The Recall Desk

Archive

July 2022 recalls

561 recalls were announced in July 2022.

What the numbers show

Critical
6
Severe
99
High
413
Moderate
40
Low
3

Of the 561 recalls this month scored against our rubric, 1% are Critical, 18% are Severe.

Which agencies issued them

1–100 of 561

  • SevereUSDA FSIS·024-2022·2022-07-30

    Rachael's Food Corporation Recalls Ready-to-Eat Meat and Poultry Wraps

    Rachael's Food Corporation is recalling ready-to-eat meat and poultry wraps due to possible Listeria monocytogenes contamination. The products were distributed in Connecticut, Massachusetts, Rhode Island, and New York.

    Product
    Rachael's Food Corporation — Rachael’s Food Corporation Recalls Ready-To-Eat Meat and Poultry Wrap Products Due to Possible Listeria Contamination
    Category
    Food
    Distribution
    4 states
  • SevereUSDA FSIS·025-2022·2022-07-30

    Conagra Recalls P.F. Chang's Beef and Broccoli for Undeclared Egg

    Conagra Brands is recalling P.F. Chang's Home Menu Beef & Broccoli because the product contains egg, an undeclared allergen. No illnesses have been reported.

    Product
    Conagra Brands (Conagra Foods Packaged Foods, LLC) — Conagra Brands, Inc., Recalls Frozen Beef Products Due to Misbranding and Undeclared Allergens
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereNHTSA·22V553000·2022-07-29

    2023 Thomas Built School Buses Recalled for Engine Control Module Defect

    Daimler Trucks North America is recalling 2023 Thomas Built Saf-T-Liner HDX and C2 school buses because the engine control module may short-circuit, causing unexpected engine shutdown.

    Product
    THOMAS BUILT BUSES — THOMAS BUILT BUSES SAF-T-LINER HDX, SAF-T-LINER C2
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·22E065000·2022-07-29

    Proterra Recalls S1-15 Battery Packs Due to Unexpected Shutdown Risk

    Proterra is recalling specific S1-15 battery packs because an insufficient connection may cause the battery management system to shut down unexpectedly, leading to a sudden loss of drive power.

    Product
    ELECTRICAL SYSTEM:PROPULSION SYSTEM:TRACTION BATTERY recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·22V552000·2022-07-29

    KZRV Travel Trailers Retractable Awning Seam Separation Drop Hazard

    KZRV is recalling 2022-2023 travel trailers due to electric retractable awnings with defective welded seams that may separate and drop, increasing the risk of injury.

    Product
    KZRV — KZRV DURANGO, VENOM, CONFLUENCE, DURANGO GOLD
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·22V554000·2022-07-29

    2023 Western Star and Freightliner trucks recalled for engine control module defect

    Daimler Trucks North America is recalling 1,375 certain 2023 Western Star and Freightliner commercial trucks due to engine control module defects that can cause unexpected engine shutdown, increasing crash risk.

    Product
    FCCC — FCCC, FREIGHTLINER, WESTERN STAR XCR, S2C 106CAB, S2RV 106CAB, XCM
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·22V556000·2022-07-29

    Electric retractable awning on multiple RV models may separate unexpectedly

    The electric retractable awning on certain 2022–2023 RV models has a welded seam that may separate, allowing the awning to drop beyond normal operation and increase injury risk.

    Product
    FOREST RIVER — FOREST RIVER, COACHMEN, EAST TO WEST WILDWOOD, SPORTSCOACH, SIERRA, SOLERA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·22V555000·2022-07-29

    2022 Vanleigh Vilano and Beacon travel trailers awning failure recall

    Vanleigh RV recalls 2022 Vilano and Beacon travel trailers for defective electric retractable awnings that may collapse. The welded seam can fail, creating a fall injury risk.

    Product
    VANLEIGH — VANLEIGH VILANO, BEACON
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·22193·2022-07-28

    Evaporator Coil Drain Pans Recall for Fire Hazard Risk

    Daikin Comfort Technologies is recalling about 298,300 evaporator coil drain pans that can overheat, melt, and deform, creating a fire hazard. The company has received 26 fire reports, with no injuries reported.

    Product
    Evaporator coil drain pans
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·22V549000·2022-07-28

    Nissan Recalls 2017-2019 Rogue Hybrid for Brake Booster Overheating

    Nissan is recalling 2017-2019 Rogue Hybrid vehicles because the hydraulic brake booster may overheat, causing a loss of power brake assist and increasing crash risk.

    Product
    NISSAN — NISSAN ROGUE HYBRID
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·023-2022·2022-07-28

    Danny's Sub and Pizza Recalls Frozen Meat Pizzas Lacking Federal Inspection

    USDA FSIS is recalling approximately 19,275 pounds of frozen meat pizzas from Danny's Sub and Pizza because they were produced without federal inspection.

    Product
    Danny’s Sub and Pizza Recalls Meat Pizza Products Produced Without Benefit of Inspection
    Category
    Food
    Distribution
    2 states
  • SevereNHTSA·22V551000·2022-07-28

    Eldorado Axess Recalled for Potential Steering Gear Fracture

    Eldorado is recalling 2021-2022 Axess vehicles because incorrectly assembled steering gears may fracture, causing loss of steering control and increasing crash risk.

    Product
    ELDORADO — ELDORADO AXESS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·22765·2022-07-28

    NUK First Choice Glass Baby Bottles Recalled for Excess Lead Content

    NUK First Choice 240 mL glass baby bottles sold on Amazon.com from January 2018 to May 2022 contain lead markings that exceed the federal lead content ban. Lead is toxic to young children if ingested.

