Browse recalls
Issuing authority: US FDA — Medical Devices
- 2024-10-31 · US FDA — Medical DevicesClass II
BACTEC 9240 System Version or Model: 445475 Catalog Number: 445475 - 2024-10-28 · US FDA — Medical DevicesClass II
smiths medical PORTEX Tracheal Tube Exchange Guide, 15Ch x 70cm, REF 14-504-68 and REF 14-504-68JP - 2024-10-28 · US FDA — Medical DevicesClass II
Galaxy System (GAL-001). Intended to provide bronchoscopic visualization of and access to patient airways for diagnosti - 2024-10-28 · US FDA — Medical DevicesClass II
smiths medical PORTEX Tracheal Tube Exchange Guide, 10Ch x 70cm, REF 14-504-76 - 2024-10-28 · US FDA — Medical DevicesClass II
smiths medical portex Venn Reusable Tracheal Tube Introducer, 15Ch x 60cm, REF 14-504-17 and REF 14-504-17JP - 2024-10-25 · US FDA — Medical DevicesClass II
Galaxy bronchoscope (Product GALB-001) used with Instructions for use, Part: 10000752, part of the Noah Medical Galaxy S - 2024-10-23 · US FDA — Medical DevicesClass II
MICRO-X Rover Mobile X-ray System, # MXU-RV19 - 2024-10-22 · US FDA — Medical DevicesClass II
MICRO-X Rover Mobile X-ray System, # MXU-RV35 - 2024-10-21 · US FDA — Medical DevicesClass I
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482; use in Peritoneal Dialysis - 2024-10-21 · US FDA — Medical DevicesClass I
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482S; use in Peritoneal Dialysis - 2024-10-21 · US FDA — Medical DevicesClass I
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4482; use in Peritoneal Dialysis - 2024-10-21 · US FDA — Medical DevicesClass I
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4483; use in Peritoneal Dialysis - 2024-10-21 · US FDA — Medical DevicesClass I
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4482E; use in Peritoneal Dialysis - 2024-10-14 · US FDA — Medical DevicesClass II
Defibtech DDP-2001: Adult Defibrillation Pads For use with AED Models: Lifeline View Auto, lifeline Pro, lifeline ECG, - 2024-10-11 · US FDA — Medical DevicesClass II
Hillrom Welch Allyn Vision Express Holter Analysis System; Electrocardiograph - 2024-10-11 · US FDA — Medical DevicesClass II
Hillrom Welch Allyn Q-Stress Cardiac Stress Testing System; cardiac stress test - 2024-10-11 · US FDA — Medical DevicesClass II
Hillrom Welch Allyn Diagnostic Cardiology Suite (formerly Connex Cardio); Diagnostic spirometer - 2024-10-09 · US FDA — Medical DevicesClass II
Autosampler, Models: SIL-40C XR CL, SIL-40C X3 CL - 2024-10-04 · US FDA — Medical DevicesClass II
Stryker Neptune SafeAir Rocker-Switch Smoke Evacuation Pencil, Coated, 70mm - Designed for general electrosurgical appli - 2024-10-04 · US FDA — Medical DevicesClass II
Stryker Neptune SafeAir Smoke Evacuation Pencil Non coated 70 mm Blade Push-Button - Designed for general electrosurgica - 2024-10-04 · US FDA — Medical DevicesClass II
Stryker Neptune SafeAir Rocker-Switch Smoke Evacuation Pencil, Non-coated, 70mm - Designed for general electrosurgical a - 2024-10-04 · US FDA — Medical DevicesClass II
Stryker Neptune SafeAir Smoke Evacuation Pencil Coated Rocker-Switch, Bulk Non-Sterile - Designed for general electrosur - 2024-10-04 · US FDA — Medical DevicesClass II
Stryker Neptune SafeAir Smoke Evacuation Pencil, Coated, 70mm Blade, Push Button Switch - Designed for general electrosu - 2024-10-04 · US FDA — Medical DevicesClass II
