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Found 12,722 results for "product recalls and alerts"
Health CanadaExpanded recall: Plush robes with various prints recalled due to flammability hazard
Expanded recall: Plush robes with various prints recalled due to flammability hazard
Flammability hazard
Health CanadaUrban Shades Roller Shades recalled due to strangulation hazard
Urban Shades Roller Shades recalled due to strangulation hazard
Strangulation hazard
Health CanadaWiifo Children’s Tower Stools recalled due to fall and entrapment hazards
Wiifo Children’s Tower Stools recalled due to fall and entrapment hazards
Fall hazard - Entrapment hazard
Health CanadaPMS-Fluconazole 50 mg tablets; Incorrect quantity of tablets
PMS-Fluconazole 50 mg tablets; Incorrect quantity of tablets
Packaging
Health CanadaBaxter Corporation products recall; Blue cap breakage
Baxter Corporation products recall; Blue cap breakage
Packaging
Health CanadaCosyland Kids Kitchen Step Stools recalled due to fall and entrapment hazards
Cosyland Kids Kitchen Step Stools recalled due to fall and entrapment hazards
Consumer products
Health CanadaTako Wasabi products recalled due to undeclared fish
Tako Wasabi products recalled due to undeclared fish
Fish
Health CanadaHJ Window Roller Blind recalled due to strangulation hazard
HJ Window Roller Blind recalled due to strangulation hazard
Strangulation hazard
Health CanadaSteambow Archery AR-Series Laser Sight (Green) recalled due to eye injury hazard
Steambow Archery AR-Series Laser Sight (Green) recalled due to eye injury hazard
Injury hazard
Health CanadaSafrax ODOR-CLO2 Chlorine Dioxide Odor Removal- Air Freshener & Deodorizer recalled due to improper labelling and lack of child-resistant packaging
Safrax ODOR-CLO2 Chlorine Dioxide Odor Removal- Air Freshener & Deodorizer recalled due to improper labelling and lack of child-resistant packaging
Labelling and packaging
Health CanadaRenpure Tea Tree & Rosemary Scalp Rebalancing Shampoo & Conditioner recalled due to microbial contamination
Renpure Tea Tree & Rosemary Scalp Rebalancing Shampoo & Conditioner recalled due to microbial contamination
Microbial hazard
Health CanadaWyze Solar Cam Pan recalled due to burn and fire hazards
Wyze Solar Cam Pan recalled due to burn and fire hazards
Burn hazard - Fire hazard
Health CanadaVornado SRTH Small Room Tower Heater recalled due to fire hazard
Vornado SRTH Small Room Tower Heater recalled due to fire hazard
Fire hazard
UK FSAFood Alert "For Action": To: Food Businesses and Consumers who have purchased and sold frozen products supplied by Inarah’s Frozen Foods Ltd
Food Alert "For Action": To: Food Businesses and Consumers who have purchased and sold frozen products supplied by Inarah’s Frozen Foods Ltd
Inarah’s Frozen Foods Ltd has been unable to demonstrate that the products in this alert have been produced and handled safely. Products that have not met food hygiene and safety requirements pose a risk to consumers and may be unsafe to eat. The products are known to have been supplied to food businesses across the UK. Photos of these brand labels are attached below. These brands cover a wide range of frozen products including chicken, beef, fish and vegetarian items, packaged in different size packaging with multiple best before dates and/or batch numbers. These products have one of the below company names and addresses on the labels: Inarah Frozen Foods LTD, Regal Drive, Walsall, WS2 9HQ Four Seasons Food Group, Unit 7-8 Monarch Works, Elswick Road, Fenton Industrial Estate, Stoke-on-Trent, ST4 2SH KBH Foods, BD9 4TS All frozen products with either “Inarah’s Frozen Foods”, “Inarah’s Fine Foods” or “New York Crispy” with one of the above addresses are included in this alert. Food businesses selling these products in the UK are advised to immediately stop sales, undertake product withdrawals and where there have been retail sales, to undertake product recalls. Products should be disposed of safely.
FDA DevicesGE HealthCare CARESCAPE TELEMETRY SERVER ARK-2250L - NORTH AMERICA, REF #5697603, Product Code KSA; used in conjunction wtih ApexPro CARESCAPE Telemetry Server (CTS) v6.0; Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
GE HealthCare CARESCAPE TELEMETRY SERVER ARK-2250L - NORTH AMERICA, REF #5697603, Product Code KSA; used in conjunction wtih ApexPro CARESCAPE Telemetry Server (CTS) v6.0; Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involving ApexPro CARESCAPE Telemetry Server (CTS) v5.0 and v6.0, can result from a persistent NO COMM or OFF NETWORK condition at the CARESCAPE Central Station or CIC Pro Clinical Information Center (Central Station).