    Product
    NUK First Choice 240 mL Glass Baby Bottles
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·22V546000·2022-07-28

    International LoneStar and LT Battery Cable Defect Poses Stall and Burn Risks

    Navistar is recalling 2018–2021 International LoneStar and 2016–2021 LT vehicles due to defective battery cables that may overheat and cause personal injury or engine stall without warning, increasing crash risk.

    Product
    INTERNATIONAL — INTERNATIONAL LT, LONESTAR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·22763·2022-07-28

    Arctic Cat Alterra 600 and Tracker 600 ATVs Recalled for Crash Hazard

    Textron Specialized Vehicles is recalling about 1,750 Arctic Cat Alterra 600 and Tracker 600 ATVs because a fuse in the electrical system can fail during operation, causing sudden loss of engine power and headlights, which poses a crash hazard.

    Product
    Arctic Cat Alterra 600 and Tracker 600 All-Terrain Vehicles (ATVs)
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·22762·2022-07-28

    KTM, Husqvarna, and GASGAS Competition Motorcycles Recalled for Crash Hazard

    KTM, Husqvarna, and GASGAS are recalling about 3,310 closed course competition motorcycles because the connecting rod can break, posing crash and injury hazards. Owners should stop riding and contact an authorized dealer for a free repair.

    Product
    Closed Course Competition Motorcycles
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·22191·2022-07-28

    Ocean Technology Systems Recalls Underwater Communication Devices for Fire Hazard

    Ocean Technology Systems is recalling about 500 underwater communication devices (PowerCom and MilCom models) with RBLi-4 lithium battery packs because water can leak into the battery pack and cause the circuit board to short and ignite after diving, posing a fire hazard.

    Product
    Underwater Communication Devices
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·22E063000·2022-07-28

    Cummins Recalls Diesel Engines Due to Electrical Short-Circuit Risk

    Cummins is recalling specific diesel engines because the engine control module may short-circuit, causing the engine to stall and increasing crash risk.

    Product
    ENGINE AND ENGINE COOLING:ENGINE:ENGINE CONTROL MODULE (ECU/ECM) recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·22764·2022-07-28

    Ceramic Pulleys for Cabrinha Switchblade and Drifter Kites Recalled for Injury Hazard

    Adventure Sports is recalling about 1,950 ceramic pulleys used in Cabrinha Switchblade and Drifter kiteboarding kites because the pulleys can cause bridle line breakage, reducing steering and control and risking kiteboarder injury.

    Product
    Ceramic Pulley for Switchblade and Drifter kite sailing kites
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·22E062000·2022-07-28

    Chrysler Recalls Mopar Tail Light Assemblies Due to Visibility Defect

    Chrysler is recalling specific Mopar tail light assemblies because the side markers may fail to illuminate, reducing vehicle visibility and increasing crash risk.

    Product
    EXTERIOR LIGHTING:TAIL LIGHTS recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·22192·2022-07-28

    Kidoozie Play Tents and Playhouses Recalled for Flammability Risk

    Epoch Everlasting Play is recalling about 251,600 Kidoozie play tents and playhouses because the fabric fails to meet flammability standards, posing a burn hazard to children.

    Product
    Kidoozie™ Play Tents and Playhouses
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·22V547000·2022-07-28

    Commercial trucks recalled for faulty steering gear assemblies

    PACCAR Incorporated is recalling certain 2022–2023 Peterbilt and Kenworth commercial trucks due to incorrectly assembled steering gears that may fracture. A fractured steering gear can cause loss of steering control, increasing crash risk.

    Product
    KENWORTH — KENWORTH, PETERBILT T470, 520, T170, C500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·22194·2022-07-28

    Black Diamond Avalanche Transceivers Recalled for Loss of Search Mode

    Black Diamond Equipment is recalling about 76,300 avalanche transceivers that may fail to switch from SEND mode to SEARCH mode, preventing rescuers from locating buried skiers and risking severe injury or death.

    Product
    Avalanche Transceivers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·22V545000·2022-07-28

    2022 Winnebago Voyage Travel Trailer Awning Separation Hazard

    Winnebago is recalling certain 2022 Voyage travel trailers because the awning's welded seam may separate, causing it to drop and increase injury risk.

    Product
    WINNEBAGO — WINNEBAGO VOYAGE!
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·22T012000·2022-07-28

    Shandong Tires Recalled for Sidewall Separation Risk

    Shandong New Continent Tire Co. is recalling specific Rolling Big Power Repulsor M/T tires because the sidewall may separate, increasing crash risk.

    Product
    TIRES:SIDEWALL recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·22V544000·2022-07-28

    2021-2022 Jeep Grand Cherokee Tail Light Side Marker Assembly Replacement

    Chrysler is recalling certain 2022 Jeep Grand Cherokee and 2021-2022 Jeep Grand Cherokee L vehicles due to damaged tail light side marker assemblies that may not illuminate, reducing visibility and increasing crash risk.

    Product
    JEEP — JEEP GRAND CHEROKEE 4XE, GRAND CHEROKEE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • ModerateCPSC·22190·2022-07-28

    Aesop Bathroom Deodorizer Drops and Oil Burner Blends Recalled

    Aesop USA is recalling Aesop Post-Poo Drops and four Aesop Oil Burner Blend products because their packaging does not meet child-resistant requirements and labels lack mandatory safety information, posing a poisoning risk.

    Product
    Aesop Post-Poo Drops and Aesop Oil Burner Blends
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1500-2022·2022-07-27

    Blazos Pie Shoppe peanut butter cream pies recalled for possible Salmonella contamination

    Blazos Pie Shoppe is recalling 9-inch peanut butter cream pies possibly contaminated with Salmonella. The affected products with code dates 6/23 and 6/27 were distributed in Michigan.

