Medicines & devicesClass II
Medline Industries, LP recalls 11 products
Kits contain a potentially contaminated component which were recalled by the manufacturer
· FDA · Nationwide
Safety recalls that rarely make the news, straight from the official U.S. agency records (FDA, USDA, CPSC, NHTSA). Every listing links to its official notice. We only copy what the record says.
Checked Nov 3, 4:06 PM ET · refreshed about every 2.5 hours · RSS · Get recall alerts
State filter: shows recalls whose official distribution lists that state, plus nationwide ones. CPSC and NHTSA recalls apply nationwide.
781 recalls for “AI”
Medicines & devicesClass II
Kits contain a potentially contaminated component which were recalled by the manufacturer
· FDA · Nationwide
Medicines & devicesClass II
The kit component was subjected to EO sterilization, contrary to the manufacturer recommendation, which may have led to the component leaking in a kit.
· FDA · Nationwide
Medicines & devicesClass II
A software vulnerability may allow unauthorized persons to gain privileged access to the device, which could result in loss of patient monitoring, missed patient alarms, and/or access to Protected Health Information (PHI
· FDA · Nationwide
FoodClass II
Allergen missing from contains statement: fish
· FDA · CA, NJ
Medicines & devicesClass II
Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex.
· FDA · Nationwide
Medicines & devicesClass I
Potential for arterial sheath tip separation or partial tip separation during use.
· FDA · Nationwide
Household & products
The recalled ranges' front-mounted knobs can be activated accidentally by humans or pets, posing a risk of serious injury from a fire hazard.
· CPSC · Nationwide
Household & products
The tempered glass window in the pizza oven can shatter during use, posing a risk of serious injury from laceration hazard.
· CPSC · Nationwide
Household & products
Charging the lithium-ion batteries through the USB-C port, while the batteries are inserted in the yard power tools can cause the batteries to short-circuit, posing a risk of serious injury from fire hazard.
· CPSC · Nationwide
Household & products
The recalled bed rails violate the mandatory standard for adult portable bed rails because users can become entrapped within the bed rail or between the bed rail and the side of the mattress, posing a serious entrapment
· CPSC · Nationwide
Kids & Babies
The recalled infant walkers violate the mandatory standard for infant walkers because they can fit through a standard doorway and fail to stop at the edge of a step, posing a risk of serious injury or death due to a fall
· CPSC · Nationwide
FoodClass IIUpdated
Undeclared colors: Yellow#5, and Yellow#6. No labeling. Undeclared wheat and colors: Yellow#5, Yellow#6.
· FDA · CA, NM
Medicines & devicesClass II
Failed Dissolution Specifications; Olmesartan Medoxomil content below specifications
· FDA · Nationwide
Medicines & devicesClass II
Specific item(s) and lot(s) of Medline convenience kits containing Pilling Wecksorb Neurosponges and Neurosponge Strips are being recalled due to potential out-of-specification levels of endotoxin of the neurosponges.
· FDA · Nationwide
Medicines & devicesClass II
Under certain conditions, the battery mounting tabs may become damaged, allowing the battery to move within the device enclosure, potentially leading to an internal short circuit. This may cause localized heating and gas
· FDA · Nationwide
Medicines & devicesClass II
The Automated Field Steam Sterilizer's water recovery system 120V Amphenol connector may experience an intermittent loss of ground continuity, which could result in an unreliable fault current return path.
· FDA · Nationwide
Medicines & devicesClass II
Devices could potentially contain an occluded or partially occluded Guedel Airway tip.
· FDA · Nationwide
Medicines & devicesClass III
Failed Dissolution Specifications
· FDA · Nationwide
Medicines & devicesClass I
Manufacturing firm, Huons, was cited for issues regarding product quality and sterility assurance. If the product sterility is compromised, patients may be exposed to microorganisms, endotoxins, or foreign matter. This m
· FDA · CA, FL, NC, OK, TX, VA
Medicines & devicesClass II
The affected Endo-Model replacement set for a Rotating Hinge tibial plateau incorrectly contains a Pure Hinge plateau. The incorrect plateau could lead to a prolonged or modified surgery as the plateau cannot be inserted
· FDA · IN
Medicines & devicesClass II
Processing of urine albumin assay on the CI analyzers may lead to the following issues: Falsely depressed Atellica CH Urea Nitrogen (UN_c) results; Falsely depressed Atellica CH Enzymatic Hemoglobin A1c (A1c_E) results;
· FDA · Nationwide
FoodPublic Health Alert
Public Health Alert · Public Health Alert
· USDA FSIS · OK
Medicines & devicesClass II
Potential for false negative patient results.
· FDA · Nationwide
FoodClass IIUpdated
Foreign Manufacturer label contains Undeclared allergen ingredients Wheat, Soy, Sesame, Yellow #5 and Blue #1 in Frozen Flounder Products.
· FDA · CA, NJ
FoodClass II
Product label allergen "contains" statement does not include anchovy(fish)
· FDA
Medicines & devicesClass I
Microbial Contamination of Sterile Products - out of specifications results were obtained for bacterial endotoxin.
· FDA · Nationwide
Medicines & devicesClass II
Device will intermittently provide inaccurate data related to native heart rate.
· FDA · Nationwide
Medicines & devicesClass II
Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedullary Bone Saw Blade Assembly due to potential sterile barrier packaging damage caused by an exposed saw blade.
· FDA
Medicines & devicesClass II
Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization.
· FDA · Nationwide
Medicines & devicesClass III
Failed Impurities/Degradation Specifications: OOS result was observed during the related substance test analysis with respect to Impurity II, Impurity III and Total impurity testing for 12 Month Long-Term Stability.
· FDA · Nationwide
Recall data comes from official U.S. government sources: openFDA (food, drugs, devices), USDA FSIS (meat, poultry, egg products), CPSC (consumer and children’s products) and NHTSA (vehicles, equipment, car seats). openFDA notes its data should not be relied on for medical decisions. Always confirm with the official notice. Check your vehicle by VIN at nhtsa.gov/recalls.