The Recall Desk

Archive

January 2023 recalls

460 recalls were announced in January 2023.

What the numbers show

Critical
4
Severe
46
High
307
Moderate
103

Of the 460 recalls this month scored against our rubric, 1% are Critical, 10% are Severe.

1–100 of 460

  • SevereUSDA FSIS·003-2023·2023-01-31

    Conagra Recalls Canned Meat and Poultry Due to Packaging Defect

    Conagra Brands is recalling approximately 2.6 million pounds of canned meat and poultry products due to a packaging defect that could allow contamination.

    Product
    ConAgra Brands, Inc. — Conagra Brands Recalls Canned Meat and Poultry Products Due to Possible Packaging Defect
    Category
    Food
    Distribution
    Distributed nationwide
  • HighNHTSA·23V038000·2023-01-31

    2022–2023 Hyundai Santa Cruz and Tucson roof moldings may detach

    Hyundai is recalling certain 2022 Santa Cruz and 2023 Santa Cruz vehicles, as well as 2022 Tucson vehicles, because the roof moldings may detach and become a road hazard.

    Product
    HYUNDAI — HYUNDAI TUCSON, SANTA CRUZ
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·002-2023·2023-01-30

    Wild Cajun Meals Recalls Frozen Jambalaya and Gumbo for Lack of Inspection

    Wild Cajun Meals LLC is recalling approximately 18,418 pounds of frozen jambalaya and gumbo produced without federal inspection. The products were distributed in Louisiana and Texas.

    Product
    Wild Cajun Meals LLC Recalls Frozen, Fully Cooked Jambalaya and Gumbo Products Produced without Benefit of Inspection
    Category
    Food
    Distribution
    2 states
  • HighNHTSA·23V035000·2023-01-29

    2023 Kia Telluride Side Air Bag Wire Harness Damage Recall

    Kia is recalling certain 2023 Telluride vehicles because manufacturing errors may have damaged the second row seat side air bag wire harnesses, preventing deployment in a crash.

    Product
    KIA — KIA TELLURIDE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·001-2023·2023-01-29

    Daniele International Recalls Ready-to-Eat Sausage Products Due to Listeria Risk

    Daniele International LLC is recalling approximately 69,255 pounds of ready-to-eat sausage products that may be contaminated with Listeria monocytogenes.

    Product
    Daniele Operating, LLC - Stedagio — Daniele International LLC Recalls Ready-to-Eat Sausage Products Due to Possible Listeria Contamination
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereNHTSA·23V034000·2023-01-27

    Bentley Recalls 2020 Continental GT Models Due to Fire Risk

    Bentley is recalling 2020 Continental GT and GTC vehicles because liquid entering the coolant pump may cause an electrical short circuit, increasing the risk of a vehicle fire.

    Product
    BENTLEY — BENTLEY CONTINENTAL GT, CONTINENTAL GT CABRIO
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V033000·2023-01-27

    Porsche Panamera coolant pump electrical short circuit increases fire risk

    Porsche is recalling certain 2017-2021 Panamera models because humidity can enter the external coolant pump, causing an electrical short circuit that increases the risk of vehicle fire. Dealers will replace the pump and inspect connections at no cost.

    Product
    PORSCHE — PORSCHE PANAMERA 4S, PANAMERA TURBO, PANAMERA TURBO EXECUTIVE, PANAMERA 4S SPORT TURISMO
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • ModerateNHTSA·23V032000·2023-01-27

    2023 Winnebago Revel: incorrect tire size on safety label

    Certain 2023 Winnebago Revel camper vans have an incorrect tire size listed on the Tire and Loading Information Label (R16 instead of R17). Installing the wrong tires based on this incorrect information could increase the risk of a crash.

    Product
    WINNEBAGO — WINNEBAGO REVEL
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·23107·2023-01-26

    ZLINE Gas Ranges Recalled Due to Carbon Monoxide Emission Hazard

    ZLINE is recalling about 30,000 gas ranges (30-inch, 36-inch, and 48-inch models) because the oven compartment can emit dangerous levels of carbon monoxide, posing a serious risk of injury or death. Consumers should stop using the oven immediately until repaired.

    Product
    ZLINE 30-inch, 36-inch and 48-inch RG gas ranges
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·23106·2023-01-26

    Children's Lounge Pants Recalled for Flammability Standards Violation

    Properly Tied is recalling about 1,960 children's lounge pants that fail to meet federal flammability standards for sleepwear, posing a burn injury risk to children. Consumers should stop using them immediately and contact Properly Tied for return instructions.

    Product
    Children's Lounge Pants
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·23V030000·2023-01-26

    Jaguar I-PACE vehicles recalled for insufficient pedestrian warning sounds

    Jaguar is recalling 2021-2022 I-PACE vehicles because they fail to produce sufficient pedestrian warning sounds when stationary or in reverse, violating federal safety standards. Dealers will update the audio amplifier software at no charge.

    Product
    JAGUAR — JAGUAR I-PACE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V031000·2023-01-26

    Land Rover Range Rover Sport PHEV Pedestrian Warning Sound Defect

    Land Rover is recalling certain 2020-2022 Range Rover PHEV and Range Rover Sport PHEV vehicles because they fail to make sufficient warning sounds when stationary and in reverse, violating federal safety standards for hybrid and electric vehicles.

    Product
    LAND ROVER — LAND ROVER RANGE ROVER SPORT PHEV, RANGE ROVER PHEV
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0886-2023·2023-01-25

    Cardiosave IABP may shut down unexpectedly due to blood contamination

    The Cardiosave Rescue Intra-Aortic Balloon Pump may shut down unexpectedly if blood enters the device through a compromised balloon catheter. Approximately 46 units have been distributed worldwide.

    Product
    Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85, 0998-UC-0800-75, 0998-UC-0800-83, 0998-UC-0800-85.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0296-2023·2023-01-25

    Dough Ball Products Recalled for Undeclared Milk Allergen

    Sysco Merchandising and Supply is recalling Greco and Sons Dough Room dough ball products because they contain undeclared milk allergen, which poses a serious risk to milk-allergic consumers.

