FDA Medical Devices
U.S. Food and Drug Administration — Medical device recalls
26,000 recalls · Page 52 of 520
Moderate Oct 30, 2024
smiths medical portex, Thermovent 1200, 15mm/22mm: a) REF 100/582/000; b) REF 100/582/000JP; c) REF 100/582/000JS
Smiths Medical ASD Inc.
Moderate Oct 30, 2024
Medline DIALYSIS PACK, REF DYNJ36932A; medical procedure convenience kit
MEDLINE INDUSTRIES, LP - Northfield
Moderate Oct 30, 2024
Centurion EP LAB INSTRUMENT KIT, REF MNS10480; medical procedure convenience kit
MEDLINE INDUSTRIES, LP - Northfield
Moderate Oct 30, 2024
bk3000, model #2300-11; bk3500, model #2300-41; bk5000, model #2300-61; and bkActive 2300, model #2300-66, ultrasound system with battery option.
B-K Medical A/S
Moderate Oct 30, 2024
medex TranStar KIDS KIT 7INCH CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA, Product Code REF MX9547
Smiths Medical ASD, Inc.
Moderate Oct 30, 2024
Medline CENTRAL CATHETER INSERTION TRA, REF CVI680C; medical procedure convenience kit
MEDLINE INDUSTRIES, LP - Northfield
Critical Oct 30, 2024
Aespire 7100, 7100 (Variant), and Aespire 7100 S/5 Protiva configurations. These anesthesia gas machines are intended to provide general inhalation a…
Datex-Ohmeda, Inc.
Moderate Oct 30, 2024
Baxter Operating Table TruSystem 7000 V, Product code REF 1841050
Baxter Healthcare Corporation
Moderate Oct 30, 2024
ENT RES 100 ML Non-Sterile W CLAMP, TUBING FLAG, & FEMALE LUER, Product Code 68-2230-28
Smiths Medical ASD Inc.
Moderate Oct 30, 2024
Medline TUBAL LIGATION PACK, REF DYNJ66230B; medical procedure convenience kit
MEDLINE INDUSTRIES, LP - Northfield
Moderate Oct 30, 2024
Medline brand medical procedure convenience kits, labeled as: 1) THORACENTESIS TRAY, REF 00-400616J; 2) HH PACK SONICATION SPEC CONTAI, REF 3706WHST…
MEDLINE INDUSTRIES, LP - Northfield
Moderate Oct 30, 2024
Soltive Premium SuperPulsed Laser - Intended for incision, excision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue, …
Olympus Corporation of the Americas
Moderate Oct 30, 2024
medex TranStar KIDS KIT 34IN. CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA, Product Code REF MX9545
Smiths Medical ASD, Inc.
Moderate Oct 30, 2024
Baxter Operating Table TruSystem 7000, Product code REF 1841046
Baxter Healthcare Corporation
Moderate Oct 30, 2024
Centurion PEDIATRIC/ADULT TRACHEOSTOMY T, REF TC7895; medical procedure convenience kit
MEDLINE INDUSTRIES, LP - Northfield
Moderate Oct 30, 2024
medex TranStar Patient Mount Monitoring Kit 10/EA, Product Code REF MX9501T
Smiths Medical ASD, Inc.
Moderate Oct 30, 2024
medex TranStar MONITORING SET W/SAMPLING PORT 10/EA, Product Code REF MXG300260
Smiths Medical ASD, Inc.
Moderate Oct 30, 2024
STERILIZABLE INTERNAL DEFIBRILLATION PADDLES REF LP20 STERILIZABLE INTERNAL DEFIBRILLATION PADDLES REF LP15 Defibrillation is indicated for the t…
Physio-Control, Inc.
Moderate Oct 30, 2024
medex TranStar KIDS KIT 10IN. CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA, Product Code REF MX9548
Smiths Medical ASD, Inc.
Moderate Oct 30, 2024
Medline brand, medical procedure convenience kits, labeled as: a) RADIOLOGY LP TRAY, REF DYNDH1609; b) CARDIAC CATH PACK-LF, REF DYNJ19010I; c…
MEDLINE INDUSTRIES, LP - Northfield
Moderate Oct 30, 2024
medex TranStar DPT w/Two Stopcocks 10/EA, Product Code REF MX950X2SC
Smiths Medical ASD, Inc.
Moderate Oct 30, 2024
Medtronic Percept RC Implantable Neurostimulators (INS), Model B35300.
Medtronic Neuromodulation
Moderate Oct 30, 2024
Baxter Operating Table TruSystem 7000 (dV), Product code REF 1841049
Baxter Healthcare Corporation
Moderate Oct 30, 2024
Medline brand medical procedure convenience kits, labeled as: a) UNIVERSAL DRAPE PACK, REF DYNJ44114; b) DRAPE PACK, REF DYNJ82663B
MEDLINE INDUSTRIES, LP - Northfield
Moderate Oct 30, 2024
medex TranStar 84in (213cm) Single Monitoring Kit 10/EA, Product Code REF MX9505T
Smiths Medical ASD, Inc.
