2026-05-18 to 2026-05-24
Sources: NHTSA, CPSC, FDA_FOOD, FDA_DRUG, FDA_DEVICE
Other Recalls
Air bags that deploy unintentionally during a crash increase the risk of injury.
A loose hub securing nut can cause vibration and a loss of steering control, increasing the risk of a crash.
Broken shock retainer bolt heads and washers may detach and become a road hazard, increasing the risk of a crash.
The LED lights on the recalled illuminated spheres can overheat, posing a risk of serious injury or death from a fire hazard.
The recalled Orb Funkee squeeze toys may contain fibrous tremolite (asbestos) in the sand, which can cause adverse health issues if inhaled.
The recalled portable hook-on chairs violate the mandatory standard for portable hook-on chairs because the crotch restraints can be removed without the use of a tool and infants can fall through an opening, posing a deadly fall hazard.
The recalled resistance bands can forcefully separate from the handle during use, posing a risk of serious injury from impact hazard.
The recalled children's toys violate the mandatory standard for toys because they contain button cell batteries and the compartments that hold the batteries can be easily accessed by children, posing a deadly ingestion hazard to children. When button cell and coin batteries are swallowed, the ingested batteries can cause serious injuries, internal chemical burns and death.
The recalled glasses violate the mandatory standard for consumer products with button cell and coin batteries because the button cell batteries can be accessed easily by children, posing an ingestion hazard.?Additionally, the packaging and product do not have the warnings required under Reese's Law. When button cell or coin batteries are swallowed, the ingested batteries can cause serious injuries, internal chemical burns, and death.
The recalled youth ATVs violate the federal mandatory ATV safety standard, posing a risk of serious injury or death. The youth ATVs fail to meet mechanical suspension requirements, and the reverse indicator light fails to illuminate, posing a crash hazard. The parking brakes fail to hold, posing a collision hazard. Additionally, the surfaces near the footwell can reach high temperatures, posing a risk of severe burns.
A rearview image that does not display reduces the driver's view behind the vehicle, increasing the risk of a crash.
A rearview image that does not display reduces the driver's view behind the vehicle, increasing the risk of a crash.
Broken shock retainer bolt heads and washers may detach and become a road hazard for other vehicles, increasing the risk of a crash.
A detached end cap or inflator rupture can allow compressed gas to escape and project the end cap or fragments of the inflator into the vehicle, increasing the risk of injury.
A rearview camera that does not display an image can reduce the driver's rear view, increasing the risk of a crash.
The heating pad may overheat in the battery compartment, increasing the risk of a fire.
An inflator rupture may result in sharp metal fragments striking the driver or other occupants, resulting in serious injury or death.
Product has the potential to be contaminated with Salmonella.
An unsecured wheelchair can move during transit, increasing the risk of injury.
An unsecured wheelchair can move during transit, increasing the risk of injury.
A loss of drive power increases the risk of a crash.
Foreign object (stainless steel dust/flakes or shreds of plastic)
Failed Dissolution Specifications
Incomplete seals on sterile product
Incomplete seals on sterile product
Affected kits contain Medline Namic RA Syringes, which are recalled by their manufacturer due to risk of syringe rotating adapter unwinding during use, which may result in a loose connection or full disconnection between syringe and manifold. If unwinding occurs, there is a potential for biohazard exposure, blood loss, infection. or air embolism.
GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used in conjunction with certain Revolution Apex, Revolution Ascend, and Revolution CT systems.
Medline has identified the presence of particulate within the fluid path of the Manifolds.
Out-of-specification endotoxin result that did not meet the acceptance criteria.
Incomplete seals on sterile product
Medline has identified the presence of particulate within the fluid path of the Manifolds.
Incomplete seals on sterile product
Foreign object (stainless steel dust/flakes or shreds of plastic)
Product may contain foreign objects, specifically glass.
Contains undeclared allergens (cashews, milk, and soy).
