Medical Devices Recalls
Medical device recalls including implants, diagnostic equipment, and surgical tools
27,372 recalls · Page 47 of 548
FDA Devices Moderate Dec 18, 2024
Philips Allura Xper Systems (R7.6-R8.1). Labeled as the following: 1. Allura Xper FD10, Model Number: 722010. 2. Allura Xper FD10/10, Model Nu…
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
FDA Devices Moderate Dec 18, 2024
Hologic Sizer Set- sterilization tray and 6 individual sizers, intended as a Surgical instrument guide Model/Catalog Number: F0101
Hologic, Inc
FDA Devices Moderate Dec 18, 2024
MICRO-X Rover Mobile X-ray System, # MXU-RV35
Micro-X Ltd.
FDA Devices Moderate Dec 18, 2024
MICRO-X Rover Mobile X-ray System, # MXU-RV19
Micro-X Ltd.
FDA Devices Moderate Dec 18, 2024
BD Pyxis CII Safe ES, REF: 1116-00
CareFusion 303, Inc.
FDA Devices Moderate Dec 18, 2024
Cardinal Health SMS Elastic Cuff Thumbhook Level 3 Isolation Gown, Full-Back, Product Codes AT6588-2XL, AT6588-BD, AT6588-XL, AT6688-2XL, AT6688-BD, …
Cardinal Health 200, LLC
FDA Devices Moderate Dec 18, 2024
BD Pyxis MedStation ES 7 Drawer Auxiliary Tower, REF: 324
CareFusion 303, Inc.
FDA Devices Moderate Dec 18, 2024
Convertor Isolation Gown, AAMI Level 3 protection, Product Codes AT6100, AT6100-XL, AT6200, and AT6200-XL
Cardinal Health 200, LLC
FDA Devices Moderate Dec 18, 2024
Galaxy bronchoscope (Product GALB-001) used with Instructions for use, Part: 10000752, part of the Noah Medical Galaxy System (GAL-001)
Noah Medical
FDA Devices Moderate Dec 18, 2024
ChemoLock Close Vial Spike REF CL-80 The Chemolock Closed System Transfer Device prevents the transfer of environmental contaminants. The Chemolo…
ICU Medical, Inc.
FDA Devices Moderate Dec 18, 2024
BD Pyxis MedStation ES, REF: 323
CareFusion 303, Inc.
FDA Devices Moderate Dec 18, 2024
DiaSorin LIAISON Q.S.E.T. Device Plus, REF 319060; intended for use in the preparation of human stool specimens
Diasorin Inc.
FDA Devices Moderate Dec 18, 2024
Hybrid Recon software on Hermes Medical Imaging Suite version 6.1 Hybrid Recon software versions affected are 4.0.0x and 5.0.0
Hermes Medical Solutions AB
FDA Devices Moderate Dec 11, 2024
Non-ablative Fractional Laser Systems, Model: WFB-01
WINGDERM ELECTRO-OPTICS LTD.
FDA Devices Moderate Dec 11, 2024
MEDLINE convenience kits labeled as: PORT INSERTION PACK, REF DYNJ81597
MEDLINE INDUSTRIES, LP - Northfield
FDA Devices Moderate Dec 11, 2024
MEDLINE medical convenience kits labeled as: 1) ACETABULAR PACK-LF, REF DYNJ0572894I; 2) LOCAL BASIC, REF DYNJ34418L; 3) LOCAL BASIC, REF DYNJ…
MEDLINE INDUSTRIES, LP - Northfield
FDA Devices Moderate Dec 11, 2024
MEDLINE convenience kits labeled as: 1) ANGIO PACK #2, REFDYNJ39185D; 2) CV MINOR CATH LAB PACK, REFDYNJ44997J; 3) PLASTIC PACK, REFDYNJ58409C…
MEDLINE INDUSTRIES, LP - Northfield
FDA Devices Moderate Dec 11, 2024
MEDLINE convenience kits labeled as: L&D MINOR PACK, REF DYNJ82672
MEDLINE INDUSTRIES, LP - Northfield
FDA Devices Moderate Dec 11, 2024
GE Healthcare Revolution ACE, Model number 6670000-3; X-ray/computed tomography systems
GE Healthcare (China) Co., Ltd.
FDA Devices Moderate Dec 11, 2024
GE Healthcare Optima 680 Expert, Model number 6670000; X-ray/computed tomography system
GE Healthcare (China) Co., Ltd.
FDA Devices Moderate Dec 11, 2024
GE Healthcare Revolution Eagle, Model Number 5849504-3, X-ray/computed tomography system
GE Healthcare (China) Co., Ltd.
FDA Devices Moderate Dec 11, 2024
MEDLINE convenience kits labeled as: 1) C-SECTION OR 30 CDS, REF CDS820075V; 2) C-SECTION OR 30 CDS, REF CDS820075W; 3) C-SECTION, REF CDS980774M…
MEDLINE INDUSTRIES, LP - Northfield
FDA Devices Moderate Dec 11, 2024
MEDLINE convenience kits labeled as: COLON WOUND CLOSURE PACK, REF DYNJ52141B
MEDLINE INDUSTRIES, LP - Northfield
FDA Devices Moderate Dec 11, 2024
MEDLINE convenience kits labeled as: 1) MAJOR VASCULAR-LF, REF CDS840232L; 2) AVF-LF, REF CDS840233I; 3) GENERAL AAA #11-RF, REF CDS840261AB; 4)…
MEDLINE INDUSTRIES, LP - Northfield
FDA Devices Moderate Dec 11, 2024
MEDLINE convenience kits labeled as: 1) BASIC NEURO PACK, REF CDS780202P; 2) BASIC NEURO PACK, REF CDS780202Q; 3) BASIC NEURO PACK, REF CDS780…
MEDLINE INDUSTRIES, LP - Northfield
FDA Devices Moderate Dec 11, 2024
GE Healthcare Discovery RT, Model Number 2374681-17, X-ray/computed tomography systems labeled as:
GE Healthcare (China) Co., Ltd.
