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Health CanadaRaha Generator Shield
Raha Generator Shield
Performance
Health CanadaBoneless Chicken Thighs recalled due to semicarbazide
Boneless Chicken Thighs recalled due to semicarbazide
Contamination
Health CanadaSunshade and alternating blind by Stores d’aujourd’hui Gatineau Inc. recalled due to strangulation and choking hazards
Sunshade and alternating blind by Stores d’aujourd’hui Gatineau Inc. recalled due to strangulation and choking hazards
Choking hazard - Strangulation hazard
Health CanadaKlask 4 recalled due to ingestion hazard
Klask 4 recalled due to ingestion hazard
Ingestion hazard
Health CanadaTrilogy EVO and EV300
Trilogy EVO and EV300
Device compatibility
FDA DevicesMedline medical convenience kits packaged as: ANESTHESIA ARTLINE PACK, Kit SKU DYNJ47387B
Medline medical convenience kits packaged as: ANESTHESIA ARTLINE PACK, Kit SKU DYNJ47387B
Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may exhibit an open seal on the packaging of the applicators.
FDA DevicesBrevera Breast Biopsy System Disposable 9 Gauge Needle. Biopsy Instrument.
Brevera Breast Biopsy System Disposable 9 Gauge Needle. Biopsy Instrument.
Presence of particulates in affected devices that can be deposited into breast tissue during use.
FDA DevicesReprocessed Livewire Steerable Diagnostic Electrophysiology Catheters: Livewire Steerable Electrophysiology Catheter,10 Elec. 2-5-2mm 401582RH 401940RH; Livewire Steerable Electrophysiology Catheter,20 Elec. 2-10-2mm 401904RH; Livewire Steerable Electrophysiology Catheter,20 Elec. 2-5-2mm 401914RH; Livewire Steerable Electrophysiology Catheter,20 Elec. 2-8-2-60-2-8-2mm 401932RH; Livewire Steerable Electrophysiology Catheter,8 Elec. 2-2-2mm 401652RH;
Reprocessed Livewire Steerable Diagnostic Electrophysiology Catheters: Livewire Steerable Electrophysiology Catheter,10 Elec. 2-5-2mm 401582RH 401940RH; Livewire Steerable Electrophysiology Catheter,20 Elec. 2-10-2mm 401904RH; Livewire Steerable Electrophysiology Catheter,20 Elec. 2-5-2mm 401914RH; Livewire Steerable Electrophysiology Catheter,20 Elec. 2-8-2-60-2-8-2mm 401932RH; Livewire Steerable Electrophysiology Catheter,8 Elec. 2-2-2mm 401652RH;
These lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of inflammatory response, systemic infection, or granulomatous reaction or thrombus reaction which may lead to cerebral or pulmonary embolism, or deep vein thrombosis. Expansion of recall Z-2610/2614-2025
FDA DrugsPro Numb Tattoo Numbing Spray, 5% Lidocaine, [1 FL OZ/28.4 ML or 4 oz/120 mL] per bottle, Distributed by: Pro Numb Tattoo numbing spray LLC, Melbourne, FL 32907, NDC 83389-111-11
Pro Numb Tattoo Numbing Spray, 5% Lidocaine, [1 FL OZ/28.4 ML or 4 oz/120 mL] per bottle, Distributed by: Pro Numb Tattoo numbing spray LLC, Melbourne, FL 32907, NDC 83389-111-11
cGMP deviations
FDA DrugsESTRADIOL, 37.5 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3037-32.
ESTRADIOL, 37.5 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3037-32.
Presence of Foreign substance - potential presence of metal particulate matter
FDA FoodCREAMY PEANUT BUTTER NET WT 1.12 OZ(32g)/GRAPE JELLY NET WT 1 OZ (28g) POCO PAC DISTRIBUTED BY DYMA BRANDS, INC. ATLANTA, GA 30328 CREAMY PEANUT BUTTER NET WT 1.12 OZ(32g)/GRAPE JELLY NET WT 1 OZ (28g) POCO PAC DISTRIBUTED BY DYMA BRANDS, INC. ATLANTA, GA 30328
CREAMY PEANUT BUTTER NET WT 1.12 OZ(32g)/GRAPE JELLY NET WT 1 OZ (28g) POCO PAC DISTRIBUTED BY DYMA BRANDS, INC. ATLANTA, GA 30328 CREAMY PEANUT BUTTER NET WT 1.12 OZ(32g)/GRAPE JELLY NET WT 1 OZ (28g) POCO PAC DISTRIBUTED BY DYMA BRANDS, INC. ATLANTA, GA 30328
Foreign material. During production, the firm found pieces of blue plastic in a filter.
