The Recall Desk

Archive

February 2022 recalls

666 recalls were announced in February 2022.

What the numbers show

Critical
14
Severe
241
High
229
Moderate
176
Low
6

Of the 666 recalls this month scored against our rubric, 2% are Critical, 36% are Severe.

501–600 of 666

  • SevereFDA (Food)·F-0539-2022·2022-02-02

    Fresh Express "Chopped Asian" Salad Recalled for Listeria Risk

    Fresh Express Inc is recalling "Chopped Asian" salad products in multiple package sizes due to potential Listeria monocytogenes contamination. The products were distributed to domestic and Canadian retailers.

    Product
    "Chopped Asian" (salad product) packed in 12oz., 12.3oz., and 13.6oz. packages
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Drugs)·D-0392-2022·2022-02-02

    Metformin Hydrochloride Extended-Release Tablets Recalled for NDMA Contamination

    Viona Pharmaceuticals is recalling Metformin Hydrochloride Extended-Release 750 mg tablets due to detection of N-Nitrosodimethylamine (NDMA) at levels exceeding the acceptable daily intake limit. The contamination resulted from manufacturing deviations.

    Product
    METFORMIN HYDROCHLORIDE — METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE)
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Food)·F-0572-2022·2022-02-02

    Fresh Express Organic Baby Arugula & Spinach Recall for Listeria Contamination

    Fresh Express Inc is recalling approximately 12,107 cases of Organic Baby Arugula & Baby Spinach salad mix due to potential contamination with Listeria monocytogenes. The affected product was distributed across multiple states and Canada.

    Product
    "Organic Baby Arugula & Baby Spinach" (salad product) packed in 5oz. packages
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Drugs)·D-0424-2022·2022-02-02

    Vancomycin HCl Ophthalmic Solution Recalled for Sterility Assurance

    Edge Pharma LLC is recalling Vancomycin HCl sterile ophthalmic solution for injection due to lack of assurance of sterility. The affected product was distributed nationwide.

    Product
    Vancomycin HCl, Sterile Ophthalmic Solution for Injection, Preservative Free, 8 mg/0.8mL (10 mg/mL) (vancomycin equivalent), 0.8 mL per syringe, Single Use Syringe, For Intraocular Injection, Edge Pharma LLC, 856 Hercules Dr., Colchester, VT, 05446, NDC 05446-0736-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0566-2022·2022-02-02

    Fresh Express Kale Caesar Salad Recalled for Listeria Contamination Risk

    Fresh Express Inc is recalling Kale Caesar salad in 8.5oz packages due to potential Listeria monocytogenes contamination. Affected products were distributed across 23 US states and Canada.

    Product
    "Kale Caesar" (salad product) packed in 8.5oz. packages
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Drugs)·D-0422-2022·2022-02-02

    Ophthalmic Solution Recalled for Lack of Sterility Assurance

    Edge Pharma is recalling a combination ophthalmic solution (Phenylephrine HCl/Tropicamide/Cyclopentolate HCl/Ketorolac) distributed nationwide due to lack of assurance of sterility. The product is used for topical eye application.

    Product
    Phenylephrine HCl/Tropicamide/Cyclopentolate HCl/ Ketorolac Sterile Ophthalmic Solution, 10%/ 0.25%/ 0.25%/0.125%, 10 mL per dropper, Multiple Dose Droptainer for Topical Ophthalmic Use, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT, NDC 05446-0859-03
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0544-2022·2022-02-02

    Chopped Chipotle Cheddar Salad Recalled for Listeria Contamination

    Fresh Express Inc is recalling Chopped Chipotle Cheddar salad in 11.4oz packages due to potential Listeria monocytogenes contamination. The product was distributed to retailers in 20 U.S. states and Canada.

