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

18151–18175 of 27534

HighFDA (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
HighFDA (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
HighFDA (Devices)·Z-1749-2018·2018-05-16
DePuy Mitek Recalls Latarjet EXPERIENCE Sharp Curved Ostetome
DePuy Mitek is recalling 84 units of the Latarjet EXPERIENCE Sharp Curved Ostetome due to reports of the product loosening or coming unscrewed from the handle.
Product
LATARJET EXPERIENCE Sharp Curved Ostetome Product Usage: The Latarjet EXPERIENCE Instability Shoulder Set is intended to provide to the orthopedic surgeon with a means of bone fixation and to assist in the management of reconstructive surgeries.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1758-2018·2018-05-16
Synthes Sciatic Nerve Retractor Recalled for Potential Microspore Formation
Synthes (USA) Products LLC is recalling 235 Sciatic Nerve Retractors due to a potential for microspores to form on the hollow handle, which could allow fluid entry.
Product
Retractor f/Sciatic Nerve; Part number: 03.100.013; UDI: 10886982070623
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1738-2018·2018-05-16
Zimmer Biomet Recalls Gentle Threads Interference Screws Due to Sterilization Issue
Zimmer Biomet is recalling 54 Gentle Threads interference screws because overexposure to ethylene oxide sterilization may compromise the sterile barrier, potentially leading to infection.
Product
Gentle Threads, Interference Screw; Model No. 905608, for soft tissue reattachment procedures in the ankle/foot and knee.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1795-2018·2018-05-16
TP Orthodontics Recalls Jasper Vektor Class II Correction Appliance
TP Orthodontics is recalling Jasper Vektor Class II Correction Appliances because the devices have broken in patients' mouths, posing a risk of injury.
Product
Jasper Vektor, Class II Correction Appliance, Part No. 610-536R 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
HighFDA (Devices)·Z-1736-2018·2018-05-16
Zimmer Biomet Recalls Gentle Threads Interference Screws Due to Sterilization Issues
Zimmer Biomet is recalling 53 Gentle Threads Interference Screws because overexposure to ethylene oxide sterilization may have compromised the sterile barrier, potentially leading to infection.
Product
Gentle Threads, Interference Screw; Model No. 905605, for soft tissue reattachment procedures in the ankle/foot and knee.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (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
HighFDA (Devices)·Z-1793-2018·2018-05-16
TP Orthodontics Recalls Jasper Vektor Class II Correction Appliances
TP Orthodontics is recalling Jasper Vektor Class II Correction Appliances because the devices may break in the patient's mouth, posing a risk of injury.
Product
Jasper Vektor, Class II Correction Appliance, Part No. 610-533R 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
HighFDA (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
HighFDA (Devices)·Z-1481-2018·2018-05-16
Draeger Fabius MRI Anesthesia Machines Recalled for Ventilation Failure Risk
Draeger Medical is recalling eight Fabius MRI anesthesia machines because automatic or manual ventilation may fail if the motor position is disturbed or the ventilator cover is damaged.
Product
Fabius MRI, anesthesia machine, catalog no. 8607300 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 mounted…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1565-2018·2018-05-16
Vyaire Medical Recalls Pediatric AirLife Resuscitation Devices Due to Mask Sticking
Vyaire Medical is recalling 1,800 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 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
HighFDA (Devices)·Z-1786-2018·2018-05-16
TP Orthodontics Recalls Jasper Vektor Class II Correction Appliances
TP Orthodontics is recalling 119 Jasper Vektor Class II Correction Appliances because the devices have broken in patients' mouths, posing a risk of injury.
Product
Jasper Vektor, Class II Correction Appliance, Part No. 610-533 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
HighFDA (Devices)·Z-1624-2018·2018-05-16
Boston Scientific Recalls Pinnacle Anterior Apical Pelvic Floor Repair Kits
Boston Scientific is voluntarily recalling 34 Pinnacle Anterior Apical pelvic floor repair kits due to a Class II safety concern. The devices were distributed worldwide.
