FDA Medical Devices
U.S. Food and Drug Administration — Medical device recalls
26,000 recalls · Page 58 of 520
Moderate Sep 18, 2024
Medline Convenience kits, labeled as: 1) SINGLE SHOT EPIDURAL PACK-LF, Pack Number DYNJ0708470K ; 2) EPIDURAL CSTM PACK-LF , Pack Number DYNJ08440…
MEDLINE INDUSTRIES, LP - Northfield
Moderate Sep 18, 2024
Medline Convenience kits labeled as: TONSIL & ADENOID PACK, Pack Number DYNJ43427C
MEDLINE INDUSTRIES, LP - Northfield
Moderate Sep 18, 2024
Medtronic Handset with Communicator, Model TH90Q01, InterStim Smart Programmer and Communicator Kits, containing the Model HH90 Handset and the TM…
Medtronic Neuromodulation
Moderate Sep 18, 2024
Spacelabs Ultraview DM3 Vital Signs Monitor (all variations -M, -MT, -N, -NT), Model Number 91330
Zoe Medical Incorporated
Critical Sep 18, 2024
smiths medical portex BLUgriggs Percutaneous Dilation Procedural Trays with BLUselect tracheotomy tubes, labeled as follows: 1) BLUgriggs Percutan…
Smiths Medical ASD Inc.
Moderate Sep 18, 2024
Medline Convenience kits labeled as: 1) DIALYSIS CATHETER INSERTION KIT, Pack Number CVI4815; 2) ANGIO PACK, Pack Number CVI5045; 3) CHILDRENS…
MEDLINE INDUSTRIES, LP - Northfield
Moderate Sep 18, 2024
ADVIA Centaur CA 19-9 (50 Test)-In vitro diagnostic use in the quantitative measurement of the CA 19-9 tumor-associated antigen in human serum using …
Siemens Healthcare Diagnostics, Inc.
Moderate Sep 18, 2024
Medline Convenience kits, containing Shenli syringes, labeled as: 1) LOCAL PACK, Pack Number DYNJ34129C ; 2) FTMC LOCAL PACK-LF, Pack Number DYN…
MEDLINE INDUSTRIES, LP - Northfield
Moderate Sep 18, 2024
Brand Name: Transcend Product Name: Transcend Econo Kit (UB) - Singles Model/Catalog Number: 4817- Software Version: N/A Product Description: Tra…
Ultradent Products, Inc.
Moderate Sep 18, 2024
Medline Convenience kits labeled as: 1) MINOR BASIC PACK-LF, Pack Number DYNJ0281516M; 2) MINOR ACUTE PACK-LF, Pack Number DYNJ0484979B
MEDLINE INDUSTRIES, LP - Northfield
Moderate Sep 18, 2024
Medline Convenience kits labeled as: 1) FILTER-.8 MICRON, Pack Number 2008; 2) ANES CIRCUIT 90IN EXP-LF, Pack Number DYNJAA10295A
MEDLINE INDUSTRIES, LP - Northfield
Moderate Sep 18, 2024
Medline Convenience kits labeled as: 1) GROTH PELVISCOPY CDS, Pack Number CDS984187T ; 2) GROTH PELVISCOPY, Pack Number CDS984187U ; 3) DERMAT…
MEDLINE INDUSTRIES, LP - Northfield
Moderate Sep 18, 2024
Medline Convenience kits labeled as: 1) BIOPSY PROCEDURE PACK, Pack Number 00-400162J; 2) BIOPSY PROCEDURE TRAY , Pack Number 00-400405C ; 3) BIO…
MEDLINE INDUSTRIES, LP - Northfield
Moderate Sep 18, 2024
Medline Convenience kits, labeled as: 1) KNEE ARTHROSCOPY CDS-LF , Pack Number CDS983874F ; 2) HAND, Pack Number CDS984080F
MEDLINE INDUSTRIES, LP - Northfield
Moderate Sep 18, 2024
Atellica IM CA 19-9 (250 Test - REF)-In vitro diagnostic use in the quantitative measurement of the CA 19-9 tumor-associated antigen in human serum u…
Siemens Healthcare Diagnostics, Inc.