    Product
    "Chopped Chipotle Cheddar" (salad product) packed in 11.4oz. packages
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Devices)·Z-0494-2022·2022-02-02

    Trilogy Evo Ventilator Repair Kit Recalled for Degrading Foam Material

    Philips Respironics recalled 205 Trilogy Evo ventilator repair kits containing non-conforming foam material that may degrade into particles potentially inhaled or ingested by users. The affected kits were distributed in the US and internationally.

    Product
    Trilogy Evo Repair Kit, RP-Trilogy Evo Muffler Assembly, Material Number 1135257 The Trilogy Evo ventilator provides continuous or intermittent positive pressure ventilation for the care of individuals who require mechanical ventilation. Trilogy Evo is intended for pediatric…
    Category
    Medical Device
    Distribution
    17 states
  • SevereFDA (Food)·F-0552-2022·2022-02-02

    Chopped Sunflower Bacon Salad Recall for Listeria Contamination

    Fresh Express Inc is recalling Chopped Sunflower Bacon salad products (13.8oz and 22.3oz packages) due to potential Listeria monocytogenes contamination. The recall affects domestic and Canadian distributors across multiple states.

    Product
    "Chopped Sunflower Bacon" (salad product) packed in 13.8oz. and 22.3oz. packages
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Food)·F-0554-2022·2022-02-02

    Fresh Express Coleslaw Recalled for Potential Listeria Contamination

    Fresh Express Inc is recalling coleslaw products in 14oz., 16oz., and 24oz. packages due to potential contamination with Listeria monocytogenes. The recall affects 46,083 cases distributed across 20 U.S. states and Canada.

    Product
    "Coleslaw" (salad product) packed in 14oz., 16oz, and 24oz. packages
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Food)·F-0607-2022·2022-02-02

    Fresh Express Twisted Avocado Caesar Salad Recalled for Listeria Risk

    Fresh Express Inc is recalling Twisted Avocado Caesar salad in 9.7oz. packages due to potential Listeria monocytogenes contamination. The product was distributed to retailers across 20 U.S. states and Canada.

    Product
    "Twisted Avocado Caesar" (salad product) packed in 9.7oz. packages
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Food)·F-0582-2022·2022-02-02

    Organic Lettuce Blend Recall Due to Listeria Contamination Risk

    Fresh Express Inc is recalling Organic Lettuce Blend in 16oz packages due to potential Listeria monocytogenes contamination. The product was distributed to 110 domestic and 3 foreign distributors across multiple states and Canada.

    Product
    "Organic Lettuce Blend" (salad product) packed in 16oz. packages
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Drugs)·D-0401-2022·2022-02-02

    Edge Pharma Edetate Disodium Ophthalmic Solution Recall for Sterility Concerns

    Edge Pharma is recalling Edetate Disodium (EDTA) 3% Sterile Ophthalmic Solution due to lack of assurance of sterility. The product is a single-dose eye drop used for topical ophthalmic use.

    Product
    Edetate Disodium (EDTA), Sterile Ophthalmic Solution, (PF) 3%, 10mL per dropper, Single Dose Droptainer for Topical Ophthalmic Use, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT, 05446, NDC 05446-1428-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0584-2022·2022-02-02

    Organic Spring Mix Salad Recalled Due to Listeria Contamination Risk

    Fresh Express Inc is recalling Organic Spring Mix salad in 5oz., 10oz., and 16oz. packages due to potential Listeria monocytogenes contamination. Affected products were distributed to retailers and distributors across 20 US states and Canada.

    Product
    "Organic Spring Mix" (salad product) packed in 5oz., 10oz., and 16oz. packages
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Drugs)·D-0402-2022·2022-02-02

    Epinephrine/Lidocaine Ophthalmic Injection Syringe Recall for Sterility Assurance

    Edge Pharma is recalling Epinephrine/Lidocaine HCl Sterile Ophthalmic Solution for Injection due to lack of assurance of sterility. The recall affects 2,568 single-use syringes distributed nationwide.

