Medical Devices Recalls
Medical device recalls including implants, diagnostic equipment, and surgical tools
27,372 recalls · Page 60 of 548
FDA Devices 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
FDA Devices 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.
FDA Devices 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
FDA Devices 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
FDA Devices 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
FDA Devices 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
FDA Devices 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
FDA Devices 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.
FDA Devices 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
FDA Devices 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
FDA Devices 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
FDA Devices Moderate Sep 18, 2024
Medline Convenience kits labeled as: PUH ESOPHAGECTOMY CDS, Pack Number CDS984309I
MEDLINE INDUSTRIES, LP - Northfield
FDA Devices 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
FDA Devices 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
FDA Devices 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
FDA Devices Moderate Sep 18, 2024
FILMARRAY 2.0 INSTRUMENT, REF: FLM2-ASY-0001, FLM2-ASY-0001-W
BioFire Diagnostics, LLC
FDA Devices 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
FDA Devices 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
FDA Devices Moderate Sep 18, 2024
25-LHP-828, HeNe Laser System, 35 mW
PACIFIC LASERTECH, LLC
FDA Devices 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
FDA Devices 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
FDA Devices 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
FDA Devices 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
FDA Devices 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
FDA Devices 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
FDA Devices 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
FDA Devices 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
FDA Devices Moderate Sep 18, 2024
Medline Convenience kits, labeled as: BIOPSY TRAY-LF, Pack Number DYNDH1229
MEDLINE INDUSTRIES, LP - Northfield
FDA Devices 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.
FDA Devices 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
FDA Devices 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
FDA Devices 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
FDA Devices 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
FDA Devices 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
FDA Devices 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
FDA Devices 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
FDA Devices 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
FDA Devices 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
FDA Devices 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
CPSC Moderate Sep 12, 2024
About 866,000 AirJet and HydroJet Spa Pumps Recalled Due to Fire Hazard; One Death Reported; Manufactured by Bestway and Sold with SaluSpa, Coleman, …
Bestway (Hong Kong) International Ltd., of China
FDA Devices Moderate Sep 11, 2024
ImpellaCP SmartAssistSetAPAC, Delo1895; Product Code: 1000302;
Abiomed, Inc.
FDA Devices 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
FDA Devices 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
FDA Devices Moderate Sep 11, 2024
Impella CP Pump 371 Set, Clinical Trial; Product Code: 0048-0040;
Abiomed, Inc.
FDA Devices Moderate Sep 11, 2024
Isoflurane 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
FDA Devices Critical Sep 11, 2024
Vivo 45 LS, pressure and volume ventilator capable of delivering continuous or intermittent ventilatory support for patients who require invasive or …
Breas Medical, Inc.
FDA Devices Moderate Sep 11, 2024
Impella 5.5 SmartAssist Set, JP; Product Code: 1000211;
Abiomed, Inc.
FDA Devices Moderate Sep 11, 2024
Pump 381 Pump Set (US); Product Code: 1000080;
Abiomed, Inc.
FDA Devices Moderate Sep 11, 2024
Impella 5.5 with SmartAssist Set, EU; Product Code: 0550-0002;
Abiomed, Inc.
FDA Devices Moderate Sep 11, 2024
Impella CP Smart Assist Set APAC; Product Code: 0048-0047;
Abiomed, Inc.