Medical Devices Recalls
Medical device recalls including implants, diagnostic equipment, and surgical tools
27,372 recalls · Page 48 of 548
FDA Devices Moderate Dec 11, 2024
Cartiva Synthetic Cartilage Implant (SCI) Catalog: CAR-06-US (6mm), CAR-08-US (8mm), CAR-10-US (10mm), CAR-12-US (12mm)
Cartiva, Inc
FDA Devices Moderate Dec 11, 2024
MEDLINE convenience kits labeled as: 1) MAJOR LITHOTOMY CDS-LF, REF CDS760056G; 2) LAVH CDS, REF CDS983411J; 3) MAJOR VAGINAL, REF CDS983497L;…
MEDLINE INDUSTRIES, LP - Northfield
FDA Devices Moderate Dec 11, 2024
MEDLINE convenience kits labeled as: 1) CVL PACK, REF DYNJ00281O; 2) VASCULAR ACCESS PACK-LF, REF DYNJ0101291F; 3) MAJOR VASCULAR PACK-LF, REF…
MEDLINE INDUSTRIES, LP - Northfield
FDA Devices Moderate Dec 11, 2024
BD EpiCenter Single User Software Version or Model: 441007 Catalog Number: 441007
Becton Dickinson & Co.
FDA Devices Moderate Dec 11, 2024
Refer to RES or lead review memo for complete list of affected reference/catalog numbers
MEDLINE INDUSTRIES, LP - Northfield
FDA Devices Moderate Dec 11, 2024
GE Healthcare Revolution Ascend, Model number 6969000-100; X-ray/computed tomography system
GE Healthcare (China) Co., Ltd.
FDA Devices Moderate Dec 11, 2024
MEDLINE convenience kits labeled as: 1) ORAL SURGERY PK RFID, REF DYNJ52404I; 2) ORL PACK, REF DYNJ59073B; 3) ORAL MAXILOFACIAL PK, REF DYNJ8…
MEDLINE INDUSTRIES, LP - Northfield
FDA Devices Moderate Dec 11, 2024
GE Healthcare Revolution Maxima M, Model Number, 6670000-2; X-ray/computed tomography system
GE Healthcare (China) Co., Ltd.
FDA Devices Moderate Dec 11, 2024
Ziehm Vision system, x-ray, tomography, computed.
Orthoscan, Inc.
FDA Devices Moderate Dec 11, 2024
GE Healthcare Revolution EVO, Model Number 5454001-260; X-ray/computed tomography system
GE Healthcare (China) Co., Ltd.
FDA Devices Moderate Dec 11, 2024
MEDLINE convenience kits labeled as: 1) CLEAN CLOSING PACK, REF DYNJ80686A; 2) CLEAN CLOSURE PACK GREEN, REF DYNJ84667
MEDLINE INDUSTRIES, LP - Northfield
FDA Devices Moderate Dec 11, 2024
McKesson Calcium Alginate Dressing MFR# 3562 Wound dressing indicated for moderate to heavily exuding chronic and acute wounds, and to control min…
Advanced Medical Solutions Ltd.
FDA Devices Moderate Dec 11, 2024
BD EpiCenter Data Management System, Multi User Software Version or Model: 440981 Catalog Number: 440981
Becton Dickinson & Co.
FDA Devices Moderate Dec 11, 2024
GE Healthcare Optima 520, Catalog number 5439126; X-ray/computed tomography systems
GE Healthcare (China) Co., Ltd.
FDA Devices Moderate Dec 11, 2024
MEDLINE convenience kits labeled as: 1) VAGINAL, REF CDS984955M; 2) DAY SURG LARGE VAG CDS, REF CDS984995M; 3) MAJOR VAGINAL PACK-LF, REF DYNJ…
MEDLINE INDUSTRIES, LP - Northfield
FDA Devices Moderate Dec 11, 2024
GE Healthcare Revolution Maxima, Model Numbers: 1) 6665000-2, 2) 6670000-2, 3) 6670000-200, 4) 6670000-6; X-ray/computed tomography system
GE Healthcare (China) Co., Ltd.
FDA Devices Moderate Dec 11, 2024
MEDLINE convenience kits labeled as: 1) LITHOTOMY/PELVISCOPY PACK, REF DYNJ0531985R; 2) PELVISCOPY PACK-LF, REF DYNJ0843760I; 3) PELVISCOPY PA…
MEDLINE INDUSTRIES, LP - Northfield
FDA Devices Moderate Dec 11, 2024
MEDLINE convenience kits labeled as: 1) ZALE HEAD & NECK CDS, REF CDS983184I; 2) ENT MINOR, REF CDS983466L; 3) EAR, REF CDS983486K; 4) HEAD AND …
MEDLINE INDUSTRIES, LP - Northfield
FDA Devices Moderate Dec 11, 2024
GE Healthcare Operator Console Upgrade Types, FRU Spare Parts Number B80662DA: China Only: Discovery CT750HD
GE Healthcare (China) Co., Ltd.
FDA Devices Moderate Dec 11, 2024
Ziehm Vision R. Iterventional fluoroscopic x-ray system
Orthoscan, Inc.
FDA Devices Moderate Dec 11, 2024
Atellica¿ CH ¿2-Microglobulin (B2M) - In vitro diagnostic use in the quantitative determination of ¿2-microglobulin in human serum and plasma. Sieme…
Siemens Healthcare Diagnostics, Inc.
FDA Devices Moderate Dec 11, 2024
MEDLINE convenience kits labeled as: 1) MINOR EYE TRAY #81, REF DYNJ27466S; 2) EYE PACK, REF DYNJ41207C; 3) CATARACT PACK, REF DYNJ43147G; 4…
MEDLINE INDUSTRIES, LP - Northfield
FDA Devices Moderate Dec 11, 2024
BACTEC 9240 System Version or Model: 445475 Catalog Number: 445475
Becton Dickinson & Co.