    Product
    Epinephrine/Lidocaine HCl Sterile Ophthalmic Solution for Injection, Preservative Free, 0.025%/0.75%, 0.8 mL per syringe, Single Use Syringe, For Intraocular Injection, Edge Pharma, LLC, 856 Hercules Dr. Colchester, VT 05446, NDC 05446-0863-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0608-2022·2022-02-02

    Fresh Express Twisted Chopped Asian Caesar Salad Recalled for Listeria

    Fresh Express Inc is recalling Twisted Chopped Asian Caesar salad in 9.6oz packages due to potential Listeria monocytogenes contamination. The product was distributed to domestic and Canadian distributors.

    Product
    "Twisted Chopped Asian Caesar" (salad product) packed in 9.6oz. packages
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Food)·F-0585-2022·2022-02-02

    Organic Spring Mix and Spinach Salad Recalled for Listeria Risk

    Fresh Express Inc is recalling Organic Spring Mix and Spinach salad products in multiple package sizes due to potential Listeria monocytogenes contamination. The products were distributed to retailers in 20 U.S. states and Canada.

    Product
    "Organic Spring Mix and Spinach" (salad product) packed in 5oz., 11oz., and 16oz. packages
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Food)·F-0571-2022·2022-02-02

    Organic Baby Arugula Recalled for Potential Listeria Contamination

    Fresh Express Inc is recalling Organic Baby Arugula in 5oz. and 16oz. packages due to potential contamination with Listeria monocytogenes. The product was distributed across multiple U.S. states and Canada.

    Product
    "Organic Baby Arugula" (salad product) packed in 5oz. and 16oz. packages
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Food)·F-0599-2022·2022-02-02

    Spinach & Bacon Salad Recalled for Listeria Contamination Risk

    Fresh Express Inc is recalling 14,832 cases of "Spinach & Bacon" salad in 10.2oz. packages due to potential Listeria monocytogenes contamination. The product was distributed to domestic and Canadian retailers.

    Product
    "Spinach & Bacon" (salad product) packed in 10.2oz. packages
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Food)·F-0536-2022·2022-02-02

    Caesar Supreme Salad Recalled for Potential Listeria Contamination

    Fresh Express Inc is recalling Caesar Supreme salad products in 10.5oz packages due to potential contamination with Listeria monocytogenes. The recall affects 41,544 cases distributed to retailers and distributors across multiple states and Canada.

    Product
    "Caesar Supreme" (salad product) packed in 10.5oz. packages
    Category
    Food
    Distribution
    20 states
  • SevereNHTSA·22V051000·2022-02-02

    Kia Recalls Sportage and K900 Models for Fire Risk

    Kia is recalling 2014-2018 Sportage and K900 vehicles because a faulty module could cause an engine compartment fire.

    Product
    KIA — KIA SPORTAGE, K900
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0412-2022·2022-02-02

    MVASI Sterile Ophthalmic Solution Lacks Assured Sterility

    Edge Pharma is recalling MVASI (bevacizumab-awwb) intraocular injection syringes nationwide due to lack of assurance of sterility. The recall affects 199 syringes with code 11-2021-01@2 dated 12/15/2021.

    Product
    MVASI, (bevacizumab-awwb), Sterile Ophthalmic Solution for Injection, 3.25mg/0.13mL (25 mg/mL) 0.13 mL per syringe, Dose: 1.25mg/0.05mL, Single Use Syringe For Intraocular Injection, Edge Pharma, LLC, 856 Hercules Dr. Colchester, VT 05446, NDC 05446-1661-13
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0622-2022·2022-02-02

    NutriCrafters MCT Powder Recalled Due to Supplier Recall

    NutriCrafters LLC is recalling Nutricrafters MCT Instant Coconut Milk Mixer (1 lb. bottles) because the medium chain triglyceride powder was repacked and distributed from a supplier product that is itself under recall.

