The Recall Desk

Archive

September 2022 recalls

527 recalls were announced in September 2022.

What the numbers show

Critical
21
Severe
147
High
304
Moderate
53
Low
2

Of the 527 recalls this month scored against our rubric, 4% are Critical, 28% are Severe.

Which agencies issued them

101–200 of 527

  • ModerateFDA (Food)·F-1754-2022·2022-09-28

    Strawberry, Blueberry, and Blackberry Products Recalled for Inadequate Wash Sanitizer

    Russ Davis Wholesale is recalling strawberry, blueberry, and blackberry products sold under brands including Crazy Fresh and Kowalski's Markets due to inadequate sanitizer in wash water. Products with use-by dates of July 9 through August 2, 2022, are affected.

    Product
    Strawberry, Blueberry, and Blackberry packaged in the following brands and sizes: 1. Item 80610. Triple Berry Blend Net Wt. 14 oz. Crazy Fresh 2. Item 80867. Triple Berry Blend Net Wt 20 oz. Crazy Fresh, quick & easy, and grocery store branded. 3. Item 89272.…
    Category
    Food
    Distribution
    6 states
  • ModerateFDA (Food)·F-1763-2022·2022-09-28

    Four berry blend recalled due to inadequate wash water sanitization

    Russ Davis Wholesale is recalling 87,915 units of Four Berry Blend products distributed across the Midwest due to inadequate sanitizer in wash water.

    Product
    Four Berry Blend containing Strawberry, Blackberry, Blueberry, Raspberry. Keep Refrigerated. Item 80847. Net Wt. 12 oz. packaged in the following brands: .Crazy Fresh, quick & easy, and grocery store branded.
    Category
    Food
    Distribution
    6 states
  • ModerateFDA (Food)·F-1753-2022·2022-09-28

    Strawberry, Kiwi, and Mango Products Recalled Due to Inadequate Sanitizer

    Russ Davis Wholesale is recalling strawberry, kiwi, and mango products sold under the Crazy Fresh and Strawberry Sunrise brands due to inadequate sanitizer in wash water. Products were distributed across six Midwestern states.

    Product
    Strawberry, Kiwi, Mango. Packaged in the following brands and sizes: 1. Item 80595. Net Wt. 14 oz. Crazy Fresh 2. Item 80866. Net Wt 20 oz. Crazy Fresh, quick & easy, and grocery store branded. 3. Item 89269. Strawberry Sunrise Net Wt. 16 oz. Kowalski's Markets 4.…
    Category
    Food
    Distribution
    6 states
  • SevereNHTSA·22E082000·2022-09-27

    Manchester Tank Recalls Propane Tanks Due to Valve Thread Depth Defect

    Manchester Tank & Equipment Co is recalling ManTank Propane Tanks because valve thread depth is less than spec, creating a risk of propane leaks and fire.

    Product
    EQUIPMENT:RECREATIONAL VEHICLE/TRAILER:LPG SYSTEMS recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·22E081000·2022-09-27

    Haldex Air Disc Brake Pads Recalled for Loose Retaining Clip

    Haldex is recalling certain ModulT Gen II Air Disc Brakes because a loose retaining clip may detach, creating a road hazard and increasing crash risk.

    Product
    SERVICE BRAKES, AIR:DISC:PADS recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·22V720000·2022-09-27

    Lightning eMotors Recalls 2022 FE4 and FT3 for Brake Warning Light Defect

    Lightning eMotors is recalling 2022 FE4 and FT3 vehicles because the instrument panel may fail to display brake and ABS warning lights, increasing crash risk.

    Product
    LIGHTNING EMOTORS — LIGHTNING EMOTORS FE4, FT3
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·22V719000·2022-09-26

    Seagrave Recalls 2022 Emergency Vehicles Due to Tie Rod Clamp Defect

    Seagrave is recalling 2022 Marauder and Capitol emergency vehicles because improperly heat-treated tie rod clamps may fail, causing a loss of steering.

    Product
    SEAGRAVE — SEAGRAVE CAPITAL, MARAUDER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·22V718000·2022-09-26

    2023 Volkswagen Atlas Models Recalled for Brake Line Leaks

    Volkswagen is recalling 2023 Atlas and Atlas Cross Sport models due to brake lines that may leak at threaded connections. A brake fluid leak can increase stopping distance, raising crash risk.

    Product
    VOLKSWAGEN — VOLKSWAGEN ATLAS CROSS SPORT, ATLAS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·22V717000·2022-09-26

    Doosan Recalls 2021-2022 Portable Air Compressors Due to Brake Seal Leak

    Doosan is recalling 2021-2022 Portable Air Compressors because wheel bearing seals may leak grease into drum brakes, reducing braking performance and increasing crash risk.

    Product
    DOOSAN — DOOSAN PORTABLE AIR COMPRESSOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·034-2022·2022-09-24

    Behrmann Meat and Processing Inc. Recalling Ready-to-Eat Meat Products Due to Listeria Contamination

    Behrmann Meat and Processing Inc. is recalling approximately 87,382 pounds of ready-to-eat meat products because tests detected possible Listeria monocytogenes contamination. No confirmed cases of illness have been reported since the September 24, 2022 recall announcement.

    Product
    Behrmann Meat & Processing, Inc. — Behrmann Meat and Processing Inc. Recalls Various Ready-to-Eat Meat Products Due to Possible Listeria Contamination
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·033-2022·2022-09-23

    Empanadas Valrico Recalls Beef and Chicken Empanadas Produced Without Inspection

    Empanadas Valrico Inc. is recalling approximately 6,247 pounds of frozen beef and chicken empanadas produced without federal inspection. The products were distributed in Florida.

