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

23776–23800 of 40175

SevereFDA (Devices)·Z-1560-2018·2018-05-16
Vyaire Medical Recalls AirLife Infant Resuscitation Devices Due to Mask Sticking
Vyaire Medical is recalling 4,640 AirLife Infant Resuscitation Devices because the mask may stick to the elbow, making it difficult or impossible to disconnect.
Product
AirLife Resuscitation, Infant, with mask, 40inch oxygen reservoir tubing, pressure-relief valve, Broselow Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1715-2018·2018-05-16
Datascope recalls Better Bladder device due to seal separation risk
Datascope is recalling the Better Bladder device because seal separation may cause balloon collapse and reduced blood flow in ECMO circuits.
Product
BEQ-TOP 24202 ADULT ECC, Catalog No. 701054295
Category
Medical Device
Distribution
13 states
SevereFDA (Devices)·Z-1563-2018·2018-05-16
Vyaire Medical Recalls AirLife Pediatric Resuscitation Devices Due to Mask Sticking
Vyaire Medical is recalling 2,340 AirLife Pediatric Resuscitation Devices because the mask may stick to the elbow, making it difficult or impossible to disconnect.
Product
AirLife Resuscitation, Pediatric, with mask, 28inch large bore tubing, pressure-relief valve Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1562-2018·2018-05-16
Vyaire Medical Recalls AirLife Resuscitation Devices Due to Mask Sticking
Vyaire Medical is recalling 8,100 AirLife Resuscitation devices because the mask may stick to the elbow, making it difficult to disconnect.
Product
AirLife Resuscitation, Adult, with mask, 28inch large bore tubing Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1725-2018·2018-05-16
Datascope recalls NICU ECC Pack custom tubing kits due to seal defect
Datascope is recalling specific NICU ECC Pack custom tubing kits because a seal defect may allow air to enter the device, potentially reducing blood flow in ECMO circuits.
Product
NICU ECC Pack BEQ-TOP 39202, Custom Tubing Kit, Catalog No. 701067313R01
Category
Medical Device
Distribution
13 states
SevereFDA (Devices)·Z-1720-2018·2018-05-16
Datascope Recalls Custom Neonatal ECC Tubing Kits Due to Seal Defect
Datascope is recalling seven custom neonatal ECMO tubing kits because a seal defect may allow air entry, potentially causing a drop in blood flow.
Product
BEQ-TOP 50900 Custom ECC Pack-Neonatal 1/4, Custom Tubing Kit, Catalog No. 709000069R02
Category
Medical Device
Distribution
13 states
SevereFDA (Devices)·Z-1666-2018·2018-05-16
Baxter Infusion Pump Recalled for Improper Testing Documentation
Baxter Healthcare Corporation is recalling 444 Sigma Spectrum Infusion Pumps because service technicians omitted required release tests, which could lead to serious adverse health consequences.
Product
Baxter Sigma Spectrum Infusion Pump with Master Drug Library (Version 6) 35700BAXRP Product Usage: The Baxter Sigma Spectrum Infusion Pump with master Drug Library is intended to be used for the controlled administration of fluids. These fluids may includes pharmaceutical…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1574-2018·2018-05-16
Vyaire Medical Recalls Pediatric AirLife Resuscitation Devices Due to Mask Sticking
Vyaire Medical is recalling 498 pediatric AirLife resuscitation devices because the mask may stick to the elbow, making it difficult to disconnect.
Product
AirLife Resuscitation, Pediatric, with mask, oxygen reservoir bag, pressure-relief valve, PEEP valve Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1552-2018·2018-05-16
Vyaire Medical Recalls AirLife Resuscitation Devices Due to Mask Sticking
Vyaire Medical is recalling 305,136 AirLife Resuscitation devices because the mask may stick to the elbow, making it difficult or impossible to disconnect.
Product
AirLife Resuscitation, Adult, with mask, 40" oxygen reservoir tubing 6/cs Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1482-2018·2018-05-16
Draeger Fabius GS Premium Anesthesia Machines Recalled for Ventilation Failure Risk
Draeger Medical is recalling 27 Fabius GS Premium anesthesia machines because automatic ventilation may fail if motor position detection is disturbed.
Product
Fabius GS Premium, anesthesia machine, catalog no. 8607000 Product Usage: The products are inhalation anesthesia machines for use in operating, induction and recovery rooms. They may be used with O2, N2O, and AIR supplied by a medical gas pipeline system or by externally…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1722-2018·2018-05-16
Datascope Better Bladder Custom Tubing Kit Recalled for Seal Separation
Datascope Corporation is recalling Better Bladder custom tubing kits because seal separation may allow air to enter the housing, potentially collapsing the balloon and reducing ECMO blood flow.
Product
BEQ-T 25502 1/4 Better Bladder , Custom Tubing Kit, Catalog No. 709000434
Category
Medical Device
Distribution
13 states
SevereFDA (Devices)·Z-1579-2018·2018-05-16
Vyaire Medical Recalls AirLife Resuscitation Replacement Kits Due to Mask Sticking
Vyaire Medical is recalling 150 AirLife Resuscitation replacement kits because the mask component may stick to the elbow, preventing disconnection.
Product
