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

27351–27375 of 40357

ModerateFDA (Devices)·Z-1688-2017·2017-04-05
Siemens Syngo.x PACS Software Recalled for Addressing Multiple Issues
Siemens Medical Solutions is recalling 104 Syngo.x PACS systems to install software updates that address several unspecified issues.
Product
Syngo.x, Picture archiving and communication system Syngo via is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images. It can be used as a standalone device or together with a variety of cleared and unmodified syngo…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1694-2017·2017-04-05
Medtronic Recalls Single SynchroMed II Implantable Drug Infusion Pump
Medtronic is recalling one SynchroMed II implantable drug infusion pump in Illinois due to a programmer error code that prevented updates.
Product
SynchroMed II implantable drug infusion pump, Model 8637-40,
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-1689-2017·2017-04-05
Siemens Syngo.via Software Recall for Medical Image System Issues
Siemens Medical Solutions is recalling 104 units of Syngo.via picture archiving software to address several identified issues.
Product
Syngo.via, Picture archiving and communication system Syngo via is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images. It can be used as a standalone device or together with a variety of cleared and unmodified syngo…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1693-2017·2017-04-05
Baxter SIGMA Spectrum Infusion Pump Software Anomaly Recall
Baxter is recalling SIGMA Spectrum Infusion Pumps with Master Drug Library due to a software anomaly that may cause a Sharp Watchdog Timeout error.
Product
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library, Model #/Product Code 35700BAX2
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-1701-2017·2017-04-05
Biomet 3i Recalls Dental Implants Due to Potential Label Mismatch
Biomet 3i is recalling five units of LTX dental implants because a single part in the lot may not match the label due to a supplier error.
Product
BIOMET 3i LTX DENTAL IMPLANTS Model LTX610 (6x10mm) - Plastic tray within Tyvek tray within cardboard box; one (1) unit per box. Labeled Sterile"
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-1681-2017·2017-04-05
Merge Eye Care Systems Software Recall Due to Image Acquisition Failure
Merge Healthcare is recalling Eye Care Systems software because incompatible versions prevent the downloading or acquisition of new images.
Product
Merge Eye Care Systems, consisting of Merge Eye Station, Merge Eye Care PACS, and Merge Eye Station Import Utility (ESIU).
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1686-2017·2017-04-05
Focus Diagnostics Legionella IFA Substrate Slide Recalled for Regulatory Status
Focus Diagnostics is recalling Legionella IFA Substrate Slides because the device was found not to be 510(k) exempt.
Product
Legionella IFA Substrate Slide (IF0951) intended for qualitatively detecting and semi-quantitating human serum antibodies to Legionella pneumophila.
Category
Medical Device
Distribution
3 states
LowFDA (Devices)·Z-1685-2017·2017-04-05
Focus Diagnostics Legionella IFA Recalled for Regulatory Status Error
Focus Diagnostics is recalling Legionella IFA devices because the company discovered the product is not 510(k) exempt. The recall affects 196 units distributed to three testing laboratories.
Product
Legionella IFA (IF0950) intended for qualitatively detecting and semi-quantitating human serum antibodies to Legionella pneumophila.
Category
Medical Device
Distribution
3 states
LowFDA (Devices)·Z-1698-2017·2017-04-05
AGFA DX-D100 X-Ray System Recalled for Missing Allen Wrench Storage Instructions
AGFA Healthcare Corp. is recalling 308 DX-D100 Digital Radiography X-Ray Systems because the user manual did not specify where to store the Allen wrench used for manual movement.
Product
AGFA Digital Radiography X-Ray System DX-D100 DX-D100 is indicated for use in providing diagnostic quality images to aid the physician with diagnosis
Category
Medical Device
Distribution
35 states
SevereFDA (Devices)·Z-1505-2017·2017-03-29
Ohmeda Medical Recalls Giraffe Incubators Due to Power Cord Overheating
Ohmeda Medical is recalling Giraffe Incubators because certain power cords may overheat, posing a risk of fire or thermal injury.
Product
Giraffe Incubator Ohmeda Medical Giraffe Incubator-The Giraffe Incubator is an infant incubator. Incubators provide heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. They achieve this by providing an enclosed temperature…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1501-2017·2017-03-29
Ohmeda Giraffe Exam Light Recalled Due to Power Cord Overheating Risk
Ohmeda Medical is recalling Giraffe Exam Lights because certain power cords may overheat, posing a risk of fire, smoke, or thermal injury.
Product
Giraffe Exam Light The Exam Light illuminates body surfaces and facilitates patient observation during a medical examination. It increases ambient light to facilitate performance of procedures on the mattress field. It is designed to mount on the accessory railings of the…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1509-2017·2017-03-29
Ohmeda Medical Recalls Giraffe OmniBed Infant Incubators Due to Fire Risk
Ohmeda Medical is recalling Giraffe OmniBed infant incubators and warmers because certain power cords may overheat, posing a risk of fire or thermal injury.
Product
Giraffe OmniBed Ohmeda Medical Omnibed- The OmniBed is a combination of an infant incubator ( incubator ) and an infant radiant warmer ( warmer ). Incubators and warmers provide heat in a controlled manner to neonates who are unable to thermo-regulate based on their own…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1506-2017·2017-03-29
Ohmeda Infant Radiant Warmers Recalled for Power Cord Overheating Risk
Ohmeda Medical is recalling Giraffe and Panda infant radiant warmers because certain power cords may overheat, posing a fire or thermal injury risk.
Product
Giraffe Bedded Warmer, Panda Warmer Giraffe and Panda Warmer- Infant radiant warmers provide infrared heat in a controlled manner to neonates who are unable to thermoregulate based on their own physiology. Infant radiant warmers may be used to facilitate the neonate's…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1503-2017·2017-03-29