    Product
    Greco and Sons Dough Room Product No. 9009 Teresa's 9 oz.; Greco and Sons Dough Room Product No. 9012 Teresa's 12 oz.; Greco and Sons Dough Room Product No. 9020 Teresa's 22 oz.; Greco and Sons Dough Room Product No. 9046 Teresa's 48 oz.
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Food)·F-0301-2023·2023-01-25

    Dough Ball Products Recalled for Undeclared Milk Allergen

    Sysco Merchandising and Supply is recalling Greco and Sons Dough Room pizza dough products due to undeclared milk allergen. Consumers with milk allergies should not consume these products.

    Product
    Greco and Sons Dough Room Product No. 12 Vic's Pizza 10 oz.; Greco and Sons Dough Room Product No. 17 Vic's Pizza 20 oz.
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Food)·F-0297-2023·2023-01-25

    Greco and Sons dough products recalled for undeclared milk allergen

    Sysco Merchandising and Supply recalls Greco and Sons dough products containing undeclared milk allergen. Affected products were distributed to food service locations in six states.

    Product
    Greco and Sons Dough Room Product No. 92 House of 1000 10 oz.; Greco and Sons Dough Room Product No. 81 House of 1000 15 oz.; Greco and Sons Dough Room Product No. 37 Handlebar 27 oz.; Greco and Sons Dough Room Product No. 38 Handlebar 23 oz.; Greco and Sons Dough Room Product No
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Food)·F-0294-2023·2023-01-25

    Sysco Greco and Sons Dough Products Recalled for Undeclared Milk Allergen

    Sysco Merchandising and Supply is recalling Greco and Sons dough products sold in six states due to undeclared milk allergen. The recall affects approximately 2,325 cases with Best if Used By dates between December 1, 2022 and June 1, 2023.

    Product
    Greco and Sons Dough Room Product No. 28 Stefano 12 oz.; Greco and Sons Dough Room Product No. 29 Stefano 20 oz.; Greco and Sons Dough Room Product No. 30 Stefano 26 oz.; Greco and Sons Dough Room Product No. 36 Stefano 24 oz.; Greco and Sons Dough Room Product No. 35 Stefano 15
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Food)·F-0300-2023·2023-01-25

    Greco and Sons dough ball products recalled for undeclared milk allergen

    Sysco is recalling Greco and Sons dough ball products due to undeclared milk allergen. Consumers with milk allergies should not consume these products.

    Product
    Greco and Sons Dough Room Product No. 79 North Park Lounge 10 oz.; Greco and Sons Dough Room Product No. 64 North Park Lounge 16 oz.
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Drugs)·D-0131-2023·2023-01-25

    Daptomycin for Injection Recalled Due to Incorrect Labeling Dosage

    Accord Healthcare is recalling Daptomycin for Injection labeled as 350 mg/vial but containing 500 mg/vial vials. The labeling error poses a dosing risk to patients.

    Product
    Daptomycin for Injection 350 mg/vial 1 Single-dose vial, Rx only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, India. NDC 16729-0434-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·23V026000·2023-01-25

    2022-2023 BMW i4 and iX Vehicles Lack Pedestrian Warning Sounds

    BMW is recalling 2022-2023 i4 eDrive40 and iX xDrive50 electric vehicles because the external pedestrian warning sound system may fail during start-up. Pedestrians could be unaware of approaching vehicles, increasing injury risk.

    Product
    BMW — BMW IX, I4
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0885-2023·2023-01-25

    Cardiosave Hybrid Intra-Aortic Balloon Pump may shut down unexpectedly

    The Cardiosave Hybrid Intra-Aortic Balloon Pump may shut down unexpectedly when blood enters the device through a compromised balloon catheter during use.

    Product
    Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0998-00-0800-36, 0998-00-0800-45, 0998-00-0800-52, 0998-00-0800-53, 0998-00-0800-55, 0998-00-0800-65, 0998-UC-0800-31, 0998-UC-08
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0293-2023·2023-01-25

    Greco and Sons Dough Room Products Recalled for Undeclared Milk Allergen

    Sysco Merchandising and Supply is recalling multiple Greco and Sons Dough Room products distributed in six states due to undeclared milk allergen. Consumers with milk allergies should not consume these products.

    Product
    Greco and Sons Dough Room Product No. 333 PUB DOUGH 9 oz.; Greco and Sons Dough Room Product No. 88 Christopher's 14 oz.; Greco and Sons Dough Room Product No. 84 Christopher's 20 oz.; Greco and Sons Dough Room Product No. 86 Christopher's 36 oz.; Greco and Sons Dough Room Produ
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Food)·F-0295-2023·2023-01-25

    Greco and Sons Dough Room Garlic Knots recalled for undeclared milk allergen

    Sysco Merchandising and Supply is recalling Greco and Sons Dough Room Garlic Knots due to undeclared milk allergen. Affected cases were distributed across six states with best-if-used-by dates between December 1, 2022, and June 1, 2023.

    Product
    Greco and Sons Dough Room Product No. 65 Garlic Knots 180/CS
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Devices)·Z-0926-2023·2023-01-25

    Medical device controller software update addresses critical failure

    Cardiac Assist is issuing a software update for LifeSPARC Controller units that may experience critical failure causing the system to freeze, crash, or lose display functionality. Affected units are identified by specific serial numbers.

    Product
    SHIP KIT, LIFESPARC, CONTROLLER AND ACCESSORIES - 5900-0000; SHIP KIT, LIFESPARC, CONTROLLER ONLY - 5900-0001. Component of LifeSPARC System, used to pump the blood through an extracorporeal circuit.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0298-2023·2023-01-25

    Sysco Greco and Sons Dough Products Recalled for Undeclared Milk Allergen

    Sysco is recalling Greco and Sons Dough Room products due to undeclared milk allergen. Affected products include 8 oz and 16 oz sizes distributed to six states.

