Medical Devices Recalls
Medical device recalls including implants, diagnostic equipment, and surgical tools
27,372 recalls · Page 66 of 548
FDA Devices Moderate Aug 28, 2024
1,5L MED-SOFT SINGLE LINER WITH SOLIDIFIER, REF OR1920PG
MEDLINE INDUSTRIES, LP - Northfield
FDA Devices Moderate Aug 28, 2024
Product Name: 25+ CMB PAK 10K CPM,V,WA 0.9 Model/Catalog Number: 8065752451 Software Version: N/A Component: N/A
Alcon Research LLC
FDA Devices Moderate Aug 28, 2024
Product Name: Alcon Custom Pak Model/Catalog Number: Many Software Version: N/A Product Description: Alcon Custom Paks are customer-designed steri…
Alcon Research LLC
FDA Devices Moderate Aug 28, 2024
Product Name: ClearCut S Safety Sideport Knife 1.0mm Dual Bevel Model/Catalog Number: 8065771540 Software Version: N/A Product Description: Ophtha…
Alcon Research LLC
FDA Devices Critical Aug 28, 2024
ClotTriever XL Catheter, 30 mm, REF: 41-102, used with Instructions for Use ClotTriever XL Catheter ClotTriever Thrombectomy System, Reference: IU-…
Inari Medical - Oak Canyon
FDA Devices Moderate Aug 28, 2024
Multiple Digital Analog Products labeled as: NobelBiocare Tri-Lobe-compatible 6.0mm Digital Analog, REF 9000703 Straumann Tissue-Level-compatible W…
Preat Corp
FDA Devices Moderate Aug 28, 2024
Medline medical procedure kits labeled as follows: a) AAA CDS, REF CDS984011C; b) CAN KIT, REF DYKM1184; c) DENTAL CDS, REF CDS984010B; d) E…
MEDLINE INDUSTRIES, LP - Northfield
FDA Devices Moderate Aug 28, 2024
BIOFIRE FILMARRAY Pneumonia Panel, REF: RFIT-ASY-0144
BioFire Diagnostics, LLC
FDA Devices Moderate Aug 28, 2024
Vial Decanter, REF 2006S. Packaged on a form, fill and seal machine with a poly/Tyvek material then placed 50 products to a case (cs).
Microtek Medical Inc.
FDA Devices Moderate Aug 28, 2024
Medline medical procedure kits labeled as follows: a) TURNOVER KIT, REF DYKC1289F
MEDLINE INDUSTRIES, LP - Northfield
FDA Devices Moderate Aug 28, 2024
BD BACTEC MGIT 960 PZA Kit)- IVD qualitative procedure for susceptibility testing of Mycobacterium tuberculosis, from culture to pyrazinamide (PZA) …
Becton Dickinson & Co.
FDA Devices Moderate Aug 28, 2024
Spectrum Wireless Battery Modules A/B/G/N, product code 36010, used with either of the following 35700BAX2 (Spectrum V8 infusion pump) and 3570009 (S…
Baxter Healthcare Corporation
FDA Devices Moderate Aug 28, 2024
Covideien McGRATH MAC Video Laryngoscope, REF: 301-000-000, Non-Sterile, RxOnly
Covidien
FDA Devices Moderate Aug 28, 2024
Product Desc: Product Name: CLEARCUT SATINSLIT FULL HANDLE3.0MM ANG Model/Catalog Number: 8065993045 Software Version: N/A Product Description: Op…
Alcon Research LLC
FDA Devices Moderate Aug 28, 2024
IBA Proton Therapy System - PROTEUS 235- Designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other …
Ion Beam Applications S.A.
FDA Devices Moderate Aug 28, 2024
Product Name: 25+ TOTALPLUSr CP PAK 20K CPM BWV .9 IU Model/Catalog Number: 8065000093 Software Version: N/A Component: N/A
Alcon Research LLC
FDA Devices Moderate Aug 28, 2024
Product Name: 25+ CMB PAK 10K CPM,V,STD 0.9 Model/Catalog Number: 8065752450 Software Version: N/A Component: N/A
Alcon Research LLC
FDA Devices Moderate Aug 28, 2024
1,5L MED-SOFT LINER W/ 6MMX1,8M TUB. & ADULT VC, REF OR53926
MEDLINE INDUSTRIES, LP - Northfield
FDA Devices Moderate Aug 28, 2024
Baxter Spectrum Wireless Battery Modules A/B/G/N, product code 35223, used with either of the following: 35700BAX2 (Spectrum V8 infusion pump) or 35…
Baxter Healthcare Corporation
FDA Devices Moderate Aug 28, 2024
Regard Kit containing the Microtek decanter
ROi CPS LLC
FDA Devices Moderate Aug 28, 2024
Medline medical procedure kits labeled as follows: a) KIT CANISTER SUCT W 12FT, REF DYKM2169
MEDLINE INDUSTRIES, LP - Northfield
FDA Devices Moderate Aug 28, 2024
Medline medical procedure kits labeled as follows: DENTAL, REF DYNJ909211A
MEDLINE INDUSTRIES, LP - Northfield
CPSC Moderate Aug 22, 2024
Head Rush Technologies Recalls TRUBLUE Speed Auto Belay Devices Due to Fall Hazard
Head Rush Technologies, of Louisville, Colorado
FDA Devices Moderate Aug 21, 2024
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Rapid Response Waste Management …
Merit Medical Systems, Inc.
