOSTASIS INTRODUCER 5f 1.67 MM
Abbott
FDA Devices Moderate Jan 5, 2022
VIDAS SARS-COV-2 IgM, Ref 423833-01
bioMerieux, Inc.
FDA Devices Moderate Jan 5, 2022
VIDAS TOXO IgG Avidity (TXGA), REF 30222-01
bioMerieux, Inc.
FDA Devices Moderate Jan 5, 2022
Affected components are limited to the Monoprice charging cable (Product # 4867) and 24W iClever Boost Cube charging brick components for the SoundPO…
Forbes Rehab Services Inc
FDA Devices Moderate Jan 5, 2022
VIDAS Estradiol II, REF 30431-01
bioMerieux, Inc.
FDA Devices Moderate Jan 5, 2022
Atellica CH ¿2-Microglobulin (B2M) -M) Assay for in vitro diagnostic use in the quantitative determination of ¿2-microglobulin in human serum and pla…
Siemens Healthcare Diagnostics, Inc.
FDA Devices Moderate Jan 5, 2022
VIDAS Lyme IgG II (LYM), REF 417401
bioMerieux, Inc.
FDA Devices Moderate Jan 5, 2022
Catalys Precision Laser System, Models: Catalys-U (United States), Catalys-I (International), Catalys-C (China); and Catalys Precision Laser System N…
AMO Manufacturing USA, LLC
FDA Devices Moderate Jan 5, 2022
VIDAS PRG Progesterone, REF 30409-01
bioMerieux, Inc.
FDA Devices Moderate Jan 5, 2022
VIDAS LH, REF 30406-01
bioMerieux, Inc.
FDA Devices Moderate Jan 5, 2022
VIDAS Measles IgG (MSG), REF 30219
bioMerieux, Inc.
FDA Devices Moderate Jan 5, 2022
VIDAS Clostridium Difficile GDH, REF 30125-01
bioMerieux, Inc.
FDA Food Moderate Dec 29, 2021
Signature Select Pumpkin Spice mini cupcakes 10 oz. UPC 0 21130 98478 7 Bake Shop Pumpkin Spice mini cupcakes 10 oz. UPC 4 09910 02729 56 two-bite …
GIVE AND GO
FDA Devices Moderate Dec 29, 2021
Torosa Saline-Filled Testicular Prosthesis (Size Small)
Coloplast Manufacturing US, LLC
FDA Devices Moderate Dec 29, 2021
These are communication systems, labeled as: a. NaviCare Nurse Call, Part Numbers: 3.6, 3.7, 3.9 b. Voalte Nurse Call, Part Number 4.0 *Produ…
Hill-Rom Inc.
FDA Devices Moderate Dec 29, 2021
VirtuTRAX Instrument Navigator, 14 Ga VirtuTRAX
Civco Medical Instruments Co. Inc.
FDA Devices Moderate Dec 29, 2021
Custom Assemblies, Inc., Single Spike Tumescent Set w/o Chamber, Reorder Number CMS-1212NS Bulk
Stradis Medical, LLC dba Stradis Healthcare
FDA Devices Moderate Dec 29, 2021
Malosa Core SMILE Pack 1-Medical Refractive Kit intended to be used to aid in cataract, corneal, or refractive surgery. Part Number: MMK884
Beaver Visitec International, Inc.
FDA Devices Moderate Dec 29, 2021
Stryker DARCO Screw, Locking, Ti6A14V, REF DC2825016, 2.7mm x 16mm.
Wright Medical Technology Inc
FDA Devices Moderate Dec 29, 2021
SYNCHRON Systems Cholesterol (CHOL) Reagent, REF: 467825
Beckman Coulter Inc.
FDA Devices Moderate Dec 29, 2021
Stealth Autoguide Tracker, Model: 28248, which is an instrument in the Stealth Autoguide Basic Instrument Kit, Mode: 9736188, and the Bundle Autoguid…
Medtronic Navigation, Inc.
FDA Devices Moderate Dec 29, 2021
VirtuTRAX Instrument Navigator, Sensor with 14 Ga VirtutTRAX
Civco Medical Instruments Co. Inc.
FDA Devices Moderate Dec 29, 2021
Malosa Core SMILE Pack 2-Beaver-Visitec- A Medical Refractive Kit intended to be used to aid in cataract, corneal, or refractive surgery. Part Number…
Beaver Visitec International, Inc.
FDA Devices Moderate Dec 29, 2021
Wright Medical Technology Inc. CHARLOTTE MTP Hex Screw, Model #41122718, 2.7mm x 18mm, a component of the CHARLOTTE Lisfranc Reconstruction System.
Wright Medical Technology, Inc.
FDA Devices Critical Dec 29, 2021
Stealthstation System w/ Stealthstation Cranial Software 3.1.1,3.1.2,3.1. or SynergyCranial Software. Synergy Cranial, Model: 9733763, and Stealt…
Medtronic Navigation, Inc.
FDA Devices Moderate Dec 29, 2021
Hemashield Gold Knitted Bifurcated, 18 mm x 9 mm; reference number M002020851890
Maquet Cardiovascular, LLC
FDA Devices Moderate Dec 29, 2021
Philips Allura Xper FD series with Software Version Number: 2.1.x- intended for Vascular, cardiovascular and neurovascular imaging applications, incl…
Philips North America Llc
FDA Devices Moderate Dec 29, 2021
VirtuTRAX Instrument Navigator, 10 17 GA VirtuTRAX
Civco Medical Instruments Co. Inc.
FDA Devices Moderate Dec 29, 2021
Skinny Needle with Chiba Tip. RPN 090010, 090010-ET; GPN G14254, G15290. Rigid needle available with EchoTip to provide enhanced visualization of …
Cook Inc.
FDA Devices Moderate Dec 29, 2021
Malosa Core LASIK Pack 2-Medical Refractive Kit- intended to be used to aid in cataract, corneal, or refractive surgery. Part Number: MMK100/2
Beaver Visitec International, Inc.