FDA Medical Devices
U.S. Food and Drug Administration — Medical device recalls
26,000 recalls · Page 64 of 520
Moderate Aug 28, 2024
Product Desc: Product Name: A-OK SATINSLIT FULL HANDLE2.75MM ANG SG Model/Catalog Number: 8065992761 Software Version: N/A Product Description: Op…
Alcon Research LLC
Moderate Aug 28, 2024
Product Name: TOTAL PLUS,25+,10K VALVE WD Model/Catalog Number: 8065752438 Software Version: N/A Component: N/A
Alcon Research LLC
Moderate Aug 28, 2024
Medline medical procedure kits labeled as follows: a) BASIC NASAL, REF DYNJ909932; b) BRONCH KIT, REF DYKE1007B; c) ENT, REF DYNJ909935; d…
MEDLINE INDUSTRIES, LP - Northfield
Moderate Aug 28, 2024
Philips Allura Xper systems (R8.1 with Poly-G Stand) Interventional Fluoroscopic X-Ray System, Model Numbers 722010, 722012, 722013
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Moderate Aug 28, 2024
Product Name: 25GA VALVED ENTRY SYSTEM,3CT Model/Catalog Number: 8065751658 Software Version: N/A Product Description: Valved Trocar Entry System …
Alcon Research LLC
Moderate Aug 28, 2024
Product Name: 25+TTLPL VPK 20000CPM BEV VAL Model/Catalog Number: 8065753106 Software Version: N/A Component: N/A
Alcon Research LLC
Moderate Aug 28, 2024
1,5L MED-SOFT SINGLE LINER WITH SOLIDIFIER, REF OR1920PG
MEDLINE INDUSTRIES, LP - Northfield
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
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
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
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
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
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
Moderate Aug 28, 2024
BIOFIRE FILMARRAY Pneumonia Panel, REF: RFIT-ASY-0144
BioFire Diagnostics, LLC
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.
Moderate Aug 28, 2024
Medline medical procedure kits labeled as follows: a) TURNOVER KIT, REF DYKC1289F
MEDLINE INDUSTRIES, LP - Northfield
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.
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
Moderate Aug 28, 2024
Covideien McGRATH MAC Video Laryngoscope, REF: 301-000-000, Non-Sterile, RxOnly
Covidien
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
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.
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
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
Moderate Aug 28, 2024
1,5L MED-SOFT LINER W/ 6MMX1,8M TUB. & ADULT VC, REF OR53926
MEDLINE INDUSTRIES, LP - Northfield
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
Moderate Aug 28, 2024
Regard Kit containing the Microtek decanter
ROi CPS LLC
Moderate Aug 28, 2024
Medline medical procedure kits labeled as follows: a) KIT CANISTER SUCT W 12FT, REF DYKM2169
MEDLINE INDUSTRIES, LP - Northfield
Moderate Aug 28, 2024
Medline medical procedure kits labeled as follows: DENTAL, REF DYNJ909211A
MEDLINE INDUSTRIES, LP - Northfield
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.
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.
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.
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.
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.
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.
Moderate Aug 21, 2024
Cepheid, Sample Collection Device, Part: 900-0370
Cepheid
Moderate Aug 21, 2024
Discrete photometric chemistry analyzer for clinical use.
Beckman Coulter, Inc.
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.
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
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
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.
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
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.
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.
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.
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.
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
Critical Aug 21, 2024
RMU-2000 Automated Chest Compression Device
Defibtech, LLC
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.
Moderate Aug 21, 2024
VITROS Immunodiagnostic VITROS Folate Reagent Pack 1/2
Ortho-Clinical Diagnostics, Inc.
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.