    Product
    Empanadas Valrico Inc. Recalls Beef and Chicken Empanada Products Produced Without Benefit of Inspection
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereNHTSA·22V716000·2022-09-23

    McNeilus Recalls 2021-2023 Zero Radius Trucks Due to Weld Failure Risk

    McNeilus is recalling 2021-2023 Zero Radius trucks because ejector welds may fail, causing hydraulic cylinders to penetrate the truck body and increasing injury risk.

    Product
    MCNEILUS — MCNEILUS ZERO RADIUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·22V715000·2022-09-23

    Micro Bird Recalls School Buses Due to Fire Risk from Loose Cable

    Micro Bird is recalling 2,753 school buses because a loose power cable connection may cause the air conditioning control board to overheat and melt, increasing the risk of a fire.

    Product
    MICRO BIRD — MICRO BIRD G5 SCHOOL BUS, T-SERIES SCHOOL BUS, MB II SCHOOL BUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·22V714000·2022-09-23

    Micro Bird Transit Bus Recall for Air Conditioning Fire Risk

    Micro Bird is recalling 2012-2022 transit buses because a loose power cable connection to the air conditioning control board may overheat and cause a fire.

    Product
    MICRO BIRD — MICRO BIRD T-SERIES TRANSIT BUS, G5 TRANSIT BUS, MB II TRANSIT BUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·22V711000·2022-09-22

    Navistar Recalls 2022-2023 International HX Trucks for Steering Defect

    Navistar is recalling 2022-2023 International HX vehicles because improperly heat-treated tie rod clamps may fail, causing loss of steering and increasing crash risk.

    Product
    INTERNATIONAL — INTERNATIONAL HX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·22227·2022-09-22

    Spalding Momentous EZ Portable Basketball Goals Recalled for Impact Injury Risk

    Russell Brands is recalling about 13,400 Spalding Momentous EZ Portable Basketball Goals because welds in the arm attaching the backboard to the pole can fail, causing the backboard to fall and strike users. The firm has received 26 reports of weld failures and 2 injury reports.

    Product
    Spalding Momentous EZ Portable Basketball Goals
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·22777·2022-09-22

    Canyon Furniture Ladders Recalled for Entrapment and Strangulation Hazards

    Canyon Furniture Company is recalling approximately 2,100 ladders sold with Canyon Lake and Cottage Colors bunk bed and hutch sets due to a gap wider than 3.5 inches between the fourth ladder step and the hutch cross-member that poses entrapment and strangulation hazards. No injuries have been reported.

    Product
    Ladders sold with Canyon Lake and Cottage Colors Bunk Bed and Hutch Sets
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·22773·2022-09-22

    Pool and Spa Drain Covers Recalled for Entrapment Hazard

    Chyir Myd pool and spa drain covers do not meet federal entrapment-protection standards and pose a hazard to swimmers. About 300 units were sold on Amazon from September 2021 through June 2022.

    Product
    Pool and spa drain covers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·22V708000·2022-09-22

    2023 Cadillac XT6, XT5, and GMC Acadia: illegible tire certification label

    General Motors is recalling 2023 Cadillac XT6, XT5, and GMC Acadia vehicles due to illegible tire size information on the driver's side certification label. The illegibility may result in incorrect tires being installed, increasing crash risk.

    Product
    CADILLAC — CADILLAC, GMC XT6, XT5, ACADIA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·22776·2022-09-22

    Pool and Spa Drain Covers Recalled for Entrapment Hazard

    Angzhili pool and spa drain covers do not meet the Virginia Graeme Baker Pool and Spa Safety Act entrapment protection standards, posing a risk to swimmers and bathers. About 1,000 units sold on Amazon from June 2021 through June 2022 are affected.

    Product
    Pool and spa drain covers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·22V709000·2022-09-22

    2020-2021 GMC Acadia rearview camera may fail due to improper connector crimping

    General Motors is recalling certain 2020-2021 GMC Acadia vehicles with defective rearview camera coaxial cables that may fail or malfunction. The improperly crimped connectors can reduce rear visibility and increase crash risk.

    Product
    CADILLAC — CADILLAC, GMC XT5, XT6, ACADIA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·22775·2022-09-22

    Pool and Spa Drain Covers Recalled for Entrapment Hazard

    Goetas pool and spa drain covers do not meet the Virginia Graeme Baker Pool and Spa Safety Act standards, creating an entrapment hazard for swimmers and bathers. About 300 units were sold on Amazon from October 2021 through April 2022.

    Product
    Pool and spa drain covers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·22V713000·2022-09-22

    Osage Recalls 2022 Warrior Emergency Vehicles Due to Lighting Failure Risk

    Osage Industries is recalling 2022 Warrior and Super Warrior emergency vehicles because a defective circuit board can cause vehicle lighting to fail, increasing crash risk.

    Product
    OSAGE — OSAGE WARRIOR, SUPER WARRIOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·22V710000·2022-09-22

    2023 Cadillac LYRIQ Instrument Panel Software Error May Cause Display to Go Blank

    General Motors is recalling certain 2023 Cadillac LYRIQ vehicles due to a software error that may cause the instrument panel display to go blank, potentially preventing drivers from seeing critical safety information.

    Product
    CADILLAC — CADILLAC redundant LYRIQ
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·22V712000·2022-09-22

    2022 Subaru Outback Windshield Defect May Cause Detachment in Crash

    Subaru is recalling 42 2022 Outback and Impreza vehicles due to incorrect paint clearcoat that may insufficiently bond the windshield. The windshield could detach during a crash, increasing injury risk.

