2026-04-27 to 2026-05-03
Sources: NHTSA, CPSC, FDA_DEVICE, FDA_FOOD, FDA_DRUG
Other Recalls
A loose base may allow the seat to move during a crash, increasing the risk of injury.
A detached solar panel can become a road hazard for other vehicles, increasing the risk of a crash.
The elevator's StrikeLock hoistway door locking device can allow the elevator cab to move with a landing door open, posing a risk of serious injury or death due to fall and injury hazards.
The recalled dressers are unstable if they are not anchored to the wall, posing tip-over and entrapment hazards that can result in risks of serious injuries or death to children. The dressers violate the mandatory safety standard as required by the STURDY Act.
If perishable food or beverages are stored in the container for an extended period of time, the stopper can forcefully eject when opened, which can result in serious impact injury and laceration hazards to the consumer.
The 6 mL nasal sprays contain an imidazoline, which must be in child-resistant packaging or meet the labeling requirements for non-complying packaging, as required by the Poison Prevention Packaging Act. The 6 mL nasal spray's packaging is not child-resistant nor bears the required labeling statement, posing a risk of serious injury or illness from poisoning, if the contents are swallowed by young children.
The recalled drain covers violate the entrapment protection standards of the Virginia Graeme Baker Pool and Spa Safety Act (VGBA), posing entrapment and drowning hazards to swimmers and bathers.
A loose screw can cause the front tube to fold down unexpectedly, posing a risk of injury from a fall hazard.
The recalled dressers are unstable if they are not anchored to the wall, posing tip-over and entrapment hazards that can result in risks of serious injuries or death to children. The dressers violate the mandatory safety standard as required by the STURDY Act.
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 hazard and risk of death by asphyxiation. The bed rails also do not meet structural stability or retention strap requirements, posing a fall hazard. The bed rails' push pins and push pin holes are incorrectly sized, posing a laceration hazard. In addition, the bed rails do not bear the required hazard warning labels.
The pre-filled fuel containers violate the mandatory safety standards for portable fuel containers because they lack flame mitigation devices required under the Portable Fuel Container Safety Act, posing a deadly risk of flash fire. In addition, the Children's Gasoline Burn Prevention Act requires all closures on portable kerosene fuel containers to be child-resistant. The container is not child-resistant, posing a risk of burn and poisoning to children.
The handlebar's clamp can unexpectedly cause the handlebar to rotate, posing a risk of serious injury or death due to a crash hazard.
The zipper slider on the side pouch can detach, posing a risk of serious injury or death from choking hazard to children.
An overloaded control unit may shutdown, causing a loss of drive power and increasing the risk of a crash.
The toys' plastic cube can break into small parts or sharp edges, posing a risk of serious injury from choking and laceration hazards.
The recalled pressure washers lack an integral ground-fault circuit-interrupter (GFCI), posing a serious risk of injury or death from shock and electrocution hazards.
The recalled bicycle lights violate the mandatory standard for consumer products with button cell and coin batteries because they contain button cell batteries that can be accessed easily by children, posing an ingestion hazard. Additionally, the bicycle lights 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 bicycle lights violate the mandatory standard for consumer products with button cell and coin batteries because they contain button cell batteries that can be accessed easily by children, posing an ingestion hazard. Additionally, the bicycle lights 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.
Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
Customers reported observing unexpectedly elevated results when using certain third-party micro-collection devices to collect capillary samples for testing with the LeadCare Test Systems. False positive lead results may cause delayed results and additional unnecessary testing.
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
The product correction was initiated because B Braun is issuing a voluntary Urgent Medical Device Correction for gravity IV administration sets as well as pump administration sets utilized with BBMI s Infusomat Space Large Volume Pump, Outlook Pump and Vista Basic Pump due to potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers or other connections and the ability to prime (occlusion).
Customers reported observing unexpectedly elevated results when using certain third-party micro-collection devices to collect capillary samples for testing with the LeadCare Test Systems. False positive lead results may cause delayed results and additional unnecessary testing.
Certain lots of product were associated with a manufacturing nonconformance involving use of a non-gamma sterilization compatible drape.
In some foreseeable use conditions, the Products can expose nearby persons to UVC radiation at levels significantly above limits recommended by international safety guidelines for skin and eye exposure.
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured
Potential for spontaneous closures of Hamilton HxRunControl software during execution of Autolys protocols after deployment of the PCT software for AutoLys Hamilton STAR.
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
Product(s) contain undeclared colors, FD&C Yellow #6 and FD&C Red #40
Undeclared milk.
Undeclared milk.
Unapproved design changes to the products outside of the 510(k) clearance.
Lead level was higher than NYSAGM Standard.
Hard corn starch lumps were found in the product
Undeclared milk.
Failed Capsule Specifications: Out of specification results obtained during routine stability testing for Loss on Drying of Capsule Shells.
Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
Product(s) contain undeclared colors, FD&C Yellow #6 and FD&C Red #40
CGMP Deviations; presence of N-nitroso-Furosemide (NNF) above the recommended intake limit.
Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
Discoloration: Firm received five (5) complaints stating that, "Tablets discolored darker than normal and have lighter-colored spots."
Products were incorrectly labeled with a 5-year shelf life. The approved and validated shelf life is four years.
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
The catheter inflation tag attached to the device may contain an incorrect part number with incorrect balloon diameter sizes and inflation pressures for each stage.
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
Unapproved design changes to the products outside of the 510(k) clearance.
Unapproved design changes to the products outside of the 510(k) clearance.
Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured
Software issue that renders the touch screen unresponsive.
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
Medical procedure kits were distributed containing Webcol Large Alcohol Prep Pads which were subsequently recalled for non-sterility.
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
In some foreseeable use conditions, the products can expose nearby persons to UVC radiation at levels significantly above limits recommended by international safety guidelines for skin and eye exposure.
