Vereinigte Staaten Recalls
Verbraucherrückrufe von FDA, CPSC, NHTSA und USDA FSIS.
CPSCABC Trading Recalls Children's Toys Due to Risk of Serious Injury or Death from Battery Ingestion; Violates Mandatory Standard for Toys
ABC Trading Recalls Children's Toys Due to Risk of Serious Injury or Death from Battery Ingestion; Violates Mandatory Standard for Toys
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.
NHTSAGeneral Motors, LLC - Roof Rail Air Bag Inflator Endcap May Detach
General Motors, LLC - Roof Rail Air Bag Inflator Endcap May Detach
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.
NHTSAChrysler (FCA US, LLC) - Rearview Camera Image May Not Display/FMVSS 111
Chrysler (FCA US, LLC) - Rearview Camera Image May Not Display/FMVSS 111
A rearview image that does not display reduces the driver's view behind the vehicle, increasing the risk of a crash.
NHTSAHonda (American Honda Motor Co.) - Air Bags May Deploy Unintentionally During a Crash
Honda (American Honda Motor Co.) - Air Bags May Deploy Unintentionally During a Crash
Air bags that deploy unintentionally during a crash increase the risk of injury.
FDA DevicesBARD EP XT Steerable, Product Number 200794; REPROCESSED ELECTROPHYSIOLOGY CATHETER
BARD EP XT Steerable, Product Number 200794; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Incomplete seals on sterile product
FDA DevicesCustom Convenience Kit containing recalled Medline Namic Angiographic Control Syringes with Rotating Adapter (Namic RA Syringes) Angio Pack Part numbers AMS6908E, AMS6908F
Custom Convenience Kit containing recalled Medline Namic Angiographic Control Syringes with Rotating Adapter (Namic RA Syringes) Angio Pack Part numbers AMS6908E, AMS6908F
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.
FDA DevicesCannon II Plus Hemodialysis Catheter, REF: CS-15242-VSP, CS-15282-VSP, CS-15322-VSP, CS-15362-VSP, CS-15552-VSP, CSD-15242-SP, CSD-15282-SP; Cannon II Plus Hemodialysis Catheter with Arrow Simplicity Micro-Introducer, REF: CS-15242-SPM, CS-15282-SPM, CS-15322-SPM, CS-15362-SPM
Cannon II Plus Hemodialysis Catheter, REF: CS-15242-VSP, CS-15282-VSP, CS-15322-VSP, CS-15362-VSP, CS-15552-VSP, CSD-15242-SP, CSD-15282-SP; Cannon II Plus Hemodialysis Catheter with Arrow Simplicity Micro-Introducer, REF: CS-15242-SPM, CS-15282-SPM, CS-15322-SPM, CS-15362-SPM
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.
FDA DevicesBARD Dynamic Tip Steerable, Product Number 200131; REPROCESSED ELECTROPHYSIOLOGY CATHETER
BARD Dynamic Tip Steerable, Product Number 200131; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Incomplete seals on sterile product
FDA FoodPure Ground Ingredients-Organic Peppermint Leaf Powder. wholesale bulk; tea/food manufacturers. Closed container stored in a cool settings at ambient/room temperature, free of direct sunlight. Packaging: Box with poly liner. Net wt: total produced 581 lbs. Firm Name/Address: Pure Ground Ingredients; 2535 Business Parkway, Minden NV 89423
Pure Ground Ingredients-Organic Peppermint Leaf Powder. wholesale bulk; tea/food manufacturers. Closed container stored in a cool settings at ambient/room temperature, free of direct sunlight. Packaging: Box with poly liner. Net wt: total produced 581 lbs. Firm Name/Address: Pure Ground Ingredients; 2535 Business Parkway, Minden NV 89423
Product has the potential to be contaminated with Salmonella.
FDA DevicesBrand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM iOS App Model/Catalog Number: SW12300 Software Version: Versions 2.9.0 through 2.11.2 Product Description: Dexcom G7 CGM iOS App Component: Dexcom G7 Continuous Glucose Monitoring System, Dexcom G7 15 Day Continuous Glucose Monitoring System
Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM iOS App Model/Catalog Number: SW12300 Software Version: Versions 2.9.0 through 2.11.2 Product Description: Dexcom G7 CGM iOS App Component: Dexcom G7 Continuous Glucose Monitoring System, Dexcom G7 15 Day Continuous Glucose Monitoring System
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.
FDA DevicesDaig Livewire Steerable, Product Number 401904; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Daig Livewire Steerable, Product Number 401904; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Incomplete seals on sterile product
FDA DevicesBARD Dynamic XT Deca Steerable, Product Number 201102, REPROCESSED ELECTROPHYSIOLOGY CATHETER
BARD Dynamic XT Deca Steerable, Product Number 201102, REPROCESSED ELECTROPHYSIOLOGY CATHETER
Incomplete seals on sterile product
FDA DevicesBARD Dynamic XT Steerable, Product Number 201104; REPROCESSED ELECTROPHYSIOLOGY CATHETER
BARD Dynamic XT Steerable, Product Number 201104; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Incomplete seals on sterile product
FDA DrugsOasis Tears PF, Preservative-Free Lubricant Eye Drops, 10mL/0.34 Fl OZ Bottle, Sterile, Manufactured for: OASIS Medical, Inc., 514 S. Vermont Ave., Glendora, CA 91741, USA, Made in France, NDC 42126-6400-1.
