FDA Medical Devices
U.S. Food and Drug Administration — Medical device recalls
26,000 recalls · Page 46 of 520
Moderate Dec 11, 2024
BD MAX System, BD MAX Instrument Version or Model: 441916 Catalog Number: 441916
Becton Dickinson & Co.
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
Moderate Dec 11, 2024
GE Healthcare Revolution Maxima Select, Model Number, 6670000-55; X-ray/computed tomography system
GE Healthcare (China) Co., Ltd.
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.
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
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.
Moderate Dec 11, 2024
MEDLINE convenience kits labeled as: 1) TRACH TOTE, REF DYNJ85691; 2) TRACHEOSTOMY, REF DYNJ902123J
MEDLINE INDUSTRIES, LP - Northfield
Moderate Dec 11, 2024
BIORAPTOR Suture Anchors. Tendon/ligament, non-bioabsorbable bone anchor.
Smith & Nephew Inc.
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
Moderate Dec 11, 2024
Spectral CT and Spectral CT Plus. Model Numbers: 728333, 728340, 728344.
Philips North America Llc
Moderate Dec 11, 2024
BD BACTEC FX, Instrument Top, Packaged Version or Model: 441385 Catalog Number: 441385
Becton Dickinson & Co.
Moderate Dec 11, 2024
GE Healthcare Revolution Ascend Elite, Model Number 6967000-100; X-ray/computed tomography system
GE Healthcare (China) Co., Ltd.
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
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
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
Moderate Dec 11, 2024
BD EpiCenter Single User Software Version or Model: 441007 Catalog Number: 441007
Becton Dickinson & Co.
Moderate Dec 11, 2024
Refer to RES or lead review memo for complete list of affected reference/catalog numbers
MEDLINE INDUSTRIES, LP - Northfield
Moderate Dec 11, 2024
GE Healthcare Revolution Ascend, Model number 6969000-100; X-ray/computed tomography system
GE Healthcare (China) Co., Ltd.
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
Moderate Dec 11, 2024
GE Healthcare Revolution Maxima M, Model Number, 6670000-2; X-ray/computed tomography system
GE Healthcare (China) Co., Ltd.
Moderate Dec 11, 2024
Ziehm Vision system, x-ray, tomography, computed.
Orthoscan, Inc.
Moderate Dec 11, 2024
GE Healthcare Revolution EVO, Model Number 5454001-260; X-ray/computed tomography system
GE Healthcare (China) Co., Ltd.
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
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.
Moderate Dec 11, 2024
BD EpiCenter Data Management System, Multi User Software Version or Model: 440981 Catalog Number: 440981
Becton Dickinson & Co.
Moderate Dec 11, 2024
GE Healthcare Optima 520, Catalog number 5439126; X-ray/computed tomography systems
GE Healthcare (China) Co., Ltd.
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
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.
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
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
Moderate Dec 11, 2024
GE Healthcare Operator Console Upgrade Types, FRU Spare Parts Number B80662DA: China Only: Discovery CT750HD
GE Healthcare (China) Co., Ltd.
Moderate Dec 11, 2024
Ziehm Vision R. Iterventional fluoroscopic x-ray system
Orthoscan, Inc.
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.
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
Moderate Dec 11, 2024
BACTEC 9240 System Version or Model: 445475 Catalog Number: 445475
Becton Dickinson & Co.
Moderate Dec 11, 2024
BD COR MX Instrument Version or Model: 443989 Catalog Number: 443989
Becton Dickinson & Co.
Moderate Dec 4, 2024
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482EJ; use in Peritoneal Dialysis
Baxter Healthcare Corporation
Moderate Dec 4, 2024
Autosampler, Models: SIL-40C XR CL, SIL-40C X3 CL
Shimadzu Corp. Analytical & Measuring Instruments Div.
Moderate Dec 4, 2024
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482; use in Peritoneal Dialysis
Baxter Healthcare Corporation
Moderate Dec 4, 2024
AMS Artificial Urinary Sphincter Control Pump
Boston Scientific Corporation
Moderate Dec 4, 2024
dS Breast 16ch 1.5T
Philips North America Llc
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
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
Critical Dec 4, 2024
BioZorb Marker. Radiographic soft tissue marker.
Hologic, Inc
Moderate Dec 4, 2024
AMS Artificial Urinary Sphincter Pressure Regulating Balloon 61-70 cm H2O
Boston Scientific Corporation
Moderate Dec 4, 2024
Mammotrak Interventional Coil 3.0T
Philips North America Llc
Moderate Dec 4, 2024
TriALTIS TORQUE LIMITER, RATCHET, 11.3 Nm, Model Number 5161-00-5048 (G919509)
Gauthier Biomedical, Inc.
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
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
Moderate Dec 4, 2024
Mammotrak Diagnostic Coil 1.5T
Philips North America Llc