    Product
    Greco and Sons Dough Room Product No. 61 Dad's 8 oz.; Greco and Sons Dough Room Product No. 62 Dad's 16 oz.
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Food)·F-0299-2023·2023-01-25

    Greco and Sons Frozen Dough Products Recalled for Undeclared Milk

    Sysco Merchandising and Supply is recalling multiple Greco and Sons frozen dough products because they contain undeclared milk allergen. Consumers with milk allergies should not consume these products.

    Product
    Greco and Sons Dough Room Product No. 15 FRZN DOUGH 6 oz.; Greco and Sons Dough Room Product No. 16 FRZN DOUGH 8 oz.; Greco and Sons Dough Room Product No. 18 FRZN DOUGH 10 oz.; Greco and Sons Dough Room Product No. 26 FRZN DOUGH 12 oz.; Greco and Sons Dough Room Product No. 19 F
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Food)·F-0290-2023·2023-01-25

    Alfalfa Sprouts Recalled Due to Potential Salmonella Contamination

    Sun Sprouts Alfalfa Sprouts packaged in 4 oz clamshells and 2.5 lb boxes have been recalled due to potential Salmonella contamination. The affected products were sold to distributors and retailers in Nebraska, Kansas, and Iowa.

    Product
    Sun Sprouts Alfalfa Sprouts packaged in 4 oz plastic clamshell, 6/4 oz or 12/4 oz containers per case; Sun Sprouts Alfalfa Sprouts packaged in 2.5lb plastic lined box.
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-0278-2023·2023-01-25

    Multigrain Bread Products Recalled for Insanitary Storage Conditions

    Klosterman Baking Company recalled 109,343 units of multigrain bread and buns distributed in Indiana, Ohio, and Tennessee due to products being held under insanitary conditions.

    Product
    Breads: Multigrain product 3481 Clear Bag Buns 12 62 g Multigrain product 8017 Clear Bag Loaf 1 28 oz.
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-0995-2023·2023-01-25

    Vasoshield Syringe Ink Chips May Cause Embolic Events

    Ink on the Vasoshield syringe may chip off, potentially causing blood clots and foreign body reactions in patients. About 9,817 devices are affected.

    Product
    Hemopro 2 with Vasoshield, Model VH-4001
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0988-2023·2023-01-25

    Cardinal Health Jackson-Pratt Channel Drain Recalled for Performance Defects

    Cardinal Health Jackson-Pratt Channel Drains (19 Fr, REF JP-2230) are recalled due to performance issues including lack of radiopacity, dull trocars, reduced flexibility, and broken tips affecting 29,515 units.

    Product
    Cardinal Health Jackson-Pratt Channel Drain, 19 Fr, REF JP-2230
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0981-2023·2023-01-25

    Cardinal Health Jackson-Pratt Channel Drains recalled for multiple performance defects

    Cardinal Health is recalling Jackson-Pratt Channel Drains (10 Fr, REF JP-2221) due to multiple performance issues including broken wound tips, dull trocars, lack of radiopacity, and reduced flexibility affecting 179 units distributed worldwide.

    Product
    Cardinal Health Jackson-Pratt Channel Drain, 10 Fr, REF JP-2221
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0264-2023·2023-01-25

    Klosterman 100% Whole Wheat Breads Recalled for Insanitary Conditions

    Klosterman Baking Company is recalling 100% whole wheat breads distributed in Indiana, Ohio, and Tennessee due to products being held under insanitary conditions. Affected breads were delivered between December 12-16, 2022.

    Product
    Breads: 100% whole wheat product 1415 Klosterman Retail UPC # 0005172100367 Loaf 1 12 oz. 100% whole wheat product 1448 Klosterman Retail UPC # 0005172100401 Loaf 1 24 oz.
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-0276-2023·2023-01-25

    Klosterman Honey White Bread and Buns Recalled for Insanitary Conditions

    Klosterman Baking Company recalls honey white bread and buns held under insanitary conditions. Affected products were distributed in Indiana, Ohio, and Tennessee between December 12-16.

    Product
    Breads: Honey white product 3136 Clear Bag Buns 60 60 g Honey white product 3140 Klosterman Retail UPC # 0005172100106 Buns 12 60 g
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-0997-2023·2023-01-25

    Thoracic Stent-Graft System Recalled Due to Dimensional Defect

    Bolton Medical's RELAY PRO thoracic stent-graft system is being recalled because affected units may be shorter than their packaging indicates. The recall affects 129 units distributed worldwide.

    Product
    RELAY PRO, THORACIC STENT-GRAFT SYSTEM, REF 28-M4-XX-XXX-XXX
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0128-2023·2023-01-25

    Prescription Anesthetic Drug Recalled for Subpotent Epinephrine Content

    Fresenius Kabi is recalling Sensorcaine anesthetic injections nationwide due to subpotent epinephrine content. Affected batches may not provide adequate anesthesia or hemostasis during procedures.

    Product
    SENSORCAINE — SENSORCAINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0132-2023·2023-01-25

    FDA Recalls Akorn AK-POLY-BAC Eye Ointment for CGMP Violations

    Akorn Inc. voluntarily recalls 36,025 tubes of AK-POLY-BAC Bacitracin/Polymixin B eye ointment nationwide due to manufacturing process deviations affecting product quality and sterility.

    Product
    AK-POLY-BAC brand of Bacitracin cand Polymixin B Sulfate Ophthalmic Ointment USP, 3.5 g (1/8 oz.) tube, Rx only, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-238-35
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0282-2023·2023-01-25

    Klosterman Baking raisin breads recalled due to insanitary handling conditions

    Klosterman Baking Company is recalling raisin breads and bagels that were held under insanitary conditions. About 109,343 units were distributed to Indiana, Ohio, and Tennessee.