Foreign object (stainless steel dust/flakes or shreds of plastic)
Foreign object (stainless steel dust/flakes or shreds of plastic)
Contains undeclared Blue 1
Undeclared allergens (wheat and soy).
Possible Salmonella in croutons. The firm was notified by their supplier that the non-fat milk powder used to manufacture the product was recalled due to possible salmonella.
Products contain undeclared soy, specifically soy lecithin.
Foreign object (stainless steel dust/flakes or shreds of plastic)
Contains undeclared FD&C Yellow 6
Undeclared allergen ingredient (fish)
Lack of Assurance of Sterility: The recall is being initiated out of an abundance of caution following FDA observations noted during a recent inspection of Excelvision.
Presence of particulate matter: identified as Buprenorphine free base
Medline has identified the presence of particulate within the fluid path of the Manifolds.
GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used in conjunction with certain Revolution Apex, Revolution Ascend, and Revolution CT systems.
Incomplete seals on sterile product
Stent-assisted coiling device may due to commingling during manufacturing have dimensional nonconformance and/or incorrect device configuration. If device is oversized may lead to increased vessel wall stress, neointimal hyperplasia, vessel injury/rupture; if undersized may lead to incomplete expansion/malposition, acute stent thrombosis, distal embolization, ischemic neurological events
Due to broken connector which may result in a temporary interruption of prescribed cold therapy.
Complaints have been received of systems developing loose, missing, or broken internal bolts over time.
Potential for mislabeled syringe produced by the i.v.STATION device.
GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used in conjunction with certain Revolution Apex, Revolution Ascend, and Revolution CT systems.
Medline has identified the presence of particulate within the fluid path of the Manifolds.
Medline has identified the presence of particulate within the fluid path of the Manifolds.
Software issue: When programming the SynchroMed Pump with the A810 CP App in Flex Infusion Mode, the infusion steps should automatically be arranged in consecutive order, from earliest to latest. However, in rare cases, the steps may be displayed out of order. If this occurs, the programmed Flex Infusion schedule will not be delivered at the intended time, if at all.
Incomplete seals on sterile product
Incomplete seals on sterile product
Incomplete seals on sterile product
Incomplete seals on sterile product
Heart valves were released and distributed before all required testing was complete, so it cannot be confirmed that they meet all release specifications.
GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used in conjunction with certain Revolution Apex, Revolution Ascend, and Revolution CT systems.
16F dual-valved splittable sheath introducer, the subject of a supplier recall, was included in impacted hemodialysis kits & sets. Sheath introducer may not split as intended, and may result in withdrawal resistance, prolonged procedure time, pain, bleeding, hematoma, tissue injury, vessel wall injury.
Due to nonconforming products being inadvertently distributed.
16F dual-valved splittable sheath introducer, the subject of a supplier recall, was included in impacted hemodialysis kits & sets. Sheath introducer may not split as intended, and may result in withdrawal resistance, prolonged procedure time, pain, bleeding, hematoma, tissue injury, vessel wall injury.
Product has the potential for false positive results
A software defect in which a low-priority file I/O check blocks the higher-priority thread responsible for processing estimated glucose values (EGVs) and trend arrows. When the app is running in the background, EGV notifications may queue up and then "replay" sequentially when the user brings the app to the foreground, causing the Glucose Compass to flicker through previous EGVs. In more severe instances, the app may perceive signal loss and deploy signal loss mitigations. This delay in EGV and alert processing creates a risk that users may miss detection of a hypoglycemic or hyperglycemic event, or make treatment decisions based on outdated glucose information.
16F dual-valved splittable sheath introducer, the subject of a supplier recall, was included in impacted hemodialysis kits & sets. Sheath introducer may not split as intended, and may result in withdrawal resistance, prolonged procedure time, pain, bleeding, hematoma, tissue injury, vessel wall injury.
