The Recall Desk

Archive

September 2024 recalls

704 recalls were announced in September 2024.

What the numbers show

Critical
8
Severe
100
High
396
Moderate
199
Low
1

Of the 704 recalls this month scored against our rubric, 1% are Critical, 14% are Severe.

401–500 of 704

  • SevereNHTSA·24V659000·2024-09-09

    Mercedes-Benz G 550 rear door latch defect poses safety risk

    Mercedes-Benz recalls 2019-2023 G 550 and 2019-2022 G63 AMG vehicles with faulty rear door latches that may fail to engage or prevent door operation, creating crash and injury risks.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ AMG G63, G 550
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V656000·2024-09-06

    Airstream Recalls 2024 Trade Wind Trailers Due to Fire Risk

    Airstream is recalling 2024 Trade Wind travel trailers because the air conditioner soft start device may overheat, increasing the risk of a fire.

    Product
    AIRSTREAM — AIRSTREAM TRADE WIND
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V655000·2024-09-06

    Phoenix Motorcars Transit Buses Recalled for Electrical System Fire Risk

    Phoenix Motorcars is recalling certain 2019-2021 800V Catalyst and 2020-2022 ZX5 transit buses. The vehicle software may cause the radiator fan electrical circuit to overheat, increasing fire risk.

    Product
    PROTERRA — PROTERRA ZX5, CATALYST
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24E076000·2024-09-06

    Holley Sniper 2 EFI Throttle Body Recall for Fuel Leak Risk

    Holley is recalling 736 Sniper 2 EFI Throttle Bodies that may be missing a fuel plug, creating a risk of fuel leaks and fire.

    Product
    FUEL SYSTEM, GASOLINE:FUEL INJECTION SYSTEM:THROTTLEBODY/MANIFOLD recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·24V653000·2024-09-05

    RAM 1500 Models Recalled for Anti-Lock Brake Software Malfunction

    Chrysler is recalling certain 2019, 2021-2024 RAM 1500 vehicles because a software malfunction in the ABS control module may disable the electronic stability control system, increasing crash risk.

    Product
    RAM — RAM 1500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·24E075000·2024-09-05

    Chrysler Recalls MOPAR ABS Modules for Electronic Stability Control Failure

    Chrysler is recalling MOPAR anti-lock braking system control modules used as replacement parts in certain Ram 1500 vehicles. A software malfunction may disable the electronic stability control system, increasing crash risk.

    Product
    ELECTRONIC STABILITY CONTROL (ESC):CONTROL MODULE recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V654000·2024-09-05

    2024 Porsche Taycan Headlight Control Software Defect Recall

    Porsche is recalling 954 model year 2024 Taycan vehicles due to incorrect headlight control module software that may prevent parking lights from functioning when turn signals are activated, potentially reducing visibility and increasing crash risk.

    Product
    PORSCHE — PORSCHE TAYCAN
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V652000·2024-09-05

    Instrument Panel Cluster May Fail in Jeep Wrangler Vehicles

    Jeep is recalling certain 2018-2024 Wrangler and 2020-2024 Gladiator vehicles because the instrument panel cluster may fail due to an internal short circuit, preventing drivers from seeing the speedometer and warning lights.

    Product
    JEEP — JEEP WRANGLER, GLADIATOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·24354·2024-09-05

    Delta Cycle Ceiling Hoists with Straps Recalled for Buckle Breakage Injury Risk

    Delta Cycle Corp is recalling ceiling hoists with straps because plastic buckles can break when holding kayaks, canoes, or other large objects. The company has received four incident reports, including one minor injury.

    Product
    Ceiling Hoists with Straps
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2611-2024·2024-09-04

    Smiths Medical Recalls Bivona Tracheostomy Tubes Due to Flange Defect

    Smiths Medical is recalling specific lots of Bivona tracheostomy tubes because the securement flange may tear due to a manufacturing defect.

    Product
    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PEDIATRIC TRACHEOSTOMY TUBE 4.0mm TTS FLEXTEND PLUS V FLANGE , Product Code/List Number/Item Code 67PFP40; b) PEDIATRIC TRACHEOSTOMY TUBE 4.5mm TTS FLEXTEND PLUS V FLANGE , Product Code/List Number/Item Code 67PFP45;
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-2606-2024·2024-09-04

    Smiths Medical Bivona Neonatal Tracheostomy Tubes Recalled for Flange Tear

    Smiths Medical recalls PORTEX Bivona Neonatal Tracheostomy Tubes due to manufacturing defect that may cause securement flange to tear, compromising tube stability.

    Product
    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS NEONATAL TRACH TUBE , Product Code/List Number/Item Code 67N025; b) TTS NEONATAL TRACH TUBE , Product Code/List Number/Item Code 67N030; c) TTS NEONATAL TRACH TUBE , Product Code/List Number/Item Code 67N035
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-2592-2024·2024-09-04

    PORTEX Bivona Tracheostomy Tubes Recalled for Flange Tearing Defect

    Smiths Medical is recalling PORTEX Bivona Tracheostomy Tubes because the securement flange may tear due to a manufacturing defect, risking loss of airway securement.

    Product
    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE 2.5FLEXTEND PLUS , Product Code/List Number/Item Code 60NFP25; b) NEONATAL TRACHEOSTOMY TUBE 3.0FLEXTEND PLUS , Product Code/List Number/Item Code 60NFP30; c) NEONATAL TRACHEOSTOMY TUBE
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2605-2024·2024-09-04

    Bivona Tracheostomy Tubes Recalled for Potential Securement Flange Failure

    Smiths Medical recalled specific lots of Bivona Tracheostomy Tubes after identifying a manufacturing defect that may cause the securement flange to tear, risking tube displacement.

    Product
    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: 2.5MM AIRE-CUF NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65SN025; 3.0MM AIRE-CUF NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65SN030; 3.5MM AIRE-CUF NEONATAL TRACHEOSTOMY TUBE ,
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2590-2024·2024-09-04

    PORTEX Bivona Tracheostomy Tube Securement Flange May Tear

    Smiths Medical is recalling specific lots of PORTEX Bivona Tracheostomy Tubes because the securement flange may tear due to a manufacturing defect. The recall affects neonatal, pediatric, and adult versions distributed worldwide.