Moderate Oct 30, 2024
AD-TECH Spencer Probe Depth Electrode, REF SD04R-AP58X-000 4-Contact 1.12mm (A style) Depth Electrode
Ad-Tech Medical Instrument Corporation
Moderate Oct 30, 2024
medex TranStar 60in (152cm) Single Monitoring Kit 10/EA, Product Code REF MX9504T
Smiths Medical ASD, Inc.
Moderate Oct 30, 2024
(1) Centurion Sterile CirClamp, Reorder #200CR; (2) Centurion CirClamp with 1.1cm Bell and Insert, Reorder #210CR, Sterile; (3) Centurion CirClamp …
MEDLINE INDUSTRIES, LP - Northfield
Moderate Oct 30, 2024
medex TranStar SINGLE 84IN SET WITH ANTI-SHUNT STOPCOCK 10/EA, Product Code REF MXG300243R1
Smiths Medical ASD, Inc.
Moderate Oct 30, 2024
Baxter Operating table TruSystem 7000 U (MB), Product codes: a) REF 1604786; b) REF 1604788; c) REF 1723633
Baxter Healthcare Corporation
Moderate Oct 30, 2024
CADD Medication Cassette Reservoir, 100mL, FS, YELLOW, Product Code 21-7300-24
Smiths Medical ASD Inc.
Moderate Oct 23, 2024
Leica Biosystems Cryostat Model Number CM1900, Material Numbers: a) 14045227382, b) 14901900100, c) 14901900700, d) 1491900UVU2; for freezing and se…
LEICA BIOSYSTEMS NUSSLOCH GMBH
Moderate Oct 23, 2024
MEDLINE KIT CV I II, REF DYNJ906071B
MEDLINE INDUSTRIES, LP - Northfield
Critical Oct 23, 2024
GE Heathcare Giraffe OmniBed; neo natal incubator
DATEX--OHMEDA, INC.
Moderate Oct 23, 2024
EVIS EXERA III Video System Center Model Number CV-190. Intended to be used with OLYMPUS camera heads, endoscopes, light sources, monitors, EndoThera…
Olympus Corporation of the Americas
Moderate Oct 23, 2024
basixTOUCH Inflation Device, REF: IN8130/JPC, IN8152/C, IN8302/C, IN8352/C, IN8802/C, IN8130/C, IN8130/C
Merit Medical Systems, Inc.
Moderate Oct 23, 2024
Melrose Wakefield Hospital REF K05T-2159 Injector And Syringe, Angiographic/Syringe, Balloon Inflation - The 30 ATM Monarch syringe is used to inf…
Merit Medical Systems, Inc.
Moderate Oct 23, 2024
MEDLINE OPEN HEART, REF DYNJ904261B
MEDLINE INDUSTRIES, LP - Northfield
Moderate Oct 23, 2024
MEDLINE OPEN HEART PACK, REF DYNJ66216C
MEDLINE INDUSTRIES, LP - Northfield
Moderate Oct 23, 2024
IMMAGE Immunochemistry Systems IGM Immunoglobulin M Reagent REF 447610 IGM reagent, when used in conjunction with IMMAGE Immunochemistry Systems a…
Beckman Coulter Inc.
Moderate Oct 23, 2024
Leica Biosystems Cryostat Model Number CM1100, Material Number 14046931130, for freezing and sectioning tissue samples
LEICA BIOSYSTEMS NUSSLOCH GMBH
Moderate Oct 23, 2024
Custom Inflation Kit, REF: K05-00052M, K05-00053H, K05-00109G, K05-00137K, K05-00296L, K05-00399D, K05-00404C, K05-00410G, K05-00438G, K05-00502F, K0…
Merit Medical Systems, Inc.
Moderate Oct 23, 2024
Brand Name: NOVA ORTHO-MED INC. Product Name: MONARCH ROLLATOR RED Model/Catalog Number: 4329RD Product Description: ROLLING WALKER MOBILITY AID
Nova Ortho-Med Inc
Moderate Oct 23, 2024
Cue Health COVID-19 Test Cartridge REF 2900005 Cue COVID-19 Test Cue COVID-19 Test for Home and Over The Counter (OTC)
CUE HEALTH INC
Moderate Oct 23, 2024
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM EVAL - ZERO COST US; the system utilizes an interactive display to prov…
Boston Scientific Corporation
Moderate Oct 23, 2024
basixSKY Inflation Device, REF: SKY1802
Merit Medical Systems, Inc.
Moderate Oct 23, 2024
Monarch Inflation Device 30 atm/bar MAP152 AssessPLUS Large Bore Hemostasis Valve Metal Insertion Tool Torque Device REF IN2530 Injector And Syrin…
Merit Medical Systems, Inc.
Moderate Oct 23, 2024
MEDLINE HEART CABG CDS, REF CDS983376R
MEDLINE INDUSTRIES, LP - Northfield
Low Oct 23, 2024
Beckman Coulter IRISPEC CA/CB/CC Urine Chemistry Controls, Catalog Number REF 800-7211 and 800-7702, in vitro diagnostic device.
Beckman Coulter, Inc.
Moderate Oct 23, 2024
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + INT SYSTEM - ZERO COST JAPAN; the system utilizes an interactive display to provid…
Boston Scientific Corporation