Potential for detachment of a distal tip component of the device during use.
Failed Impurities/Degradation Specifications: Out of specification for specific impurity Tretinoin
Unapproved design changes to the products outside of the 510(k) clearance.
A detached spoiler may become a road hazard, increasing the risk of a crash.
When the dipstick is removed while the crankcase is pressurized, oil may eject from the fill spout, increasing the risk of injury.
Incorrect weight information can allow the vehicle to be overloaded, increasing the risk of a crash.
A pop-top that lifts during transit can distract the driver, or detach if the secondary safety straps fail, increasing the risk of a crash.
The inability to shift into "Park" can result in a vehicle rollaway, increasing the risk of a crash.
Unapproved design changes to the products outside of the 510(k) clearance.
Undeclared hazelnut and soy lecithin.
Product may be contaminated with Salmonella.
Labeling: Incorrect or Missing Lot and/or Exp Date:The expiration date has an extra digit and is printed as 2709114 instead of the correct 270914 (2027-09-14). It is important to note that this error is limited to the vial itself; the saleable unit of the box of 12 bottles has the correct expiration date printed.
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
X-Ray generator may malfunction resulting in the X-Ray being inoperable.
Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured
Due to receiving a notice from a supplier that the liquid adhesive were incorrectly manufactured
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
A loss of drive power increases the risk of a crash.
The catheter inflation tag attached to the device may contain an incorrect part number with incorrect balloon diameter sizes and inflation pressures for each stage.
Potential for product to contain foreign matter, confirmed to be inspect fragments.
Medical procedure kits were distributed containing Webcol Large Alcohol Prep Pads which were subsequently recalled for non-sterility.
Lack of Assurance of Sterility
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
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Medical procedure kits were distributed containing Webcol Large Alcohol Prep Pads which were subsequently recalled for non-sterility.
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
Unapproved design changes to the products outside of the 510(k) clearance.
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
Potential for detachment of a distal tip component of the device during use.
Unapproved design changes to the products outside of the 510(k) clearance.
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
Certain lots of product were associated with a manufacturing nonconformance involving use of a non-gamma sterilization compatible drape.
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
Unapproved design changes to the products outside of the 510(k) clearance.
Beckman Coulter has identified that Access Total T4 Calibrator lots (PN 33805) exhibit a negative bias on DxI 600/800 instruments, with slopes outside product specifications. A false low patient result could cause a patient to undergo unnecessary additional diagnostic testing. A patient may be treated for a disorder not present or receive delayed treatment for hyperthyroidism. For a pregnant patient being monitored for thyroid hormone supplementation, incorrect treatment or dose may be used. A delayed patient results could cause repeat blood draw with associated complications.
Unapproved design changes to the products outside of the 510(k) clearance.
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured
The catheter inflation tag attached to the device may contain an incorrect part number with incorrect balloon diameter sizes and inflation pressures for each stage.
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
Customers reported observing unexpectedly elevated results when using certain third-party micro-collection devices to collect capillary samples for testing with the LeadCare Test Systems. False positive lead results may cause delayed results and additional unnecessary testing.
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
The product correction was initiated because B Braun is issuing a voluntary Urgent Medical Device Correction for gravity IV administration sets as well as pump administration sets utilized with BBMI s Infusomat Space Large Volume Pump, Outlook Pump and Vista Basic Pump due to potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers or other connections and the ability to prime (occlusion).
Medical procedure kits were distributed containing Webcol Large Alcohol Prep Pads which were subsequently recalled for non-sterility.
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
Unapproved design changes to the products outside of the 510(k) clearance.
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
Medical procedure kits were distributed containing Webcol Large Alcohol Prep Pads which were subsequently recalled for non-sterility.
Certain lots of product were associated with a manufacturing nonconformance involving use of a non-gamma sterilization compatible drape.
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
Potential for detachment of a distal tip component of the device during use.
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
The catheter inflation tag attached to the device may contain an incorrect part number with incorrect balloon diameter sizes and inflation pressures for each stage.
Unapproved design changes to the products outside of the 510(k) clearance.
Unapproved design changes to the products outside of the 510(k) clearance.
Potential for detachment of a distal tip component of the device during use.
Unapproved design changes to the products outside of the 510(k) clearance.
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
Unapproved design changes to the products outside of the 510(k) clearance.
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
The product correction was initiated because B Braun is issuing a voluntary Urgent Medical Device Correction for gravity IV administration sets as well as pump administration sets utilized with BBMI s Infusomat Space Large Volume Pump, Outlook Pump and Vista Basic Pump due to potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers or other connections and the ability to prime (occlusion).
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
Unapproved design changes to the products outside of the 510(k) clearance.
Possible increase in phasing, potentially resulting in false-positive BARD1 splice site indel artifact variants
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
Affected lots are not performing to IFU criteria showing cross reactions with 2-0 within 60 seconds. Cross-reactivity may result in the misidentification of a Salmonella 9-O serotype as a 2-O serotype.
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
Unapproved design changes to the products outside of the 510(k) clearance.
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
Medical procedure kits were distributed containing Webcol Large Alcohol Prep Pads which were subsequently recalled for non-sterility.
Unapproved design changes to the products outside of the 510(k) clearance.
The water could reach scalding temperatures without the mixing valve, increasing the risk of injury.
A loss of drive power can increase the risk of a crash.
A guard with inadequate strength may not sufficiently protect a following vehicle, increasing the risk of injury during a rear end crash.
A seat with a dislodged bolt may not properly restrain an occupant in a crash, increasing the risk of injury.
Improperly restrained occupants have an increased risk of injury during a crash.
Referencing the incorrect GVWR may lead to unintentionally overloading the vehicle, increasing the risk of a crash.