    Product
    9-inch pie Blazos Pie Shoppe Chocolate Peanut Butter Cream Pie (UPC 9438600049) 9-inch pie Blazos Pie Shoppe Peanut Butter Cream Pie (UPC 9438600025)
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1337-2022·2022-07-27

    FDA Recalls Launch Sequence Euphoria Capsules for Undeclared Tadalafil

    Launch Sequence Euphoria Capsules have been recalled because the product contains undeclared tadalafil, an unapproved active ingredient. The capsules were distributed nationwide in the USA and Canada.

    Product
    Launch Sequence Euphoria Capsules, 10- count tins, ASIN B08ZJX4V9J, UPC Code 661020846864.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1296-2022·2022-07-27

    Ortiga mas Ajo Rey supplement recalled for undeclared diclofenac

    FDA recalls Ortiga mas Ajo Rey dietary supplement sold nationwide due to undeclared diclofenac. Product marketed as supplement contains pharmaceutical ingredient not listed on label.

    Product
    Ortiga mas Ajo Rey Reforzado con Omega 3, 6 y 9, is packaged in a carton containing 30 tablets (500 mg c/u) in a bottle and 60 capsules (400 mg c/u) in a bottle, Hecho en Mexico por: Omega Nutrition , Jorge Washington No. 108 Col. Las Americas, Hidalgo del Parral, Chihuahua.…
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1295-2022·2022-07-27

    Artri Ajo King Tablets Recalled Due to Undeclared Diclofenac

    The FDA is recalling Artri Ajo King tablets nationwide after finding they contain undeclared diclofenac, a prescription anti-inflammatory drug. Affected bottles (lot LTARTKNGOMG30220, expiring December 2025) were sold on Amazon.

    Product
    Artri Ajo King Reforzado con Ortiga y Omega 3 tablets, 500 mg, 100-count bottle, Hecho en Mexico por: PLANTAS MEDICINALES DE MEXICO , Melchor Ocampo No. 55 Local D, Delegacion Xochimilco. C.P. 16800, Mexico, D.F., ASIN B092P4615M, UPC 7 501031 111190
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1297-2022·2022-07-27

    Artri King Herbal Supplement Tablets Recalled Nationwide for Undeclared Medication

    Amazon is recalling Artri King herbal supplement tablets nationwide due to FDA laboratory findings of undeclared diclofenac, a pharmaceutical medication not listed on the label. The product was marketed without FDA approval.

    Product
    Artri King Reforzado con Ortiga y Omega 3 tablets, 500 mg, 100-count bottle, Hecho en Mexico por: PLANTAS MEDICINALES DE MEXICO , Melchor Ocampo No. 55 Local D, Delegacion Xochimilco. C.P. 16800, Mexico, D.F., ASIN B084KSV12L, UPC 7 501031 111190
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1501-2022·2022-07-27

    Blazos Pie Shoppe Products Recalled for Possible Salmonella Contamination

    Blazos Pie Shoppe is recalling peanut butter cream and chocolate peanut butter cream pie and cup products that may be contaminated with Salmonella.

    Product
    10 oz Blazos Pie Shoppe Peanut Butter Cream Cup (UPC 9438600085)
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1389-2022·2022-07-27

    GE Healthcare Anesthesia Systems Recalled for Potential Transducer Connection Reversal

    GE Healthcare anesthesia systems may have reversed oxygen and air transducer connections, potentially affecting proper gas delivery. 5,372 devices worldwide are affected.

    Product
    GE Healthcare Aisys CS2 Anesthesia System, Part number 1011-9050-000; and Avance CS2 and Avance CS2 Pro Anesthesia System, Part number 1009-9050-000.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·22V543000·2022-07-27

    Volkswagen Recalls 2016 Audi and Golf Models for Air Bag Defect

    Volkswagen is recalling 1,216 2016 Audi and Volkswagen vehicles because the front passenger air bag may explode or deploy improperly, posing a risk of serious injury or death.

    Product
    AUDI — AUDI, VOLKSWAGEN S3, A3 SPORTBACK E-TRON, GTI, GOLF R
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1338-2022·2022-07-27

    Launch Sequence Aphrodisia Capsules recalled for undeclared tadalafil

    Launch Sequence Aphrodisia Capsules contain undeclared tadalafil, making them an unapproved drug. The recall involves 500 4-count tins distributed nationwide in the USA and Canada.

    Product
    Launch Sequence Aphrodisia Capsules, 4-count tins, ASIN B07QB3S2LV, UPC Code 661020846957.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1502-2022·2022-07-27

    Panera Bread Southwest Corn Chowder Recalled for Undeclared Wheat

    Blount Fine Foods is recalling Panera Bread at Home Southwest Corn Chowder due to undeclared wheat. The product poses a health risk to consumers with wheat allergies or celiac disease.

    Product
    Panera Bread at Home Southwest Corn Chowder, 16 oz. (453 g)
    Category
    Food
    Distribution
    12 states
  • SevereFDA (Drugs)·D-1336-2022·2022-07-27

    Dietary supplement found to contain undeclared pharmaceutical drug tadalafil

    Launch Sequence Capsules dietary supplement recalled for containing undeclared tadalafil, an FDA-approved pharmaceutical ingredient. The product was marketed without required drug approval.

    Product
    Launch Sequence Capsules, Dietary Supplement, 60- count bottles, ASIN B07TLPWXDS, UPC Code 641378938375.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1481-2022·2022-07-27

    Honey Caramels Recalled for Undeclared Tree Nuts

    Queen Bee Gardens recalls Honey Caramels Strawberry Lemonade due to undeclared tree nuts. The product may contain pecans, almonds, coconut, macadamia nuts, or walnuts, posing a risk to consumers with tree nut allergies.