FDA DevicesGE HealthCare ApexPro v6.0 eDelivery Software, REF #5700026, Product Code SUV; used in conjunction wtih ApexPro CARESCAPE Telemetry Server (CTS) v6.0; Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
GE HealthCare ApexPro v6.0 eDelivery Software, REF #5700026, Product Code SUV; used in conjunction wtih ApexPro CARESCAPE Telemetry Server (CTS) v6.0; Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involving ApexPro CARESCAPE Telemetry Server (CTS) v5.0 and v6.0, can result from a persistent NO COMM or OFF NETWORK condition at the CARESCAPE Central Station or CIC Pro Clinical Information Center (Central Station).
FDA DevicesGE HealthCare IOU ASSY ARK2250 CARESCAPE TELEMETRY SERVER, REF #2108729-901, Product Code SS9; ApexPro CARESCAPE Telemetry Server (CTS) v5.0; Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
GE HealthCare IOU ASSY ARK2250 CARESCAPE TELEMETRY SERVER, REF #2108729-901, Product Code SS9; ApexPro CARESCAPE Telemetry Server (CTS) v5.0; Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involving ApexPro CARESCAPE Telemetry Server (CTS) v5.0 and v6.0, can result from a persistent NO COMM or OFF NETWORK condition at the CARESCAPE Central Station or CIC Pro Clinical Information Center (Central Station).
Health CanadaOster Kool-Lube and Oster Blade Wash recalled due to improper labelling
Oster Kool-Lube and Oster Blade Wash recalled due to improper labelling
Labelling and packaging
Health CanadaBD Canada ChloraPrep product recall; Sterility concerns
BD Canada ChloraPrep product recall; Sterility concerns
Product quality
FDA DrugsPRED MILD, prednisolone acetate ophthalmic suspension, USP, 0.12%, 10 mL, Sterile, Rx only, Allergen, Inc., an AbbVie company, North Chicago, IL 60064, Product of France, NDC 11980-174-10.
PRED MILD, prednisolone acetate ophthalmic suspension, USP, 0.12%, 10 mL, Sterile, Rx only, Allergen, Inc., an AbbVie company, North Chicago, IL 60064, Product of France, NDC 11980-174-10.
Failed Stability Specifications
FDA DevicesHydroMARK Breast Biopsy Site Marker, Model Number: 4010-02-15-T3
HydroMARK Breast Biopsy Site Marker, Model Number: 4010-02-15-T3
Incorrect inner package labeling. Boxes labeled 4010-02-15-T3 markers may contain individual packages labeled as T4 Markers.
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.
FDA DevicesAutomated Impella Controller (AIC); Product Code: 0042-0000-US;
Automated Impella Controller (AIC); Product Code: 0042-0000-US;
A retrospective review identified that there are AIC units requiring specific hardware updates to address potential safety concerns. These hardware updates have been implemented through Abiomed s servicing process; therefore, AICs that have not received service are pending these updates. Issue 1: The proximity of the internal Video Graphics Array cable to the Digital Signal Processor chipset on the Impellatronic printed circuit assembly could potentially result in Electrostatic Discharge coupling into the Digital Signal Processor which may interrupt motor controls. Issue 2: There is a potential for the Compact Flash Memory Card dislodgement due to external applied forces, which could result in AIC startup failures and data logging issues. Issue 3: Improper routing of the fan wire within the AIC could lead to fan wire damage, which may result in console boot-up failure. Issue 4: Potential capacitor related issues on the Power Battery Manager, including the potential for the capacitors to cause pump stop, purge stop, and/or single fan fuse failures.
FDA DevicesGE HealthCare CARESCAPE TELEMETRY SERVER V5 ATO MODEL, REF #2063702-101, Product Code SS9; used in conjunction with ApexPro CARESCAPE Telemetry Server (CTS) v5.0; Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
GE HealthCare CARESCAPE TELEMETRY SERVER V5 ATO MODEL, REF #2063702-101, Product Code SS9; used in conjunction with ApexPro CARESCAPE Telemetry Server (CTS) v5.0; Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involving ApexPro CARESCAPE Telemetry Server (CTS) v5.0 and v6.0, can result from a persistent NO COMM or OFF NETWORK condition at the CARESCAPE Central Station or CIC Pro Clinical Information Center (Central Station).