Ohmeda Medical Spot PT Lite Phototherapy System Recalled for Power Cord Fire Risk
Ohmeda Medical is recalling Spot PT Lite Phototherapy Systems because certain power cords could overheat, posing a risk of fire or thermal injury.
Product
Giraffe Spot PT Ohmeda Medical Spot PT Lite Phototherapy System- The Spot PT Lite Phototherapy System provides light therapy for the treatment of hyperbilirubinemia, commonly known as neonatal jaundice, during the newborn period in the hospital
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1504-2017·2017-03-29
Ohmeda Medical Recalls Giraffe OmniBed Infant Incubators Due to Fire Risk
Ohmeda Medical is recalling Giraffe OmniBed infant incubators and warmers because certain power cords may overheat, posing a risk of fire or thermal injury.
Product
Giraffe OmniBed Ohmeda Medical Giraffe OmniBed- The OmniBed is a combination of an infant incubator and an infant warmer. The device can be operated as an incubator or as a warmer and can transition from one mode to the other on user s demand. It cannot be operated in both…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1510-2017·2017-03-29
Ohmeda-Ohio CarePlus Incubator Recall Due to Power Cord Overheating Risk
Ohmeda Medical is recalling CarePlus Incubators because certain power cords may overheat, posing a risk of fire or thermal injury.
Product
CarePlus Incubator Ohmeda-Ohio CarePlus Incubator- Incubators provide a controlled thermal environment for neonates who are unable to provide their own thermoregulation. They may also be used for short periods of time to facilitate the neonate s transition from the uterus to…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1515-2017·2017-03-29
Medtronic Poly Component Trial Knee Implants Recalled for Cracked Dovetails
Medtronic is recalling Poly Component Trial knee implants because the dovetails were observed as cracked or broken.
Product
Poly Component Trial, CR, packaged in the following sizes and configurations: a) Poly Component Trial - CR 3x10, REF 90-SRK-160310 b) Poly Component Trial - CR 3x12, REF 90-SRK-160312 c) Poly Component Trial - CR 3x14, REF 90-SRK-160314 d) Poly Component Trial - CR 4x10…
Category
Medical Device
Distribution
2 states
SevereFDA (Devices)·Z-1502-2017·2017-03-29
Ohmeda Giraffe Incubator Recall Due to Power Cord Overheating Risk
Ohmeda Medical is recalling Giraffe Incubators because certain power cords may overheat, posing a fire or thermal injury risk.
Product
Giraffe Incubator The Giraffe Incubator is an infant incubator. Incubators provide heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. Incubators provide an enclosed temperature controlled environment
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1511-2017·2017-03-29
Ohmeda Infant Warmer System Recalled Due to Overheating Power Cords
Ohmeda Medical is recalling IWS Infant Warmer Systems because certain power cords may overheat, posing a fire and thermal injury risk.
Product
IWS Infant Warmer System-Infant radiant warmers provide infrared heat, in a controlled manner, to neonates who are unable to thermoregulate based on their own physiology or necessitate external heat to smoothen the transition from the uterus to the external environment. They…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1507-2017·2017-03-29
Ohmeda Infant Warmers Recalled Due to Power Cord Overheating Risk
Ohmeda Medical is recalling Giraffe and Panda infant radiant warmers because certain power cords may overheat, posing a fire or thermal injury risk.
Product
Giraffe Bedded Warmer, Panda Warmer Modification to Giraffe and Panda Warmers (Giraffe and Panda Uninterruptible Power Supply) - Infant radiant warmers provide infrared heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology.…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1508-2017·2017-03-29
Ohmeda Infant Radiant Warmers Recalled for Power Cord Overheating Risk
Ohmeda Medical is recalling Giraffe and Panda infant radiant warmers because certain power cords could overheat, posing a risk of fire or thermal injury.
Product
Giraffe Bedded Warmer, Panda Warmer Modifiction to Giraffe and Panda Warmer- Infant radiant warmers provide infrared heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. Infant radiant warmers may be used to facilitate the…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1520-2017·2017-03-29
CareFusion Alaris System PC Unit Recall for Battery Alarm Failure
CareFusion is recalling Alaris System PC units because low battery alarms may fail to trigger before the battery discharges, stopping all infusion channels.
Product
Alaris System PC unit, model no. 8000 and 8015. The central programming, monitoring and power supply component for the Alaris infusion pump System.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1498-2017·2017-03-29
Merge Eye Station Import Utility Recalled for System Lockup Risk
Merge Healthcare is recalling the Eye Station Import Utility software because system lockups may cause patient injury or delay diagnosis.
Product
Merge Eye Station Import Utility (ESIU). The firm name on the labeling is Merge Healthcare.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1517-2017·2017-03-29
Merge Healthcare Recalls Merge Cardio Software Due to Data Integrity Issues
Merge Healthcare is recalling Merge Cardio software versions 9.0 through 9.0.8 because users can merge device files with confirmed reports, potentially adding unverified information.
Product
Merge Cardio software. Product Usage: Merge Cardio is a system intended to be used to acquire, store, print, transfer, and archive clinical information including images, Hemodynamic studies and reports, measurements (via import from DICOM Structured Reporting, text files…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1499-2017·2017-03-29
Stanley Security Recalls 500 Arial Wireless Call Pendants
Stanley Security Solutions is recalling 500 Arial Wireless Water-Resistant Call Pendants because they were incorrectly programmed, which may prevent alarms from sounding when the button is pressed.
Product
Arial Wireless Water-Resistant Call Pendant The Arial Pendant tag is part of the Arial wireless emergency call management system. It enables residents in assisted living, skilled nursing or independent living to call staff with the press of a button.
Category
Medical Device
Distribution
Distributed nationwide

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27351–27375 of 40357