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Found 12,722 results for "product recalls and alerts"
FDA DevicesAutomated Impella Controller (AIC) with the below product descriptions and corresponding Product Codes. 1. Impella Controller, Packaged, CA; Product Code: 0042-0000-CA. 2. Impella Controller, Packaged, EU; Product Code: 0042-0000-EU. 3. Impella Controller, Packaged, UK; Product Code: 0042-0000-UK. 4. Impella Controller, Packaged, US; Product Code: 0042-0000-US.
Automated Impella Controller (AIC) with the below product descriptions and corresponding Product Codes. 1. Impella Controller, Packaged, CA; Product Code: 0042-0000-CA. 2. Impella Controller, Packaged, EU; Product Code: 0042-0000-EU. 3. Impella Controller, Packaged, UK; Product Code: 0042-0000-UK. 4. Impella Controller, Packaged, US; Product Code: 0042-0000-US.
Retrospective submission for following issues identified: 1. Alarm failures, power-path faults, electrical-short risks, and inaccurate motor-current sensing were identified in certain AIC consoles. 2. There is improper alignment between the purge cassette and the motor drive in the AIC. This can result in a piston block event and lead to the inability to complete priming of the purge system, requiring the user to switch to backup AIC console.
USDA FSISSynear Foods USA, LLC Recalls Frozen Pork and Crab Soup Dumpling Products Due to Misbranding and Undeclared Allergens
Synear Foods USA, LLC Recalls Frozen Pork and Crab Soup Dumpling Products Due to Misbranding and Undeclared Allergens
Misbranding, Unreported Allergens
Health CanadaHizentra: The appearance is out of specification in the affected lot.
Hizentra: The appearance is out of specification in the affected lot.
Product quality
Health CanadaHuonje Laser Scope recalled due to eye injury hazard
Huonje Laser Scope recalled due to eye injury hazard
Injury hazard
FDA DevicesPhilips Azurion systems not configured with an optional auxiliary pan handle. Includes the below product descriptions and corresponding model numbers. 1. Azurion 3 M12; Model Numbers: 722063, 722229. 2. Azurion 3 M15; Model Numbers: 722222, 722064, 722280, 722230. 3. Azurion 5 M12; Model Numbers: 722227, 722231. 4. Azurion 5 M20; Model Numbers: 722228, 722232, 722281. 5. Azurion 7 B12; Model Numbers: 722067, 722225, 722235. 6. Azurion 7 B20; Model Numbers: 722068, 722226, 722236. 7. Azurion 7 M12; Model Numbers: 722078, 722223, 722233. 8. Azurion 7 M20; Model Numbers: 722079, 722224, 722234, 722282.
Philips Azurion systems not configured with an optional auxiliary pan handle. Includes the below product descriptions and corresponding model numbers. 1. Azurion 3 M12; Model Numbers: 722063, 722229. 2. Azurion 3 M15; Model Numbers: 722222, 722064, 722280, 722230. 3. Azurion 5 M12; Model Numbers: 722227, 722231. 4. Azurion 5 M20; Model Numbers: 722228, 722232, 722281. 5. Azurion 7 B12; Model Numbers: 722067, 722225, 722235. 6. Azurion 7 B20; Model Numbers: 722068, 722226, 722236. 7. Azurion 7 M12; Model Numbers: 722078, 722223, 722233. 8. Azurion 7 M20; Model Numbers: 722079, 722224, 722234, 722282.
Potential safety issue with Philips Azurion systems, where longitudinal and transverse table movements may be impacted due to mechanical wear of the Float Tabletop control on the control module.
Health CanadaTheKiddoSpace Children’s Christmas Tree Toy Play Sets recalled due to chemical and ingestion hazard
TheKiddoSpace Children’s Christmas Tree Toy Play Sets recalled due to chemical and ingestion hazard
Chemical hazard - Ingestion hazard
Health CanadaTheKiddoSpace Peg Dolls in Cups Toy recalled due to choking hazard
TheKiddoSpace Peg Dolls in Cups Toy recalled due to choking hazard
Choking hazard
Health CanadaTheKiddoSpace Children’s Sensory Swing recalled due to strangulation hazard
TheKiddoSpace Children’s Sensory Swing recalled due to strangulation hazard
Strangulation hazard
Health CanadaTheKiddoSpace Children’s Montessori Egg Toys recalled due to choking hazard
TheKiddoSpace Children’s Montessori Egg Toys recalled due to choking hazard
Choking hazard
Health CanadaTheKiddoSpace LED Soccer Hover Ball recalled due to burn hazard
TheKiddoSpace LED Soccer Hover Ball recalled due to burn hazard
Burn hazard
Health CanadaTheKiddoSpace Children’s Flashcard Talking Toys recalled due to chemical hazard
TheKiddoSpace Children’s Flashcard Talking Toys recalled due to chemical hazard
Chemical hazard
Health CanadaTheKiddoSpace Finger Painting Kits recalled due to chemical hazard
TheKiddoSpace Finger Painting Kits recalled due to chemical hazard
Chemical hazard
Health CanadaTheKiddoSpace Handwriting Practice Kits recalled due to chemical hazard
TheKiddoSpace Handwriting Practice Kits recalled due to chemical hazard
Chemical hazard
Health CanadaTheKiddoSpace’s Children’s Story Books recalled due to choking hazard
TheKiddoSpace’s Children’s Story Books recalled due to choking hazard
Choking hazard
AustraliaBenpen (benzylpenicillin sodium) injection products to be discontinued
Benpen (benzylpenicillin sodium) injection products to be discontinued
Progressive discontinuation of all products will start with the 600 mg strength from 30 November 2026....