    Product
    Nutricrafters MCT - Instant coconut milk mixer; 1 lb. (454 grams) Ingredients: Medium chain triglycerides, tapioca starch. Allergy information : contains oils from tree nuts (coconut) Suggested use: Stir into drinks or spoon over foods. Start with 1 teaspoon, preferably…
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0414-2022·2022-02-02

    Eye Drops Recalled for Lack of Sterility Assurance by Edge Pharma

    Edge Pharma is recalling a multi-ingredient sterile ophthalmic solution nationwide due to lack of assured sterility. The product is used for topical eye application.

    Product
    Phenylephrine HCl / Tropicamide / Ciprofloxcin / Ketorolac Sterile Ophthalmic Solution, 10%/1%/0.3%/0.125%, 0.8 mL per syringe, Single Use Syringe, For Topical Ophthalmic Use, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1270-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0557-2022·2022-02-02

    Fancy Greens Salad Recalled Due to Listeria Contamination Risk

    Fresh Express Inc is recalling Fancy Greens salad in 7oz packages due to potential Listeria monocytogenes contamination. The affected products were distributed to retailers across 20 U.S. states and Canada.

    Product
    "Fancy Greens" (salad product) packed in 7oz. packages
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Food)·F-0588-2022·2022-02-02

    Fresh Express Pear Gorgonzola Salad Recalled for Listeria Risk

    Fresh Express Inc is recalling Pear Gorgonzola salad in 6.7 oz. packages due to potential contamination with Listeria monocytogenes. The recall affects products distributed to multiple domestic and Canadian distributors.

    Product
    "Pear Gorgonzola" (salad product) packed in 6.7oz. packages
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Food)·F-0597-2022·2022-02-02

    Fresh Express Spinach Recalled for Potential Listeria Contamination

    Fresh Express Inc has recalled "Spinach" salad products in 8oz., 10oz., and 16oz. packages due to potential contamination with Listeria monocytogenes. The recall affects 130,592 cases distributed to domestic and foreign distributors.

    Product
    "Spinach" (salad product) packed in 8oz., 10oz., and 16oz. packages
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Food)·F-0613-2022·2022-02-02

    MCT Powder from Coconut Contains Undeclared Milk Allergen

    Nutralliance Inc is recalling Medium Chain Triglyceride (MCT) Powder 50% from Coconut due to undeclared milk allergen. The product was distributed in bulk 20-kilogram bags to supplement manufacturers in California, Nevada, New Jersey, New York, and Florida.

    Product
    Medium Chain Triglyceride (MCT) Powder 50% from Coconut / CocoTrim packaged in 20 kilogram brown bags with plastic inner lining for bulk sale to supplement manufacturers. Exclusively Distributed by Nutralliance / Manufactured by Bio-gen Extracts Pvt. Ltd. Store tightly sealed…
    Category
    Food
    Distribution
    5 states
  • SevereFDA (Food)·F-0569-2022·2022-02-02

    Fresh Express Lettuce Trio Salad Recalled for Listeria Risk

    Fresh Express Inc is recalling "Lettuce Trio" salad in 9oz. packages due to potential Listeria monocytogenes contamination. The product was distributed across the United States and Canada.

    Product
    "Lettuce Trio" (salad product) packed in 9oz. packages
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Food)·F-0590-2022·2022-02-02

    Premium Romaine Salad Recalled for Potential Listeria Contamination

    Fresh Express Inc is recalling Premium Romaine salad products in 9oz. and 18oz. packages due to potential contamination with Listeria monocytogenes. The recall affects 33,374 cases distributed to domestic and Canadian distributors.

    Product
    "Premium Romaine" (salad product) packed in 9oz. and 18oz. packages
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Food)·F-0574-2022·2022-02-02

    Organic Baby Romaine Salad Recalled for Listeria Contamination Risk

    Fresh Express Inc is recalling 1,105 cases of Organic Baby Romaine salad due to potential Listeria monocytogenes contamination. The product was distributed across 20 states and Canada.