    Product
    SUBARU — SUBARU OUTBACK, IMPREZA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·22774·2022-09-22

    Wadoy pool and spa drain covers recalled for entrapment hazard

    Find4Fix has recalled about 5,500 Wadoy eight-inch pool and spa drain covers sold on Amazon from August 2019 through June 2022 because they do not meet Virginia Graeme Baker Pool and Spa Safety Act entrapment protection standards.

    Product
    Pool and spa drain covers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateCPSC·22228·2022-09-22

    Accompany USA Ceramic Mugs with Cork Bottoms Recall Due to Burn Hazard

    Accompany USA is recalling about 25,000 ceramic mugs with cork bottoms because they can crack or break when hot liquid is poured into them, posing a burn hazard. One incident of breakage has been reported with no injuries.

    Product
    Ceramic Mugs with Cork Bottoms
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateCPSC·22226·2022-09-22

    Miffy First LED Lights Recalled for Overheat Burn Hazard

    About 1,400 Miffy First LED Lights can overheat during use, posing a burn hazard. No injuries have been reported. Consumers should stop using the lights and contact the company for a free module replacement.

    Product
    Miffy First LED Lights
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-1540-2022·2022-09-21

    Propofol Injectable Emulsion Recalled for Particulate Matter Contamination

    Pfizer is recalling 5,390 vials of Propofol Injectable Emulsion due to the presence of particulate matter. The affected lot (EA7470, expiration 6/1/2023) was distributed nationwide.

    Product
    PROPOFOL — PROPOFOL (PROPOFOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-1504-2022·2022-09-21

    Meijer Magnesium Citrate Laxative Recalled for Microbial Contamination

    Meijer brand magnesium citrate laxative (10 fl oz) has been recalled nationwide due to microbial contamination of Lot 0557622. Consumers should discard or return the product.

    Product
    meijer, magnesium citrate Saline Laxative, Oral Solution, (1.745 g/fl oz), Lemon Flavor, 10 FL OZ (296 mL), Dist. By Meijer Distribution, Inc. Grand Rapids, MI 49544; NDC 41250-708-38 UPC 7 13733 45945 7
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-1506-2022·2022-09-21

    FDA Recalls Citroma Magnesium Citrate Laxative for Microbial Contamination

    Citroma magnesium citrate laxative is recalled due to microbial contamination. The FDA Class I recall affects 42,912 bottles distributed in the USA, Canada, and Panama.

    Product
    CITROMA — CITROMA (MAGNESIUM CITRATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-1500-2022·2022-09-21

    CVS Health Magnesium Citrate Saline Laxative recalled for microbial contamination

    CVS Health Magnesium Citrate Saline Laxative is being recalled due to potential microbial contamination of the non-sterile product. Approximately 241,086 bottles were distributed nationwide.

    Product
    CVS Health, Magnesium Citrate SALINE LAXATIVE, Oral Solution, (1.745 g/fl oz), Lemon Flavor, 10 FL OZ (296 mL), a) UPC 0 50428 30594 2; b) UPC 0 50428 33517 8; Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895.
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-1509-2022·2022-09-21

    Walgreens Dye-Free Magnesium Citrate Laxative Recalled for Microbial Contamination

    Vi-Jon, LLC is recalling Walgreens Dye-Free Magnesium Citrate Saline Laxative due to microbial contamination of the non-sterile product. Approximately 29,172 bottles distributed nationwide in the USA, Canada, and Panama are affected.

    Product
    Walgreens, Dye-Free, Magnesium Citrate, SALINE LAXATIVE, Oral Solution, (1.745 g/fl oz), Lemon Flavor, 10 FL OZ (296 mL), Distributed By: Walgreen Co. 200 Wilmot Rd., Deerfield, IL 60015, NDC 0363-8166-38 UPC 3 11917 20160 3 (green label)
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1728-2022·2022-09-21

    Spicy shrimp rolls recalled for undeclared egg allergen

    EZ Noble Sushi is recalling spicy shrimp rolls (8 oz) with expiration 08/12/2022 due to undeclared egg. This poses a serious risk to consumers with egg allergies.

    Product
    Spicy shrimp roll (8 oz) with expiration 08/12/2022
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Devices)·Z-1653-2022·2022-09-21

    Baxter CLEARLINK System Non-DEHP Solution Set recalled due to leak reports

    Baxter Healthcare Corporation is recalling the CLEARLINK System Non-DEHP Solution Set nationwide due to increased customer reports of leaks in the in-line injection site device.

    Product
    Baxter CLEARLINK System, Non-DEHP Solution Set with DUO-VENT Spike, Product Code 2R8403. An in-line injection site.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0212-2024·2022-09-21

    Banana Boat Clear Sunscreen Spray recalled for benzene contamination

    Edgewell Personal Care Brands is recalling Banana Boat hair & scalp defense Clear Sunscreen Spray SPF 30 due to benzene contamination. The affected product was distributed nationwide in the United States.

    Product
    Banana Boat hair & scalp defense, Clear Sunscreen Spray SPF 30, Avobenzone 2.0%, Homosalate 6.0%, Octocrylene 6.0%, packaged in Net Wt 6 oz. aluminum spray can, Distributed by: Edgewell Personal Care Brands, LLC, Shelton, CT 06484, UPC 0 79656 04041 8
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1505-2022·2022-09-21

    Magnesium Citrate Laxative Recalled Due to Microbial Contamination

    Vi-Jon's Magnesium Citrate oral solution laxative is recalled nationwide due to microbial contamination. Approximately 8,682 bottles are affected.

    Product
    MAGNESIUM CITRATE — MAGNESIUM CITRATE (MAGNESIUM CITRATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1502-2022·2022-09-21

    FDA Recalls CITROMA Magnesium Citrate for Microbial Contamination

    Vi-Jon, LLC is recalling CITROMA magnesium citrate oral laxative solution due to microbial contamination. The affected product was distributed nationwide in the USA, Canada, and Panama.