    Product
    Breads: Raisin product 1645 Clear Bag Loaf 1 24 oz. Raisin product 1648 Clear Bag Loaf 1 24 oz. Raisin product 9532 Old World Bagels 6 3 oz. Raisin product 9542 Old World Bagels 6 4 oz.
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-0285-2023·2023-01-25

    Klosterman Baking Company Sour Dough Bread Recalled for Insanitary Production Conditions

    Klosterman Baking Company is recalling approximately 109,343 units of Sour Dough bread products due to insanitary production conditions. Products were distributed in Indiana, Ohio, and Tennessee.

    Product
    Breads: Sour Dough product 1728 Clear Bag Loaf 1 32 oz. Sour Dough product 1729 Clear Bag Loaf 1 32 oz. Sour Dough product 1979 Clear Bag Loaf 1 24 oz. Sour Dough product 8561 Clear Bag Loaf 1 32 oz. Sour Dough product 8563 Clear Bag Loaf 1 32 oz. Sour Dough product 8566 C
    Category
    Food
    Distribution
    3 states
  • HighFDA (Drugs)·D-0166-2023·2023-01-25

    Hand Sanitizer Recalled for Chemical Impurities and Manufacturing Defects

    SIREtizer Hand Sanitizer is recalled for containing acetal and acetaldehyde above allowable limits and manufacturing defects, including one superpotent lot.

    Product
    SIREtizer Hand Sanitizer (Ethyl Alcohol) 80%, packaged in a) 3.38 oz (100 mL), b) 10 oz (295 ml), UPC 8 60003 85882 0, and c) 16.9 oz (500 ml), UPC 8 60003 85880 6 bottles, Southwest Iowa Renewable Energy, 10868 189th Street, Council Bluffs, IA 51503; Bottled by Southwest 6th Be
    Category
    Drug
    Distribution
    2 states
  • HighFDA (Devices)·Z-0983-2023·2023-01-25

    Cardinal Health Jackson-Pratt Channel Drain Recalled for Performance Defects

    Cardinal Health is recalling Jackson-Pratt Channel Drains (19 Fr, REF JP-2225) due to multiple performance issues including lack of radiopacity, dull trocars, reduced flexibility, and broken wound tips. Approximately 4,112 units were distributed worldwide.

    Product
    Cardinal Health Jackson-Pratt Channel Drain, 19 Fr, REF JP-2225
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0971-2023·2023-01-25

    Cardinal Health Jackson-Pratt Channel Drains Recalled for Multiple Performance Defects

    Cardinal Health is recalling 3,507 Jackson-Pratt Channel Drains (19 Fr) due to performance defects including lack of radiopacity, dull trocars, lack of flexibility, and broken tips. Drains were distributed worldwide.

    Product
    Cardinal Health Jackson-Pratt Channel Drain, 19 Fr, REF JP-2190
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0957-2023·2023-01-25

    Mobile CT Scanner Injury Risk During Reverse Transport

    Mobius Imaging recalls the MobiCT-32 AIRO Mobile CT Scanner after one untrained user was injured while moving the unit in reverse. The manufacturer will add warning labels to improve instructions for safe reverse transport.

    Product
    MobiCT-32 AIRO Mobile CT Scanner, Cat. No. MobiCT-32, mobile computed tomography system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0967-2023·2023-01-25

    Cardinal Health Jackson-Pratt Channel Drains Recalled for Performance Defects

    Cardinal Health is recalling 1,150 Jackson-Pratt Channel Drains due to multiple performance defects including lack of radiopacity, dull trocars, reduced flexibility, and broken tips affecting post-surgical wound drainage.

    Product
    Cardinal Health Jackson-Pratt Channel Drain, 10 Fr, REF JP-2186
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0305-2023·2023-01-25

    Superior Crunch Salad Mix Recalled for Glass Particle Contamination

    Superior Fresh has recalled Superior Crunch salad mix (4 oz) due to contamination with small glass particles. The affected product was distributed across Indiana, Pennsylvania, Virginia, and Wisconsin.

    Product
    Superior Crunch Net Wt. 4 oz. (113g). Ingredients May Contain Green Leaf, Green Romaine, Green Oak Leaf. Keep Refrigerated. Grown for you By: Superior Fresh LLC, Hixton, WI 54635
    Category
    Food
    Distribution
    4 states
  • HighFDA (Food)·F-0307-2023·2023-01-25

    Superior Fresh Organic Spring Mix Recalled for Glass Particles

    Superior Fresh Organic Raw Spring Mix is being recalled due to small glass particles that may be present in the product. Affected packages have specific Julian date codes and were distributed in Indiana, Pennsylvania, Virginia, and Wisconsin.

    Product
    Superior Fresh Organic Raw Spring Mix. 1 lb. Bag, 4 Count. UPC 8 57871-00827 3 Keep Refrigerated. Grown for you By: Superior Fresh LLC, Hixton, WI 54635
    Category
    Food
    Distribution
    4 states
  • HighFDA (Devices)·Z-0993-2023·2023-01-25

    Cardinal Health Jackson-Pratt Wound Drain Recall Due to Performance Defects

    Cardinal Health is recalling Jackson-Pratt Channel Drains due to performance issues including lack of radiopacity, dull trocars, reduced flexibility, and broken tips. The worldwide recall affects units used in post-operative wound drainage.

    Product
    Cardinal Health Jackson-Pratt Channel Drain, 28 Fr, REF JP-2290
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0292-2023·2023-01-25

    Melissa's Pasta Para Duris Recalled for Undeclared Wheat Allergen

    Melissa's Pasta Para Duris is being recalled for containing wheat that is not declared on the label. Anyone with a wheat allergy should discard the product or return it to their retailer.

    Product
    Pasta Para Duris 12 oz. (340g) Brand Name: Melissa's UPC: 045255 152739 Distributed by: World Variety Produce, Inc. PO Box 514599 LA, CA 90051 Clear plastic bag with front label Package size: 6 count
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-1002-2023·2023-01-25

    X-ray imaging system footrests may detach from patient tables

    Siemens Luminos X-ray imaging systems may have a footrest that detaches from the patient table during use. The manufacturer is recalling 886 units distributed worldwide.