AirLife Resuscitation, Replacement kit for outer shell, Broselow Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1577-2018·2018-05-16
Vyaire Medical Recalls AirLife Resuscitation Devices Due to Mask Sticking Issue
Vyaire Medical is recalling 797 AirLife Resuscitation Broselow Hinkle Kits because the mask may stick to the elbow, preventing disconnection.
Product
AirLife Resuscitation, Broselow Hinkle Kit Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1726-2018·2018-05-16
Datascope Recalls BEQ-TOP 24500 Adult ECC Custom Tubing Kits
Datascope is recalling four BEQ-TOP 24500 Adult ECC Custom Tubing Kits because a seal defect may allow air to enter the housing, potentially collapsing the balloon and reducing blood flow.
Product
BEQ-TOP 24500 ADULT ECC, Custom Tubing Kit, Catalog No. 701050253
Category
Medical Device
Distribution
13 states
SevereFDA (Devices)·Z-1564-2018·2018-05-16
Vyaire Medical Recalls AirLife Infant Resuscitation Devices Due to Mask Sticking
Vyaire Medical is recalling 2,262 AirLife Infant Resuscitation Devices because the mask may stick to the elbow, making it difficult to disconnect.
Product
AirLife Resuscitation, Infant, with mask, 28inch large bore tubing, pressure-relief valve Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1729-2018·2018-05-16
Datascope Recalls Custom Tubing Kits Due to Potential Balloon Collapse
Datascope Corporation is recalling specific custom tubing kits because a seal defect may cause the balloon to collapse, potentially reducing blood flow in ECMO circuits.
Product
BEQ-TOP 22300, Custom Tubing Kit, Catalog No. 701049504
Category
Medical Device
Distribution
13 states
SevereFDA (Devices)·Z-1567-2018·2018-05-16
Vyaire Medical Recalls AirLife Resuscitation Devices Due to Mask Sticking
Vyaire Medical is recalling 17,172 AirLife Resuscitation devices because the mask may stick to the elbow, making it difficult to disconnect.
Product
AirLife Resuscitation, Adult, with mask, 28inch large bore tubing, pressure-relief valve Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1553-2018·2018-05-16
Vyaire Medical Recalls AirLife Resuscitation Devices Due to Mask Sticking
Vyaire Medical is recalling 54 AirLife Resuscitation devices because the mask may stick to the elbow, making it difficult or impossible to disconnect.
Product
AirLife Resuscitation, Adult, with mask, 40inch oxygen reservoir tubing, filter Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1570-2018·2018-05-16
Vyaire Medical Recalls AirLife Resuscitation Devices Due to Mask Sticking
Vyaire Medical is recalling 180 AirLife Resuscitation devices because the mask may stick to the elbow, making it difficult to disconnect.
Product
AirLife Resuscitation, Adult, with mask, oxygen reservoir bag, manometer, PEEP valve Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1550-2018·2018-05-16
Vyaire Medical Recalls AirLife Resuscitation Devices Due to Mask Sticking
Vyaire Medical is recalling 1,260 AirLife Resuscitation devices because the mask may stick to the elbow, making it difficult or impossible to disconnect.
Product
AirLife Resuscitation, Adult, with mask, oxygen reservoir bag, filter Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1784-2018·2018-05-16
TP Orthodontics Recalls Jasper Vektor Class II Correction Appliances
TP Orthodontics is recalling 10 Jasper Vektor Class II Correction Appliances because they may break in the patient's mouth, posing a risk of injury.
Product
Jasper Vektor, Class II Correction Appliance, Part No. 610-527 used for correcting class 2 malocclusions by applying light forces on the teeth using a tube, arch wire and stops.
Category
Medical Device
Distribution
20 states
SevereFDA (Devices)·Z-1573-2018·2018-05-16
Vyaire Medical Recalls AirLife Infant Resuscitation Devices Due to Mask Sticking
Vyaire Medical is recalling 900 AirLife Infant Resuscitation Devices because the mask may stick to the elbow, making it difficult to disconnect.
Product
AirLife Resuscitation, Infant, with mask, 40inch oxygen reservoir tubing, pressure-relief valve, PEEP valve Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1569-2018·2018-05-16
Vyaire Medical Recalls AirLife Resuscitation Devices Due to Mask Sticking
Vyaire Medical is recalling 2,982 AirLife Resuscitation devices because the mask may stick to the elbow, making it difficult to disconnect.
Product
AirLife Resuscitation, Adult, with mask, oxygen reservoir bag, CO2 detector, PEEP valve Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1724-2018·2018-05-16
Datascope recalls Better Bladder device in custom tubing kits
Datascope is recalling 18 custom tubing kits because a seal defect may allow air to enter the device, potentially causing a drop in ECMO blood flow.
Product
BEQ-TOP 25500 ECC 3/8 w/QiD, Custom Tubing Kit, Catalog No. 701052461
Category
Medical Device
Distribution
13 states
SevereFDA (Devices)·Z-1717-2018·2018-05-16
Datascope Recalls Better Bladder Devices in Custom Tubing Kits
Datascope is recalling specific custom tubing kits because the Better Bladder device may fail, potentially reducing blood flow in ECMO circuits.
Product
BEQ-TOP 49101 Childrens Large ECC Pack, Custom Tubing Kit, Catalog No. 701067069R01
Category
Medical Device
Distribution
13 states

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