    Product
    CITROMA — CITROMA (MAGNESIUM CITRATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1725-2022·2022-09-21

    Shrimp Tempura Sushi Rolls Recalled for Undeclared Egg and Wheat

    EZ Noble Sushi is recalling Shrimp Tempura and spice shrimp rolls (11.2 oz, expiration 08/12/2022) due to undeclared egg and wheat allergens. Consumers with allergies to eggs or wheat should not consume this product.

    Product
    Shrimp Tempura and spice shrimp roll (11.2 oz) with expiration 08/12/2022
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Drugs)·D-1510-2022·2022-09-21

    Walgreens Magnesium Citrate Laxative Recalled for Microbial Contamination

    Walgreens Dye-Free Magnesium Citrate Saline Laxative is recalled nationwide due to microbial contamination affecting certain lots. Consumers should stop using the product immediately.

    Product
    Walgreens, Dye-Free, Magnesium Citrate, SALINE LAXATIVE, Oral Solution, (1.745 g/fl oz), Grape Flavor, 10 FL OZ (296 mL), Distributed By: Walgreen Co., 200 Wilmot RD., Deerfield, IL 60015; NDC 0363-7162-38 UPC 3 11917 20159 7 (purple label).
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1733-2022·2022-09-21

    GFB Gluten Free Bites Dark Chocolate and Coconut recalled for undeclared cashews

    West Thomas Partners is recalling The GFB Gluten Free Bites Dark Chocolate and Coconut (UPC 856818008895) because the product contains undeclared cashews. Consumers with cashew allergies should not consume this product.

    Product
    The GFB Gluten Free Bites Dark Chocolate and Coconut 1.2oz. UPC 856818008895, 10 retail units per tray, 6 trays per wholesale case.
    Category
    Food
    Distribution
    25 states
  • SevereFDA (Drugs)·D-1503-2022·2022-09-21

    FDA Recalls Kroger Magnesium Citrate Laxative for Microbial Contamination

    Kroger-branded Magnesium Citrate saline laxative is being recalled due to microbial contamination. The recall affects approximately 44,976 bottles distributed in the USA, Canada, and Panama.

    Product
    MAGNESIUM CITRATE — MAGNESIUM CITRATE (MAGNESIUM CITRATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·22V706000·2022-09-21

    Mack Recalls One 2021 LR Electric Truck for Battery Fire Risk

    Mack Trucks is recalling one 2021 LR Electric truck because a coolant line may not be fully seated, creating a risk of electrical short circuit and fire.

    Product
    MACK — MACK LR ELECTRIC
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1731-2022·2022-09-21

    Shrimp tempura and lobster roll recalled for undeclared wheat allergen

    EZ Noble Sushi is recalling shrimp tempura and lobster roll products with expiration date 08/12/2022 distributed in Massachusetts and Connecticut due to undeclared wheat allergen.

    Product
    Shrimp tempura & lobster roll (12.8 oz) with expiration 08/12/2022
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Drugs)·D-1507-2022·2022-09-21

    SWAN Citroma Saline Laxative Recalled for Microbial Contamination

    Vi-Jon is recalling SWAN Citroma Magnesium Citrate Saline Laxative (10 FL OZ bottles) due to microbial contamination of a non-sterile product. The product was distributed nationwide in the USA, Canada, and Panama.

    Product
    SWAN, Citroma MAGNESIUM CITRATE, Saline Laxative, Oral Solution, (1.745 g/fl oz), Lemony Flavor, 10 FL OZ (296 mL), Distributed by: Vi-Jon, Inc. One Swan Drive Smyrna, TN 37167; NDC 0869-0166-38 UPC 0 72785 13405 8
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1730-2022·2022-09-21

    EZ Noble Sushi Rolls Recalled for Undeclared Egg Allergen

    EZ Noble Sushi is recalling Pink Lady and Salmon Avocado rolls (9 oz, expiration 08/12/2022) distributed in MA and CT due to undeclared egg. Consumers with egg allergies should not consume this product.

    Product
    Pink lady and salmon avocado roll (9 oz) with expiration 08/12/2022
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Drugs)·D-1508-2022·2022-09-21

    OTC Magnesium Citrate Laxative Recalled for Microbial Contamination

    Vi-Jon's CITROMA magnesium citrate laxative is recalled due to microbial contamination. Approximately 18,588 bottles were distributed nationwide in the USA, Canada, and Panama.

    Product
    CITROMA — CITROMA (MAGESIUM CITRATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1726-2022·2022-09-21

    Spicy salmon rolls recalled for undeclared egg allergen

    EZ Noble Sushi recalls spicy salmon rolls (9.6 oz, expiration 08/12/2022) sold in MA and CT due to undeclared egg allergen.

    Product
    Spicy salmon roll (9.6 oz) with expiration 08/12/2022
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-1732-2022·2022-09-21

    Sushi Rolls Recalled for Undeclared Wheat Allergen Content

    EZ Noble Sushi is recalling California crunch roll products due to undeclared wheat allergen. Consumers with wheat allergies should discard this product.

    Product
    California crunch roll (9.6 oz) with expiration 08/12/2022
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Drugs)·D-1501-2022·2022-09-21

    Equate Magnesium Citrate Saline Laxative Recalled Due to Microbial Contamination

    Equate Magnesium Citrate saline laxative has been recalled for microbial contamination. The FDA Class I recall affects 18,324 bottles distributed in the US, Canada, and Panama.

