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 the agency’s own highest classification or reported deaths or serious injuries, 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

25851–25875 of 27722

HighFDA (Devices)·Z-0182-2014·2013-11-20
Urologix Recalls Prostiva RF Therapy Hand Piece Kits Due to Deployment Force Issue
Urologix is recalling 142 Prostiva RF Therapy Hand Piece Kits because the hand piece deployment force exceeded maximum specifications.
Product
Prostiva RF Therapy Hand Piece Kit, REF 8929, Rx only, sterilized using Ethylene Oxide. The Prostiva RF Model 8929 Hand Piece Kit is the delivery system component of the Prostiva RF Therapy System. Prostiva RF Therapy delivers low-levels of radiofrequency (RF) energy directly…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0192-2014·2013-11-20
DePuy Mitek FMS Outflow Tubing Recalled Due to Valve Malfunction
DePuy Mitek is recalling FMS Outflow Tubing because the pillow valve may not perform as intended, potentially leading to backflow of irrigation fluid and patient cross-contamination.
Product
DePuy Mitek FMS Outflow Tubing with One-Way valve Product Code:284649 Product Usage: The Intermediary Tubing for FMS¿ Fluid Management Systems connects the Inflow Tubing to the arthroscopic sheath during arthroscopic procedures. The Polyvinyl Chloride (PVC) tubing…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0284-2014·2013-11-20
Hospira Recalls Plum A+ Infusion Systems Due to Broken Pressure Sensor Pin
Hospira is recalling 10,669 Plum A+ Infusion Systems because the distal pressure sensor pin may break. This defect can prevent the device from detecting occlusions in the administration set.
Product
The Plum A+ Infusion System is a cassette based multifunction infusion system that allows two lines in and one line out and can be used for standard, piggyback, or concurrent delivery. The Plum A+ Infusion System is designed to deliver parenteral, enteral, or epidural infusions…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0275-2014·2013-11-20
DeRoyal Surgical Eye Spears Recalled for Incorrect X-Ray Detectability Labeling
DeRoyal Industries is recalling one lot of Surgical Eye Spears because they were labeled as x-ray detectable but contained non-detectable product.
Product
DeRoyal (R) Surgical Eye Spears, REF 30-049, Sterile EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, MADE IN GUATEMALA cleaning of fluids from surgical site in or near the eye
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0282-2014·2013-11-20
Draeger Ceiling Supply Units Recalled Due to Broken Drive Screw
Draeger Medical is recalling 139 Movita 603x/DVE 803x Ceiling Supply Units because a broken drive screw caused the lift arm to fall.
Product
Draeger Movita 603x/DVE 803x Ceiling Supply Unit. It is intended for use in operating theaters and intensive care
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0270-2014·2013-11-20
GE Healthcare Recalls AW Workstations Due to Image Orientation Error
GE Healthcare is recalling AW VolumeShare and AW Server software due to a potential safety issue where images may display in the wrong orientation after rotation.
Product
AW VolumeShare 4 (ADVANTAGE WORKSTATION 4.3.), AW VolumeShare 5 (AW VOLUMESHARE 5 WITH ANGIOVIZ OPTION), AW Server. K052995: Advantage Workstation 4.3 is a review station, which allows easy selection, review, processing and filming of multi-modality DICOM images from a…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0291-2014·2013-11-20
Beckman Coulter Recalls Access 2 Immunoassay System Due to Fuse Defect
Beckman Coulter is recalling the Access 2 Immunoassay System because the fuses may have the wrong amperage.
Product
Access 2 Immunoassay System, Part Number: 81600N The Access Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0203-2014·2013-11-20
Hospira Recalls Plum A+ Hyperbaric Infusion Pumps Due to Calibration Drift
Hospira is recalling 179 Plum A+ Hyperbaric Infusion Pumps because distal pressure sensor calibration drift may cause false alarms or occlusions.
