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

37076–37100 of 40325

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
ModerateFDA (Devices)·Z-0239-2014·2013-11-20
Carestream Vue PACS Software Recall for Image Loading Issues
Carestream Health is recalling Vue PACS software because specific multi-slice images may fail to load in the viewer application.
Product
Carestream Vue PACS; MX WEB SVR W/3 MX-O LIC < 75K EXAMS The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute…
Category
Medical Device
Distribution
26 states
ModerateFDA (Devices)·Z-0189-2014·2013-11-20
Baxter Recalls SIGMA SPECTRUM Infusion Pump LCD Screens for Discharge Failure
Baxter Healthcare is recalling 346 SIGMA SPECTRUM Infusion Pump LCD screens that failed to withstand electrostatic discharge.
Product
SIGMA SPECTRUM Infusion Pump with Master Drug Library component (SHARP LCD screen, 55074-2 revision B) Product Usage: Intended to be used as a visual aid during the controlled administration of intravenous fluids. These fluids may include pharmaceutical drugs, blood, blood…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0228-2014·2013-11-20
Carestream Vue PACS Software Recall for Image Loading Defect
Carestream Health is recalling Vue PACS software because a defect may prevent some CT and MR images from loading into the viewer under specific conditions.
Product
Carestream Vue PACS; UNLIMITED READING LIC ADD 10K EX/YR The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute…
Category
Medical Device
Distribution
26 states
ModerateFDA (Devices)·Z-0210-2014·2013-11-20
Integra LifeSciences Recalls Mayfield Skull Clamps Due to Locking Issues
Integra LifeSciences is recalling 37 Mayfield Skull Clamps because the locking knob may not unlock easily or the torque knob may malfunction.
Product
Composite Series Skull Clamp, one clamp per tote. The MAYFIELD¿ Skull Clamp (A3059) is a cranial stabilization device, designed to provide rigid skeletal fixation. The Skull Clamp is placed on the patient's skull to hold their head and neck securely in a particular position…
Category
Medical Device
Distribution
14 states
ModerateFDA (Devices)·Z-0243-2014·2013-11-20
Carestream Vue PACS Software Recall for Image Loading Defect
Carestream Health is recalling Vue PACS software because specific multi-slice images may fail to load in the viewer application.
Product
Carestream Vue PACS; UPG MX-O SVR 15K EX/YR UNLIMITED The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve…
Category
Medical Device
Distribution
26 states
ModerateFDA (Devices)·Z-0226-2014·2013-11-20
Carestream Vue PACS Software Recall for Image Loading Issues
Carestream Health is recalling Vue PACS software versions 11.3.2.0, 11.3.2.4, and 11.4 because specific multi-slice images may fail to load in the viewer.
Product
Carestream Vue PACS; UNLIMITED READING LIC < 25K EX/YR The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute…
Category
Medical Device
Distribution
26 states
ModerateFDA (Devices)·Z-0260-2014·2013-11-20
Carestream Vue PACS Software Recall for Image Loading Issues
Carestream Health is recalling Vue PACS software versions 11.3.2.0, 11.3.2.4, and 11.4 because a defect may prevent some CT and MR images from loading in the viewer.
Product
Carestream Vue PACS; UPG MX-RAD SVR 75K EX/YR UNLIMITED The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute…
Category
Medical Device
Distribution
26 states
ModerateFDA (Devices)·Z-0225-2014·2013-11-20
Carestream Vue PACS Software Recall for Image Loading Issues
Carestream Health is recalling Vue PACS software because specific multi-slice images may fail to load in the viewer application.
Product
Carestream Vue PACS; MX WEB SVR W/3 MX-RAD LIC<15K EXAMS The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute…
Category
Medical Device
Distribution
26 states
ModerateFDA (Devices)·Z-0194-2014·2013-11-20
Terumo Recalls Sarns Soft-Flow Aortic Cannulas Due to Particulate
Terumo CVS is recalling 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, 7.0 mm (21 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
ModerateFDA (Devices)·Z-0245-2014·2013-11-20
Carestream Vue PACS Software Recall for Image Loading Defect
Carestream Health is recalling Vue PACS software because a defect may prevent some CT and MR images from loading in the viewer under specific conditions.
Product
Carestream Vue PACS; UPG MX-O SVR 25K EX/YR UNLIMITED The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve…
Category
Medical Device
Distribution
26 states
ModerateFDA (Devices)·Z-0227-2014·2013-11-20
Carestream Vue PACS Software Recall for Image Loading Issues
Carestream Health is recalling Vue PACS software because specific multi-slice images may fail to load in the viewer application.
Product
Carestream Vue PACS; UNLIMITED READING LIC < 50K EX/YR The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute…
Category
Medical Device
Distribution
26 states
ModerateFDA (Devices)·Z-0247-2014·2013-11-20
Carestream Vue PACS Software Recall for Image Loading Issues
Carestream Health is recalling Vue PACS software because specific multi-slice images may fail to load in the viewer application.
Product
Carestream Vue PACS; MX WEB SW/ 1 MX-O CONCUR ACCESS LIC The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute…
Category
Medical Device
Distribution
26 states
ModerateFDA (Devices)·Z-0256-2014·2013-11-20
Carestream Vue PACS Software Recall for Image Loading Issues
Carestream Health is recalling Vue PACS software because specific multi-slice images may fail to load in the viewer application.
Product
Carestream Vue PACS; UPG MX-RAD SVR 7.5K EX/YR UNLIMITED The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute…
Category
Medical Device
Distribution
26 states
ModerateFDA (Devices)·Z-0276-2014·2013-11-20
OrthoPediatrics Recalls 3.5mm Locking Screws Due to Packaging Labeling Error
OrthoPediatrics Corp is recalling 3.5mm locking screws because the packaging description incorrectly identified them as 7.0mm screws, despite the correct part number.
Product
3.5MM LOCKING SCREW, T15 HEXALOBE, SELF TAPPING, 34MM The OrthoPediatrics Proximal Femur Plating System combines implants and instruments in one convenient system. This system offers the advantages of the osteotomy blade plates and cannulated instrumentation. Osteotomy plates…
Category
Medical Device
Distribution
1 state

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37076–37100 of 40325