    Product
    equate Magnesium Citrate, SALINE LAXATIVE, (1.745g/fl oz) 10 FL OZ (296mL), Grape Flavor, Distributed By: Walmart, Inc. Bentonville, AR 72716; NDC 49035-592-38 UPC 6 81131 28715 9
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1727-2022·2022-09-21

    EZ Noble Sushi Spicy Tuna Roll Recalled for Undeclared Egg Allergen

    EZ Noble Sushi is recalling Spicy Tuna Roll (9.6 oz) with expiration 08/12/2022 due to undeclared egg. Consumers with egg allergies should not consume this product.

    Product
    Spicy tuna roll (9.6 oz) with expiration 08/12/2022
    Category
    Food
    Distribution
    2 states
  • HighFDA (Drugs)·D-1533-2022·2022-09-21

    FDA Recalls Injectable Medication Due to Sterility Assurance Failure

    Carolina Infusion's QUAD-MIX 30/2/60/0.15 injectable (Lot 08022022@12) is recalled nationwide because the manufacturer failed to assure sterility. Patients and healthcare providers should not use affected vials and should contact the manufacturer.

    Product
    QUAD-MIX 30/2/60/0.15 Injectable, 5 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1531-2022·2022-09-21

    Injectable drug recalled due to lack of sterility assurance

    Carolina Infusion is recalling TRI-MIX 30/2/40 Injectable because the manufacturer cannot assure the product's sterility. Non-sterile injectable drugs pose serious infection risks.

    Product
    TRI-MIX 30/2/40 Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1730-2022·2022-09-21

    GXL Acetabular Liners Recalled Due to Non-Conforming Packaging and Accelerated Wear Risk

    Exactech's GXL acetabular hip implant liners are being recalled because they were packaged in non-conforming bags that may cause accelerated wear of the devices.

    Product
    GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION CONSTRAINED LINER 28MM ID GROUP 1, REF 134-28-41 b. NOVATION CONSTRAINED LINER 32MM ID GROUP 2, REF 134-32-42 c. NOVATION CONSTRAINED LINER 36MM ID GROUP 3, REF 134-36-43 d.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·22E079000·2022-09-21

    Skinny Guy Campers Recalls Model 6.5 Campers Due to LP Gas Leak Risk

    Skinny Guy Campers is recalling Model 6.5 Campers because cracked quick disconnect fittings in the LP gas system may cause a gas leak, increasing fire risk.

    Product
    EQUIPMENT:RECREATIONAL VEHICLE/TRAILER:LPG SYSTEMS recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1732-2022·2022-09-21

    Exactech GXL Acetabular Hip Implant Liners Recalled for Accelerated Wear

    Exactech GXL acetabular hip implant liners may have been packaged in non-conforming bags, which could contribute to accelerated device wear. Approximately 17,929 units were distributed worldwide.

    Product
    GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION GXL LINER NEUTRAL, 32MM ID GROUP 1 CUPS, REF 130-32-51 b. NOVATION GXL LINER NEUTRAL, 36MM ID, GROUP 2 CUPS, REF 130-36-52 c. NOVATION GXL LINER NEUTRAL, 40MM ID, GROUP 3 CUPS, REF…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1748-2022·2022-09-21

    SCENARIA View software error may require additional patient radiation exposure

    SCENARIA View imaging software errors prevent image reconstruction, which may require additional scans and expose patients to unnecessary radiation.

    Product
    SCENARIA View: Software Version V1.08, V1.09B, V1.09C, V1.09D, V1.0B, V1.0C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1516-2022·2022-09-21

    MIC/B12 Injectable Vials Recalled for Lack of Sterility Assurance

    Carolina Infusion is recalling MIC/B12 injectable vials due to lack of assurance of sterility. Affected lots were distributed nationwide.

    Product
    MIC/B12 25/50/50/1 MG/ML Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1728-2022·2022-09-21

    GXL Acetabular Liners Recalled Due to Non-Conforming Packaging Bags

    Exactech recalls GXL acetabular hip implant liners packaged in non-conforming bags that may cause premature wear. No injuries have been reported.

    Product
    GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. ACUMATCH GXL 0 DEGREE LINER 28MM SZ E, REF 130-28-25 b. ACUMATCH GXL 0 DEGREE LINER 28MM SZ F, REF 130-28-26 c. ACUMATCH GXL 0 DEGREE LINER 28MM SZ G, REF 130-28-27 d. ACUMATCH GXL 0 DEGREE…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1729-2022·2022-09-21

    Philadelphia Sushi Rolls Recalled for Undeclared Milk Allergen

    EZ Noble Sushi is recalling Philadelphia avocado and cucumber classic rolls (8 oz) with expiration 08/12/2022 due to undeclared milk. The rolls were distributed in Massachusetts and Connecticut.

    Product
    Philadelphia avocado or cucumber classic roll (8 oz) with expiration 08/12/2022
    Category
    Food
    Distribution
    2 states
  • HighFDA (Drugs)·D-1518-2022·2022-09-21

    Sermorelin Acetate Injectable Recalled Due to Lack of Sterility Assurance

    Carolina Infusion is recalling Sermorelin Acetate injectable (1 MG/ML, 9 ML syringes) distributed nationwide due to lack of assurance of sterility. The manufacturer could not adequately document that the product meets required sterility standards.

    Product
    Sermorelin Acetate 1 MG/ML Injectable, 9 ML syringes, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1735-2022·2022-09-21

    Capri Sun juice drink recalled for accidental cleaning solution contamination

    Capri Sun Wild Cherry juice drinks are being recalled because cleaning solution inadvertently entered the production line. The affected product has a best-by date of June 25, 2023.