Product
Plum A+ Hyperbaric Infusion Pump; List Number 11005; Labeled in part: PLUM A+ HYPERBARIC; Product Usage: The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0204-2014·2013-11-20
Infusion pumps are recalled for distal pressure sensor drift
Hospira recalled 10,669 Plum A+ infusion pumps after reports of distal pressure sensor calibration drift. The issue may cause false occlusion alarms or distal occlusions.
Product
Plum A+ Infusion Pump; List Number: 11971; Product Usage: The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0172-2014·2013-11-20
Siemens Artis zee X-ray Systems Recalled for Collimator Filter Dislocation
Siemens Medical Solutions is recalling 17 Artis zee X-ray systems because a scatter radiation filter inside the card collimator may dislocate.
Product
Artis zee systems x-ray, angiographic system
Category
Medical Device
Distribution
14 states
HighFDA (Devices)·Z-0207-2014·2013-11-20
Hospira Recalls Plum A+ Infusion Pumps Due to Pressure Sensor Calibration Drift
Hospira is recalling 182,970 Plum A+ Infusion Pumps because pressure sensor calibration drift may cause false alarms or missed occlusions.
Product
Plum A+ Infusion Pump; List Number: 12391; Product Usage: The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0290-2014·2013-11-20
Hospira Recalls Plum A+ Infusion Systems Due to Broken Sensor Pin Risk
Hospira Inc. is recalling Plum A+ Infusion Systems because the distal pressure sensor pin may break, potentially preventing the detection of line occlusions.
Product
The Plum A+ Infusion System is a cassette based multifunction infusion system that allows two lines in and one line out and can be used for standard, piggyback, or concurrent delivery. The Plum A+ Infusion System is designed to deliver parenteral, enteral, or epidural infusions…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0289-2014·2013-11-20
Hospira Recalls Plum A+3 Infusion Systems Due to Broken Sensor Pin Risk
Hospira is recalling 21,551 Plum A+3 Infusion Systems because a distal pressure sensor pin may break, potentially preventing the detection of line occlusions.
Product
The Plum A+3 Infusion System is a cassette based multifunction infusion system that allows two lines in and one line out and can be used for standard, piggyback, or concurrent delivery. The Plum A+3 Infusion System is designed to deliver parenteral, enteral, or epidural…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0206-2014·2013-11-20
Hospira Recalls Plum A+3 Infusion Pumps Due to Pressure Sensor Drift
Hospira is recalling 214 Plum A+3 Infusion Pump Systems because distal pressure sensor calibration drift may cause false alarms or occlusions.
Product
Plum A+3 Infusion Pump System; List Number: 12348; Product Usage: The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0286-2014·2013-11-20
Hospira Recalls Plum A+3 Infusion Systems Due to Broken Pressure Sensor Pin
Hospira is recalling 214 Plum A+3 Infusion Systems because a pressure sensor pin may break, potentially preventing the detection of line occlusions.
Product
The Plum A+3 Infusion System is a cassette based multifunction infusion system that allows two lines in and one line out and can be used for standard, piggyback, or concurrent delivery. The Plum A+3 Infusion System is designed to deliver parenteral, enteral, or epidural…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0197-2014·2013-11-20
Baxter Recalls SIGMA SPECTRUM Infusion Pumps Due to Alarm Issues
Baxter Healthcare is recalling SIGMA SPECTRUM Infusion Pumps because they may trigger false upstream occlusion or air-in-line alarms during use.
Product
SIGMA SPECTRUM Infusion Pump with Master Drug Library. Intended to be used for the controlled administration of intravenous fluids.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-0208-2014·2013-11-20
Hospira Recalls Plum A+ Infusion Pumps Due to Pressure Sensor Drift
Hospira is recalling 7,691 Plum A+ Infusion Pumps because pressure sensor calibration drift may cause false alarms or undetected occlusions.
Product
Plum A+ Infusion Pump; List Number: 12618; Product Usage: The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0279-2014·2013-11-20
Medtronic Activa Neurostimulators Recalled for Loss of Stimulation
Medtronic is recalling specific Activa rechargeable neurostimulators because they may lose stimulation when switching programs. Therapy can be restored using the Physician Recharge mode.