FDA DevicesIntubation Tray (Adult) containing Suction Catheter Kits SKU DYNJAA245B
Intubation Tray (Adult) containing Suction Catheter Kits SKU DYNJAA245B
A smaller open suction catheter, the 8 Fr Suction Catheter, may have been packed within the kit instead of the required 14 Fr Suction Catheter. Use of the smaller size catheter may result in hypoxia and/or respiratory failure related to partial or full airway obstruction. Airway obstruction may require immediate emergent medical intervention to prevent respiratory failure or death. Other potential outcomes include prolonged procedure, airway irritation, or prolonged dyspnea.
FDA Fooda.) Preema brand Bright Red Food Colour Powder; Net Weight .88oz/25gm; packaged in small plastic bottle; INGREDIENTS: SODIUM CHLORIDE, COLOUR (TARTRAZINE, CARMOSINE, ALLURA RED) CHECK THE LEGAL LIMIT, CONTAINS NO ANIMAL MATTER. E102, E122, E129 may have an adverse effect on activity and attention in children b.) Preema brand Orange Food Colour Powder; Net Weight .88oz/25gm; packaged in a small plastic bottle; INGREDIENTS: SODIUM CHLORIDE, COLOUR (TARTRAZINE, CARMOSINE, ALLURA RED) CHECK THE LEGAL LIMIT, CONTAINS NO ANIMAL MATTER. E102, E122, E129 may have an adverse effect on activity and attention in children
a.) Preema brand Bright Red Food Colour Powder; Net Weight .88oz/25gm; packaged in small plastic bottle; INGREDIENTS: SODIUM CHLORIDE, COLOUR (TARTRAZINE, CARMOSINE, ALLURA RED) CHECK THE LEGAL LIMIT, CONTAINS NO ANIMAL MATTER. E102, E122, E129 may have an adverse effect on activity and attention in children b.) Preema brand Orange Food Colour Powder; Net Weight .88oz/25gm; packaged in a small plastic bottle; INGREDIENTS: SODIUM CHLORIDE, COLOUR (TARTRAZINE, CARMOSINE, ALLURA RED) CHECK THE LEGAL LIMIT, CONTAINS NO ANIMAL MATTER. E102, E122, E129 may have an adverse effect on activity and attention in children
Products contain banned color, carmoisine and undeclared FD&C Yellow 5 and FD&C Red 40
FDA DrugsESTRADIOL, 22 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3022-32.
ESTRADIOL, 22 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3022-32.
Presence of Foreign substance - potential presence of metal particulate matter
FDA FoodKarison brand ALSI PINNI; NET WT. 12 oz.; Ingredients: Wheat Flour, Butter, Sugar Flax Seeds, Almonds, Zero Trans Fat, Vegetable Shortening; UPC: 8 97307 00251 2; Distributed By: Karison Foods & Snacks Inc.; 34 Willowdale Ave., Port Washington, NY 11050; Manufactured in a facility that processes Milk, Eggs, Soybean, Tree nuts, Wheat, Peanuts and other Nuts. Product is packaged in clear plastic containers, 12-(12 oz) units/case.
Karison brand ALSI PINNI; NET WT. 12 oz.; Ingredients: Wheat Flour, Butter, Sugar Flax Seeds, Almonds, Zero Trans Fat, Vegetable Shortening; UPC: 8 97307 00251 2; Distributed By: Karison Foods & Snacks Inc.; 34 Willowdale Ave., Port Washington, NY 11050; Manufactured in a facility that processes Milk, Eggs, Soybean, Tree nuts, Wheat, Peanuts and other Nuts. Product is packaged in clear plastic containers, 12-(12 oz) units/case.
Product contains milk, which is undeclared in the ingredient statement.
FDA DevicesMedline medical convenience kits packaged as: STERILE RESUTURE PACK, Kit SKU DYNDL1980A
Medline medical convenience kits packaged as: STERILE RESUTURE PACK, Kit SKU DYNDL1980A
Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may exhibit an open seal on the packaging of the applicators.
FDA DevicesMedline medical convenience kits packaged as: SUTURE REMOVAL TRAY, Kit SKU DYNDR1277A
Medline medical convenience kits packaged as: SUTURE REMOVAL TRAY, Kit SKU DYNDR1277A
Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may exhibit an open seal on the packaging of the applicators.