Moderate Sep 18, 2024
Medline convenience kits containing semi-rigid suction liners labeled as follows: NICU ADMIT KIT, Pack Number DYKA1014G
MEDLINE INDUSTRIES, LP - Northfield
Moderate Sep 18, 2024
Medline Convenience kits labeled as: 1) PREP TRAY, Pack Number DYNDA1540; 2) STERILE PREP TRAY , Pack Number DYNDA2499; 3) ED PREP TRAY, Pack …
MEDLINE INDUSTRIES, LP - Northfield
Moderate Sep 18, 2024
Medline Convenience kits labeled as: 1) CHEST TUBE TRAY , Pack Number CHT2120; 2) CHEST TUBE INSERTION TRAY , Pack Number DYNDA2475; 3) CHEST …
MEDLINE INDUSTRIES, LP - Northfield
Moderate Sep 18, 2024
Medline Convenience kits labeled as: PUH ESOPHAGECTOMY CDS, Pack Number CDS984309I
MEDLINE INDUSTRIES, LP - Northfield
Moderate Sep 18, 2024
Brand Name: PROBEAT Product Name: PROBEAT-V Model/Catalog Number: N/A Software Version: N/A Product Description: The PROBEAT-V is a proton beam i…
Hitachi America, Ltd., Particle Therapy Division
Moderate Sep 18, 2024
Medline Convenience kits labeled as: 1) CATH LAB SPECIAL PROCEDURE, Pack Number 00-RDF036O; 2) CATH LAB SPECIAL PROCEDURE, Pack Number 00-RDF036OH…
MEDLINE INDUSTRIES, LP - Northfield
Moderate Sep 18, 2024
Medline convenience kits labeled as: 1) ANGIOGRAPHY DRAPE PACK, Pack Number 00-398281J ; 2) ANGIOGRAPHY DRAPE PACK, Pack Number 00-398650AG; 3) A…
MEDLINE INDUSTRIES, LP - Northfield
Moderate Sep 18, 2024
FILMARRAY 2.0 INSTRUMENT, REF: FLM2-ASY-0001, FLM2-ASY-0001-W
BioFire Diagnostics, LLC
Moderate Sep 18, 2024
Medline Convenience kits labeled as: 1) ANGIOGRAPHY DRAPE PACK, Pack Number 00-401327AA; 2) CORONARY ANGIO PACK-LF, Pack Number 00-401594R ; 3) I…
MEDLINE INDUSTRIES, LP - Northfield
Moderate Sep 18, 2024
Medline convenience kits containing semi-rigid suction liners labeled as follows: a) OPEN HEART KIT,ALTA BATES HOSP, Pack Number DYK1002174I; b)…
MEDLINE INDUSTRIES, LP - Northfield
Moderate Sep 18, 2024
25-LHP-828, HeNe Laser System, 35 mW
PACIFIC LASERTECH, LLC
Moderate Sep 18, 2024
Medline Convenience kits labeled as: 1) MYELOGRAM PACK, Pack Number 00-399025L ; 2) BIOPSY PROCEDURE PACK , Pack Number 00-399227G ; 3) BIOPSY PR…
MEDLINE INDUSTRIES, LP - Northfield
Moderate Sep 18, 2024
Medline Convenience kits, labeled as: 1) BLOOD CULTURE COLLECTION KIT, Pack Number BP115; 2) NICU CNTRL LINE BLOOD DRAW KIT, Pack Number DYLAB1…
MEDLINE INDUSTRIES, LP - Northfield
Moderate Sep 18, 2024
Medline convenience kits labeled as: 1) PERMANENT PACING, Pack Number 00-400361J ; 2) NORTON CHILDRENS CATH LAB-LF, Pack Number 00-401185Q ; 3) P…
MEDLINE INDUSTRIES, LP - Northfield
Moderate Sep 18, 2024
Medline Convenience kits labeled as: 1) SYRINGE CNTRL 10ML RED L/L LP , Pack Number DYNJSYCPP10R ; 2) SYRINGE CNTRL 10ML YEL L/L LP , Pack Numbe…
MEDLINE INDUSTRIES, LP - Northfield
Moderate Sep 18, 2024
Medline Convenience kits labeled as: 1) PACK VAGINAL DELIVERY , Pack Number AM185B ; 2) LABOR & DELIVERY CDS, Pack Number CDS830039AF; 3) LABOR &…
MEDLINE INDUSTRIES, LP - Northfield
Moderate Sep 18, 2024
Medline Convenience kits labeled as: 1) ADULT DRAWER 5, Pack Number ACC010647A ; 2) TUBAL LIGATION CDS, Pack Number CDS760053K ; 3) CATARACT CDS,…
MEDLINE INDUSTRIES, LP - Northfield
Moderate Sep 18, 2024
Medline Convenience kits labeled as: 1) INFECTION DRIVELINE MANAGEMENT KIT, Pack Number DM645; 2) PICU LINE TRAY, Pack Number DYNDC1960A; 3) U…
MEDLINE INDUSTRIES, LP - Northfield
Moderate Sep 18, 2024
Guidewire 70cm x 1mm (0.038 ) REF 5583705 These accessories are intended for use with Bard 14.5 Fr. Long-Term Dual Lumen Hemodialysis Catheters. …
Bard Peripheral Vascular Inc
Moderate Sep 18, 2024
Medline Convenience kits, labeled as: BIOPSY TRAY-LF, Pack Number DYNDH1229
MEDLINE INDUSTRIES, LP - Northfield
Moderate Sep 18, 2024
ADVIA Centaur CA 19-9 (250 Test)-In vitro diagnostic use in the quantitative measurement of the CA 19-9 tumor-associated antigen in human serum using…
Siemens Healthcare Diagnostics, Inc.