    Product
    Capri Sun, Wild Cherry, Flavored Juice Drink Blend in 6floz. foil pouch. Sold in carton containing 10 pouches. Carton UPC 087684001004. Four cartons per wholesale case.
    Category
    Food
    Distribution
    8 states
  • HighFDA (Devices)·Z-1742-2022·2022-09-21

    ZAP-X Radiosurgery System Software Issue May Cause Treatment Misalignment

    A software issue in the ZAP-X Radiosurgery System may cause incorrect treatment positioning in patients with large rotational deviations. The alignment algorithm could miscalculate treatment table offset values, potentially affecting treatment delivery.

    Product
    ZAP-X Radiosurgery System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1539-2022·2022-09-21

    Teva Amphetamine Tablets Recalled Due To Incorrect Strength Labeling

    Teva Pharmaceuticals is recalling 83,703 bottles of prescription amphetamine tablets nationwide because bottles labeled as 15 mg strength actually contain 20 mg tablets, creating risk of unintended overdose. Patients should contact their pharmacy or healthcare provider.

    Product
    DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE — DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE (DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1727-2022·2022-09-21

    GXL Acetabular Liners Recalled Due to Non-Conforming Packaging

    Exactech recalled 132 GXL acetabular liners (hip implant components) due to non-conforming bags that may accelerate device wear. Units were distributed worldwide to the US and 13 countries.

    Product
    GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. ACUMATCH +5MM LAT LINER 15 DEG 36MM ID, SIZE H, REF 138-36-08 b. ACUMATCH +5MM LAT LINER 15 DEG 36MM ID, SIZE J, REF 138-36-09 c. ACUMATCH LINER 15 DEG 36MM ID, SIZE H, REF 132-36-08 d.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1724-2022·2022-09-21

    ICU Medical Trifuse Extension Set Recalled for Connector Housing Gap

    ICU Medical is recalling 5.8 million Trifuse Extension Sets due to a manufacturing defect that creates a visible gap between the connector's housing parts. The gap could lead to disconnection or fluid leakage during infusion.

    Product
    6" (15 cm) Appx 0.85 ml, Smallbore Trifuse Ext Set w/3 MicroClave Clear, 2 Check Valve, 3 Clamps, Rotating Luer;
    Category
    Medical Device
    Distribution
    53 states
  • HighFDA (Devices)·Z-1709-2022·2022-09-21

    Roadrunner PC Wire Guide Recalled for Sterility Testing Failure

    Cook Incorporated is recalling 1,997 units of the Roadrunner PC Hydrophilic Wire Guide due to packaging failure in sterility testing. The device's sterility may be compromised.

    Product
    Roadrunner PC Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): RPC-35-180 ORDER NUMBER (GPN):G07518. For vascular catheter positioning and exchange in diagnostic and interventional procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1523-2022·2022-09-21

    Carolina Infusion Injectable Hormones Recalled Due to Sterility Concerns

    Carolina Infusion is recalling TEST CYP/DHEA injectable hormone products due to lack of sterility assurance. The recall affects nationwide distribution of 3 ML and 6 ML vials.

    Product
    TEST CYP/DHEA (Sesame Oil) 100 MG/2.5 MG/ML Injection, 3 ML and 6 ML vials, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1528-2022·2022-09-21

    TRI-MIX 30/1/40 Injectable Recalled Due to Lack of Sterile Assurance

    Carolina Infusion is recalling TRI-MIX 30/1/40 Injectable due to lack of assurance of sterility. Affected lots were distributed nationwide and pose risk of infection.

    Product
    TRI-MIX 30/1/40 Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1747-2022·2022-09-21

    Sterile Dental Rolls Recalled: New Cotton Source Sterility Not Validated

    Carwild Corporation is recalling FABCO ORS Dental Rolls because the sterility of a new cotton source was not validated. The recalled 90 cases (4,500 units) with lot 22B0428 were distributed nationwide.

    Product
    FABCO ORS DENTAL ROLLS, 1-1/2" STERILE, COTTON 3/8" Diameter x 1-1/2" (9.5mm x 38.1mm), packaged 5 /Pouch, 50 Pouches/Box Reorder Number: 34911510
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1532-2022·2022-09-21

    TRI-MIX 50/2.5/25 Injectable recalled for lack of sterility assurance

    Carolina Infusion is recalling TRI-MIX 50/2.5/25 Injectable (Lot 07052022@2) nationwide due to lack of assurance of sterility. Patients should not use affected vials and should consult their healthcare provider.

    Product
    TRI-MIX 50/2.5/25 Injectable, 2 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1525-2022·2022-09-21

    FDA Recalls Test Cypionate/Propionate Injectable for Lack of Sterility Assurance

    Carolina Infusion is recalling TEST CYP/PROP 100 MG/100 MG/ML injectable vials due to lack of assurance of product sterility. Patients should contact their healthcare provider.

    Product
    TEST CYP/PROP (50:50) 100 MG/100 MG/ML Injectable, 12.6 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1716-2022·2022-09-21

    Roadrunner UniGlide wire guide recalled for potential sterility compromise

    Cook Incorporated is recalling 189 Roadrunner UniGlide hydrophilic wire guides because they failed packaging testing requirements and their sterility may be compromised.

    Product
    Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWAS-35-80 ORDER NUMBER (GPN): G56175. For vascular catheter positioning and exchange in diagnostic and interventional procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1517-2022·2022-09-21

    Injectable drug product recalled for lack of sterility assurance

    Carolina Infusion is recalling MIC/B12/L-Carn (HD) injectable vials due to inability to assure product sterility. The product was distributed nationwide.

    Product
    MIC/B12/L-Carn (HD) 35/35/35/1/35 MG/ML Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1712-2022·2022-09-21

    Roadrunner UniGlide Hydrophilic Wire Guide Sterility Compromise Recall

    Cook Incorporated is recalling 35 units of Roadrunner UniGlide Hydrophilic Wire Guide due to packaging testing failures that may have compromised device sterility. Affected devices were distributed nationwide and internationally.