    Product
    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60N025
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2603-2024·2024-09-04

    Tracheostomy Tubes Recalled for Manufacturing Defect Affecting Securement Flange

    Smiths Medical recalled specific lots of PORTEX Bivona Tracheostomy Tubes due to a manufacturing defect that may cause the securement flange to tear. Affected products were distributed worldwide.

    Product
    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65N025; b) NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65N030; c) NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2589-2024·2024-09-04

    Bivona Tracheostomy Tubes Recalled Due to Securement Flange Tear Risk

    Smiths Medical is recalling specific lots of PORTEX Bivona Tracheostomy Tubes because a manufacturing defect may cause the securement flange to tear.

    Product
    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) AIRE-CUF TRACHY TUBE 6.0MM MID-RANGE , Product Code/List Number/Item Code 750160; b) AIRE-CUF TRACHY TUBE 7.0MM MID-RANGE , Product Code/List Number/Item Code 750170; c) AIRE-CUF TRACHY TUBE 8.0MM MID-RANGE , Produc
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2613-2024·2024-09-04

    Tracheostomy Tubes Recalled for Torn Securement Flange Risk

    Smiths Medical recalls PORTEX Bivona tracheostomy tubes due to a manufacturing defect that may cause the securement flange to tear, potentially leading to tube dislodgement.

    Product
    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PEDIATRIC TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND V NECK, Product Code/List Number/Item Code 67PFS25; b) PEDIATRIC TRACHEOSTOMY TUBE 3.0mm TTS FLEXTEND V NECK , Product Code/List Number/Item Code 67PFS30; c) PEDIATRIC
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2612-2024·2024-09-04

    Tracheostomy Tubes Recalled for Possible Flange Tearing Due to Manufacturing Defect

    Smiths Medical is recalling specific lots of PORTEX Bivona pediatric and neonatal tracheostomy tubes because the securement flange may tear due to a manufacturing defect. The recall affects multiple tube sizes distributed worldwide.

    Product
    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PEDIATRIC TRACHEOSTOMY TUBE 4.0mm TTS FLEXTEND PLUS STRAIGHT FLANGE , Product Code/List Number/Item Code 67PFPS40; b) PEDIATRIC TRACHEOSTOMY TUBE 4.5mm TTS FLEXTEND PLUS STRAIGHT FLANGE , Product Code/List Number/Item
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Food)·F-1758-2024·2024-09-04

    Nuts.com Paprika Recalled for Possible Salmonella Contamination

    Nuts.com is recalling 25-pound bags of paprika due to possible Salmonella contamination. Affected product was distributed to consignees in Virginia and Massachusetts.

    Product
    Nuts.com Paprika 25 lb, packaged in a clear plastic bag. 1 bag per cardboard box.
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-1793-2024·2024-09-04

    Popsicle Recall: Yummy Brand Swirly Ices Contain Undeclared Milk

    Yummy brand Swirly Ices popsicles are recalled due to undeclared milk allergen. The recall affects 282 boxes distributed across nine states.

    Product
    Yummy brand Swirly Ices Assorted Flavors Net Wt. 2.3 ounces (65g)x 8 popsicles, Total Net Wt. 18.34 ounces (520g) UPC: 734690007574. Contains Fruity Melon, Churning Cherry, Berry Blast, and Tropical Tornado flavored popsicles
    Category
    Food
    Distribution
    9 states
  • SevereFDA (Devices)·Z-2599-2024·2024-09-04

    Tracheostomy Tubes Recalled Due to Securement Flange Tears

    Smiths Medical is recalling specific lots of PORTEX Bivona Tracheostomy Tubes because the securement flange may tear due to a manufacturing defect. These tubes are used for neonatal, pediatric, and adult patients worldwide.

    Product
    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY TUBE 2.5MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS25; b) PAED. TRACHEOSTOMY TUBE 3.0MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS30; c) PAED. TRACHE
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2597-2024·2024-09-04

    PORTEX Bivona Tracheostomy Tube Securement Flange May Tear Due to Manufacturing Defect

    Smiths Medical recalls specific lots of PORTEX Bivona Tracheostomy Tubes because the securement flange may tear due to a manufacturing defect, potentially affecting tube positioning.

    Product
    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: 6.0MM FLEXTEND PEDIATRIC PLUS VEE TRACH TUBE , Product Code/List Number/Item Code 60PFP60
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2607-2024·2024-09-04

    Bivona Neonatal Tracheostomy Tubes recalled due to defective securement flanges

    Smiths Medical recalls specific lots of PORTEX Bivona neonatal and pediatric tracheostomy tubes due to manufacturing defects in the securement flange that may tear.

    Product
    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: TTS NEONATAL TRACHY TUBE 4.0MMTIGHT TO SHAFT CUFF , Product Code/List Number/Item Code 67N040
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Food)·F-1791-2024·2024-09-04

    Yummy Brand Swirly Ices Popsicles Recalled for Undeclared Milk

    Yummy brand Swirly Ices Fruity Melon popsicles are being recalled because they contain undeclared milk, a common allergen. The recall affects 268 boxes distributed to retail supermarkets in nine states.

    Product
    Yummy brand Swirly Ices Fruity Melon flavor Net Wt. 2.3 ounces (65g)x 8 popsicles, Total Net Wt. 18.34 ounces (520g) UPC:734690007536 Also packaged in 30 count packs
    Category
    Food
    Distribution
    9 states
  • SevereFDA (Devices)·Z-2596-2024·2024-09-04

    Bivona Neonatal, Pediatric, and Adult Tracheostomy Tubes Recalled for Flange Defect

    Smiths Medical is recalling specific lots of Bivona Neonatal, Pediatric, and Adult Tracheostomy Tubes because the securement flange may tear due to a manufacturing defect, potentially compromising tube security.

    Product
    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY TUBE 4.0MM FLEXTEND PLUS, Product Code/List Number/Item Code 60PFP40; b) PAED. TRACHEOSTOMY TUBE 4.0MM FLEXTEND PLUS, Product Code/List Number/Item Code 60PFP45; c) PAED. TRACHEOSTOMY TUBE 5.0MM FL
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2692-2024·2024-09-04

    FreeStyle Libre 3 Sensors Recalled for Inaccurate Glucose Readings

    FreeStyle Libre 3 sensors may report falsely high glucose levels, causing users to over-dose insulin and miss dangerous low blood sugar episodes. Abbott has recalled 8,174 units.