Health CanadaMHZ Duo Soft Roller Shade recalled due to choking hazard
MHZ Duo Soft Roller Shade recalled due to choking hazard
Choking hazard
USDA FSISFSIS Issues Public Health Alert for Beef Kofta Products Served at The Kebab Shop Restaurant Locations Due to Possible E. Coli O157:H7 Contamination
FSIS Issues Public Health Alert for Beef Kofta Products Served at The Kebab Shop Restaurant Locations Due to Possible E. Coli O157:H7 Contamination
Product Contamination
Health CanadaSecura Air Fryers recalled due to fire and burn hazards
Secura Air Fryers recalled due to fire and burn hazards
Fire hazard - Burn hazard
Health CanadaKirkland Signature Women 50+ Multivitamin: may contain the presence of foreign matter (metal fragments)
Kirkland Signature Women 50+ Multivitamin: may contain the presence of foreign matter (metal fragments)
Product quality
CPSCABC Trading Recalls WSDZ Light-up Glasses Due to Risk of Serious Injury or Death from Battery Ingestion; Violate Mandatory Standard for Consumer Products with Button Cell Batteries
ABC Trading Recalls WSDZ Light-up Glasses Due to Risk of Serious Injury or Death from Battery Ingestion; Violate Mandatory Standard for Consumer Products with Button Cell Batteries
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.
FDA DevicesDaig Livewire Steerable, Product Number 401603, REPROCESSED ELECTROPHYSIOLOGY CATHETER
Daig Livewire Steerable, Product Number 401603, REPROCESSED ELECTROPHYSIOLOGY CATHETER
Incomplete seals on sterile product
FDA DevicesBrand Name: DONJOY Product Name: ICEMAN W/,UNIV,LOOP,NS,RH Model/Catalog Number: 11-1422 Software Version: no Product Description: 11-1422 - ICEMAN W/,UNIV,LOOP,NS,RH The IceMan CLASSIC3¿ cold therapy unit helps reduce pain and swelling, speeding up rehabilitation. The IceMan¿ helps provide extended cold therapy to aid in a variety of indications and protocols as directed by a medical professional. The IceMan CLASSIC3 utilizes DonJoy's recirculation technology. Component: No
Brand Name: DONJOY Product Name: ICEMAN W/,UNIV,LOOP,NS,RH Model/Catalog Number: 11-1422 Software Version: no Product Description: 11-1422 - ICEMAN W/,UNIV,LOOP,NS,RH The IceMan CLASSIC3¿ cold therapy unit helps reduce pain and swelling, speeding up rehabilitation. The IceMan¿ helps provide extended cold therapy to aid in a variety of indications and protocols as directed by a medical professional. The IceMan CLASSIC3 utilizes DonJoy's recirculation technology. Component: No
Due to broken connector which may result in a temporary interruption of prescribed cold therapy.
FDA DevicesBrand Name: Dexcom ONE+ Continuous Glucose Monitoring System Product Name: Dexcom ONE+ iOS CGM App Model/Catalog Number: SW14244 Software Version: versions 1.5.0 and 1.6.0 Product Description: Dexcom ONE+ iOS CGM App Component: Dexcom ONE+ Continuous Glucose Monitoring System
Brand Name: Dexcom ONE+ Continuous Glucose Monitoring System Product Name: Dexcom ONE+ iOS CGM App Model/Catalog Number: SW14244 Software Version: versions 1.5.0 and 1.6.0 Product Description: Dexcom ONE+ iOS CGM App Component: Dexcom ONE+ 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 DevicesMedtronic Marinr Steerable, Product Number 72402; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Medtronic Marinr Steerable, Product Number 72402; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Incomplete seals on sterile product