FDA Devices Moderate Dec 11, 2024
Ziehm Solo. Digital Mobile C-arm
Orthoscan, Inc.
FDA Devices Moderate Dec 11, 2024
Ziehm Solo FD. Interventional fluoroscopic x-ray system
Orthoscan, Inc.
FDA Devices Moderate Dec 11, 2024
MEDLINE convenience kits labeled as: 1) BURN, REF CDS983465M; 2) BURN, REF CDS983465N; 3) BURN PACK, REF DYNJ63331D
MEDLINE INDUSTRIES, LP - Northfield
FDA Devices Moderate Dec 11, 2024
Ziehm Vision RFD. Interventional fluoroscopic x-ray system
Orthoscan, Inc.
FDA Devices Moderate Dec 11, 2024
Diode Laser Hair Removal model: WLA-01
WINGDERM ELECTRO-OPTICS LTD.
FDA Devices Moderate Dec 11, 2024
MEDLINE convenience kits labeled as: 1) LAKELAND SINGLE BASIN PACK-LF, REF DYNJ0619907I; 2) LAKELAND SINGLE BASIN PACK-LF, REF DYNJ0619907K; 3…
MEDLINE INDUSTRIES, LP - Northfield
FDA Devices Moderate Dec 11, 2024
GE Healthcare Revolution Frontier, Model Numbers: 1) 5232085-213, 2) 5873009; X-ray/computed tomography system
GE Healthcare (China) Co., Ltd.
FDA Devices Moderate Dec 11, 2024
GE Healthcare Revolution Advance, Model number 5849504; X-ray/computed tomography systems
GE Healthcare (China) Co., Ltd.
FDA Devices Moderate Dec 11, 2024
Atellica CI Analyzer. Catalog Numbers: 10947347.
Siemens Healthcare Diagnostics, Inc.
FDA Devices Moderate Dec 11, 2024
BD COR GX Instrument Version or Model: 443990 Catalog Number: 443990
Becton Dickinson & Co.
FDA Devices Moderate Dec 11, 2024
BD Synapsys Informatics Solution (Laboratory Solution) Version or Model: 444150 Catalog Number: 444150
Becton Dickinson & Co.
FDA Devices Moderate Dec 11, 2024
MEDLINE MAXORB EXTRA ALGINATE WOUND DRESSING 4X4 SQUARE REF MSC7044EP MEDLINE MOXORB EXTRA ALBINATE WOUND DRESSING 4X8 RECTANLE REF MSC7048EP Wou…
Advanced Medical Solutions Ltd.
FDA Devices Moderate Dec 11, 2024
BD MAX System, BD MAX Instrument Version or Model: 441916 Catalog Number: 441916
Becton Dickinson & Co.
FDA Devices Moderate Dec 11, 2024
MEDLINE convenience kits labeled as: 1) GYN LAPAROSCOPY-LF, REF CDS760059I; 2) GYN LAPAROSCOPY CDS #34-RF, REF CDS920099S; 3) GYN MAJOR, REF C…
MEDLINE INDUSTRIES, LP - Northfield
FDA Devices Moderate Dec 11, 2024
GE Healthcare Revolution Maxima Select, Model Number, 6670000-55; X-ray/computed tomography system
GE Healthcare (China) Co., Ltd.
FDA Devices Moderate Dec 11, 2024
GE Healthcare Operator Console Upgrade Types, FRU Spare Parts Number B80212DA: EU: Operator Console (for BrightSpeed, Elite/BrightSpeed Elite Se…
GE Healthcare (China) Co., Ltd.
FDA Devices Moderate Dec 11, 2024
MEDLINE convenience kits labeled as: 1) CIRCUMCISION PACK, REF DYNJ16826O; 2) D-CIRCUMCISION PACK, REF DYNJ64432; 3) PACK,CIRCUMCISION ASC, RE…
MEDLINE INDUSTRIES, LP - Northfield
FDA Devices Moderate Dec 11, 2024
Hollister CalciCare Calcium Alginate Dressing REF 529937R calcium alginate dressings are indicated for moderate to heavily exuding chronic and acu…
Advanced Medical Solutions Ltd.
FDA Devices Moderate Dec 11, 2024
MEDLINE convenience kits labeled as: 1) TRACH TOTE, REF DYNJ85691; 2) TRACHEOSTOMY, REF DYNJ902123J
MEDLINE INDUSTRIES, LP - Northfield
FDA Devices Moderate Dec 11, 2024
BIORAPTOR Suture Anchors. Tendon/ligament, non-bioabsorbable bone anchor.
Smith & Nephew Inc.
FDA Devices Moderate Dec 11, 2024
MEDLINE convenience kits labeled as: 1) TOT/ GYN LITHOTOMY CDS, REF CDS985431J; 2) TOT/ GYN LITHOTOMY CDS, REF CDS985431K; 3) TOT/ GYN LITHOTO…
MEDLINE INDUSTRIES, LP - Northfield
FDA Devices Moderate Dec 11, 2024
Spectral CT and Spectral CT Plus. Model Numbers: 728333, 728340, 728344.
Philips North America Llc
FDA Devices Moderate Dec 11, 2024
BD BACTEC FX, Instrument Top, Packaged Version or Model: 441385 Catalog Number: 441385
Becton Dickinson & Co.
FDA Devices Moderate Dec 11, 2024
GE Healthcare Revolution Ascend Elite, Model Number 6967000-100; X-ray/computed tomography system
GE Healthcare (China) Co., Ltd.