Stryker Neptune SafeAir Smoke Evacuation Pencil Coated Push-Button, Bulk Non-sterile - Designed for general electrosurgi - 2024-10-03 · US FDA — Medical DevicesClass II
DeRoyal CHILDREN'S LAPTRACEPACK, 89-9362.06 - 2024-10-03 · US FDA — Medical DevicesClass II
DeRoyal CHILDREN'S ORTHOPEDIC TRACEPACK, 89-9349-06 - 2024-10-03 · US FDA — Medical DevicesClass II
DeRoyal CHILDREN'S GENERAL TRACEPACK, REF 89-9342-06 - 2024-09-30 · US FDA — Medical DevicesClass II
Bard Marquee Disposable Core Biopsy Instrument Kit: BARD MARQUEE KIT 12G X 10 CM, REF: MQK1210; BARD MARQUEE 12G X 10 - 2024-09-27 · US FDA — Medical DevicesClass II
AVOXimeter 1000E, Product Number: AVOX1000E. The AVOXimeter 1000E is a battery-operated bedside whole blood oximeter. - 2024-09-25 · US FDA — Medical DevicesClass I
Monoject U-100 1 mL Insulin Syringe Luer-Lock with Tip Cap Soft Pack, REF 1188100777 - 2024-09-25 · US FDA — Medical DevicesClass I
Elekta Disposable Biopsy Needle Kit for Leksell Stereotactic System, REF 911933, Diameter / 14 Gauge, containing 6 inne - 2024-09-24 · US FDA — Medical DevicesClass II
medex Arterial Kit 1/EA, Product Code REF MX7827 - 2024-09-24 · US FDA — Medical DevicesClass II
smiths medical SurgiVet Advisor Tech Accessories, Product Code REF V2714 - 2024-09-24 · US FDA — Medical DevicesClass II
medex TranStar DPT w/Stopcock & 3cc Flush 10/EA, Product Code REF MX950SCFT - 2024-09-24 · US FDA — Medical DevicesClass II
medex TranStar Stopcock w/Ext. 10/EA, Product Code REF MXG300242 - 2024-09-24 · US FDA — Medical DevicesClass II
medex TRANSTAR MONITORING KIT 1/EA, Product Code REF MX20103R1 - 2024-09-24 · US FDA — Medical DevicesClass II
medex TranStar DPT w/Stopcock & 30cc Flush 10/EA, Product Code REF MX950SCNT - 2024-09-24 · US FDA — Medical DevicesClass II
medex TranStar KIDS KIT 7INCH CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA, Product Code REF MX9547 - 2024-09-24 · US FDA — Medical DevicesClass II
medex TranStar KIDS KIT 34IN. CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA, Product Code REF MX9545 - 2024-09-24 · US FDA — Medical DevicesClass II
medex TranStar Patient Mount Monitoring Kit 10/EA, Product Code REF MX9501T - 2024-09-24 · US FDA — Medical DevicesClass II
epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System, SMN 10736515 - 2024-09-24 · US FDA — Medical DevicesClass II
medex TranStar MONITORING SET W/SAMPLING PORT 10/EA, Product Code REF MXG300260 - 2024-09-24 · US FDA — Medical DevicesClass II
medex TranStar KIDS KIT 10IN. CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA, Product Code REF MX9548 - 2024-09-24 · US FDA — Medical DevicesClass II
medex TranStar DPT w/Two Stopcocks 10/EA, Product Code REF MX950X2SC - 2024-09-20 · US FDA — Medical DevicesClass II
Halyard KIT, SHOULDER - Medical convenience kits Model Number: ESJH014-06 - 2024-09-20 · US FDA — Medical DevicesClass II
Halyard PACEMAKER PACK - Medical convenience kits Model Number: MAMC223-08 - 2024-09-20 · US FDA — Medical DevicesClass II
Halyard KIT, CARDIAC ROBOTIC - Medical convenience kits Model Number: ESJH017-03 - 2024-09-20 · US FDA — Medical DevicesClass II
Halyard D & C PACK-CKC - Medical convenience kits Model Number: BMGT003-02 - 2024-09-20 · US FDA — Medical DevicesClass II
Halyard KIT, TOTAL KNEE - Medical convenience kits Model Number: ESJH012-07 - 2024-09-20 · US FDA — Medical DevicesClass II