    Product
    "Organic Baby Romaine" (salad product) packed in 5oz. packages
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Food)·F-0541-2022·2022-02-02

    Fresh Express Chopped Bacon Ranch Salad Recalled for Listeria Risk

    Fresh Express Inc is recalling 1,540 cases of Chopped Bacon Ranch salad (12.8oz. packages, codes Z324-Z350) because the product has the potential to be contaminated with Listeria monocytogenes. The salad was distributed to domestic and Canadian distributors.

    Product
    "Chopped Bacon Ranch" (salad product) packed in 12.8oz. packages
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Food)·F-0553-2022·2022-02-02

    Fresh Express Chopped Sweet Kale Salad Recalled for Listeria Risk

    Fresh Express Inc is recalling approximately 27,047 cases of Chopped Sweet Kale salad due to potential contamination with Listeria monocytogenes. The affected 10.9oz packages were distributed across multiple states and Canada.

    Product
    "Chopped Sweet Kale" (salad product) packed in 10.9oz. packages
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Food)·F-0532-2022·2022-02-02

    Fresh Express Bacon Thousand Island Salad Recalled for Listeria Risk

    Fresh Express Inc is recalling Bacon Thousand Island salad in 9.4 oz packages due to potential Listeria monocytogenes contamination. The recall affects 9,116 cases distributed across multiple U.S. states and Canada.

    Product
    "Bacon Thousand Island" (salad product) packed in 9.4oz. packages
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Food)·F-0580-2022·2022-02-02

    Fresh Express Organic Half & Half Salad Recalled for Listeria Risk

    Fresh Express Inc is recalling Organic Half & Half salad in 5oz. and 16oz. packages due to potential Listeria monocytogenes contamination. The product was distributed across the United States and Canada.

    Product
    "Organic Half & Half" (salad product) packed in 5oz. and 16oz. packages
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Food)·F-0523-2022·2022-02-02

    5-Lettuce Mix Salad Recalled for Potential Listeria Contamination

    Fresh Express's 5-Lettuce Mix salad (6oz packages, code Z324-Z350) is recalled due to potential Listeria monocytogenes contamination. The product was distributed to over 110 domestic and 3 international distributors.

    Product
    "5- Lettuce Mix" (salad product) packed in 6oz. packages
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Drugs)·D-0425-2022·2022-02-02

    Vancomycin HCl Injection Recall for Lack of Sterility Assurance

    Edge Pharma, LLC is recalling Vancomycin HCl in 0.9% Sodium Chloride Injection due to lack of assurance of sterility. The 1,250 mg/250 mL pre-filled bags were distributed nationwide and may pose a safety risk if used.

    Product
    Vancomycin HCl in 0.9 % Sodium Chloride Injection, USP, 1,250 mg/250 mL, Single Use Bag for IV Injection (Preservative Free), 250 mL pre-filled bag, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1456-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0562-2022·2022-02-02

    Hearts of Romaine Salad Recalled for Listeria Contamination

    Fresh Express Inc is recalling Hearts of Romaine salad in 9oz., 10oz., and 18oz. packages due to potential contamination with Listeria monocytogenes. The affected products were distributed to multiple states and Canada.

    Product
    "Hearts of Romaine" (salad product) packed in 9oz., 10oz., and 18oz. packages
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Food)·F-0612-2022·2022-02-02

    Fresh Express Veggie Spring Mix Salad Recalled for Listeria Contamination Risk

    Fresh Express Inc is recalling Veggie Spring Mix salad in 7oz. packages due to potential contamination with Listeria monocytogenes. The product was distributed to multiple states and Canada.

    Product
    "Veggie Spring Mix" (salad product) packed in 7oz. packages
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Drugs)·D-0426-2022·2022-02-02

    Vancomycin HCl Injection Recalled for Sterility Assurance Issues

    Edge Pharma LLC is recalling Vancomycin HCl in 0.9% Sodium Chloride Injection nationwide due to lack of assurance of sterility. The affected product is a 500 mL pre-filled bag for IV injection.