Incomplete seals on sterile product
A software defect in which a low-priority file I/O check blocks the higher-priority thread responsible for processing estimated glucose values (EGVs) and trend arrows. When the app is running in the background, EGV notifications may queue up and then "replay" sequentially when the user brings the app to the foreground, causing the Glucose Compass to flicker through previous EGVs. In more severe instances, the app may perceive signal loss and deploy signal loss mitigations. This delay in EGV and alert processing creates a risk that users may miss detection of a hypoglycemic or hyperglycemic event, or make treatment decisions based on outdated glucose information.
Medline has identified the presence of particulate within the fluid path of the Manifolds.
Incomplete seals on sterile product
16F dual-valved splittable sheath introducer, the subject of a supplier recall, was included in impacted hemodialysis kits & sets. Sheath introducer may not split as intended, and may result in withdrawal resistance, prolonged procedure time, pain, bleeding, hematoma, tissue injury, vessel wall injury.
Incomplete seals on sterile product
Due to broken connector which may result in a temporary interruption of prescribed cold therapy.
Kits from lot FD1265 had been packaged on 17 October 2024 and put on the market with an outdated flyer (8 October 2024), containing incorrect values for the positive control.
Software update is needed for laser systems, for topical infrared heating to provide temporary relief of minor muscle and joint pain, spasms, stiffness associated with minor arthritis, and to temporarily increase local blood circulation, operating at a maximum average power output of 70W, which is beyond the FDA cleared 60W.
Incomplete seals on sterile product
Medline has identified the presence of particulate within the fluid path of the Manifolds.
Incomplete seals on sterile product
Incomplete seals on sterile product
Medline has identified the presence of particulate within the fluid path of the Manifolds.
Potential for the bolts and plastic parts of the Cable Hose Carriers that hold the cable hose to the monitor ceiling suspension may loosen and/or break over time due to the forces applied when the monitor is moved or rotated.
Incomplete seals on sterile product
Labeling update to provide warning if functionality of the valve replacement delivery system is compromised.
Incomplete seals on sterile product
Incomplete seals on sterile product
A software defect in which a low-priority file I/O check blocks the higher-priority thread responsible for processing estimated glucose values (EGVs) and trend arrows. When the app is running in the background, EGV notifications may queue up and then "replay" sequentially when the user brings the app to the foreground, causing the Glucose Compass to flicker through previous EGVs. In more severe instances, the app may perceive signal loss and deploy signal loss mitigations. This delay in EGV and alert processing creates a risk that users may miss detection of a hypoglycemic or hyperglycemic event, or make treatment decisions based on outdated glucose information.
GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used in conjunction with certain Revolution Apex, Revolution Ascend, and Revolution CT systems.
Incomplete seals on sterile product
Due to broken connector which may result in a temporary interruption of prescribed cold therapy.
Complaints have been received of systems developing loose, missing, or broken internal bolts over time.
GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used in conjunction with certain Revolution Apex, Revolution Ascend, and Revolution CT systems.
Incomplete seals on sterile product
Incomplete seals on sterile product
Due to a subset of chest compression systems/devices where the service performed on the systems were not appropriately documented (The documents for the service performed to justify the passing results were not include in the service records).
Medline has identified the presence of particulate within the fluid path of the Manifolds.
Due to broken connector which may result in a temporary interruption of prescribed cold therapy.
Incomplete seals on sterile product
Incomplete seals on sterile product
GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used in conjunction with certain Revolution Apex, Revolution Ascend, and Revolution CT systems.
Incomplete seals on sterile product
Medline has identified the presence of particulate within the fluid path of the Manifolds.
Incomplete seals on sterile product
Medline has identified the presence of particulate within the fluid path of the Manifolds.
Incomplete seals on sterile product
A loss of vehicle control increases the risk of a crash.
Unexpected braking increases the risk of a crash.
Missing weight information provided by the label may lead to unintentionally overloading the vehicle, increasing the risk of a crash.
Loose shock bolts may cause a loss of vehicle stability, increasing the risk of a crash.
An unsecured wheelchair can move during transit, increasing the risk of injury.
A loss of drive power can increase the risk of a crash.
Hydraulic functions that do not immediately stop when the ground level E-stop is pressed, increase the risk of injury.