    Product
    FreeStyle Libre 3 Sensors, REF: 72081-01, component of the FreeStyle Libre 3 Continuous Glucose Monitoring System
    Category
    Medical Device
    Distribution
    12 states
  • SevereFDA (Devices)·Z-2600-2024·2024-09-04

    Tracheostomy Tube Recall: PORTEX Bivona Due to Manufacturing Defect in Securement Flange

    Smiths Medical is recalling specific lots of PORTEX Bivona Tracheostomy Tubes because of a manufacturing defect that may cause the securement flange to tear.

    Product
    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: 2.5MM PEDIATRIC UNCUFFED FLEXTEND PLUS TRACHEOSTOMY TUBE WITH NEONATE STRAIGHT NECKSTRAP, Product Code/List Number/Item Code 60PFSS25
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Food)·F-1790-2024·2024-09-04

    Yummy Swirly Ices popsicles recalled for undeclared milk allergen

    Yummy Swirly Ices Berry Blast popsicles are recalled due to undeclared milk allergen. Recall affects 262 boxes distributed across nine states.

    Product
    Yummy brand Swirly Ices Berry Blast flavor Net Wt. 2.3 ounces (65g)x 8 popsicles, Total Net Wt. 18.34 ounces (520g) UPC: 734690007550 Also packaged in 30 count packs
    Category
    Food
    Distribution
    9 states
  • SevereFDA (Food)·F-1755-2024·2024-09-04

    Bikano Moong Dal Recalled for Potential Salmonella Contamination

    Bikano Moong Dal Crunchy Green Gram snacks are being recalled due to potential Salmonella contamination. The recall affects 640 retail packs distributed to 7 stores in California.

    Product
    Bikano Moong Dal Crunchy Green Gram Net Weight 12.35oz (350g) Product of India Manufactured by: Bikanervala Foods Pvt. Ltd. B1-Plot No. 42 (Khasra No. 661-662), Ecotech II, Udyog Vihar, Greater Noida Gautam Buddha Nagar - 201306
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Devices)·Z-2588-2024·2024-09-04

    Smiths Medical Bivona Tracheostomy Tubes Recalled for Flange Tear Risk

    Smiths Medical is recalling PORTEX Bivona Tracheostomy Tubes due to a manufacturing defect that may cause the securement flange to tear. Affected lots include neonatal, pediatric, and adult sizes distributed worldwide with 177,340 units impacted.

    Product
    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS TRACHEOSTOMY TUBE 7.0MM TIGHT TO SHAFT CUFF, Product Code/List Number/Item Code 670170; b) TTS TRACHEOSTOMY TUBE 8.0MM TIGHT TO SHAFT CUFF 1/EA, Product Code/List Number/Item Code 670180
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2615-2024·2024-09-04

    PORTEX Bivona Neonatal and Pediatric Tracheostomy Tubes Recalled for Flange Tear

    Smiths Medical is recalling specific lots of PORTEX Bivona neonatal and pediatric tracheostomy tubes because the securement flange may tear due to a manufacturing defect.

    Product
    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 2.5mm TTS CUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SN025; b) 3.0mm TTS CUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SN030; c) 3.5mm TTS CUFFED NEONATAL TRAC
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Food)·F-1749-2024·2024-09-04

    Prime Food Steam Buns Recalled for Undeclared Sesame Allergen

    Prime Food Processing Corp. is recalling Prime Food brand Steam Buns because they may contain undeclared sesame, an allergen. Consumers with sesame allergies should not consume the product.

    Product
    Prime Food brand Steam Bun with Egg Custard Added; 10pcs/pack; NET WT. 20 oz (1lb.4 oz) 568g; KEEP FROZEN; INGREDIENTS: Dough: Bleached Wheat Flour, Water, Sugar, Salad Oil (Soybean Oil, Canola Oil), Food Starch-Modified, Baking Powder (Corn Starch, Sodium Bicarbonate, Sodium Alu
    Category
    Food
    Distribution
    27 states
  • SevereFDA (Devices)·Z-2604-2024·2024-09-04

    Bivona Tracheostomy Tubes Recalled for Manufacturing Defect in Securement Flange

    Smiths Medical recalls specific lots of Bivona Neonatal/Pediatric and Adult Tracheostomy Tubes worldwide due to a manufacturing defect that may cause the securement flange to tear.

    Product
    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY TUBE 2.5MM AIRE-CUF , Product Code/List Number/Item Code 65P025; b) PAED. TRACHEOSTOMY TUBE 3.0MM AIRE-CUF , Product Code/List Number/Item Code 65P030; c) PAED, TRACHEOSTOMY TUBE 3.5mm AIRE-CUF , P
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2595-2024·2024-09-04

    PORTEX Bivona Tracheostomy Tubes Recalled for Securement Flange Manufacturing Defect

    Smiths Medical is recalling specific lots of PORTEX Bivona Tracheostomy Tubes because the securement flange may tear due to a manufacturing defect. Products distributed worldwide.

    Product
    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY TUBE 2.5MM UNCUFFED , Product Code/List Number/Item Code 60P025; b) PAED. TRACHEOSTOMY TUBE 3.0MM UNCUFFED , Product Code/List Number/Item Code 60P030; c) PAED. TRACHEOSTOMY TUBE 3.5MM UNCUFFED , P
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2602-2024·2024-09-04

    PORTEX Bivona Tracheostomy Tubes Recalled for Defective Securement Flange

    Smiths Medical is recalling PORTEX Bivona neonatal and pediatric tracheostomy tubes worldwide due to a manufacturing defect in the securement flange that may tear and affect proper positioning.

    Product
    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 2.5 UNCUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SN025; b) 3.0 UNCUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SN030; c) 3.5 UNCUFFED NEONATAL TRACHEOSTOMY TUB
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2594-2024·2024-09-04

    PORTEX Bivona Tracheostomy Tubes Recalled Due to Flange Tearing Defect

    PORTEX Bivona Tracheostomy Tubes (3.0mm, 3.5mm, 4.0mm) are being recalled due to a manufacturing defect that may cause the securement flange to tear. This could result in airway obstruction or loss of tube securement.

