2026-07-20 to 2026-07-26
Sources: FDA_DRUG, NHTSA, CPSC, FDA_FOOD, FDA_DEVICE
Other Recalls
Presence of particulate matter identified as steel
Presence of particulate matter identified as steel
Particulate matter (cardboard) found in the solution.
The rear spring hanger may detach from the frame, increasing the risk of a crash.
Particulate matter (cardboard) found in the solution.
The recalled drain covers violate the entrapment protection standards of the Virginia Graeme Baker Pool and Spa Safety Act (VGBA), posing deadly entrapment and drowning hazards to consumers.
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 standards as required by the STURDY Act.
The snap can detach from the recalled bibs and stroller bags, posing a risk of serious injury or death from a choking hazard to young children.
The recalled teething toys violate the mandatory standard for toys because the silicone strings are smaller and longer than permitted. The strings can reach the back of children's throat and become lodged, posing a serious risk of respiratory distress and deadly choking hazard.
The recalled dressers are unstable if they are not anchored to the wall, posing tip-over and entrapment hazards that can result in risk of serious injuries or death to children. The dressers violate the mandatory safety standards as required by the STURDY Act.
Insufficient low beam headlight illumination can reduce driver visibility, increasing the risk of a crash.
An engine stall or failure of electrical systems such as the instrument display or ABS, increases the risk of a crash.
An overheated printed circuit board increases the risk of a fire.
A fuel leak in the presence of an ignition source increases the risk of a fire. In addition, pieces of the O-ring may clog the fuel lines, causing a loss of engine performance and increasing the risk of a crash.
Electrical component failure may lead to an unexpected vehicle shutdown, increasing the risk of a crash. In addition, an electrical short increases the risk of a fire.
Incorrect water tank capacity information can allow the vehicle to be overloaded and increase the risk of a crash.
The recalled drain covers violate the entrapment protection standards of the Virginia Graeme Baker Pool and Spa Safety Act (VGBA), posing deadly entrapment and drowning hazards to consumers.
The recalled teething toy sets contain a pull string teething toy that violates the mandatory standard for toys because the silicone strings are smaller and longer than permitted. The strings can reach the back of a child's throat and become lodged, posing a risk of respiratory distress and a deadly choking hazard.
Undeclared soy allergen due to inadvertent inclusion of sausage in products labeled as vegetarian
A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set.
Potential to be contaminated with Salmonella Enteritidis.
Some sterilization parameters included in the IFU may not consistently render the devices adequately sterile and therefore should no longer be used to sterilize the devices.
GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement completed, functional testing of the safety pawl may not have been performed to confirm proper assembly. If a failure of the internal counterpoise cable occurs, the Column Safety mechanism will not work, causing the arm with X-ray tube and collimator to drop downward on the column track. This could result in patient injury during an exam.
Robotic-assisted surgical system arm drapes may detach from the instrument arm due to an issue involving the drape rings located at the top of the product, which may expose a section of instrument arm, which may result in procedure delay or conversion to an alternate minimally invasive approach. Retrospectively reported recall.
Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.
The Test cup lot F level 1 low-quality control results values for the device were lower than expected on the Automated Immunoassay Analyzer (AIA) which could cause falsely elevated or falsely low total testosterone results. Such erroneous test results may lead to additional testing/diagnostic interventions and in limited cases, may lead to a delay in diagnosis and/or initiation of unnecessary or incorrect clinical treatment measures.
Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail M103 was labeled as M101, and Minirail M122 was labeled as M111
Potential for brush heads to break.
GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement completed, functional testing of the safety pawl may not have been performed to confirm proper assembly. If a failure of the internal counterpoise cable occurs, the Column Safety mechanism will not work, causing the arm with X-ray tube and collimator to drop downward on the column track. This could result in patient injury during an exam.
Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail M103 was labeled as M101, and Minirail M122 was labeled as M111
A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set.
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Subpotent Drug: Low out of specification assay results performed during long-term stability testing.
In a specific scenario, the pump will not decrement the Volume to be Infused (VTBI) displayed on the Delivery screen and may deliver up to twice the VTBI at the programmed rate.
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Getinge identified that Vasoview Hemopro 2 devices from Lot 3000547797 were exposed to an out-of-specification sterilization dose during a gamma sterilization run (Run ID 1183-28782A) performed by STERIS at its Whippany, NJ facility between March 31 and April 1 of 2026.
A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set.
Lack of Assurance of Sterility
Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.
Product may contain metal fragments.
Medtronic received two complaints of loose foreign material confirmed as containing trace levels of blood.
Some sterilization parameters included in the IFU may not consistently render the devices adequately sterile and therefore should no longer be used to sterilize the devices.
Potential for spoilage.
May contain undeclared milk, pecans, pistachios, yellow #5 and red #40.
May contain undeclared milk, pecans, pistachios, yellow #5 and red #40.
A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set.
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set.
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Foreign material (Glass) was found in the product.
Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail M103 was labeled as M101, and Minirail M122 was labeled as M111
Potential foreign material (glass)
Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.
Undeclared milk allergen.
May contain undeclared milk, pecans, pistachios, yellow #5 and red #40.
May contain undeclared milk, pecans, pistachios, yellow #5 and red #40.
In a specific scenario, the pump will not decrement the Volume to be Infused (VTBI) displayed on the Delivery screen and may deliver up to twice the VTBI at the programmed rate.