    Product
    Honey Caramels Strawberry Lemonade. Net wt. 5.87 oz. PLU Code: 788394 12154 8. Ingredients: Honey, butter (pasteurized cream & salt), cream, natural flavors, nonfat dry milk, whey, agar, algin, natural colors, citric acid and lecithin.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1341-2022·2022-07-27

    Loud Muscle Science Recalls Unapproved Capsule Product Marketed as Aphrodisia

    Loud Muscle Science is recalling Launch Sequence Aphrodisia Capsules because they were marketed without FDA approval. The product was distributed nationwide in the USA and Canada.

    Product
    Launch Sequence Aphrodisia Capsules, 4-count tins, ASIN B07QB3S2LV, UPC Code 661020846957.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1271-2022·2022-07-27

    Neostigmine Methylsulfate Injection recalled due to sterility assurance failure

    Nephron Sterile Compounding Center is recalling Neostigmine Methylsulfate Injection due to lack of assurance of sterility. The recall affects 10,700 syringes distributed nationwide.

    Product
    Neostigmine Methylsulfate Injection, USP, 4 mg/4 mL (1 mg/mL) syringe, packaged in 5 x 4 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-942-04
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1469-2022·2022-07-27

    English Toffee Chocolate Recalled for Undeclared Tree Nuts

    Queen Bee Gardens is recalling English Toffee Milk Chocolate and related products containing undeclared tree nuts. Products were sold at retail locations in Colorado, New Mexico, Wyoming, and nationwide online.

    Product
    English Toffee Milk Chocolate. PLU Code: 788394 10008 6. English Toffee M/C Bites. PLU Code: 788394 10015 4. English Toffee Bites Individual. PLU Code: 788394 10115 1
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1453-2022·2022-07-27

    Black Forest Classic Truffle recalled for undeclared tree nuts

    Queen Bee Gardens is recalling Black Forest Classic Truffle chocolates that may contain undeclared tree nuts not listed on the label.

    Product
    Black Forest Classic Truffle. Net Wt. 1.4 oz. PLU Code: 788394 11900 2. Ingredients: Dark chocolate, honey, butter (pasteurized cream & salt), cream, cherries, pecans, almonds, non-fat dry milk, whey, agar, algin, lecithin & natural flavors.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1263-2022·2022-07-27

    Lidocaine HCl Injection Syringes Recalled for Sterility Assurance

    Nephron Sterile Compounding Center recalls Lidocaine HCl Injection 2% syringes distributed nationwide due to lack of assurance of sterility. Affected lots should not be used.

    Product
    Lidocaine HCl Injection, USP 2%, 100 mg/5 mL (20 mg/mL) syringe, packaged in 5 x 5 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-949-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1452-2022·2022-07-27

    Chocolate Truffles Recalled for Undeclared Tree Nuts

    Queen Bee Gardens is recalling All Milk Classic Truffles (1.4 oz) because they may contain undeclared tree nuts, posing a risk to consumers with tree nut allergies.

    Product
    All Milk Classic Truffle. Net Wt. 1.4 oz. PLU Code: 788394 11275 1. Ingredients: Milk chocolate, honey, butter (pasteurized cream & salt), cream, non-fat dry milk, whey, agar, align & lecithin. Note: Typo on website should be algin.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1413-2022·2022-07-27

    Hill-Rom Mattress Microclimate Feature Failure Increases Pressure Ulcer Risk

    Certain Hill-Rom PRO+ MRS mattresses may have a Microclimate Management feature failure that increases patient pressure ulcer risk. Affected units were distributed to 25+ U.S. states and Canada.

    Product
    Hill-Rom PRO+ MRS Surface For Versacare With X-Ray mattress, REF P3255A01.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1491-2022·2022-07-27

    Honeymoon Patties Mint Bee Patties recalled for undeclared tree nuts

    Queen Bee Gardens is recalling Honeymoon Patties Mint Bee Patties because they may contain undeclared tree nuts (pecans, almonds, coconut, macadamia nuts, walnuts). The product was sold at retail locations in Colorado, New Mexico, Wyoming, and nationwide online.

    Product
    Honeymoon Patties Mint Bee Patties. Net wt. 8 oz. PLU Code: 788394 14896 5
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1412-2022·2022-07-27

    Hill-Rom PRO+ Mattress Microclimate Management Failure Increases Pressure Ulcer Risk

    Baxter Healthcare is recalling 404 Hill-Rom PRO+ 36" mattresses due to performance degradation in their heat and moisture management feature. This failure increases the risk of pressure ulcer development in patients.

    Product
    Hill-Rom PRO+ 36" MRS Surface mattress, REF P7924A03.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1466-2022·2022-07-27

    QBee Honeycomb Toffee Milk recalled for undeclared tree nuts

    Queen Bee Gardens is recalling QBee Honeycomb Toffee Milk due to undeclared tree nuts. Consumers with tree nut allergies face a potential allergic reaction risk.

    Product
    QBee Honeycomb Toffee Milk. Net wt. 1.5 oz. PLU Code: 788394 10404 6.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1430-2022·2022-07-27

    SIGNA Premier MRI scanner recalled for elevated acoustic noise hazard

    GE Healthcare's SIGNA Premier MRI scanner is being recalled because under rare conditions, the gradient coils can produce elevated acoustic noise that could potentially cause hearing loss with prolonged exposure.

    Product
    SIGNA Premier magnetic resonance scanner, model 5748519.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1480-2022·2022-07-27

    Queen Bee Honey Caramels Recalled for Undeclared Tree Nuts

    Queen Bee Gardens is recalling Honey Caramels Red Raspberry because the product may contain undeclared tree nuts. The recalled items were distributed to Queen Bee retail stores in Colorado, New Mexico, and Wyoming, and nationwide via internet sales.