    Product
    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 3.0MM FLEXTEND NEO STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60NFPS30; b) 3.5MM FLEXTEND NEO STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60NFPS35; c) 4.0MM FLEXTEND NEO STRAIGHT TRACH T
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2591-2024·2024-09-04

    PORTEX Bivona Neonatal Tracheostomy Tubes recalled for defective securement flange

    Smiths Medical recalls PORTEX Bivona Neonatal Tracheostomy Tubes due to a manufacturing defect in the securement flange, which may tear. Affected patients should discontinue use and contact their healthcare provider.

    Product
    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACH TUBE , Product Code/List Number/Item Code 60N030; b) NEONATAL TRACH TUBE , Product Code/List Number/Item Code 60N035; c) NEONATAL TRACH TUBE , Product Code/List Number/Item Code 60N040;
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2598-2024·2024-09-04

    Tracheostomy Tube Flange May Tear Due to Manufacturing Defect

    Smiths Medical is recalling specific lots of PORTEX Bivona Tracheostomy Tubes because the securement flange may tear due to a manufacturing defect. This affects pediatric and adult sizes distributed worldwide.

    Product
    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 4.0MM FLEXTEND PEDIATRIC PLUS STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFPS40; b) 4.5MM FLEXTEND PEDIATRIC PLUS STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFPS45; c) 5.0MM FLEXTEND
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Food)·F-1789-2024·2024-09-04

    Yummy Swirly Ices Popsicles Recalled for Undeclared Milk Allergen

    Yummy brand Swirly Ices Tropical Tornado popsicles are recalled due to undeclared milk. The recall affects 275 boxes distributed to retail supermarkets in nine states.

    Product
    Yummy brand Swirly Ices Tropical Tornado flavor Net Wt. 2.3 ounces (65g)x 8 popsicles, Total Net Wt. 18.34 ounces (520g) UPC:734690007567. Also packaged in 30 count packs
    Category
    Food
    Distribution
    9 states
  • SevereFDA (Devices)·Z-2608-2024·2024-09-04

    Bivona Neonatal Tracheostomy Tubes Recalled for Flange Tear Risk

    Smiths Medical is recalling specific lots of Bivona Neonatal and Pediatric Tracheostomy Tubes because the securement flange may tear due to manufacturing defects.

    Product
    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND V FLANGE , Product Code/List Number/Item Code 67NFP25; b) NEONATAL TRACHEOSTOMY TUBE 3.0mm TTS FLEXTEND V FLANGE , Product Code/List Number/Item Code 67NFP30; c) NEONATAL
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Food)·F-1750-2024·2024-09-04

    Prime Food Steam Buns Recalled for Undeclared Sesame Allergen

    Prime Food brand steam buns may contain undeclared sesame, an allergen not listed on the product label. The FDA classified this as a Class I recall affecting 477 cases across multiple U.S. states and international locations.

    Product
    Prime Food brand Steam Bun with Egg Custard & Coconut Added; 10pcs/pack; NET WT. 20 oz (1lb.4 oz) 568g; KEEP FROZEN; INGREDIENTS: Dough: Bleached Wheat Flour, Water, Sugar, Salad Oil (Soybean Oil, Canola Oil), Food Starch-Modified, Instant Yeast (Yeast (Saccharomyces Cerevisiae),
    Category
    Food
    Distribution
    27 states
  • SevereFDA (Food)·F-1792-2024·2024-09-04

    Yummy Swirly Ices Churning Cherry Popsicles Recalled for Undeclared Milk

    Yummy brand Swirly Ices Churning Cherry popsicles are being recalled because they contain undeclared milk, posing a risk to consumers with milk allergies.

    Product
    Yummy brand Swirly Ices Churning Cherry flavor Net Wt. 2.3 ounces (65g)x 8 popsicles, Total Net Wt. 18.34 ounces (520g) UPC:734690007543 Also packaged in 30 count packs
    Category
    Food
    Distribution
    9 states
  • SevereFDA (Devices)·Z-2609-2024·2024-09-04

    PORTEX Bivona Neonatal Tracheostomy Tubes May Tear Due to Manufacturing Defect

    Smiths Medical is recalling specific lots of PORTEX Bivona Neonatal Tracheostomy Tubes due to a manufacturing defect that may cause the securement flange to tear, affecting device positioning.

    Product
    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND STRAIGHT FLANGE , Product Code/List Number/Item Code 67NFPS25; b) NEONATAL TRACHEOSTOMY TUBE 3.0mm TTS FLEXTEND STRAIGHT FLANGE , Product Code/List Number/Item Code 67NFPS
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2601-2024·2024-09-04

    Bivona Tracheostomy Tubes Recalled Due to Defective Securement Flange

    Smiths Medical is recalling PORTEX Bivona Tracheostomy Silicone Tubes because the securement flange may tear due to a manufacturing defect. The defect affects multiple lot numbers across all size variants distributed worldwide.

    Product
    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 3.0MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS30; b) 3.5MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS35; c) 4.0MM
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2745-2024·2024-09-04

    Medline recalls three medical procedure kits with defective plastic syringes

    Medline is recalling three procedural kits containing plastic syringes with leaks and breakage issues that may pose a risk to patient health. The kits have been distributed worldwide.

    Product
    Medline procedural kits labeled as: 1) CAROTID ENDARTERECTOMY PK, Pack Number DYNJ85516; 2) PICC INSERTION TRAY W/O CATH, Pack Number PICCNC0004; 3) VASCATH INSERTION PACK, Pack Number, CVI4825
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2629-2024·2024-09-04

    Medline Procedure Packs with Defective Syringes Recalled Worldwide

    Medline recalls approximately 1.7 million procedure packs containing defective Shenli syringes due to leaks and breakage that may pose patient risks. The syringes are affected by an FDA Safety Alert from March 2024.