Halyard PACEMAKER PK - Medical convenience kits Model Number: WKMC120-02 - 2024-09-20 · US FDA — Medical DevicesClass II
Halyard KIT, TOTAL KNEE - Medical convenience kits Model Number: EUOR002-05 - 2024-09-20 · US FDA — Medical DevicesClass II
Halyard CPT PEDS ADULT CH PACK - Medical convenience kits Model Number: SHAN431-07 - 2024-09-20 · US FDA — Medical DevicesClass II
Halyard OR ENDOVASCULAR TRAY - Medical convenience kits Model Number: SAMM048-15 - 2024-09-20 · US FDA — Medical DevicesClass II
Halyard OPEN HEART PACK MAIN - Medical convenience kits Model Number: ESJH003-02 - 2024-09-20 · US FDA — Medical DevicesClass II
Halyard MANIFOLD CATH PACK - Medical convenience kits Model Number: VMED005-03 - 2024-09-20 · US FDA — Medical DevicesClass II
Halyard UPPER EXTREMITY PACK - Medical convenience kits Model Number: PANJ002-02 - 2024-09-20 · US FDA — Medical DevicesClass II
Halyard CYSTO PDS - Medical convenience kits Model Number: GVVA002-05 - 2024-09-20 · US FDA — Medical DevicesClass II
Halyard TOTAL KNEE - Medical convenience kits Model Number: GRND008-09 - 2024-09-20 · US FDA — Medical DevicesClass II
Halyard RAD PACK - Medical convenience kits Model Number: VANW017-04 - 2024-09-20 · US FDA — Medical DevicesClass II
Halyard IR ABCESS DRAINAGE PACK - Medical convenience kits Model Number: AVMD018 - 2024-09-20 · US FDA — Medical DevicesClass II
Halyard CPT CARDIAC CATH PACK - Medical convenience kits Model Number: SHAN430-02 - 2024-09-20 · US FDA — Medical DevicesClass II
Halyard VAG HYSTERECTOMY BUNDLE PK - Medical convenience kits Model Number: LANC022-29 - 2024-09-20 · US FDA — Medical DevicesClass II
Halyard IVR VASCULAR PACK - Medical convenience kits Model Number: VAST027-08 - 2024-09-20 · US FDA — Medical DevicesClass II
Halyard IR BIOPSY PACK - Medical convenience kits Model Number: AVMD019-01 - 2024-09-20 · US FDA — Medical DevicesClass II
Halyard INTERVENTIONAL TRAY - Medical convenience kits Model Number: PSSC004-03 - 2024-09-20 · US FDA — Medical DevicesClass II
Halyard EYE PLASTIC TRAY - Medical convenience kits Model Number: SAMM054-19 - 2024-09-20 · US FDA — Medical DevicesClass II
Halyard POST PARTUM TUBAL LIGATION - Medical convenience kits Model Number: LANC026-19 - 2024-09-20 · US FDA — Medical DevicesClass II
Halyard SHOULDER PACK - Medical convenience kits Model Number: PANJ005 - 2024-09-20 · US FDA — Medical DevicesClass II
Halyard ENDOVASCULAR - Medical convenience kits Model Number: VMED008-02 - 2024-09-20 · US FDA — Medical DevicesClass II
Halyard ANTERIOR HIP PACK - Medical convenience kits Model Number: EUOR001-06 - 2024-09-20 · US FDA — Medical DevicesClass II
Halyard ANGIOGRAPHY PACK - Medical convenience kits Model Number: MAMC218-18 - 2024-09-20 · US FDA — Medical DevicesClass II
Halyard PACEMAKER DRAPE - Medical convenience kits Model Number: VAST020-06 - 2024-09-20 · US FDA — Medical DevicesClass II
Halyard ORAL SURGERY HEAD - Medical convenience kits Model Number: SAMM029-15 - 2024-09-20 · US FDA — Medical DevicesClass II
Halyard ANGIO PACK - Medical convenience kits Model Number: WRNM047-05 - 2024-09-20 · US FDA — Medical DevicesClass II
Halyard TAH-BUNDLE - Medical convenience kits Model Number: LANC039-29 - 2024-09-20 · US FDA — Medical DevicesClass II
Halyard ANGIO ARTERIOGRAM PACK - Medical convenience kits Model Number: MMCC004-01 - 2024-09-20 · US FDA — Medical DevicesClass II