    Product
    Luminos Agile Max, Luminos dRF Max, and LUMINOS Lotus Max
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0991-2023·2023-01-25

    Cardinal Health Jackson-Pratt Surgical Drains Recalled for Performance Defects

    Cardinal Health is recalling 1920 Jackson-Pratt Channel Drains (15 Fr, model JP-2233) distributed worldwide due to multiple reported performance issues including lack of radiopacity, dull trocars, reduced flexibility, and broken wound tips.

    Product
    Cardinal Health Jackson-Pratt Channel Drain, 15 Fr, REF JP-2233
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0998-2023·2023-01-25

    FDA Recalls Thoracic Stent-Graft Systems Over Manufacturing Size Defect

    Bolton Medical has recalled 640 units of RELAY PRO thoracic stent-graft systems worldwide because the products may be shorter than their packaging indicates.

    Product
    RELAY PRO, THORACIC STENT-GRAFT SYSTEM, REF 28-N4-XX-XXX-XXX
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0978-2023·2023-01-25

    Cardinal Health Jackson-Pratt Channel Drains Recalled for Multiple Performance Issues

    Cardinal Health is recalling Jackson-Pratt Channel Drains due to performance issues including lack of radiopacity, dull trocars, reduced flexibility, and broken tips. No injuries have been reported.

    Product
    Cardinal Health Jackson-Pratt Channel Drain, 10 mm, REF JP-2215
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0273-2023·2023-01-25

    French Bread Products Recalled for Insanitary Holding Conditions

    Klosterman Baking Company is recalling French bread products (16 oz. loaves, SKUs 8510, 8550, 8551) distributed in Indiana, Ohio, and Tennessee because they were held under insanitary conditions.

    Product
    Breads: Frenchbread product 8510 Clear Bag Loaf 1 16 oz. Frenchbread product 8550 Clear Bag Loaf 1 16 oz. Frenchbread product 8551 Clear Bag Loaf 6 16 oz.
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-0275-2023·2023-01-25

    Klosterman Honey Wheat Breads Recalled for Insanitary Storage Conditions

    Klosterman Baking Company recalls honey wheat breads and rolls from Indiana, Ohio, and Tennessee due to products being held under insanitary conditions. Approximately 109,343 units were distributed between December 12-16, 2022.

    Product
    Breads: Honey wheat product 1318 Clear Bag Loaf 1 32 oz. Honey wheat product 1410 Klosterman Retail UPC # 0005172100366 Loaf 1 12 oz. Honey wheat product 8081 Clear Bag Rolls 12 1.4 oz. Honey wheat product 8543 Clear Bag Loaf 1 32 oz. Honey wheat product 8549 Clear Bag Loaf
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-0288-2023·2023-01-25

    Klosterman whole grain breads recalled for insanitary storage conditions

    Klosterman Baking Company is recalling 109,343 units of whole grain breads and baked goods sold in Indiana, Ohio, and Tennessee that were held under insanitary conditions. Products were delivered between December 12-16, 2022.

    Product
    Breads: Whole grain product 1290 Clear Bag Loaf 1 24 oz. Whole grain product 1292 Clear Bag Loaf 1 24 oz. Whole grain product 3474 Clear Bag Buns 12 60 g Whole grain product 3478 Clear Film Buns 60 60 g Whole grain product 3709 Clear Bag Buns 12 1.75 oz. Whole grain produc
    Category
    Food
    Distribution
    3 states
  • HighNHTSA·23V027000·2023-01-25

    2022 Kia Sorento PHEV fuel tank defect fire risk

    Kia is recalling certain 2022 Sorento Plug-In Hybrid vehicles due to improperly molded fuel tanks that may leak. A fuel leak near an ignition source could increase the risk of fire.

    Product
    KIA — KIA SORENTO PHEV
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0304-2023·2023-01-25

    Superior Fresh Spring Mix Recalled for Glass Particle Contamination

    Superior Fresh is recalling Spring Mix lettuce products that may contain small glass particles. The affected packages were distributed in Indiana, Pennsylvania, Virginia, and Wisconsin.

    Product
    Superior Fresh Lettuce Blend Ingredients May Contain Red Leaf, Green Leaf, Green Romaine, Red Romaine, Red Oak Leaf, Green Oak Leaf, Butter lettuce, Arugula, spinach. Keep Refrigerated. Packaged under the following Names and sizes: 1. Spring Mix Family Pack Net Wt. 8 oz (22
    Category
    Food
    Distribution
    4 states
  • HighFDA (Drugs)·D-0159-2023·2023-01-25

    Rasagiline Tablets Recalled for Foreign Particle Contamination

    Ascend Laboratories is recalling Rasagiline Mesylate Tablets 1 mg due to black spots and metallic specks on tablets. The recall affects 12,192 bottles distributed to customers in 19 states and Puerto Rico.

    Product
    RASAGILINE — RASAGILINE (RASAGILINE)
    Category
    Drug
    Distribution
    20 states
  • HighFDA (Devices)·Z-0975-2023·2023-01-25

    Cardinal Health Jackson-Pratt Channel Drain recalled for performance defects

    Cardinal Health is recalling Jackson-Pratt Channel Drains (10 mm, model JP-2212) due to multiple performance defects including lack of radiopacity, dull trocars, reduced flexibility, and broken wound tips.

    Product
    Cardinal Health Jackson-Pratt Channel Drain, 10 mm, REF JP-2212
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0980-2023·2023-01-25

    Cardinal Health Jackson-Pratt Channel Drains Recalled for Multiple Performance Defects

    Cardinal Health is recalling 750 units of Jackson-Pratt Channel Drains (10 mm) due to multiple performance issues including broken drain tips, lack of radiopacity, dull trocars, and reduced flexibility that could affect surgical outcomes.

    Product
    Cardinal Health Jackson-Pratt Channel Drain, 10 mm, REF JP-2217
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0956-2023·2023-01-25

    ARTIS medical imaging systems recalled for mechanical connection failure

    Siemens ARTIS pheno and ARTIS icono imaging systems are recalled because the mechanical connection between the tabletop and table base may fail. The recall affects 550 units distributed worldwide.