FDA Devices Moderate Aug 21, 2024
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Prelude SNAP (Introducer Cathete…
Merit Medical Systems, Inc.
FDA Devices Low Aug 21, 2024
Product Name: Salivary Testosterone ELISA Model/Catalog Number: SLV-3013 Product Description: An enzyme immunoassay for the quantitative in vitro d…
DRG International, Inc.
FDA Devices Moderate Aug 21, 2024
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K22C (Vein Tray Angiography kit)…
Merit Medical Systems, Inc.
FDA Devices Moderate Aug 21, 2024
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: PC (Pericardiocentesis Tray - Fl…
Merit Medical Systems, Inc.
FDA Devices Moderate Aug 21, 2024
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K09/K09T (Custom Manifold Kit), …
Merit Medical Systems, Inc.
FDA Devices Moderate Aug 21, 2024
Cepheid, Sample Collection Device, Part: 900-0370
Cepheid
FDA Devices Moderate Aug 21, 2024
Discrete photometric chemistry analyzer for clinical use.
Beckman Coulter, Inc.
FDA Devices Moderate Aug 21, 2024
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K04 (Custom Syringe Kit), REF:K0…
Merit Medical Systems, Inc.
FDA Devices Critical Aug 21, 2024
Replacement Battery List Number SUB0000594 and SUB0000864 found in Plum A+ & Plum A+3 Infusion Systems, Pump List Numbers: 11005, 11971, 12391, 12618…
ICU Medical Inc
FDA Devices Moderate Aug 21, 2024
WAVEWRITER ALPHA: Model: SC-1216, 16 IPG KIT, REF: M365SC12160; Model: SC-1232, 32 IPG KIT, REF: M365SC12320
Boston Scientific Neuromodulation Corporation
FDA Devices Moderate Aug 21, 2024
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K11 (Custom Pressure Monitoring …
Merit Medical Systems, Inc.
FDA Devices Moderate Aug 21, 2024
Orthopantomograph OP300 dental computed tomography x-ray system. The X-ray device produces conventional 2D X-ray images and Xray projection image…
Palodex Group Oy
FDA Devices Moderate Aug 21, 2024
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Safety Paracentesis Procedure Tr…
Merit Medical Systems, Inc.
FDA Devices Moderate Aug 21, 2024
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Customer Procedure Kit (Angiogra…
Merit Medical Systems, Inc.
FDA Devices Moderate Aug 21, 2024
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K04 (Custom Syringe Kit), REF: …
Merit Medical Systems, Inc.
FDA Devices Moderate Aug 21, 2024
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Customer Procedure Kit (Angiography…
Merit Medical Systems, Inc.
FDA Devices Moderate Aug 21, 2024
Brand Name: UNclog Eye Mask Product Name: UNclog Eye Mask Model/Catalog Number: AG23JW24 Serial # ag22 Product Description: Heated eye mask Compo…
EYE COMFORT CARE LLC
FDA Devices Critical Aug 21, 2024
RMU-2000 Automated Chest Compression Device
Defibtech, LLC
FDA Devices Moderate Aug 21, 2024
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: ReSolve (Catheter and Tip Suctio…
Merit Medical Systems, Inc.
FDA Devices Moderate Aug 21, 2024
VITROS Immunodiagnostic VITROS Folate Reagent Pack 1/2
Ortho-Clinical Diagnostics, Inc.
FDA Devices Moderate Aug 21, 2024
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K12T/12PI (Custom Pressure Monit…
Merit Medical Systems, Inc.
FDA Devices Moderate Aug 21, 2024
Aurora Series, Aurora 7 lighthead; Models: LED7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure vi…
DKK Dai-Ichi Shomei Co., Ltd.
FDA Devices Moderate Aug 21, 2024
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Custom Procedure Kit (Angiograph…
Merit Medical Systems, Inc.
FDA Devices Moderate Aug 21, 2024
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K10/K10-PI (Custom Waste Managem…
Merit Medical Systems, Inc.
FDA Devices Moderate Aug 21, 2024
HeartMate 3 System Controllers provided within the following HeartMate 3 Left Ventricular Assist System (LVAS) Implant Kits or distributed separately…
Thoratec LLC
FDA Devices Moderate Aug 14, 2024
SIGNA Explorer, with affected software versions: SV25.5, SV25.6, SV29.2, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System
GE Medical Systems, LLC