    Product
    Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWA-18-80 ORDER NUMBER (GPN): G56162. For vascular catheter positioning and exchange in diagnostic and interventional procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1706-2022·2022-09-21

    Roadrunner PC Hydrophilic Wire Guide Recalled Due to Sterility Compromise

    Cook Incorporated is recalling 496 units of the Roadrunner PC Hydrophilic Wire Guide due to packaging failure that may compromise sterility. No illnesses have been reported.

    Product
    Roadrunner PC Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN)RFPC-35-180 ORDER NUMBER (GPN) G07937. For vascular catheter positioning and exchange in diagnostic and interventional procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1711-2022·2022-09-21

    Vascular Wire Guide Recalled for Potential Sterility Compromise

    Cook Incorporated is recalling the Roadrunner UniGlide Hydrophilic Wire Guide due to failed packaging testing that may compromise device sterility. The affected lot numbers are 14095646 and 14174879.

    Product
    Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWA-18-150 ORDER NUMBER (GPN):G56161. For vascular catheter positioning and exchange in diagnostic and interventional procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1538-2022·2022-09-21

    Lisinopril 10 mg Tablets Recalled for Metal Fragment Contamination

    RemedyRepack Inc. is recalling Lisinopril 10 mg prescription tablets due to a metal fragment embedded in one tablet. Affected lots were distributed to pharmacies in Pennsylvania and Alaska.

    Product
    Lisinopril 10 mg tablets, 30-count Blister Card, Rx Only, MFG: Lupin Pharma, Baltimore, MD Repackaged by: RemedyRepack Inc, Indiana PA. Original NDC# 68180-0980-03, Repackaged NDC# 70518-0468-00
    Category
    Drug
    Distribution
    2 states
  • HighFDA (Drugs)·D-1537-2022·2022-09-21

    Hand Sanitizer Recalled for Manufacturing Defects and Chemical Impurities

    Superior Glove Works is recalling Synergy Hand Sanitizer due to acetaldehyde impurity and excess total impurities above specification limits. The 80% alcohol topical antiseptic was distributed nationwide.

    Product
    Synergy Hand Sanitizer, Non-Sterile Solution to help reduce bacteria that can potentially cause disease, For use when soap and water are not available, Alcohol 80% Topical Solution, Antiseptic, 8.5 oz./ 250 mL bottles, Made and Distributed by: Superior Glove Works Ltd., 36 Vimy…
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1717-2022·2022-09-21

    Roadrunner UniGlide Vascular Wire Guide Recalled for Sterility Compromise

    Cook Incorporated is recalling 30 units of Roadrunner UniGlide Hydrophilic Wire Guides due to packaging failure that may compromise device sterility.

    Product
    Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWS-35-150 ORDER NUMBER (GPN): G56152. For vascular catheter positioning and exchange in diagnostic and interventional procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1719-2022·2022-09-21

    Medical connector recalled due to manufacturing housing gap defect

    ICU Medical is recalling MicroClave Clear Neutral Connectors used in intravascular catheters due to a manufacturing defect that creates a visible gap between housing parts.

    Product
    MicroClave Clear Neutral Connector. A bidirectional connector used as an accessory to an intravascular catheter placed in the vein or artery.
    Category
    Medical Device
    Distribution
    53 states
  • HighFDA (Drugs)·D-1520-2022·2022-09-21

    Carolina Infusion Semaglutide/Cyanocobalamin Injectable Recalled for Sterility Issue

    Carolina Infusion is recalling Semaglutide/Cyanocobalamin 10/2 MG/ML Injectable syringes nationwide due to lack of sterility assurance. The affected lot 08152022@14 has a best-by date of September 14, 2022.

    Product
    Semaglutide/Cyanocobalamin 10/2 MG/ML Injectable, 0.4 ML syringe, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1713-2022·2022-09-21

    Vascular wire guides recalled due to potential sterility compromise

    Cook Incorporated is recalling 5,400 Roadrunner UniGlide Hydrophilic Wire Guides because the devices failed packaging tests required to verify sterility. The affected devices are used in diagnostic and interventional vascular procedures.

    Product
    Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWA-35-150 ORDER NUMBER (GPN): G56173. For vascular catheter positioning and exchange in diagnostic and interventional procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1515-2022·2022-09-21

    L-Carnitine Injectable Recalled Due to Sterility Assurance Failure

    Carolina Infusion is recalling L-Carnitine 500 mg/mL injectable vials nationwide due to lack of assurance of sterility. The affected lot 06132022@17 should not be administered.

    Product
    L-Carnitine 500 mg/mL Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1751-2022·2022-09-21

    iSED Tubing Spare Part Recalled for Potential Biohazard Leak Risk

    Alcor Scientific is recalling iSED Primary Pump Tubing Spare Part Kits due to potential biohazard leak from the Probe Tube when installed on the iSED ESR Analyzer. Affected lot (4/22) includes 38 units distributed nationwide and internationally.

    Product
    iSED Primary Pump Tubing Spare Part Kit- (IVD) tubing is used to move sample and wash solution from the aspiration needle, through the reading chamber, and to the waste on the iSED Automated ESR Analyzer PN: 112-13-002
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1521-2022·2022-09-21

    Semaglutide/Cyanocobalamin Injectable Syringes Recalled Due to Sterility Failure

    Carolina Infusion is recalling Semaglutide/Cyanocobalamin injectable syringes nationwide due to lack of assurance of sterility. Patients using Lot 08172022@1 should contact their healthcare provider immediately.

    Product
    Semaglutide/Cyanocobalamin 24/2 MG/ML Injectable, 0.4 ML syringe, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1720-2022·2022-09-21

    ICU Medical Infusion Extension Set Recall Due to Connector Housing Gap

    ICU Medical recalls 5.8 million infusion extension sets due to a manufacturing defect that creates a visible gap in the connector housing, potentially compromising device integrity.