    Product
    ARTIS pheno, ARTIS icono biplane, and ARTIS icono floor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0968-2023·2023-01-25

    Cardinal Health Jackson-Pratt Channel Drains recalled for performance defects

    Cardinal Health is recalling 4,111 Jackson-Pratt Channel Drains (10 Fr) due to multiple performance issues including dull trocars, broken tips, reduced flexibility, and lack of radiopacity that may affect device function.

    Product
    Cardinal Health Jackson-Pratt Channel Drain, 10 Fr, REF JP-2187
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0994-2023·2023-01-25

    Cardinal Health Jackson-Pratt Surgical Drains Recalled for Multiple Defects

    Cardinal Health recalls Jackson-Pratt Channel Drains due to reported defects including non-visibility on imaging, dull insertion trocars, reduced flexibility, and broken drain tips.

    Product
    Cardinal Health Jackson-Pratt Channel Drain, 32 Fr, REF JP-2292
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0153-2023·2023-01-25

    Proparacaine Ophthalmic Solution Recalled for Manufacturing Quality Deviations

    Akorn is voluntarily recalling Proparacaine Ophthalmic Solution nationwide due to Current Good Manufacturing Practice deviations.

    Product
    Proparacaine Hydrochloride Ophthalmic Solution, USP 0.5%, 15 mL per dropper bottle, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031 NDC: 17478-263-12
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0308-2023·2023-01-25

    Frozen Manicotti Pasta Recalled for Listeria Contamination Risk

    Caesar's Pasta, LLC is recalling frozen manicotti pasta due to possible contamination with Listeria monocytogenes. Consumers should not consume the affected product.

    Product
    Orefresco Pasta Manicotti Net Wt. 10lbs. 3 oz. Keep Frozen 70019O UPC 048200237727 Caesar's Pasta Manicotti Net Wt. 10.3 lbs Keep Frozen 70019 UPC: 078411 100770
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1000-2023·2023-01-25

    Medical X-ray equipment patient table footrests recalled due to detachment risk

    Siemens recalls four fluoroscopy and radiographic imaging equipment models worldwide because patient table footrests may detach during clinical use, potentially causing patient injury.

    Product
    AXIOM Luminos TF, AXIOM Iconos R100, AXIOM Iconos R200 and AXIOM Luminos dRF
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0970-2023·2023-01-25

    Cardinal Health Jackson-Pratt Channel Drains Recalled for Multiple Performance Defects

    Cardinal Health is recalling Jackson-Pratt Channel Drains due to performance defects including dull trocars, broken tips, and radiopacity issues. 921 units affected worldwide.

    Product
    Cardinal Health Jackson-Pratt Channel Drain, 15 Fr, REF JP-2189
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0982-2023·2023-01-25

    Jackson-Pratt Wound Drain Recalled for Performance Issues

    Cardinal Health recalls Jackson-Pratt Channel Drains (15 Fr) due to performance issues: broken tips, dull trocars, lack of radiopacity, and reduced flexibility affecting surgical wound drainage.

    Product
    Cardinal Health Jackson-Pratt Channel Drain, 15 Fr, REF JP-2223
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0133-2023·2023-01-25

    Drug Recall: Artificial Tears Eye Ointment Due to Manufacturing Deviations

    Akorn, Inc. is recalling Artificial Tears Ointment (1.16 million tubes nationwide) due to manufacturing practice deviations. The firm voluntarily initiated this recall.

    Product
    Artificial Tears OINTMENT, Lubricant Eye Ointment, Net Wt. 3.5 g (1/8 oz.) per tube, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-062-35
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0127-2023·2023-01-25

    Injectable Anesthetic Sensorcaine Recalled for Subpotent Epinephrine

    Sensorcaine injectable anesthetic is being recalled because testing showed the epinephrine component is below the required potency level. No illnesses or injuries have been reported.

    Product
    SENSORCAINE — SENSORCAINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0141-2023·2023-01-25

    Ketorolac Tromethamine ophthalmic solution recalled due to manufacturing deviations

    Akorn is recalling Ketorolac Tromethamine Ophthalmic Solution nationwide due to manufacturing practice deviations. The voluntary recall affects multiple lot numbers of the 0.5% formulation.

    Product
    Ketorolac Tromethamine Ophthalmic Solution, 0.5%, Packaged as a) 10 mL dropper bottle, NDC 17478-209-11; (b) 3 mL dropper bottle, NDC 17478-209-19; (c) 5 mL dropper bottle, NDC 17478-209-10; Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0129-2023·2023-01-25

    Local anesthetic Sensorcaine vials recalled for subpotent epinephrine

    Fresenius Kabi is recalling Sensorcaine-MPF local anesthetic vials due to subpotent epinephrine levels. The affected batch (31,600 vials) was distributed nationwide.

    Product
    SENSORCAINE — SENSORCAINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0284-2023·2023-01-25

    Klosterman Baking seeded bread and buns held under insanitary conditions

    Klosterman Baking Company recalls seeded bread and bun products held under insanitary conditions. 109,343 units were distributed in Indiana, Ohio, and Tennessee.

    Product
    Breads: Seeded product 3340 Clear Bag Buns 12 60 g Seeded product 3510 Clear Film Buns 30 68 g Seeded product 3600 Clear Bag Buns 12 92 g
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-0992-2023·2023-01-25

    Cardinal Health Jackson-Pratt Channel Drains recalled for performance defects

    Cardinal Health is recalling 22,847 units of Jackson-Pratt Channel Drains due to performance issues including dull trocars, broken tips, lack of flexibility, and lack of radiopacity.

    Product
    Cardinal Health Jackson-Pratt Channel Drain, 24 Fr, REF JP-2234
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0979-2023·2023-01-25

    Cardinal Health Jackson-Pratt Drain Recalled for Multiple Performance Issues

    Cardinal Health is recalling Jackson-Pratt Channel Drains due to multiple performance issues including dull trocars, lack of radiopacity, reduced flexibility, and broken tips. The affected devices were distributed worldwide.