Product
PFR Kit- Pinnacle, Anterior Apical; Model #M0068317100. Indicated for tissue reinforcement in women with pelvic organ prolapse.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1727-2018·2018-05-16
Datascope recalls custom tubing kits due to seal separation risk
Datascope is recalling four custom tubing kits because a seal defect may allow air to enter the device, potentially reducing blood flow in ECMO circuits.
Product
ECC Small - Respiratory BEQ-TOP 5210, Custom Tubing Kit, Catalog No. 701055604
Category
Medical Device
Distribution
13 states
HighFDA (Devices)·Z-1683-2018·2018-05-16
Siemens Recalls IMMULITE Assays Due to Biotin Interference Risk
Siemens Healthcare Diagnostics is recalling specific IMMULITE assay lots because the instructions fail to list biotin interference concentrations, potentially causing inaccurate test results.
Product
IMMULITE 2000/IMMULITE ¿ 2000 XPi OM-MA (CA125)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1571-2018·2018-05-16
Vyaire Medical Recalls AirLife Resuscitation Devices Due to Mask Sticking
Vyaire Medical is recalling 4,500 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, 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 adequately…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1788-2018·2018-05-16
TP Orthodontics Recalls Jasper Vektor Class II Correction Appliances
TP Orthodontics is recalling Jasper Vektor Class II Correction Appliances because the devices may break in the patient's mouth, posing a risk of injury.
Product
Jasper Vektor, Class II Correction Appliance, Part No. 610-527R 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
HighFDA (Devices)·Z-1547-2018·2018-05-16
Vyaire Medical Recalls AirLife Resuscitation Devices Due to Mask Sticking
Vyaire Medical is recalling 5,400 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 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
HighFDA (Devices)·Z-1617-2018·2018-05-16
Boston Scientific Recalls Capio SLIM Box 5 Sutures Due to Breakage Risk
Boston Scientific is recalling 60,538 units of Capio SLIM Box 5 sutures because they may break or detach during open surgery.
Product
Capio SLIM Box 5, Model #M0068318261; Intended for use in general suturing applications during open surgery to assist in the placement of suture material in tissues at the operative site.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1551-2018·2018-05-16
Vyaire Medical Recalls AirLife Resuscitation Devices Due to Mask Sticking
Vyaire Medical is recalling 30 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 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
HighFDA (Devices)·Z-1557-2018·2018-05-16
Vyaire Medical Recalls Pediatric AirLife Resuscitation Devices Due to Mask Sticking
Vyaire Medical is recalling 24 pediatric AirLife resuscitation devices because the mask may stick to the elbow, making it difficult to disconnect.
Product
AirLife Resuscitation, Pediatric, with mask, 40inch oxygen reservoir tubing, pressure-relief valve, CO2 monitor 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
HighFDA (Devices)·Z-1652-2018·2018-05-16
Siemens Dimension Glucose Assay Recalled for Drug Interference
Siemens Healthcare Diagnostics is recalling Dimension Glucose assays because they may produce inaccurate results when used with certain drugs.
Product
Dimension Glucose (GLUC) assay (Product Number: DF40/10444973) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-1576-2018·2018-05-16
Vyaire Medical Recalls Pediatric AirLife Resuscitation Devices Due to Mask Sticking
Vyaire Medical is recalling 1,140 pediatric AirLife resuscitation devices because the mask may stick to the elbow, making it difficult to disconnect.
Product
AirLife Resuscitation, Pediatric, 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
HighFDA (Devices)·Z-1697-2018·2018-05-16
Straumann Emdogain Recalled for Unverified Raw Material Shelf Life Change
Straumann Manufacturing is recalling Emdogain multipacks because a raw material shelf-life change was implemented without submitting data to demonstrate continued product efficacy.
Product
Straumann¿ Emdogain 0.7 ml Multipack USA. Enamel Matrix Derivative. Article Number 075.115
Category
Medical Device
Distribution
Distributed nationwide

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18151–18175 of 27534