Product
Medtronic Activa PC, model 37601, and Activa RC, model 37612, Activa SC, models 37602 and 37603. Multi-program Rechargeable Neurostimulator for Deep Brain Stimulation.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0195-2014·2013-11-20
Terumo Recalls Sarns Soft-Flow Aortic Cannulas Due to Particulate
Terumo is recalling 30 units of Sarns Soft-Flow Aortic Cannulas because loose fiber particulate was found during inspection.
Product
Sarns" Soft-Flow¿ Aortic Cannula without Suture Flange, straight tip, wire-reinforced with luer port, aortic cannula, 8.0 mm (24 Fr) OD with 3/8" connector, 14" (36 cm) long. Indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery.
Category
Medical Device
Distribution
9 states
HighFDA (Devices)·Z-0285-2014·2013-11-20
Hospira Recalls Plum A+ Infusion Systems Due to Broken Sensor Pin Risk
Hospira is recalling 71 Plum A+ Infusion Systems because a pressure sensor pin may break, potentially preventing the detection of line occlusions.
Product
The Plum A+ Infusion System is a cassette based multifunction infusion system that allows two lines in and one line out and can be used for standard, piggyback, or concurrent delivery. The Plum A+ Infusion System is designed to deliver parenteral, enteral, or epidural infusions…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0269-2014·2013-11-20
Philips IntelliSpace PACS 4.4 Software Recall for Image Storage Defect
Philips is recalling IntelliSpace PACS 4.4 software due to a timing issue that may prevent the system from storing additional images, potentially affecting clinical diagnoses.
Product
Philips brand IntelliSpace PACS 4.4, Image Management System; The system is a software package used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment. Product is manufactured…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0191-2014·2013-11-20
DePuy Mitek FMS Intermediary Tubing Recalled Due to Valve Malfunction
DePuy Mitek is recalling FMS Intermediary Tubing with One-Way Valve because the pillow valve may not perform as intended, potentially leading to patient cross-contamination.
Product
DePuy Mitek FMS Intermediary Tubing with One-Way valve Product Code: 281142 Product Usage: The Intermediary Tubing for FMS¿ Fluid Management Systems connects the Inflow Tubing to the arthroscopic sheath during arthroscopic procedures. The Polyvinyl Chloride (PVC) tubing…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0283-2014·2013-11-20
Hospira Recalls Plum A+ Infusers Due to Broken Pressure Sensor Pin
Hospira Inc. is recalling 179 Plum A+ Hyperbaric Infusion Systems because the distal pressure sensor pin may break, potentially preventing the detection of line occlusions.
Product
The Plum A+ Hyperbaric Infusion System is a cassette based multifunction infusion system that allows two lines in and one line out and can be used for standard, piggyback, or concurrent delivery. The Plum A+ Hyperbaric Infusion System is designed to deliver parenteral, enteral…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0287-2014·2013-11-20
Hospira Recalls Plum A+ Infusion Systems Due to Broken Sensor Pin Risk
Hospira Inc. is recalling 182,971 Plum A+ Infusion Systems because a distal pressure sensor pin may break, potentially preventing the detection of line occlusions.
Product
The Plum A+ Infusion System is a cassette based multifunction infusion system that allows two lines in and one line out and can be used for standard, piggyback, or concurrent delivery. The Plum A+ Infusion System is designed to deliver parenteral, enteral, or epidural infusions…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0288-2014·2013-11-20
Hospira Recalls Plum A+3 Infusion Systems Due to Broken Sensor Pin Risk
Hospira is recalling 7,692 Plum A+3 Infusion Systems because a pressure sensor pin may break, potentially preventing the detection of line occlusions.
Product
The Plum A+3 Infusion System is a cassette based multifunction infusion system that allows two lines in and one line out and can be used for standard, piggyback, or concurrent delivery. The Plum A+3 Infusion System is designed to deliver parenteral, enteral, or epidural…
Category
Medical Device
Distribution
Distributed nationwide

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25851–25875 of 27722