    Product
    8.5" (22 cm) Appx 0.85 ml, Bifuse Pressure Infusion (400 psig) Ext Set w/2 Remv MicroClave Clear, 2 Purple Clamps, Rotating Luer;
    Category
    Medical Device
    Distribution
    53 states
  • HighFDA (Drugs)·D-1526-2022·2022-09-21

    Injectable Drug Recall: TRI-MIX 30/1/10 Vials Lack Sterility Assurance

    Carolina Infusion is recalling TRI-MIX 30/1/10 injectable vials nationwide because the sterility of the product cannot be assured. This FDA Class II recall affects 16 vials distributed across multiple lots with expiration dates through October 2022.

    Product
    TRI-MIX 30/1/10 Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1708-2022·2022-09-21

    Roadrunner PC Hydrophilic Wire Guide Recalled Due to Sterility Testing Failure

    Cook Incorporated is recalling 1,450 units of Roadrunner PC Hydrophilic Wire Guide devices due to failed sterility packaging testing. The devices may not meet sterility requirements for safe use in vascular procedures.

    Product
    Roadrunner PC Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN):RLPC-35-180 ORDER NUMBER (GPN) G07516. For vascular catheter positioning and exchange in diagnostic and interventional procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1734-2022·2022-09-21

    GXL Acetabular Liners Packaging Defect May Cause Accelerated Wear

    Exactech GXL acetabular hip implant liners in non-conforming bags may experience accelerated wear. Approximately 7,946 devices were distributed worldwide. No injuries have been reported.

    Product
    GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. ACUMATCH 0 DEGREE LINER 28MM 46MM, REF 130-28-05; b. ACUMATCH 0 DEGREE LINER 28MM 48MM, REF 130-28-06; c. ACUMATCH 0 DEGREE LINER 28MM 50/52MM, REF 130-28-07; d. ACUMATCH 0 DEGREE LINER…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1721-2022·2022-09-21

    Extension Set Recall Due to Connector Housing Manufacturing Defect

    ICU Medical is recalling bifurcated extension sets used in medical infusions. The sets have a manufacturing defect causing visible gaps in the connector housing, affecting millions of units distributed in the U.S. and internationally.

    Product
    6.5" (17 cm) Appx 0.84 ml, Smallbore Bifuse Ext Set w/2 MicroClave Clear, 2 Check Valves, Luer Lock;
    Category
    Medical Device
    Distribution
    53 states
  • HighFDA (Devices)·Z-1744-2022·2022-09-21

    Pinnacle3 Radiation Therapy Planning System dose-calculation software error

    Philips Pinnacle3 radiation therapy planning systems may export incorrect dose information when multiple beams are used with certain Edit Prescription settings. 169 systems are affected.

    Product
    Pinnacle3 Radiation Therapy Planning System, Model numbers 870231 and 870237.
    Category
    Medical Device
    Distribution
    21 states
  • HighFDA (Devices)·Z-1714-2022·2022-09-21

    Vascular Wire Guide Recalled Due to Sterility Concerns From Packaging Failure

    Cook Incorporated is recalling Roadrunner UniGlide Hydrophilic Wire Guides (Lot 14156569) because packaging testing failed, indicating the device's sterility may be compromised. The recall affects 75 units distributed in the U.S. and internationally.

    Product
    Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWA-35-80 ORDER NUMBER (GPN): G56172. For vascular catheter positioning and exchange in diagnostic and interventional procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1710-2022·2022-09-21

    Vascular Catheter Wire Guide Recalled for Possible Sterility Compromise

    Cook Incorporated is recalling 585 Roadrunner UniGlide Hydrophilic Wire Guides because they failed packaging sterility tests, potentially compromising device sterility.

    Product
    Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPW-35-150 ORDER NUMBER (GPN):G56149. For vascular catheter positioning and exchange in diagnostic and interventional procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1749-2022·2022-09-21

    FUJIFILM Surpria Imaging Software May Fail During Scanning

    Surpria software versions V3.11 and V3.22 may encounter processing errors that prevent image reconstruction, potentially requiring additional scans and exposing patients to unnecessary radiation.

    Product
    Surpria: Software Version V3.11, V3.22
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1524-2022·2022-09-21

    Injectable Steroid Product Recalled for Lack of Sterility Assurance

    Carolina Infusion is recalling its TEST CYP/DHEA injectable steroid vials nationwide because the manufacturer cannot assure they are sterile. The recall affects 348 vials with lot numbers from June-August 2022.

    Product
    TEST CYP/DHEA (Sesame) 200 MG/2.5 MG/ML Injectable, 10 ML vial, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1746-2022·2022-09-21

    Laboratory device displays incorrect sample volume guidance during setup

    A laboratory automation device's setup screen indicates minimal volume when the exact volume should be loaded, potentially causing over-diluted, under-diluted, or improperly prepared samples and false test results.

    Product
    QIAcube Connect MDx, Model No. 9003070
    Category
    Medical Device
    Distribution
    26 states
  • HighFDA (Devices)·Z-1707-2022·2022-09-21

    Roadrunner PC Hydrophilic Wire Guide Recalled Due to Packaging Integrity Failure

    Cook Incorporated is recalling 2,407 units of Roadrunner PC Hydrophilic Wire Guide due to failed packaging integrity testing that may compromise device sterility. No illnesses or injuries have been reported.

    Product
    Roadrunner PC Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): RFSPC-35-180 ORDER NUMBER (GPN) G09608. For vascular catheter positioning and exchange in diagnostic and interventional procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide

Looking for a different month? Back to 2022.