FDA DrugsTestosterone, 18.0 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1018-32.
Testosterone, 18.0 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1018-32.
Presence of Foreign substance - potential presence of metal particulate matter
FDA DevicesReprocessed St. Jude Supreme and Response Diagnostic Electrophysiology Catheters: St. Jude Medical Supreme Diagnostic Electrophysiology Catheter 4 Elec. 2-5-2mm 401211RH 401222RH 401223RH 401226RH 401227RH 401260RH 401261RH 401306RH 401309RH 401312RH 401430RH 401433RH 401435RH 401441RH 401442RH 401443RH 401448RH 401449RH 401450RH 401451RH 401474RH 401860RH 401877RH 401878RH 401890RH 401891RH 401994RH; St. Jude Medical Supreme Diagnostic Electrophysiology Catheter 4 Elec. 5-5-5mm 402012RH; St. Jude Medical Supreme Diagnostic Electrophysiology Catheter 4 Elec. 5mm 402004RH; St. Jude Medical Supreme Diagnostic Electrophysiology Catheter 6 Elec. 2-5-2mm 402010RH; St. Jude Medical Supreme Diagnostic Electrophysiology Catheter 6 Elec. 5-5-5mm 402008RH 402009RH
Reprocessed St. Jude Supreme and Response Diagnostic Electrophysiology Catheters: St. Jude Medical Supreme Diagnostic Electrophysiology Catheter 4 Elec. 2-5-2mm 401211RH 401222RH 401223RH 401226RH 401227RH 401260RH 401261RH 401306RH 401309RH 401312RH 401430RH 401433RH 401435RH 401441RH 401442RH 401443RH 401448RH 401449RH 401450RH 401451RH 401474RH 401860RH 401877RH 401878RH 401890RH 401891RH 401994RH; St. Jude Medical Supreme Diagnostic Electrophysiology Catheter 4 Elec. 5-5-5mm 402012RH; St. Jude Medical Supreme Diagnostic Electrophysiology Catheter 4 Elec. 5mm 402004RH; St. Jude Medical Supreme Diagnostic Electrophysiology Catheter 6 Elec. 2-5-2mm 402010RH; St. Jude Medical Supreme Diagnostic Electrophysiology Catheter 6 Elec. 5-5-5mm 402008RH 402009RH
These lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of inflammatory response, systemic infection, or granulomatous reaction or thrombus reaction which may lead to cerebral or pulmonary embolism, or deep vein thrombosis. Expansion of recall Z-2610/2614-2025
FDA DevicesAzurion 3 M12 System Model Numbers: (1) 722063, (2) 722221, (3) 722229; Software Version Number - All versions: R1.X, R2.X, R3.X
Azurion 3 M12 System Model Numbers: (1) 722063, (2) 722221, (3) 722229; Software Version Number - All versions: R1.X, R2.X, R3.X
Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.
FDA DevicesAzurion 7 B12 System Model Numbers:(1) 722067, (2) 722225, (3) 722235; Software Version Number - All versions: R1.X, R2.X, R3.X
Azurion 7 B12 System Model Numbers:(1) 722067, (2) 722225, (3) 722235; Software Version Number - All versions: R1.X, R2.X, R3.X
Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.
FDA DevicesMedline medical convenience kits packaged as: PEDIATRIC CATH SECUREMENT DRSG, Kit SKU DYNDC3108
Medline medical convenience kits packaged as: PEDIATRIC CATH SECUREMENT DRSG, Kit SKU DYNDC3108
Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may exhibit an open seal on the packaging of the applicators.
FDA DevicesBarco MNA with the HexaVue IP Integration System, Model/Catalog Number: MNA-6x0-H
Barco MNA with the HexaVue IP Integration System, Model/Catalog Number: MNA-6x0-H
This is a sub-recall of event RES 96885. The supplier identified that during their manufacturing process for a limited batch of MNA-6x0 (adapter) components the incorrect configuration file was used.
FDA Devicesda Vinci 5 Surgeon Console Viewer Display, ASSY, DV5 CONSOLE, IS5000, Part Number: 380730-45
da Vinci 5 Surgeon Console Viewer Display, ASSY, DV5 CONSOLE, IS5000, Part Number: 380730-45
Robotic-assisted surgical system has Viewer Display manufactured with outdated firmware, may result in loss of one display-loss of 3D surgical field (depth perception) but 2D maintained, or loss of both displays-complete visualization loss, without fault, instruments remain active, could lead to instrument contact with tissue, resulting in injury/bleeding; may require alternate surgical modality.