    Product
    Medline procedure packs containing Shenli syringes, labeled as follows: 1) CVC INSERT BUNDLE 16CM, Pack Number ECVC3260; 2) VANTEX 7FR 3L 20CM CVC BUNDLE US, Pack Number ECVC8045
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2733-2024·2024-09-04

    GE Healthcare Proteus XR/a X-Ray System Missing De-Installation Manual

    GE Healthcare's Proteus XR/a stationary X-ray system lacks a required de-installation manual, creating risk of personnel injury during device removal.

    Product
    GE Healthcare Proteus XR/a, stationary X-Ray System, Model/Catalog Numbers: 1) 2259973; 2) 2259988; 3) 2266999; 4) 2373519; 5) 2379827; 6) 5729352; 7) 2259973-1; 8) 2259973-2; 9) 2259973-3; 10) 2259973-4; 11) Not Available
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2742-2024·2024-09-04

    Medline Procedural Kits with Defective Syringes Recalled Worldwide

    Medline procedural kits containing defective plastic syringes have been recalled worldwide due to potential leaks and breakage. The affected products include ultrasound catheter insertion and circumcision kits distributed globally.

    Product
    Medline procedural kits labeled as: 1) PERIPHERAL ULTRASOUND CATHETER INSERTION, Pack Number MNS9865; 2) CIRCUMCISION TRAY, Pack Number CIT6715; 3) OSF SMMC CIRCUMCISION KIT, Pack Number CIT7095
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2720-2024·2024-09-04

    Medical Device: Ion Endoluminal System Recalled for Instrument Arm Screw Failure

    Intuitive Surgical is recalling the Ion Endoluminal System due to potential screw failure in the instrument cart arm, which could cause uncontrolled catheter motion in patient airways.

    Product
    Ion Endoluminal System, REF: 380748-65
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2759-2024·2024-09-04

    Medline Procedural Kits Recalled for Syringe Quality Defects

    Medline is recalling NEURO TRAY procedural kits (Pack DYNJ55909B, Lot 23IBB122) due to plastic syringe defects including leaks and breakage that may pose a risk to patient health.

    Product
    Medline procedural kits labeled as: NEURO TRAY, Pack Number DYNJ55909B
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2764-2024·2024-09-04

    Medline procedural kits recalled for plastic syringe defects

    Medline is recalling procedural kits containing plastic syringes with leaks, breakage, and other quality defects. These defects may pose a risk to patient safety.

    Product
    Medline procedural kits labeled as: 1) ALL DOC EYE PACK, Pack Number DYNJ51654A ; 2) ASC CATARACT PACK , Pack Number DYNJ0855117O ; 3) BAI , Pack Number DYNJ53847D ; 4) BASIC EYE PACK, Pack Number DYNJ83699A ; 5) BASIC EYE PACK, Pack Number DYNJ81805; 6) BASIC EYE PACK, Pa
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2779-2024·2024-09-04

    Centurion Procedure Packs With Defective Syringes Recalled Worldwide

    Medline Industries is recalling Centurion procedure packs containing plastic syringes with identified leaks, breakage, and quality defects. The recall affects units distributed worldwide.

    Product
    Centurion procedure packs, containing Caina syringes, labeled as: 1) ARTHROGRAM TRAY, Pack Number MNS11965A; 2) CIRCUMCISION TRAY, Pack Number CIT6720; 3) CIRCUMCISION TRAY, Pack Number CIT6720A
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2739-2024·2024-09-04

    Medline pediatric anesthesia circuit kits with defective plastic syringes

    Medline procedural kits contain plastic syringes with leaks, breakage, and quality issues that may pose patient health risks. Affected units have been distributed worldwide.

    Product
    Medline procedural kits labeled as: 1) ANESTHESIA CIRCUIT PEDS-LF, Pack Number DYNJAA0327F; 2) ANESTHESIA CIRCUIT PEDS-LF, Pack Number DYNJAA0327G
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-1748-2024·2024-09-04

    La Superior Bakery Pan Guatemalteco Recalled for Undeclared Sesame

    La Superior Bakery is recalling Pan Guatemalteco pastries due to undeclared sesame seeds. Consumers with sesame allergies face risk of allergic reaction.

    Product
    La Superior Bakery - Pan Guatemalteco packaged in clear plastic bag - 5 pastries per bag
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2765-2024·2024-09-04

    Medline Procedural Kits Recalled for Defective Plastic Syringes

    Medline Industries is recalling multiple procedural kits containing plastic syringes affected by an FDA Safety Alert. The syringes have quality issues including leaks and breakage that may pose a risk to patient health.

    Product
    Medline procedural kits labeled as: 1) AFCH ANTERIOR SEGMENT PK, Pack Number DYNJ63330B ; 2) ANTERIOR HIP PACK , Pack Number DYNJ82317; 3) ARTHROGRAM, Pack Number DYNDH1446A ; 4) ARTHROGRAM TRAY, Pack Number DYNDH1648; 5) ARTHROGRAM TRAY, Pack Number PAIN1396 ; 6) AR
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2755-2024·2024-09-04

    Medline Procedural Kits Recalled Due to Defective Plastic Syringes

    Medline is recalling multiple procedural kits containing defective plastic syringes that may leak or break. The syringes were identified in an FDA Safety Alert issued on March 19, 2024.

    Product
    Medline procedural kits labeled as: 1) CIRCUMCISION TRAY, Pack Number CIT6715; 2) NICU CIRCUMCISION TRAY W/OUT CLAMP, Pack Number CIT6920; 3) PORT DRESSING CHANGE TRAY, Pack Number DT18415; 4) UCLA - BREAST BIOPSY KIT, Pack Number DYNDH1512
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2756-2024·2024-09-04

    Medline Procedural Kits Recalled Due to Defective Plastic Syringes

    Medline Industries is recalling multiple procedural kits containing defective plastic syringes that may leak or break. The affected kits were distributed worldwide.

    Product
    Medline procedural kits labeled as: 1) CIRCUMCISION TRAY, Pack Number CIT6715; 2) NICU CIRCUMCISION TRAY W/OUT CLAMP, Pack Number CIT6920; 3) OSF SMMC CIRCUMCISION KIT, Pack Number CIT7095; 4) RETINAL INJECTION KIT, Pack Number MNS12465; 5) UCLA - BREAST BIOPSY KIT, Pa
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2766-2024·2024-09-04

    Centurion procedure kits recalled due to defective plastic syringes

    Medline Industries is recalling Centurion procedure kits containing plastic syringes with leaks and breakage issues. The defective syringes may pose a risk to patient health during medical procedures.