    Product
    Vancomycin HCl in 0.9% Sodium Chloride Injection, 1,500 mg/500 mL, USP, Single Use Bag for IV Injection (Preservative Free), 500 mL pre-filled bag, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1458-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0530-2022·2022-02-02

    Fresh Express Baby Spinach Recalled for Listeria Contamination Risk

    Fresh Express Inc has recalled approximately 97,461 cases of Baby Spinach sold in 5oz. to 20oz. packages due to potential Listeria monocytogenes contamination. The affected product was distributed to wholesalers across 20 U.S. states and Canada.

    Product
    "Baby Spinach" (salad product) packed in 5oz., 6oz., 10oz., 11oz., 16oz., and 20oz. packages
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Food)·F-0543-2022·2022-02-02

    Chopped Cherry Almond Gorgonzola Salad Recalled for Listeria Risk

    Fresh Express Inc is recalling Chopped Cherry Almond Gorgonzola salad products (13.7 oz packages, codes Z324-Z350) due to potential Listeria monocytogenes contamination. The salad was distributed across 20 U.S. states and Canada.

    Product
    "Chopped Cherry Almond Gorgonzola" (salad product) packed in 13.7oz. packages
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Food)·F-0540-2022·2022-02-02

    Fresh Express Chopped Avocado Ranch salad recalled for Listeria risk

    Fresh Express is recalling 'Chopped Avocado Ranch' salad (codes Z324-Z350) due to potential Listeria monocytogenes contamination. Affected packages in 12.3oz, 12.8oz, and 13.2oz sizes were distributed across 20 states and Canada.

    Product
    "Chopped Avocado Ranch" (salad product) packed in 12.3oz., 12.8oz., and 13.2oz. packages
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Food)·F-0576-2022·2022-02-02

    Fresh Express Organic Baby Spinach & Kale Mix Recall: Listeria Risk

    Fresh Express Inc is recalling "Organic Baby Spinach & Baby Kale Mix" salad in 5oz packages due to potential contamination with Listeria monocytogenes. The affected product was distributed to over 110 domestic distributors across multiple states and Canada.

    Product
    "Organic Baby Spinach & Baby Kale Mix" (salad product) packed in 5oz. packages
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Drugs)·D-0396-2022·2022-02-02

    Edge Pharma Lidocaine HCl/Epinephrine Injection Lacks Sterility Assurance

    Edge Pharma is recalling approximately 8,140 syringes of Lidocaine HCl/Epinephrine sterile buffered injection solution due to lack of assurance of sterility. The product was distributed nationwide.

    Product
    Lidocaine HCl/Epinephrine, Sterile Buffered Solution for Injection (PF) 1% / 1:100,000, 3 mL per syringe, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, (802) 992-1178, NDC 05446-1268-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0551-2022·2022-02-02

    Chopped Sunflower Salad Recall: Listeria Contamination Risk

    Fresh Express Inc is recalling Chopped Sunflower salad products in 11.1oz. and 11.3oz. packages due to potential Listeria monocytogenes contamination. The products were distributed to multiple states and Canada.

    Product
    "Chopped Sunflower" (salad product) packed in 11.1oz. and 11.3oz. packages
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Food)·F-0581-2022·2022-02-02

    Organic Herb Mix Salad Recalled for Potential Listeria Contamination

    Fresh Express Inc's Organic Herb Mix salad product has been recalled due to potential Listeria monocytogenes contamination. The recall affects 6,137 cases distributed across multiple states and Canada.

    Product
    "Organic Herb Mix" (salad product) packed in 5oz. packages
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Food)·F-0579-2022·2022-02-02

    Organic Fresh Herb Mix Salad Recalled for Listeria Contamination Risk

    Fresh Express Inc is recalling Organic Fresh Herb Mix in 5oz packages due to potential contamination with Listeria monocytogenes. The product was distributed to wholesalers across 20 US states and Canada.