    Product
    Cardinal Health Jackson-Pratt Channel Drain, 7 mm, REF JP-2216
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0156-2023·2023-01-25

    Eye-drop drug recall: Timolol solution due to manufacturing deviations

    Akorn is recalling over 1.3 million bottles of Timolol Maleate eye drops distributed nationwide due to manufacturing process violations. The voluntary recall addresses risks from Current Good Manufacturing Practice deviations.

    Product
    Timolol Maleate Ophthalmic Solution, USP, 0.5%, Packaged in (a) 5 mL dropper bottle, NDC 17478-288-10; (b) 10 mL dropper bottles: NDC 17478-288-11; (c) 15 mL dropper bottles, NDC 17478-288-12; Rx Only, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0306-2023·2023-01-25

    Superior Fresh Mighty Mix salad recall: glass particle contamination

    Superior Fresh LLC is recalling Mighty Mix salad mix (4 oz packages, Best By 1/23) due to potential contamination with small glass particles. No injuries have been reported; consumers should discard the product.

    Product
    Superior Fresh Mighty Mix, Net Wt. 4 oz. (113g). UPC 8 57871-00883 9. Ingredients May Contain Red Leaf, Green Leaf, Green Romaine, Red Romaine, Red Oak Leaf, Green Oak Leaf, Arugula, Mizuna, Pak Choi, Spinach. Keep Refrigerated. Grown for you By: Superior Fresh LLC, Hixt
    Category
    Food
    Distribution
    4 states
  • HighFDA (Food)·F-0286-2023·2023-01-25

    Klosterman Wheat Bread Loaves Recalled for Insanitary Storage Conditions

    Klosterman Baking Company is recalling approximately 109,343 wheat bread loaves distributed in Indiana, Ohio, and Tennessee that were held under insanitary conditions, creating a potential contamination risk.

    Product
    Breads: Wheat product 1305 Klosterman Foodservice UPC # 0005172100452 Loaf 1 28 oz. Wheat product 1306 Clear Bag Loaf 1 32 oz. Wheat product 1310 Clear Bag Loaf 1 24 oz. Wheat product 1358 Klosterman Retail UPC # 0005172100714 Loaf 1 24 oz. Wheat product 1380 Pennington Ret
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-0263-2023·2023-01-25

    Pepper Collection 8 Tube Gift Set recalled for mold and ochratoxin contamination

    Something South African LLC recalls Pepper Collection 8 Tube Gift Set due to mold (Aspergillus brasiliensis) and Ochratoxin A contamination. The recall affects 4,200 units distributed nationwide.

    Product
    Pepper Collection 8 Tube Gift Set - a colorful assortment of dried peppers. This product contains peppers in 8 different glass tube and packaged in a printed paperboard sleeve and are visible through a window in the sleeve. Net wt. is 4.87oz/138g. The UPC is 6 009686 793712. Pa
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0147-2023·2023-01-25

    Eye drop medication Olopatadine HCl recalled nationwide for manufacturing deviations

    Akorn, Inc. is recalling 31,073 bottles of Olopatadine HCl ophthalmic solution nationwide due to current good manufacturing practice deviations. This voluntary recall was initiated by the manufacturer.

    Product
    Olopatadine HCl Ophthalmic Solution, USP 0.1%, 5 mL per dropper bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-105-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0281-2023·2023-01-25

    Klosterman Baking Company recalls pretzel buns for insanitary storage conditions

    Klosterman Baking Company is recalling 109,343 pretzel buns due to insanitary storage conditions. Products distributed to Indiana, Ohio, and Tennessee have expiration dates of December 21, 2022 or earlier.

    Product
    Breads: Pretzel product 8309 Clear Bag Buns 48 2.1 oz.
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-0270-2023·2023-01-25

    Klosterman English Muffins recalled for insanitary storage conditions

    Klosterman Baking Company is recalling English Muffins that were held under insanitary conditions. The recall affects over 109,000 units distributed to Indiana, Ohio, and Tennessee.

    Product
    Breads: English Muffin product 9525 Clear Bag English Muffins 12 2 oz.
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-0280-2023·2023-01-25

    Klosterman Baking Company recalls potato flour buns due to insanitary holding conditions

    Klosterman Baking Company is recalling potato flour buns sold in Indiana, Ohio, and Tennessee due to products being held under insanitary conditions that could pose health risks.

    Product
    Breads: Potato flour product 3555 Clear Bag Buns 12 80 g Potato flour product 3561 Clear Film Buns 20 92 g Potato flour product 6057 Clear Bag Buns 24 34 g
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-0973-2023·2023-01-25

    Cardinal Health Jackson-Pratt Channel Drain Recalled for Performance Defects

    Cardinal Health is recalling Jackson-Pratt Channel Drains (7mm, REF JP-2210) for performance issues including lack of radiopacity, dull trocars, poor flexibility, and broken tips. Affected units may not function properly.

    Product
    Cardinal Health Jackson-Pratt Channel Drain, 7 mm, REF JP-2210
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0279-2023·2023-01-25

    Klosterman Baking Company onion buns and bread recalled for insanitary storage

    Klosterman Baking Company is recalling onion buns and bread distributed in Indiana, Ohio, and Tennessee for products held under insanitary conditions. Consumers should discard affected items.

    Product
    Breads: Onion product 3655 Clear Film Buns 20 69 g
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-0289-2023·2023-01-25

    Klosterman Baking breads and buns recalled for insanitary storage conditions

    Klosterman Baking Company is recalling approximately 109,343 bread and bun products that were held under insanitary conditions. Products were distributed in Indiana, Ohio, and Tennessee.