FDA Devices Moderate Dec 11, 2024
BD COR MX Instrument Version or Model: 443989 Catalog Number: 443989
Becton Dickinson & Co.
FDA Devices Moderate Dec 4, 2024
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482EJ; use in Peritoneal Dialysis
Baxter Healthcare Corporation
FDA Devices Moderate Dec 4, 2024
Autosampler, Models: SIL-40C XR CL, SIL-40C X3 CL
Shimadzu Corp. Analytical & Measuring Instruments Div.
FDA Devices Moderate Dec 4, 2024
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482; use in Peritoneal Dialysis
Baxter Healthcare Corporation
FDA Devices Moderate Dec 4, 2024
AMS Artificial Urinary Sphincter Control Pump
Boston Scientific Corporation
FDA Devices Moderate Dec 4, 2024
dS Breast 16ch 1.5T
Philips North America Llc
FDA Devices Moderate Dec 4, 2024
MEDLINE procedure kits labeled as follows: 1) CONT EPI 20G W/HUSTEAD, REF PAIN1069B; 2) CSE TRAY, REF PAIN1941; 3) TRAY CON EPID 20G NYL W/TUOHY,…
MEDLINE INDUSTRIES, LP - Northfield
FDA Devices Moderate Dec 4, 2024
Defibtech DDP-2001: Adult Defibrillation Pads For use with AED Models: Lifeline View Auto, lifeline Pro, lifeline ECG, lifeline View (DDU-2XXX Serie…
Defibtech, LLC
FDA Devices Critical Dec 4, 2024
BioZorb Marker. Radiographic soft tissue marker.
Hologic, Inc
FDA Devices Moderate Dec 4, 2024
AMS Artificial Urinary Sphincter Pressure Regulating Balloon 61-70 cm H2O
Boston Scientific Corporation
FDA Devices Moderate Dec 4, 2024
Mammotrak Interventional Coil 3.0T
Philips North America Llc
FDA Devices Moderate Dec 4, 2024
TriALTIS TORQUE LIMITER, RATCHET, 11.3 Nm, Model Number 5161-00-5048 (G919509)
Gauthier Biomedical, Inc.
FDA Devices Moderate Dec 4, 2024
Arial Server Software Versions 11.1.4 through 11.1.6, SKU 54305, in conjunction with the Arial Mobile Application or Arial Care Giver Application
Securitas Healthcare LLC
FDA Devices Moderate Dec 4, 2024
MEDLINE procedure kits labeled as follows: 1) 20G EPI CATH SINGLE STERILE, REF EPICATH19 2) 20G EPI CATH SINGLE STERILE, REF EPICATH20
MEDLINE INDUSTRIES, LP - Northfield
FDA Devices Moderate Dec 4, 2024
Mammotrak Diagnostic Coil 1.5T
Philips North America Llc
FDA Devices Moderate Dec 4, 2024
(1) Medline Pacer Implant Pack, REF DYNJ59194A, 4 kits/case, sterile; and (2) Medline Thoracotomy Morristown, REF DYNJ904220F, 1 kit/case, non-steri…
MEDLINE INDUSTRIES, LP - Northfield
FDA Devices Moderate Dec 4, 2024
Brand Name: MST Duet Reusable Handle for Single Use Heads Product Name: Reusable Handle for Single Use Heads (Forceps and Scissors) Model/Catalog N…
MicroSurgical Technology Inc
FDA Devices Moderate Dec 4, 2024
smiths medical PORTEX Tracheal Tube Exchange Guide, 15Ch x 70cm, REF 14-504-68 and REF 14-504-68JP
Smiths Medical ASD, Inc.
FDA Devices Moderate Dec 4, 2024
MEDLINE procedure kits labeled as follows: 1) ECHOSTIM BLOCK SET, REF DYNJRA9043S; 2) ULTRASOUND BLOCK PREP TRAY, REF PAIN1622A
MEDLINE INDUSTRIES, LP - Northfield
FDA Devices Moderate Dec 4, 2024
(1) Medline Open Heart CDS, REF CDS840132O, packaged 1 kit/case, non-sterile; and (2) Medline Dr. Davies CV, REF DYNJ903016G, packaged 1 kit/case, n…
MEDLINE INDUSTRIES, LP - Northfield
FDA Devices Moderate Dec 4, 2024
Baxter MiniCap Extended Life PD Transfer Set (short) with Titanium Spike, Part Number T5C4326K; use in Peritoneal Dialysis
Baxter Healthcare Corporation
FDA Devices Moderate Dec 4, 2024
dS Breast 7ch 3.0T
Philips North America Llc
FDA Devices Moderate Dec 4, 2024
SIGNA Architect AIR, Nuclear Magnetic Resonance Imaging System
GE Medical Systems, LLC
FDA Devices Moderate Dec 4, 2024
GE Proteus XR/A radiographic system
GE Healthcare (China) Co., Ltd.
FDA Devices Low Dec 4, 2024
Brand Name: Z-800 Infusion System Product Name: Z-800WF Model/Catalog Number: Z-800WF. The Z-800 Infusion system is intended to provide intravenou…
Zyno Medical LLC
FDA Devices Moderate Dec 4, 2024
RENASYS EDGE The RENASYS¿ EDGE pump is indicated for patients who would benefit from a suction pump (NPWT), as it may promote wound healing via re…
Smith & Nephew Medical, Ltd.
FDA Devices Moderate Dec 4, 2024
ST SENSE Breast Dx Coil
Philips North America Llc