Halyard KIT, TOTAL KNEE - Medical convenience kits Model Number: EUOR002-06 - 2024-09-20 · US FDA — Medical DevicesClass II
Halyard LOWER EXTREMITY PACK - Medical convenience kits Model Number: PANJ001-03 - 2024-09-20 · US FDA — Medical DevicesClass II
Halyard BASIC PROCEDURE PACK - Medical convenience kits Model Number: GRAN019-06 - 2024-09-20 · US FDA — Medical DevicesClass II
Halyard PACK, MINOR - Medical convenience kits Model Number: VMED018-02 - 2024-09-20 · US FDA — Medical DevicesClass II
Halyard EXTREMITY PACK - Medical convenience kits Model Number: MMOK009-03 - 2024-09-20 · US FDA — Medical DevicesClass II
Halyard PACEMAKER TRAY - Medical convenience kits Model Number: VMPB0003-10 - 2024-09-20 · US FDA — Medical DevicesClass II
Halyard SAMMC ANGIOGRAPHY - Medical convenience kits Model Number: SAMM066-15 - 2024-09-20 · US FDA — Medical DevicesClass II
Halyard KNEE ARTHROSCOPY PACK - Medical convenience kits Model Number: MAMC204-16 - 2024-09-20 · US FDA — Medical DevicesClass II
Halyard AORTA PACK - Medical convenience kits Model Number: ESJH004-02 - 2024-09-20 · US FDA — Medical DevicesClass II
Halyard ENT T AND A PACK - Medical convenience kits Model Number: EAMC106-02 - 2024-09-19 · US FDA — Medical DevicesClass II
AD-TECH Spencer Probe Depth Electrode, REF SD08R-AP58X-000 8-Contact 1.12mm (A style) Depth Electrode - 2024-09-18 · US FDA — Medical DevicesClass II
A1CNow+ Multi-Test HbA1c System consists of (1) a semi-disposable plastic-encased device (the monitor), (2) a plastic ca - 2024-09-17 · US FDA — Medical DevicesClass II
Saphena Medical Venapax XL- Endoscopic Vessel Harvesting System for use in minimally invasive surgery allowing access fo - 2024-09-17 · US FDA — Medical DevicesClass II
Cartesion Prime, Digital PET-CT, Model: PCD-1000A/3D.004, PCD-1000A/3D, is a diagnostic imaging system that combines Pos - 2024-09-16 · US FDA — Medical DevicesClass I
Phasitron5 Breathing Circuit (P5-10, P5-HC, P5-UC-10). component of Intrapulmonary Percussive Ventilation, used to provi - 2024-09-13 · US FDA — Medical DevicesClass III
17-OH Progesterone ELISA 96 well kit- An enzyme immunoassay for the quantitative in vitro diagnostic measurement of 17-O - 2024-09-13 · US FDA — Medical DevicesClass II
EZDilate Wire Guided Balloon- Indicated for use in adult and adolescent (> 12 years) populations to endoscopically dilat - 2024-09-12 · US FDA — Medical DevicesClass II
Abbott Alinity m HPV AMP Kit, used with the Alinity m System, product codes: a) REF 09N15-095; b) REF 09N15-090; c) REF - 2024-09-12 · US FDA — Medical DevicesClass II
Abbott Alinity m STI AMP Kit, used with the Alinity m System, product codes: a) REF 09N17-095; b) REF 09N17-090; c) REF - 2024-09-06 · US FDA — Medical DevicesClass II
Enterprise Imaging XERO Viewer- software application used for reference and diagnostic viewing of multispecialty medical - 2024-09-05 · US FDA — Medical DevicesClass II
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM EVAL - ZERO COST US; the system utilizes a - 2024-09-05 · US FDA — Medical DevicesClass II
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + INT SYSTEM - ZERO COST JAPAN; the system utilizes an - 2024-09-05 · US FDA — Medical DevicesClass II
NxTAG Respiratory Pathogen Panel +SARS-CoV-2, REF: I056C0468 - 2024-09-05 · US FDA — Medical DevicesClass II
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM JAPAN; the system utilizes an interactive