    Product
    Honey Caramels Red Raspberry. Net wt. 5.87 oz. PLU Code: 788394 12143 2. Ingredients: Honey, Butter (Pasteurized Cream & Salt), Cream, Freeze dried Raspberries, Grade A Non-Fat Dry Milk, Whey, Natural Flavors, Agar, Algin and Lecithin.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1445-2022·2022-07-27

    Spinal fusion cross connector recalled for insufficient clamping force

    Aesculap is recalling AESCULAP S4 Cervical Cross Connectors used in spinal fusion surgery due to insufficient clamping force that may cause the connectors to loosen or shift on the spinal rods.

    Product
    AESCULAP S4 Cervical Cross Connector, L26mm, S4C CROSS CONNECTOR FIXED 26MM, product code SW114T. Used in spinal fusion surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1437-2022·2022-07-27

    BD Connecta Plus1 360 Infusion Connector: Potential Housing Leakage

    Becton Dickinson is recalling certain BD Connecta Plus1 360 Blue Blend infusion connectors due to potential leakage at the housing stopcock that could interrupt treatment and expose patients to contamination and biohazardous material.

    Product
    BD Connecta" Plus1 360 Blue Blend Catalog No. 394911 (OUS)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1484-2022·2022-07-27

    Honeymoons Dark Chocolate Almond Recalled for Undeclared Tree Nuts

    Queen Bee Gardens is recalling Honeymoons Dark Chocolate Almond for undeclared tree nuts including pecans, almonds, coconut, macadamia nuts, and walnuts. The product was distributed to retail locations in Colorado, New Mexico, and Wyoming, and nationwide online.

    Product
    Honeymoons Dark Chocolate Almond. PLU Code: 788394 14792 0.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1272-2022·2022-07-27

    Neostigmine Methylsulfate Injection Recalled for Lack of Sterility Assurance

    Nephron Sterile Compounding Center is recalling 64,365 syringes of Neostigmine Methylsulfate Injection nationwide due to lack of assurance of sterility. Patients using affected lots should contact their healthcare provider.

    Product
    Neostigmine Methylsulfate Injection, USP, 5 mg/5 mL (1 mg/mL) syringe, packaged in 5 x 5 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-902-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1475-2022·2022-07-27

    Honey Caramels Recalled for Undeclared Tree Nuts

    Queen Bee Gardens is recalling Honey Caramels Cinna Honey due to potential undeclared tree nuts (pecans, almonds, coconut, macadamia nuts, walnuts). Affected products were sold at 10 retail locations in Colorado, New Mexico, and Wyoming, as well as nationwide via internet.

    Product
    Honey Caramels Cinna Honey. Net wt. 5.87 oz. PLU Code: 788394 12404 4. Ingredients: Honey, butter (pasteurized cream & salt), cream, nonfat dry milk, whey, cinnamon oil, beet juice (color), lecithin, algin & agar.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1476-2022·2022-07-27

    Honey Caramels Creamy Fudge Recalled for Undeclared Tree Nuts

    Queen Bee Gardens, LLC is recalling Honey Caramels Creamy Fudge because the product may contain undeclared tree nuts (pecans, almonds, coconut, macadamia nuts, and walnuts). People with tree nut allergies should not consume this product.

    Product
    Honey Caramels Creamy Fudge. Net wt. 5.87. PLU Code: 788394 12354 2.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1419-2022·2022-07-27

    Orthopedic Surgical Guide with Defective Spring Subject to Corrosion

    DePuy Orthopaedics is recalling 872 units of the ATTUNE Measured Sizing and Rotation Guide due to a manufacturing defect. A galvanized steel spring was used instead of stainless steel, which may cause corrosion and surgical complications.

    Product
    ATTUNE Measured Sizing and Rotation Guide-to size the femur and align rotation of the bone cuts in preparation for the femoral implant Part Number: 254400525
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1432-2022·2022-07-27

    BD Connecta Stopcock Recalled for Potential Housing Leakage

    Becton Dickinson is recalling its BD Connecta Stopcock due to potential leakage at the housing component, which may interrupt treatment and cause exposure to biohazardous material.

    Product
    BD Connecta Stopcock Without Extension Tube Catalog No. 394600 (OUS)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1265-2022·2022-07-27

    Morphine Sulfate Injection Recalled for Lack of Sterility Assurance

    Nephron Sterile Compounding Center is recalling Morphine Sulfate Injection due to lack of assurance of sterility. The recall affects 5,495 pre-filled syringes distributed nationwide.

    Product
    Morphine Sulfate Injection, USP, 50 mg/50 mL (1 mg/mL) syringe, packaged in 5 x 50 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-979-50
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1477-2022·2022-07-27

    Honey Caramels Huckleberry Recalled for Undeclared Tree Nuts

    Queen Bee Gardens is recalling Honey Caramels Huckleberry (5.87 oz) because they may contain undeclared tree nuts including pecans, almonds, coconut, macadamia nuts, and walnuts. This poses a serious health risk to people with tree nut allergies.

    Product
    Honey Caramels Huckleberry. Net wt. 5.87 oz. PLU Code: 788394 12623 9. Ingredients: Honey, butter (pasteurized cream & salt), cream, nonfat dry milk, natural flavors, purple cabbage (coloring), whey, lecithin, algin & agar.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1450-2022·2022-07-27

    LumiraDx SARS-CoV-2 Antibody Test Strip Modified Outside Approved Scope

    LumiraDx recalled SARS-CoV-2 Antibody Test Strips after discovering modifications were made outside the FDA-approved Emergency Use Authorization scope. The recall affects 635 units in 13 states.

    Product
    LumiraDx SARS-CoV-2 Antibody (Ab) Test Strip
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Drugs)·D-1339-2022·2022-07-27

    Dietary Supplement Marketed as Unapproved Drug Recalled by FDA

    Launch Sequence Capsules, a dietary supplement sold in 60-count bottles, were recalled because they were marketed without FDA approval as a drug based on label claims.

