Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means deaths or serious injuries are reported, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

Agency

All agencies FDA (Food)FDA (Drugs)FDA (Devices)USDA FSIS CPSC NHTSA EPA

151–175 of 582

CriticalFDA (Devices)·Z-0035-2026·2025-10-15
Infusion pump sets recalled over flow rate and occlusion alarm accuracy
CareFusion is recalling BD Alaris Pump Infusion Sets because the pump module used with them may perform outside established ranges for flow rate, bolus accuracy and occlusion alarm timing.
Product
BD Alaris Pump Infusion Sets for the following reference numbers: C24101E, Amber Tubing, 15 Micron Filter, 0.2 Micron Filter, SmartSite Y-Site 10015414, 180 Micron Filter 2447-0007, Ball Valve SmartSite Port (Burette) 2 SmartSites Y-Sites 24201-0007, 2 SmartSite Y-sites
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-0069-2026·2025-10-15
Heart pump controllers recalled over potential operating system cybersecurity vulnerabilities
Abiomed is recalling 10,153 Automated Impella Controllers over potential cybersecurity vulnerabilities related to the controller's operating system.
Product
Automated Impella Controller (AIC), used for left heart support blood pump, labeled as the following with corresponding Product Codes: 1. Impella Controller, Packaged, AU; Product Code: 0042-0000-AU. 2. Impella Controller, Packaged, CA; Product Code: 0042-0000-CA. 3. Impella
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-0028-2026·2025-10-15
Nitric oxide delivery systems recalled over dose fluctuations at low flow
NOxBOX is recalling 1,667 NOxBOXi Nitric Oxide Delivery Systems because delivered dose may fluctuate when total flow through the device sensor falls below its 0.5 LPM minimum.
Product
NOxBOXi Nitric Oxide Delivery System; Model Numbers: NOXBOX-I
Category
Medical Device
Distribution
1 state
CriticalFDA (Devices)·Z-0029-2026·2025-10-15
Nitric oxide systems recalled over fault from rapid button presses
NOxBOX is recalling 1,667 NOxBOXi Nitric Oxide Delivery Systems because a rapid succession of button selections can trigger an unexpected internal fault or system diagnostic error.
Product
NOxBOXi Nitric Oxide Delivery System; Model Numbers: NOXBOX-I
Category
Medical Device
Distribution
1 state
CriticalFDA (Devices)·Z-2666-2025·2025-10-08
MAGNETOM Verio Dot Upgrade systems recalled over magnet venting ice blockage
Siemens is recalling 78 MAGNETOM Verio Dot Upgrade systems because an ice blockage in the magnet venting system could stop helium escaping during a quench.
Product
MAGNETOM Verio Dot Upgrade. Model Number: 10684334.
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2610-2025·2025-10-08
Reprocessed steerable electrophysiology catheters recalled over residual particulates on surfaces
Medline is recalling 7,913 reprocessed Livewire Steerable Electrophysiology Catheters because specific lots may carry small residual particulates on patient-contacting surfaces.
Product
Reprocessed Livewire Steerable Electrophysiology Catheter Item Numbers 401575RH 401582RH 401600RH 401603RH 401606RH 401652RH 401653RH 401654RH 401904RH 401905RH 401908RH 401914RH 401915RH 401918RH 401932RH 401933RH 401934RH 401938RH 401939RH 401940RH 401941
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2659-2025·2025-10-08
MAGNETOM Prisma MRI systems recalled over helium venting ice blockage
Siemens is recalling 101 MAGNETOM Prisma MRI systems because an ice blockage in the magnet venting system could prevent helium escaping during a quench.
Product
MAGNETOM Prisma. Model Number: 10849582.
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2593-2025·2025-10-08
Surgical extremity packs recalled after being labeled sterile without sterilization
Medline is recalling 88 Extremity Pack convenience kits that were labeled as sterile but never went through the sterilization process.
Product
Sterile Medline Convenience Kits: 1) EXTREMITY PACK, Model Number: DYNJ45701B
Category
Medical Device
Distribution
4 states
CriticalFDA (Devices)·Z-2655-2025·2025-10-08
BIOGRAPH One scanner recalled over ice blockage in magnet venting system
Siemens is recalling one BIOGRAPH One (DE) system because an ice blockage in the magnet venting system could prevent helium escaping during a quench.
Product
BIOGRAPH One (DE). Model Number: 11689172.
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2665-2025·2025-10-08
MAGNETOM Verio Dot systems recalled over magnet venting ice blockage risk
Siemens is recalling 59 MAGNETOM Verio Dot systems because an ice blockage in the magnet venting system could stop helium escaping during a quench.
Product
MAGNETOM Verio Dot. Model Number: 10684333.
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2657-2025·2025-10-08
MRI scanner recalled over ice blockage in magnet helium venting system
A MAGNETOM Connectom.X MRI system is being recalled because an ice blockage in the magnet venting system could prevent helium from escaping during a quench.
Product
MAGNETOM Connectom.X. Model Number: 11371480.
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2616-2025·2025-10-08
Atlan A350 anesthesia workstations recalled after mechanical ventilation failures were reported
Draeger is recalling 530 Atlan A350 anesthesia workstations that either indicated a piston ventilator failure before use or suffered a mechanical ventilation failure during use.
Product
Brand Name: Atlan Product Name: Atlan A350 Model/Catalog Number: 8211500 Software Version: Not applicable Product Description: The Atlan is an anesthesia workstation intended for use in anesthetizing adults, pediatrics, and neonates. The device can be used for mechanical vent
Category
Medical Device