    Product
    Centurion procedure kits labeled as: 1) BIOPSY KIT, Pack Number DYNDA1466A; 2) BIOPSY SKIN/LACERATION TRAY, Pack Number SUT20455; 3) CHEST TUBE INSERTION TRAY, Pack Number CHT560; 4) CUSTOM BIOPSY TRAY, Pack Number MNS4815; 5) PERITONSILLAR ABSCESS TRAY, Pack Number MN
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2734-2024·2024-09-04

    Electrocardiograph Recall: CARDIOVIT AT-180 May Produce Signal Artifacts

    Schiller is recalling CARDIOVIT AT-180 electrocardiographs due to potential high-frequency signal artifacts during ECG acquisition that may affect diagnostic accuracy. 1,084 units are affected worldwide.

    Product
    CARDIOVIT AT-180. Model Number: 0A.110000; Catalog number: 3.920570
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2919-2024·2024-09-04

    BVI CustomEyes Procedure Packs Recalled Due to Sol-M Syringe Quality Concern

    Beaver Visitec International is recalling 227 units of BVI CustomEyes Procedure Packs containing syringes from Sol-Millennium Medical due to a quality concern affecting those syringes.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001838;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2744-2024·2024-09-04

    Medline Circumcision Kits Recalled Due to Defective Syringes

    Medline is recalling two circumcision tray kit models due to plastic syringes with leaks, breakage, and quality defects that may harm patients. The kits have been distributed worldwide.

    Product
    Medline procedural kits labeled as: 1) MEDICAL CIRCUMCISION TRAY, Pack Number CIT6780; 2) NICU CIRCUMCISION TRAY W/OUT CLAMP, Pack Number CIT6920
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2758-2024·2024-09-04

    Medline Medical Procedural Kits Recalled for Defective Plastic Syringes

    Multiple Medline procedural kits contain defective plastic syringes that may leak or break during medical procedures. The FDA has advised of potential patient health risks from these manufacturing quality issues.

    Product
    Medline procedural kits labeled as: 1) GLMI ARTHROGRAM KIT:PCL, Pack Number SPEC0300B; 2) MERCY MEDICAL CIRCUMCISION TRAY, Pack Number CIT6780; 3) NURSERY CIRCUMCISION TRAY, Pack Number CIT4845; 4) PERIPHERAL ULTRASOUND CATHETER INSERTION, Pack Number MNS9865; 5) STERI
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2751-2024·2024-09-04

    Medline Procedural and Medical Kits Recalled for Defective Syringes

    Medline is recalling procedural kits worldwide containing plastic syringes with identified leaks and breakage. The defective syringes were identified in an FDA Safety Alert from March 19, 2024, and may pose risks to patients.

    Product
    Medline procedural kits labeled as: 1) DRAWER 3 LAB DRAW & IV START, Pack Number ACC010417 ; 2) DRAWER 3 LAB DRAW & IV START, Pack Number ACC010417A; 3) DRAWER 9L , Pack Number ACC010427A; 4) MEDICATION DELIVERY MODULE, Pack Number ACC010605 ; 5) DRAWER 3, Pack Number
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2864-2024·2024-09-04

    BVI CustomEyes Procedure Packs with Sol-M Syringes Recalled

    Beaver Visitec International, Inc. is recalling BVI CustomEyes Procedure Packs containing Sol-M manufactured syringes. The voluntary recall affects approximately 1,629 units distributed nationwide.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001376;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2748-2024·2024-09-04

    Medline Fetal Surgery Kits Recalled Due to Defective Plastic Syringes

    Medline Industries is recalling procedural kits containing plastic syringes that may leak or break. The syringes were identified in a March 2024 FDA Safety Alert and may pose a risk to patient health.

    Product
    Medline procedural kits labeled as: 1) FETAL SURGERY-LF, Pack Number CDS840214Q; 2) FETAL SURGERY CDS-LF, Pack Number CMPJ26754O
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2628-2024·2024-09-04

    Medical Convenience Kits with Plastic Syringes Recalled Due to Quality Defects

    Medline Industries is recalling medical convenience kits containing plastic syringes due to quality issues including leaks and breakage that may pose a risk to patient health. The recall affects 1,679,067 units distributed worldwide.

    Product
    See RES description
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2749-2024·2024-09-04

    Medline Circumcision Tray Kits Recalled for Defective Syringes

    Medline procedural kits containing circumcision trays are being recalled due to plastic syringes affected by an FDA Safety Alert. The syringes have identified leaks and breakage that may pose risks to patient health.

    Product
    Medline procedural kits labeled as: CIRCUMCISION TRAY, Pack Number DYNDA2271
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2829-2024·2024-09-04

    Voluntary Recall of BVI CustomEyes Procedure Packs With Sol-M Syringes

    BVI CustomEyes Procedure Packs containing Sol-M manufactured low dead space and Luer Slip syringes are subject to a voluntary recall. Approximately 142 units were distributed nationwide.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000866;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2718-2024·2024-09-04

    Nanoplasty 3D Bunion Implant System Recalled for Mechanical Failure Risk

    Treace Medical Concepts is recalling its Nanoplasty 3D Bunion Implant (Model SK57) nationwide due to potential mechanical failures where locking screws may strip or fail to seat properly. No injuries have been reported.

    Product
    Nanoplasty 3D Bunion Correction System Implant, Model Number: SK57. System contains the 01-00066 1st Metatarsal Plate as a component.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2593-2024·2024-09-04

    Smiths Medical Recalls Bivona Tracheostomy Tubes Due to Flange Defect

    Smiths Medical is recalling specific lots of Bivona tracheostomy tubes because the securement flange may tear due to a manufacturing defect.

    Product
    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: 2.5MM UNCUFFED NEONATAL FLEXTEND PLUS TRACHEOSTOMY TUBE W/NEO STRAIGHT STRAP, Product Code/List Number/Item Code 60NFPS25
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2754-2024·2024-09-04

    Medline Procedural Kits with Defective Syringes Recalled Worldwide

    Medline procedural kits with defective plastic syringes are recalled due to risks of leaks and breakage. The affected syringes were flagged in an FDA safety alert and may compromise patient safety during medical procedures.