    Product
    Launch Sequence Capsules, Dietary Supplement, 60- count bottles, ASIN B07TLPWXDS, UPC Code 641378938375.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1492-2022·2022-07-27

    Honeymoon Cinna-Bee Patties recalled due to undeclared tree nuts

    Queen Bee Gardens is recalling Honeymoon Cinna-Bee Patties due to potential undeclared tree nuts: pecans, almonds, coconut, macadamia nuts, and walnuts. Products were distributed in Colorado, New Mexico, Wyoming, and nationwide online.

    Product
    Honeymoon Cinna-Bee Patties. PLU Code: 788394 14892 7
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1483-2022·2022-07-27

    Honeymoons Milk Chocolate Almond Recalled for Undeclared Tree Nuts

    Queen Bee Gardens is recalling Honeymoons Milk Chocolate Almond candy due to undeclared tree nuts including pecans, almonds, coconut, macadamia, and walnuts. The product was distributed in Colorado, New Mexico, Wyoming, and nationwide online.

    Product
    Honeymoons Milk Chocolate Almond. PLU Code: 788394 14756 2.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1435-2022·2022-07-27

    Revive Superfoods Strawberry Zen Smoothie Mix Recalled for Norovirus Risk

    Revive Superfoods Strawberry Zen smoothie mix is being recalled due to potential norovirus contamination in IQF raspberries used as an ingredient. The recall affects 57,960 units distributed to consumers in Pennsylvania, California, Illinois, and Texas.

    Product
    Revie Superfoods Strawberry Zen 222g Ready-to-Blend Strawberry Banana Smoothie Made in Canada UPC 8 54681 00003 9 Revive Superfoods 1880 Bonhill Road, Mississauga, Ontario, Canada
    Category
    Food
    Distribution
    4 states
  • HighFDA (Food)·F-1490-2022·2022-07-27

    Honeymoons Ivory Chocolate Pecan Recalled for Undeclared Tree Nuts

    Queen Bee Gardens is recalling Honeymoons Ivory Chocolate Pecan due to undeclared tree nuts, which may affect consumers with tree nut allergies. The product was sold at retail locations in Colorado, New Mexico, and Wyoming, plus nationwide internet sales.

    Product
    Honeymoons Ivory Chocolate Pecan. PLU Code: 788394 14730 0
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1285-2022·2022-07-27

    Aripiprazole 20mg Tablets Recalled for Failed Dissolution

    Apotex Corp. is recalling 2,010 bottles of Aripiprazole Tablets 20mg nationwide due to failed dissolution specifications. Tablets may not dissolve properly, potentially affecting medication effectiveness.

    Product
    Aripiprazole Tablets, USP 20 mg, packaged in a) 1,000-count bottle (NDC 60505-2676-8, UPC 3 60505 26768 2), b) 30-count bottle (NDC 60505-2676-3, UPC 3 60505 26763 7), Rx only, Manufactured by: Apotex, Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apotex Corp. Weston…
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighNHTSA·22V542000·2022-07-27

    2022 Volkswagen Golf R Sunroof Switch May Close Unexpectedly

    Volkswagen is recalling certain 2022 Golf R and Golf GTI vehicles because the sunroof touch switch may be too sensitive and inadvertently pressed, causing unintended sunroof auto-closure and risking injury.

    Product
    VOLKSWAGEN — VOLKSWAGEN GTI, GOLF R
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1499-2022·2022-07-27

    Dark Raspberry Classic Snack Recalled for Undeclared Tree Nuts

    Queen Bee Gardens is recalling Dark Raspberry Classic snacks due to undeclared tree nuts (pecans, almonds, coconut, macadamia nuts, walnuts) that may be present, posing a risk to consumers with tree nut allergies.

    Product
    Dark Raspberry Classic. Net wt. 1.4 oz. UPC 788394 10003 1.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1441-2022·2022-07-27

    Nexiva IV Catheter Stopcock May Leak During Infusion

    Becton Dickinson is recalling specific lots of Nexiva IV catheters because the stopcock housing may leak, potentially interrupting treatment and exposing patients to infusate and biohazardous material.

    Product
    Nexiva with Single BD Connecta Stopcock Version (20 Ga Blue) Catalog No.383682 (OUS)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1434-2022·2022-07-27

    Revie Superfoods Raspberry & Mango Smoothie Recalled for Potential Norovirus

    Revive Organics is recalling Revie Superfoods Raspberry & Mango Smoothie products because they may contain norovirus from contaminated raspberries. Consumers in PA, CA, IL, and TX who have purchased this product should not consume it.

    Product
    Revie Superfoods Raspberry & Mango 188g Ready-to-Blend Smoothie Made in Canada UPC 8 54681 00026 8 Revive Superfoods 1880 Bonhill Road, Mississauga, Ontario, Canada
    Category
    Food
    Distribution
    4 states
  • HighFDA (Drugs)·D-1258-2022·2022-07-27

    FDA Recalls HYDROmorphone Injection Syringes Due to Sterility Concerns

    Nephron Sterile Compounding Center is recalling 3,740 HYDROmorphone injection syringes due to lack of assurance of sterility. The affected lot was distributed nationwide.

    Product
    HYDROmorphone HCl Injection, USP, 50 mg/50 mL (1 mg/mL) syringes, packaged in 5 x 50 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-559-50
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1437-2022·2022-07-27

    Chuckanut Bay Cheesecake Bites Recalled for Undeclared Soy Allergen

    Chuckanut Bay Foods LLC is recalling New York Cheesecake Bites because the label declares sunflower lecithin when the product actually contains undeclared soy lecithin, posing a risk to consumers with soy allergies.