Distribution
25 states
CriticalFDA (Devices)·Z-2663-2025·2025-10-08
MAGNETOM Spectra MRI systems recalled over helium venting ice blockage
Siemens is recalling three MAGNETOM Spectra MRI systems because an ice blockage in the magnet venting system could prevent helium escaping during a quench.
Product
MAGNETOM Spectra as the following: 1. MAGNETOM Spectra. Model Number: 10837643. 2. MAGNETOM Spectra (CN). Model Number: 10655588.
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2614-2025·2025-10-08
Reprocessed ultrasound catheters recalled over residual particulates on patient contacting surfaces
Medline is recalling 7,913 reprocessed ACUSON AcuNav ultrasound catheters because specific lots may carry small residual particulates on patient-contacting surfaces.
Product
Reprocessed ACUSON AcuNav Ultrasound Catheter for intracardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart. For imaging guidance only, not treatment delivery, during cardiac interventio
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2664-2025·2025-10-08
MAGNETOM Verio MRI systems recalled over magnet venting ice blockage risk
Siemens is recalling 154 MAGNETOM Verio MRI systems because an ice blockage in the magnet venting system could stop helium escaping during a quench.
Product
MAGNETOM Verio. Model Number: 10276755.
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2592-2025·2025-10-08
Surgical convenience kits recalled after being labeled sterile without sterilization process
Medline is recalling 22 Major Pack L-F and LB Basic Custom Pack convenience kits that were labeled as sterile but never went through the sterilization process.
Product
Sterile Medline Convenience Kits: 1) MAJOR PACK L-F, Model Number: DYNJ0382730O; 2) LB BASIC CUSTOM PACK, Model Number: DYNJ61038B
Category
Medical Device
Distribution
4 states
CriticalFDA (Devices)·Z-2654-2025·2025-10-08
Biograph mMR scanners recalled over ice blockage in magnet venting
Siemens is recalling 27 Biograph mMR systems because an ice blockage in the magnet venting system could stop helium escaping during a quench.
Product
Biograph mMR. Model Number: 10433372.
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2660-2025·2025-10-08
MAGNETOM Skyra MRI systems recalled over ice blockage in venting system
Siemens is recalling 586 MAGNETOM Skyra (DE) MRI systems because an ice blockage in the magnet venting system could prevent helium escaping during a quench.
Product
MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2667-2025·2025-10-08
MAGNETOM Vida MRI systems recalled over ice blockage in magnet venting
Siemens is recalling 498 MAGNETOM Vida (DE) MRI systems because an ice blockage in the magnet venting system could stop helium escaping during a quench.
Product
MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2670-2025·2025-10-08
Surgical valve pack kits recalled after cannulas may not retain shape
Medline is recalling 828 VALVE PACK-LF kits because they contain lots of cannula products where the catheter may not retain its shape.
Product
Medline Kits: 1) VALVE PACK-LF, Model Number: DYNJ0415366P; 2) VALVE PACK-LF, Model Number: DYNJ0415366Q
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2612-2025·2025-10-08
Reprocessed electrophysiology catheters recalled over residual particulates on patient surfaces
Medline is recalling 7,913 reprocessed Inquiry Steerable Diagnostic Catheters because specific lots may carry small residual particulates on patient-contacting surfaces.
Product
Reprocessed Inquiry Steerable Diagnostics Catheter for electrogram recording and cardiac stimulation during diagnostic electrophysiologic studies; Medline Item Numbers 81102RH 81104RH 81107RH 81174RH 81402RH 81404RH 81405RH 81472RH 81473RH 81474RH 81531RH 81532RH
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2661-2025·2025-10-08
MAGNETOM Skyra fit MRI systems recalled over magnet vent ice blockage
Siemens is recalling 56 MAGNETOM Skyra fit MRI systems because an ice blockage in the magnet venting system could stop helium escaping during a quench.
Product
MAGNETOM Skyra fit. Model Number: 10849580.
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2617-2025·2025-10-08
Atlan A350XL anesthesia workstations recalled after piston ventilator failures during use
Draeger is recalling 223 Atlan A350XL anesthesia workstations that either indicated a piston ventilator failure before use or suffered a mechanical ventilation failure during use.
Product
Brand Name: Atlan Product Name: Atlan A350XL Model/Catalog Number: 8621600 Software Version: Not Applicable Product Description: The Atlan is an anesthesia workstation intended for use in anesthetizing adults, pediatrics, and neonates. The device can be used for mechanical ve
Category
Medical Device
Distribution
25 states
CriticalFDA (Devices)·Z-2613-2025·2025-10-08
Reprocessed cardiac imaging catheters recalled over residual particulates on device surfaces
Medline is recalling 7,913 reprocessed ViewFlex Xtra ICE catheters because specific lots may carry small residual particulates on patient-contacting surfaces.
Product
Reprocessed ViewFlex Xtra ICE Catheter to visualize cardiac structures; blood flow and other devices within the heart. Medline Item Numbers D087031RH
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2656-2025·2025-10-08
MAGNETOM Cima.X systems recalled over ice blockage in helium venting system
Siemens is recalling 22 MAGNETOM Cima.X (DE) systems because an ice blockage in the magnet venting system could prevent helium escaping during a quench.
Product
MAGNETOM Cima.X (DE). Model Number: 11647158.
Category
Medical Device
Distribution
Distributed nationwide

How to read this listing

Filters

151–175 of 582