    Product
    Medline procedural kits labeled as: ARTHROGRAPH TRAY, Pack Number MNS12670A
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2723-2024·2024-09-04

    Stryker iBur 4.0mm surgical bur recall: excessive heat risk during bone surgery

    Stryker iBur 4.0mm precision surgical burs may overheat where the shank meets the distal bushing. Excessive heat could cause minor tissue damage or thermal injury requiring medical intervention.

    Product
    Stryker iBur 4.0mm Precision Round, Distal Bend- intended to cut bone in the following manner: drilling, reaming, decorticating, shaping, dissecting, shaving, and smoothing for the following medical applications: Neuro; Spine; Ear, Nose, and Throat (ENT)/ Otorhinolaryngology; an
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2746-2024·2024-09-04

    Medline procedural kits recalled due to defective plastic syringes

    Medline is recalling procedural kits with defective syringes due to leaks and breakage that may pose patient health risks. Affected products include biopsy packs, circumcision trays, and breast biopsy kits.

    Product
    Medline procedural kits labeled as: 1) BIOPSY PACK, Pack Number DYNJ63370A; 2) CIRCUMCISION TRAY, Pack Number CIT7210; 3) CIRCUMCISION TRAY, Pack Number DYNDA2271; 4) MERCY MEDICAL CIRCUMCISION TRAY, Pack Number CIT6780; 5) UCLA - BREAST BIOPSY KITDYNDH1512A
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2623-2024·2024-09-04

    Medline procedure packs with syringes recalled due to leaks and breakage

    Medline is recalling procedure packs containing Shenli syringes due to leaks, breakage, and quality issues that may pose risks to patient health. Over 1.6 million units have been distributed worldwide.

    Product
    Medline procedure packs containing Shenli syringes, labeled as follows: 1) LOCAL PACK, pack number DYNJ34129C, 2) FTMC LOCAL PACK-LF, pack number DYNJ54607A, 3) LOCAL PACK, pack number DYNJ61839B
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2778-2024·2024-09-04

    Medline Centurion Procedure Packs with Syringes Recalled for Defects

    Medline has recalled Centurion procedure packs containing syringes due to leaks, breakage, and quality issues. These defects may pose a risk to patient health.

    Product
    Centurion procedure packs, containing Caina syringes, labeled as: SHAVE KIT, Pack Number MNS8250
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-1747-2024·2024-09-04

    La Superior Bakery Pan De Rancho Pastries Recalled for Undeclared Sesame

    La Superior Bakery is recalling Pan De Rancho pastries distributed in Alabama due to undeclared sesame allergen. Consumers with sesame allergies should not consume the product and should return it to the point of purchase.

    Product
    La Superior Bakery - Pan De Rancho packaged in clear plastic bag - 5 pastries per bag
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2750-2024·2024-09-04

    Medline Procedural Kits with Defective Plastic Syringes Recalled

    Medline procedural kits contain plastic syringes affected by an FDA Safety Alert. The syringes may leak or break, posing risks to patients during medical procedures.

    Product
    Medline procedural kits labeled as: 1) BOTOX KIT - CHRONIC MIGRAINE, Pack Number DYKM2000; 2) BREAST, Pack Number DYNJ902703K; 3) ENT TYMPANOPLASTY PACK-LF , Pack Number DYNJ38988J; 4)FREE FLAP TRAM ADD ON PACK, Pack Number DYNJ82179A; 5) FREE FLAP TRAM ADD ON PACK, Pa
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2769-2024·2024-09-04

    Medline Centurion Procedure Kits Recalled for Syringe Leaks and Breakage

    Medline Industries is recalling Centurion procedure kits with plastic syringes affected by an FDA Safety Alert. The syringes may leak, break, or develop quality issues that could pose risks to patient health.

    Product
    Centurion procedure kits labeled as: UMBILICAL VESSEL TRAY, Pack Number UVT1100
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2797-2024·2024-09-04

    BVI CustomEyes Procedure Packs Recalled for Sol-M Syringe Components

    Beaver Visitec International voluntarily recalls BVI CustomEyes Procedure Packs containing syringes manufactured by Sol-Millennium Medical. The recall affects 351 units distributed nationwide.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000126;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2772-2024·2024-09-04

    Medline Centurion Procedure Kits Recalled for Syringe Quality Issues

    Medline is recalling Centurion procedure kits because they contain plastic syringes affected by a March 2024 FDA Safety Alert regarding leaks and breakage.

    Product
    Centurion procedure kits, labeled as: 1) ARTHROGRAM TRAY, Pack Number DYNDH1349; 2) ARTHROGRAM TRAY-LF, Pack Number SPEC0400; 3) ARTHROGRAM/LP/MYELOGRAM TRAY, Pack Number PT220; 4) BIOPSY KIT, Pack Number DYNDH1570; 5) BIOPSY TRAY-LF, Pack Number SPEC4380; 6) BMA BX
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2730-2024·2024-09-04

    Stryker iBur surgical bur may overheat during bone-cutting procedures

    Stryker iBur 3.0mm Diamond Match Head surgical cutting tools may reach temperatures exceeding safe operating limits during bone surgery, potentially causing thermal tissue injury. About 2,507 units worldwide are affected.

    Product
    Stryker iBur 3.0mm Diamond Match Head, Distal Bend - intended to cut bone in the following manner: drilling, reaming, decorticating, shaping, dissecting, shaving, and smoothing for the following medical applications: Neuro; Spine; Ear, Nose, and Throat (ENT)/ Otorhinolaryngology
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2838-2024·2024-09-04

    BVI CustomEyes Procedure Packs with Sol-M Syringes Recalled

    Beaver Visitec International recalls BVI CustomEyes Procedure Packs containing Sol-M brand syringes due to manufacturer's voluntary recall. 130 units distributed nationwide.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001020;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2771-2024·2024-09-04

    Breast biopsy kits recalled due to defective syringes with leaks and breakage

    Medline Industries recalls Centurion breast biopsy procedure kits due to defective plastic syringes that may leak or break. The syringes are affected by an FDA safety alert and pose potential risks during medical procedures.