    Product
    Item 32001-56, Chuckanut Bay New York Cheesecake Bites (Milk Compound) BULK. Perishable - Keep Refrigerated. There are 14 pieces per pack and 56 packs per case. Item 34001-12, Chuckanut Bay Cheesecake Bites New York. Perishable - Keep Refrigerated. Net Wt. 6.4 oz. There…
    Category
    Food
    Distribution
    13 states
  • HighFDA (Devices)·Z-1446-2022·2022-07-27

    Cervical spinal implant connectors may have insufficient clamping force

    Aesculap S4 Cervical Cross Connectors used in spinal fusion surgery may have insufficient clamping force, potentially causing movement of the connectors on the rods or wear debris.

    Product
    AESCULAP S4 Cervical Cross Connector L 28-33mm, S4C CROSS CONNECTOR VARIABLE 28-33MM, SW115T. Used in spinal fusion surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1387-2022·2022-07-27

    SX-One MicroKnife Recalled for Potential Dull Blade Defect

    Sonex Health LLC is recalling approximately 3,752 SX-One MicroKnife surgical instruments nationwide due to potential blade dulling that may compromise proper function.

    Product
    SX-One MicroKnife
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1253-2022·2022-07-27

    Glycopyrrolate Injection Recalled for Lack of Sterility Assurance

    Nephron is recalling Glycopyrrolate Injection pre-filled syringes distributed nationwide due to lack of sterility assurance. The recall affects 3,690 syringes from lot GL2001A, expiration 7/15/2022.

    Product
    Glycopyrrolate Injection, USP, 1 mg/5 mL (0.2 mg/mL) syringes, packaged in 5 x 5 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-903-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1421-2022·2022-07-27

    Medical Device Thawing Kit Recalls Due to Spanish Instruction Translation Error

    CooperSurgical recalls its LifeGlobal Fast Freeze Thawing Kit due to a Spanish instruction translation error that specifies 5 minutes instead of 5 seconds for blastocyte air thawing, affecting 403 units.

    Product
    LifeGlobal Fast Freeze Thawing Kit, Model No. GFT5-055
    Category
    Medical Device
    Distribution
    31 states
  • HighFDA (Drugs)·D-1261-2022·2022-07-27

    Ketamine HCl Injection Recalled for Lack of Sterility Assurance

    Nephron is recalling 47,905 pre-filled syringes of Ketamine HCl Injection nationwide due to lack of sterility assurance. Users should contact the manufacturer for handling instructions.

    Product
    Ketamine HCl Injection, USP, 50 mg/1 mL (50 mg/mL*) syringe, packaged in 5 x 1 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-511-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1467-2022·2022-07-27

    QBee Honeycomb Toffee Dark Recalled for Undeclared Tree Nuts

    Queen Bee Gardens is recalling QBee Honeycomb Toffee Dark due to undeclared tree nuts. The product may contain pecans, almonds, coconut, macadamia nuts, or walnuts.

    Product
    QBee Honeycomb Toffee Dark. Net wt. 1.5 oz. PLU Code: 788394 10504 3.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1432-2022·2022-07-27

    Coconut cream smoothie recalled for potential norovirus contamination

    Revive Organics is recalling Revie Superfoods Coconut Cream 190g due to potential norovirus contamination from individually quick-frozen raspberries. Affected units were distributed to consumers in Pennsylvania, California, Illinois, and Texas.

    Product
    Revie Superfoods Coconut Cream 190g Ready-to-Blend Coconut Delight Smoothie Made in Canada UPC 8 54681 00016 9 Revive Superfoods 1880 Bonhill Road, Mississauga, Ontario, Canada
    Category
    Food
    Distribution
    4 states
  • HighFDA (Devices)·Z-1440-2022·2022-07-27

    Nexiva Infusion Device Stopcock May Leak During Treatment

    Becton Dickinson is recalling Nexiva infusion devices with pink stopcock components due to potential leakage at the housing that could interrupt treatment or expose patients to infusate and biohazardous material.

    Product
    Nexiva with Single BD Connecta Stopcock Version (Pink) Catalog No. 383687 (OUS)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1396-2022·2022-07-27

    Surgical Seal Packaging May Compromise Sterility in Laparoscopic Devices

    Surgical Innovations Ltd recalls YelloPort Elite Universal Seals due to potential holes in packaging that may affect product sterility. Worldwide distribution affected.

    Product
    YelloPort Elite Universal Seal. For use in laparoscopic procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1458-2022·2022-07-27

    Fudge Classic Truffle recalled for undeclared tree nuts

    Queen Bee Gardens is recalling Fudge Classic Truffle candy because it may contain undeclared tree nuts including pecans, almonds, coconut, macadamia nuts, and walnuts. Consumers with tree nut allergies should not consume this product.

    Product
    Fudge Classic Truffle. Net wt. 1.4 oz. PLU Code: 788394 11045 0. Ingredients: Dark chocolate, milk chocolate, honey, butter (pasteurized cream & salt), cream, non-fat dry milk, whey, agar, algin, lecithin & natural flavors.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1431-2022·2022-07-27

    BD Connecta Infusion Stopcock Recall Due to Potential Housing Leakage

    BD Connecta Stopcock infusion devices may leak at the housing component, potentially delaying or interrupting treatment and exposing patients to biohazardous material. The recall affects 485,000 units distributed worldwide.

    Product
    BD Connecta Stopcock with OFF Directed Tap Without Extension Tube (500 eaches/carton) Catalog No. 394910 (US)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1427-2022·2022-07-27

    GE Anesthesia Systems Base Cracking and Fall Hazard Recalled

    GE Healthcare anesthesia systems may develop cracks in the base, potentially causing the device to tip and fall. The FDA recalled 667 units distributed across multiple U.S. states and countries.