    Product
    Breads: Yellow product 1444 Clear Bag Loaf 1 32 oz. Yellow product 1675 Clear Bag Loaf 1 24 oz. Yellow product 3139 Clear Bag Buns 12 60 g Yellow product 3148 Clear Bag Buns 12 60 g Yellow product 3385 Clear Bag Buns 12 85 g Yellow product 3396 Clear Bag Buns 12 85 g Yello
    Category
    Food
    Distribution
    3 states
  • HighFDA (Drugs)·D-0157-2023·2023-01-25

    Prescription Eye Drops Recalled for Manufacturing Control Deviations

    Akorn, Inc. is voluntarily recalling over 2 million bottles of Tobramycin Ophthalmic Solution due to Current Good Manufacturing Practice deviations affecting four product lots distributed nationwide.

    Product
    Tobramycin Ophthalmic Solution, USP, 0.3%, 5 mL per dropper bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC 17478-290-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighNHTSA·23V028000·2023-01-25

    2022 Hyundai Santa Fe Plug-In Hybrid fuel tank defect recall

    Hyundai is recalling certain 2022 Santa Fe Plug-In Hybrid vehicles due to improperly molded fuel tanks that may leak gasoline. A fuel leak in the presence of an ignition source can increase the risk of fire.

    Product
    HYUNDAI — HYUNDAI SANTA FE PLUG-IN HYBRID
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0268-2023·2023-01-25

    Klosterman croissant products recalled for insanitary storage conditions

    Klosterman Baking Company is recalling approximately 109,343 croissant products distributed in Indiana, Ohio, and Tennessee due to insanitary storage conditions. Products were delivered between December 12 and December 16, 2022.

    Product
    Breads: Croissant product 9013 Clear film Croissants 64 2.3 oz.
    Category
    Food
    Distribution
    3 states
  • HighFDA (Drugs)·D-0139-2023·2023-01-25

    FDA Recalls Nationwide Supply of Erythromycin Ophthalmic Ointment for Manufacturing Deviations

    Akorn, Inc. is recalling 36,455 cartons of Erythromycin Ophthalmic Ointment USP 0.5% nationwide due to manufacturing process deviations. The company voluntarily initiated this Class II recall.

    Product
    Erythromycin Ophthalmic Ointment USP, 0.5%, Net Weight: 1 g per tube (50 unit-dose tubes per carton), Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-070-31
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0302-2023·2023-01-25

    Superior Fresh Lettuce Blend Recalled for Small Glass Particles

    Superior Fresh Lettuce Blend products have been recalled due to the presence of small glass particles. Affected products include Spring Mix, Midwest Medley, and Midwest Medley Family Pack distributed in Indiana, Pennsylvania, Virginia, and Wisconsin.

    Product
    Superior Fresh Lettuce Blend Ingredients May Contain Red Leaf, Green Leaf, Green Romaine, Red Romaine, Red Oak Leaf, Green Oak Leaf, Butter lettuce, Arugula, Kale, Spinach, Mustard, Mizuna, Pax Choi. Keep Refrigerated. Packaged under the following Names and sizes: 1. Spring
    Category
    Food
    Distribution
    4 states
  • HighFDA (Devices)·Z-0977-2023·2023-01-25

    Cardinal Health Jackson-Pratt Channel Drain Recalled for Performance Defects

    Cardinal Health is recalling Jackson-Pratt Channel Drains (10 mm) due to performance issues including lack of radiopacity, dull trocars, reduced flexibility, and broken wound tips that may impair drain function.

    Product
    Cardinal Health Jackson-Pratt Channel Drain, 10 mm, REF JP-2214
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0303-2023·2023-01-25

    Superior Fresh Organic Spring Mix Recalled for Glass Particles

    Superior Fresh Organic Spring Mix Family Pack is being recalled due to potential glass particle contamination. The recall affects 1,516 cases distributed in Indiana, Pennsylvania, Virginia, and Wisconsin.

    Product
    Superior Fresh Organic Spring Mix Family Pack. UPC 8 50038-27430 6. Ingredients May Contain Red Leaf, Green Leaf, Green Romaine, Red Romaine, Red Oak Leaf, Green Oak Leaf. Keep Refrigerated. Grown for you By: Superior Fresh LLC, Hixton, WI 54635
    Category
    Food
    Distribution
    4 states
  • HighFDA (Devices)·Z-0972-2023·2023-01-25

    Cardinal Health Jackson-Pratt Channel Drains recalled due to performance defects

    Cardinal Health is recalling Jackson-Pratt Channel Drains (19 Fr, REF JP-2191) due to multiple performance issues including lack of radiopacity, dull trocars, reduced flexibility, and broken wound tips. Approximately 3,520 units were distributed worldwide.

    Product
    Cardinal Health Jackson-Pratt Channel Drain, 19 Fr, REF JP-2191
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0165-2023·2023-01-25

    Prescription Rifampin Capsules Recalled Due to Failed Quality Specifications

    Amerisource Health Services is recalling Rifampin Capsules USP 300 mg nationwide due to failed impurities and degradation specifications. Affected patients should contact their healthcare provider before using remaining inventory.

    Product
    RIFAMPIN — RIFAMPIN (RIFAMPIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0135-2023·2023-01-25

    Betaxolol ophthalmic solution recalled for manufacturing process violations

    Akorn, Inc. is voluntarily recalling Betaxolol ophthalmic solution (6,273 bottles, lot 1A08A, exp. 12/31/2022) due to manufacturing deviations. Consumers should consult their healthcare provider.

    Product
    Betaxolol Ophthalmic Solution, USP 0.5%, (Betaxolol HCl 5.6 mg/mL), 5 mL per bottle, Sterile, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-705-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0989-2023·2023-01-25

    Cardinal Health Jackson-Pratt Channel Drain recall for performance defects

    Cardinal Health is recalling Jackson-Pratt Channel Drains due to performance defects: dull trocars, broken tips, lack of flexibility, and radiopacity issues. The 8,563 affected units were distributed worldwide.

    Product
    Cardinal Health Jackson-Pratt Channel Drain, 19 Fr, REF JP-2231
    Category
    Medical Device
    Distribution
    Distributed nationwide

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