    Product
    Centurion procedure kits, labeled as: 1) BREAST BIOPSY KIT, Pack Number MNS6950A; 2) BREAST BIOPSY PACK, Pack number BT515A
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2757-2024·2024-09-04

    Medline procedural kits recalled due to syringe quality issues

    Medline is recalling specific procedural kits because they contain plastic syringes affected by an FDA Safety Alert regarding leaks, breakage, and other quality issues.

    Product
    Medline procedural kits labeled as: 1) BABY ADMIT, Pack Number DYKB1011C; 2) BABY ADMIT KIT W/ PAMPERS, Pack Number DYKB1011B; 3) BABY KIT, Pack Number DYKP1021; 4) BABY KIT MED CENTER, Pack Number DYKM2149; 5) BABY KIT MED CENTER, Pack Number DYKM2149A; 6) GIRAFFE
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2792-2024·2024-09-04

    BVI CustomEyes Procedure Packs with Sol-M Syringes Subject to Voluntary Recall

    Beaver Visitec International is voluntarily recalling BVI CustomEyes Procedure Packs containing Sol-M syringes distributed nationwide. The recall affects 35 units with Part Number 584770 and is classified as FDA Class II.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 584770;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2777-2024·2024-09-04

    Medline Centurion Procedure Packs Recalled Due to Syringe Quality Issues

    Medline Industries is recalling Centurion procedure packs containing defective Caina syringes due to leaks and breakage risks.

    Product
    Centurion procedure packs, containing Caina syringes, labeled as: 1) CIRCUMCISION TRAY, Pack Number CIT6860A; 2) RETINAL INJECTION KIT, Pack Number MNS12465
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2722-2024·2024-09-04

    Stryker iBur Surgical Bur Recalled Due to Excessive Temperature Risk

    Stryker recalls iBur 3.0mm Precision Round surgical burs due to potential for excessive temperatures where the bur shank meets the bushing. Thermal injury risk may require medical intervention.

    Product
    Stryker iBur 3.0mm Precision Round, Distal Bend- Intended to cut bone in the following manner: drilling, reaming, decorticating, shaping, dissecting, shaving, and smoothing for the following medical applications: Neuro; Spine; Ear, Nose, and Throat (ENT)/ Otorhinolaryngology; an
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2839-2024·2024-09-04

    BVI CustomEyes Procedure Packs Recalled Due to Sol-M Syringe Recall

    Beaver Visitec International is recalling BVI CustomEyes Procedure Packs because they contain Sol-Millennium Medical syringes that are subject to a manufacturer recall. A total of 103 units were distributed nationwide.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001025;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2736-2024·2024-09-04

    Lab analyzer incorrectly configured for complex testing at waived facilities

    Five Afinion 2 lab analyzers were distributed with incorrect configuration, potentially allowing waived laboratories to perform moderately complex assays that could produce erroneous results.

    Product
    Afinion 2 Analyzer, model #1116986, US refurbished, CLIA waived.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2941-2024·2024-09-04

    FRT250 Telescopic Implant Cartridge Recalled for Component Substitution

    OrthoPediatrics Canada is recalling FRT250 cartridges used in the Fassier-Duval Telescopic IM System because an incorrect component was substituted during assembly.

    Product
    FRT250 - 4.0-6.4 CARTRIDGE. Component of the Fassier-Duval Telescopic IM System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2763-2024·2024-09-04

    Medline Recalls LEEP and Trab Buckle Kits Due to Syringe Defects

    Medline is recalling specific LEEP and Trab Buckle procedural kits because they contain plastic syringes with leaks or breakage risks.

    Product
    Medline procedural kits labeled as: 1) LEEP PACK, Pack Number DYNJ40348G; 2) TRAB BUCKLE DSC, Pack Number DYNJ63036B
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2761-2024·2024-09-04

    Medline Circumcision Kits Recalled Due to Plastic Syringe Quality Issues

    Medline is recalling specific circumcision procedure kits because they contain plastic syringes with identified leaks, breakage, and other quality issues that may pose a risk to patient health.

    Product
    Medline Procedure kits labeled as: 1) CIRCUMCISION SET, Pack Number CIT6335; 2) CIRCUMCISION TRAY , Pack Number CIT6135BH; 3) CIRCUMCISION TRAY , Pack Number CIT2465; 4) CIRCUMCISION TRAY , Pack Number CIT4920; 5) CIRCUMCISION TRAY , Pack Number CIT7455; 6) CIRCUMCIS
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-1757-2024·2024-09-04

    ALB Flavor cinnamon powder recalled for elevated lead levels

    ALB Flavor cinnamon powder is recalled due to elevated lead contamination. The product was distributed in NY, CT, MI, and MA and poses a serious health risk.

    Product
    ALB Flavor brand CINNAMON Powder; 100 g; ALB-USA Enterprises Inc 529 Bryant Av, Bronx, NY 10474; UPC 5 304000 333362; packaged in a plastic bag inside a brown carton box with an image of cinnamon powder and two cinnamon sticks centered at the bottom.
    Category
    Food
    Distribution
    4 states
  • HighFDA (Devices)·Z-2633-2024·2024-09-04

    Medline procedure packs recalled due to syringe quality issues

    Medline is recalling procedure packs containing Shenli syringes due to leaks, breakage, and other quality issues that may pose a risk to patient health.

    Product
    Medline procedure packs containing Shenli syringes, labeled as follows: NEURO ANGIO PACK, Pack Number DYNDA1431A
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2610-2024·2024-09-04

    Smiths Medical Recalls Bivona Tracheostomy Tubes Due to Flange Defect

    Smiths Medical is recalling specific lots of Bivona Tracheostomy Tubes because the securement flange may tear due to a manufacturing defect.

    Product
    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS PEDIATRIC TRACH TUBE , Product Code/List Number/Item Code 67P025; b) TTS PEDIATRIC TRACH TUBE , Product Code/List Number/Item Code 67P030; c) TTS PEDIATRIC TRACH TUBE , Product Code/List Number/Item Code 67P035;
    Category
    Medical Device
    Distribution
    0 states

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