Oasis Tears PF, Preservative-Free Lubricant Eye Drops, 10mL/0.34 Fl OZ Bottle, Sterile, Manufactured for: OASIS Medical, Inc., 514 S. Vermont Ave., Glendora, CA 91741, USA, Made in France, NDC 42126-6400-1.
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.
FDA DevicesArrow Edge Hemodialysis Catheterization Product, REF: CS-15242-I, CS-15282-I, CS-15322-I
Arrow Edge Hemodialysis Catheterization Product, REF: CS-15242-I, CS-15282-I, CS-15322-I
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.
FDA DevicesBARD Dynamic Deca Steerable, Product Number 201101; REPROCESSED ELECTROPHYSIOLOGY CATHETER
BARD Dynamic Deca Steerable, Product Number 201101; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Incomplete seals on sterile product
FDA DevicesSELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS. Model Numbers: SDA-SYS-3000-2D-HTC, SDA-SYS-3000-3D, SDM-SYS-6000-2D, SDM-SYS-6000-3D, SDM-00001-2D, SDM-00001-3D, SDM-00001-M2D, SDM-00001-M3D, SDM-05000-2A2, SDM-05000-2A3, SDM-05000-2AC, SDM-05000-2D2, SDM-05000-2D3, SDM-05000-2DC, SDM-05000-3D2, SDM-05000-3D3, SDM-05000-3DC, SDM-SYS-9000-2D, SDM-SYS-9000-3D.
SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS. Model Numbers: SDA-SYS-3000-2D-HTC, SDA-SYS-3000-3D, SDM-SYS-6000-2D, SDM-SYS-6000-3D, SDM-00001-2D, SDM-00001-3D, SDM-00001-M2D, SDM-00001-M3D, SDM-05000-2A2, SDM-05000-2A3, SDM-05000-2AC, SDM-05000-2D2, SDM-05000-2D3, SDM-05000-2DC, SDM-05000-3D2, SDM-05000-3D3, SDM-05000-3DC, SDM-SYS-9000-2D, SDM-SYS-9000-3D.
Complaints have been received of systems developing loose, missing, or broken internal bolts over time.
NHTSABlue Bird Body Company - Wheelchair Restraint Retractor May Not Lock
Blue Bird Body Company - Wheelchair Restraint Retractor May Not Lock
An unsecured wheelchair can move during transit, increasing the risk of injury.
NHTSAToyota Motor Engineering & Manufacturing - Debris in Engine May Cause Stall
Toyota Motor Engineering & Manufacturing - Debris in Engine May Cause Stall
A loss of drive power increases the risk of a crash.
FDA DevicesBARD Dynamic Tip Steerable, Product Number 200344; REPROCESSED ELECTROPHYSIOLOGY CATHETER
BARD Dynamic Tip Steerable, Product Number 200344; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Incomplete seals on sterile product
FDA DevicesPhilips Azurion. System Code Description (Model Number): Azurion 3 M12 (722221, 722229), Azurion 3 M15 (722222, 722230), Azurion 5 (722281), Azurion 5 M12 (722227, 722231), Azurion 5 M20 (722228, 722232, 722281), Azurion 7 (722282), Azurion 7 B12 (722225, 722235), Azurion 7 B20 (722068, 722226, 722236), Azurion 7 M12 (722078, 722223, 722233), Azurion 7 M20 (722079, 722224, 722234, 722282).
Philips Azurion. System Code Description (Model Number): Azurion 3 M12 (722221, 722229), Azurion 3 M15 (722222, 722230), Azurion 5 (722281), Azurion 5 M12 (722227, 722231), Azurion 5 M20 (722228, 722232, 722281), Azurion 7 (722282), Azurion 7 B12 (722225, 722235), Azurion 7 B20 (722068, 722226, 722236), Azurion 7 M12 (722078, 722223, 722233), Azurion 7 M20 (722079, 722224, 722234, 722282).
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.
FDA DevicesNamic Preceptor Manifold, custom, Medline Product Number/SKU 64037107; Extravascular blood pressure transducer
Namic Preceptor Manifold, custom, Medline Product Number/SKU 64037107; Extravascular blood pressure transducer
Medline has identified the presence of particulate within the fluid path of the Manifolds.
FDA DevicesOn-X Mitral Heart Valve with Conform-X Sewing Ring, Model: ONXMC-25/33
On-X Mitral Heart Valve with Conform-X Sewing Ring, Model: ONXMC-25/33
Heart valves were released and distributed before all required testing was complete, so it cannot be confirmed that they meet all release specifications.
FDA DevicesNamic Preceptor Manifold, custom, Medline Product Number/SKU 64039307; Extravascular blood pressure transducer
Namic Preceptor Manifold, custom, Medline Product Number/SKU 64039307; Extravascular blood pressure transducer
Medline has identified the presence of particulate within the fluid path of the Manifolds.