    Product
    GE Healthcare Avance CS2, Avance CS2 Pro Anesthesia Systems, Part #1009-9050-000; and Aisys CS2 Anesthesia Systems, Part # 1011-9050-000.
    Category
    Medical Device
    Distribution
    28 states
  • HighFDA (Devices)·Z-1447-2022·2022-07-27

    Aesculap S4 Cervical Cross Connector Recalled Due to Clamping Force Defect

    Aesculap Implant Systems is recalling the S4 Cervical Cross Connector L 33-42mm due to insufficient clamping force that may cause connector movement or microparticle abrasion in spinal fusion implants.

    Product
    AESCULAP S4 Cervical Cross Connector L 33-42mm, S4C CROSS CONNECTOR VARIABLE 33-42MM, product code SW116T. Used in spinal fusion surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1473-2022·2022-07-27

    Honey Caramels Butterscotch Recalled for Undeclared Tree Nuts

    Queen Bee Gardens is recalling Honey Caramels Butterscotch due to undeclared tree nuts including pecans, almonds, coconut, macadamia nuts, and walnuts. Consumers with tree nut allergies should not consume this product.

    Product
    Honey Caramels Butterscotch. Net wt. 5.87 oz. PLU Code: 788394 12675 8. Ingredients: Honey, Butter (Pasteurized Cream & Salt), Cream, Grade A Non-Fat Dry Milk, Whey, Natural Flavors, Agar, Algin and Lecithin.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1269-2022·2022-07-27

    FDA Recalls Nephron Cardioplegia Solution Over Sterility Assurance Concerns

    Nephron Sterile Compounding Center is recalling del Nido Cardioplegia Solution due to lack of assurance of sterility. The 1765 bags affected were distributed nationwide.

    Product
    del Nido Cardioplegia Solution 1000 mL (1000 mL) Single-Dose Container IV bag, 4 x 1 IV Bag per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-984-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1275-2022·2022-07-27

    Phenylephrine HCl injection recalled for lack of sterility assurance

    Nephron Sterile Compounding Center recalls Phenylephrine HCl Injection syringes nationwide due to lack of sterility assurance. Patients with affected lots should contact their healthcare provider.

    Product
    Phenylephrine HCl Injection, USP, 0.8 mg/10 mL (80 mcg/mL)syringe, packaged in 5 x 10 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-956-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1441-2022·2022-07-27

    Espresso Cheesecake Bites recalled due to undeclared soy lecithin

    Chuckanut Bay Foods is recalling Espresso Cheesecake Bites because the product contains undeclared soy lecithin. The label states sunflower lecithin, but soy—a major allergen—is actually present.

    Product
    Item 32023-56, Chuckanut Bay Espresso Cheesecake Bites (Dark Compound) BULK. Perishable - Keep Refrigerated. There are 14 pieces per pack and 56 packs per case. Item 35023-12, Espresso Cheesecake Bites. Edible brand. Distributed by Wish Foods, LLC. Perishable - Keep…
    Category
    Food
    Distribution
    13 states
  • HighFDA (Drugs)·D-1280-2022·2022-07-27

    Anticoagulant Sodium Citrate Solution Recalled for Sterility Assurance Failure

    Nephron Sterile Compounding Center is recalling 85,300 pre-filled syringes of Anticoagulant Sodium Citrate Solution due to failure to assure sterility. Affected patients should contact their healthcare provider.

    Product
    Anticoagulant Sodium Citrate Solution, USP 4%, 200 mg/5 mL (40 mg/mL) syringe, packaged in 5 x 5 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-906-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1448-2022·2022-07-27

    Cervical spinal implant connectors may fail to maintain proper clamping force

    Aesculap Implant Systems has recalled certain cervical spine implant connectors due to insufficient clamping force. The defect may allow movement on the rods or cause microparticle abrasion.

    Product
    AESCULAP S4 Cervical Cross Connector L 42-58mm, S4C CROSS CONNECTOR VARIABLE 42-58MM, product code SW117T. Used in spinal fusion surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1443-2022·2022-07-27

    Cheesecake Bites Recalled for Undeclared Soy Lecithin Allergen

    Chuckanut Bay Cheesecake Bites Lemon are being recalled due to undeclared soy lecithin in the product. The label incorrectly lists sunflower lecithin as an ingredient, posing a risk to consumers with soy allergies.

    Product
    Item 34032-12, Chuckanut Bay Cheesecake Bites Lemon. Perishable - Keep Refrigerated. There are 8 pieces per pack and 12 packs per case. Net Wt. 6.4 oz. UPC 6 03812 34032 8. The label is read in parts: "***INGREDIENTS: CREAM CHEESE***, CHOCOLATE COMPOUND (sunflower…
    Category
    Food
    Distribution
    13 states
  • HighFDA (Devices)·Z-1407-2022·2022-07-27

    Nonsterile Components in Medical Convenience Kits Recalled

    ROi CPS LLC is recalling 86 nonsterile medical convenience kits distributed in Missouri because components that were supposed to be sterile were packaged as nonsterile.

    Product
    Nonsterile convenience kits: (1) regard Item #830099008, CV01005H - CV Part 1 Bundle; and (2) regard Item #830019017, CV00214Q - CV.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1435-2022·2022-07-27

    BD Connecta Stopcock Without Extension Tube Recalled for Potential Leakage Risk

    Becton Dickinson & Company is recalling BD Connecta Stopcock units worldwide due to a potential housing leakage defect that could interrupt treatment or cause exposure to biohazardous material.

    Product
    BD Connecta Stopcock Without Extension Tube Catalog No. 394605 (OUS)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1416-2022·2022-07-27

    Hill-Rom Centrella Pro+ mattress reduced heat-moisture management performance

    Affected Hill-Rom Centrella Pro+ 36-inch mattresses may have reduced Microclimate Management performance, increasing risk of pressure ulcer development. The failure affects heat and moisture control.

    Product
    Hill-Rom Centrella Pro+ 36" Surface mattress, REF P7923A03.
    Category
    Medical Device
    Distribution
    Distributed nationwide

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