Due to manufacturing issues, there is a potential for the 14Fr and 23Fr introducer sheaths to leak from the sidearm, under the sheath cap, and along the hub score lines in the hub region.
Subpotent for Vitamin A. The firm discovered that the testing laboratory used the wrong method when testing for Vitamin A. The test results gave a higher concentration of vitamin A than what is actually in the product.
May contain undeclared milk, pecans, pistachios, yellow #5 and red #40.
A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set.
Calibrated Output was not calculating correctly - UV Sensor GAIN being applied was incorrect - GAIN seemed to be "4/5" instead of "7" (counts were at ~1000 instead of ~5000).
Some sterilization parameters included in the IFU may not consistently render the devices adequately sterile and therefore should no longer be used to sterilize the devices.
May contain undeclared milk, pecans, pistachios, yellow #5 and red #40.
Subpotent for Vitamin A. The firm discovered that the testing laboratory used the wrong method when testing for Vitamin A. The test results gave a higher concentration of vitamin A than what is actually in the product.
Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.
Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.
Calibrated Output was not calculating correctly - UV Sensor GAIN being applied was incorrect - GAIN seemed to be "4/5" instead of "7" (counts were at ~1000 instead of ~5000).
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Due to manufacturing issues, there is a potential for the 14Fr and 23Fr introducer sheaths to leak from the sidearm, under the sheath cap, and along the hub score lines in the hub region.
GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement completed, functional testing of the safety pawl may not have been performed to confirm proper assembly. If a failure of the internal counterpoise cable occurs, the Column Safety mechanism will not work, causing the arm with X-ray tube and collimator to drop downward on the column track. This could result in patient injury during an exam.
Calibrated Output was not calculating correctly - UV Sensor GAIN being applied was incorrect - GAIN seemed to be "4/5" instead of "7" (counts were at ~1000 instead of ~5000).
Some sterilization parameters included in the IFU may not consistently render the devices adequately sterile and therefore should no longer be used to sterilize the devices.
A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set.
Potential for brush heads to break.
A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set.
Kits contain Zimmer Biomet mixing bowls and spatulas, which were recalled due to seal nonconformities which present risk of sterility breach. Health consequences from use of product include clinically insignificant extension of surgery to find another readily available device.
Devices contain recalled Medline Namic Angiographic Control Syringe with Rotating Adaptor. There is a risk of syringe loosening or disconnecting from the manifold, resulting in loose connection or complete disconnection. May lead to difficulty connecting syringe, inability to aspirate or inject properly, fluid leakage, or separation of the syringe from the system, potentially requiring device exchange and prolonging the procedure.
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Lack of Assurance of Sterility: Affected product may exhibit an open or incomplete seal on the packaging of the applicator
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
May contain undeclared milk, pecans, pistachios, yellow #5 and red #40.
May contain undeclared milk, pecans, pistachios, yellow #5 and red #40.
May contain undeclared milk, pecans, pistachios, yellow #5 and red #40.
May contain undeclared milk, pecans, pistachios, yellow #5 and red #40.
May contain undeclared milk, pecans, pistachios, yellow #5 and red #40.
May contain undeclared milk, pecans, pistachios, yellow #5 and red #40.
May contain undeclared milk, pecans, pistachios, yellow #5 and red #40.
May contain undeclared milk, pecans, pistachios, yellow #5 and red #40.
May contain undeclared milk, pecans, pistachios, yellow #5 and red #40.
May contain undeclared milk, pecans, pistachios, yellow #5 and red #40.
A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set.
A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set.
A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set.
Due to manufacturing issues, there is a potential for the 14Fr and 23Fr introducer sheaths to leak from the sidearm, under the sheath cap, and along the hub score lines in the hub region.
A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set.
Packaging and labeling discrepancy involving product size identification and associated Unique Device Identifier (UDI/GTIN).
A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set.
Medtronic received two complaints of loose foreign material confirmed as containing trace levels of blood.
Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail M103 was labeled as M101, and Minirail M122 was labeled as M111
Kits contain Zimmer Biomet mixing bowls and spatulas, which were recalled due to seal nonconformities which present risk of sterility breach. Health consequences from use of product include clinically insignificant extension of surgery to find another readily available device.
Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.
A winch that operates unintentionally may increase the risk of injury.
Potential foreign material (glass)
A wheelchair lift that continues to move while occupied increases the risk of injury.
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Potential to be contaminated with Salmonella Enteritidis.
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
A rearview camera that fails to display an image can reduce the driver’s view behind the vehicle, increasing the risk of a crash.
Potential presence of soft plastic in the finished product.
Potential presence of soft plastic in the finished product.
An incorrect VIN on the label can make it difficult for owners to recognize that their vehicle is involved in a safety recall, increasing the risk of crash or injury.
A short circuit in the engine compartment can create heat or spark, increasing the risk of a fire.
Potential cross contamination with Ranitidine
Potential cross contamination with Ranitidine
A headrest that shifts unexpectedly may increase the risk of injury in a crash.
An overheated printed circuit board increases the risk of a fire.
A rear impact guard that is not properly installed can increase the risk of injury during a crash.
A brake fluid leak in the presence of an ignition source such as hot engine or exhaust components can increase the risk of a fire. Additionally, a brake fluid leak can extend the distance required to stop, increasing the risk of a crash.
A brake fluid leak in the presence of an ignition source such as hot engine or exhaust components can increase the risk of a fire. Additionally, a brake fluid leak can extend the distance required to stop, increasing the risk of a crash.