Moderate Sep 18, 2024
Spacelabs Ultraview DM4 Vital Signs Monitor (all variations -M, -N, -MF, -NF, -MW, -NW, -MFW, -NFW), Model Number 91331
Zoe Medical Incorporated
Moderate Sep 18, 2024
Olympus Triangle Tip Electrosurgical Knives- to be used with Olympus endoscopes and electrosurgical units to cut tissue using high-frequency current …
Olympus Corporation of the Americas
Moderate Sep 18, 2024
Medline Convenience kits labeled as: 1) SYR CONTROL PAD 12ML L/L, Pack Number DYNJSYR12CP; 2) MSC - AHMC ANAHEIM REG MED CTR, Pack Number 148056…
MEDLINE INDUSTRIES, LP - Northfield
Moderate Sep 18, 2024
Medline Convenience kits labeled as: 1) OFFICE PACK FOR HYSTEROSCOPY, Pack Number C040100; 2) LAVH CDS, Pack Number CDS760049AD; 3) LAVH CDS, Pac…
MEDLINE INDUSTRIES, LP - Northfield
Moderate Sep 18, 2024
Medline Convenience kits labeled as: 1) OSTEOTOMY ORAL PROCEDURE, Pack Number CDS983010J ; 2) ORAL SURGERY PACK , Pack Number DYNJ00354K ; 3) …
MEDLINE INDUSTRIES, LP - Northfield
Moderate Sep 18, 2024
Medline Semi-rigid suction liners labeled as follows: a) SEMI RIGID SUCTION LINER, REF OR515; b) SEMI RIGID SUCTION LINER WITH TUBING, REF OR526K;…
MEDLINE INDUSTRIES, LP - Northfield
Moderate Sep 18, 2024
Medline Convenience kits, labeled as: 1) TRACH CDS-LF , Pack Number CDS983142B ; 2) MER TRACH CDS , Pack Number CDS984376B ; 3) Flexible LMA …
MEDLINE INDUSTRIES, LP - Northfield
Moderate Sep 18, 2024
Medline convenience kits containing semi-rigid suction liners labeled as follows: a) LAMINECTOMY CDS, Pack Number CDS981510L; b) ORTHO TRAUMA-LF, …
MEDLINE INDUSTRIES, LP - Northfield
Moderate Sep 18, 2024
Medline convenience kits containing semi-rigid suction liners labeled as follows: ANES TURNOVER KIT-LF, Pack Number DYNJAA10338J
MEDLINE INDUSTRIES, LP - Northfield
Moderate Sep 18, 2024
Medline Convenience kits labeled as: 1) GB GENERAL ENDO , Pack Number CDS984155G ; 2) BAPTIST FLOYD ENDO GI KIT , Pack Number DYKE1455B; 3) EN…
MEDLINE INDUSTRIES, LP - Northfield
Moderate Sep 11, 2024
ImpellaCP SmartAssistSetAPAC, Delo1895; Product Code: 1000302;
Abiomed, Inc.
Moderate Sep 11, 2024
Sevoflurane E_Vap.(Safety Filling adapter) used with the A9 Anesthesia System-Used to provide the vapor of an anesthetic agent with controllable conc…
Mindray DS USA, Inc. dba Mindray North America
Moderate Sep 11, 2024
Desflurane E_Vap.(Saf-T-Fill) used with the A9 Anesthesia System-Used to provide the vapor of an anesthetic agent with controllable concentration to …
Mindray DS USA, Inc. dba Mindray North America
Moderate Sep 11, 2024
Impella CP Pump 371 Set, Clinical Trial; Product Code: 0048-0040;
Abiomed, Inc.