    Product
    "Organic Fresh Herb Mix" (salad product) packed in 5oz. packages
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Drugs)·D-0419-2022·2022-02-02

    Edge Pharma Phenylephrine/Lidocaine Ophthalmic Solution Sterility Recall

    Edge Pharma is recalling Phenylephrine HCl/Lidocaine sterile ophthalmic solution for injection due to lack of assurance of sterility. The recalled product consists of 2,750 single-use syringes distributed nationwide.

    Product
    Phenylephrine HCl/Lidocaine, Sterile Ophthalmic Solution for Injection, Preservative Free, 1.5%/1%, 0.8mL per syringe, Single Use Syringe For Intraocular Injection, Edge Pharma LLC, 856 Hercules Dr, Colchester, VT 05446, NDC 05446-1118-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0408-2022·2022-02-02

    Mitomycin-C Sterile Ophthalmic Solution Lacks Sterility Assurance

    Edge Pharma is recalling Mitomycin-C Sterile Ophthalmic Solution because the manufacturer cannot assure that the product is sterile. The recall affects 163 syringes distributed nationwide.

    Product
    Mitomycin-C Sterile Ophthalmic Solution, Preservative Free, 0.32mg/0.8 mL (0.4mg/mL) 0.8 mL per syringe, Single Use Syringe, For Topical Ophthalmic Use, Edge Pharma LLC, 856 Hercules Dr. Colchester, VT 05446, NDC 05446-1009-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0413-2022·2022-02-02

    Phenol Injection Solution Recall Due to Lack of Sterility Assurance

    Edge Pharma, LLC is recalling Phenol Sterile Solution for Injection (6%, 5 mL vials) nationwide due to lack of assurance of sterility. The recall affects 309 vials distributed under specific lot codes.

    Product
    Phenol, Sterile Solution for Injection (PF), 6%, 5 mL per vial, Single Use Vial for Perineural Injection, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1476-05, packaged in vials.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0493-2022·2022-02-02

    Trilogy Evo Ventilator Recalled for Foam Degradation Risk

    Philips Respironics recalls 473 Trilogy Evo ventilators due to non-conforming foam that may degrade and release particles. Affected patients risk inhaling or ingesting foam particles and chemicals during device use.

    Product
    Trilogy Evo, Material Numbers DS2110X11B (USA) and KR2110X15B (Korea) The Trilogy Evo ventilator provides continuous or intermittent positive pressure ventilation for the care of individuals who require mechanical ventilation. Trilogy Evo is intended for pediatric through…
    Category
    Medical Device
    Distribution
    17 states
  • SevereFDA (Drugs)·D-0411-2022·2022-02-02

    Neostigmine Methylsulfate Injectable Syringes Recalled for Sterility Assurance

    Edge Pharma, LLC is recalling Neostigmine methylsulfate 5 mg/5mL single-use syringes for IV or IM injection due to lack of assurance of sterility. Approximately 160 syringes nationwide may be affected.

    Product
    Neostigmine methylsulfate, 5 mg/5mL (1 mg/mL), 5 mL per syringe, Single Use Syringe for IV or IM Injection, Edge Pharma, LLC, 856 Hercules Dr. Colchester, VT 05446, NDC 05446-1549-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0598-2022·2022-02-02

    Fresh Express Spinach & Arugula Salad Recall for Listeria Contamination

    Fresh Express Inc is recalling 2,519 cases of 5oz. Spinach & Arugula salad packages due to potential Listeria monocytogenes contamination. The products were distributed across multiple U.S. states and Canada.

    Product
    "Spinach & Arugula" (salad product) packed in 5oz. packages
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Food)·F-0595-2022·2022-02-02

    Fresh Express Shredded Lettuce Recall Due to Listeria Contamination Risk

    Fresh Express Inc is recalling shredded lettuce products in multiple package sizes due to potential Listeria monocytogenes contamination. The recall affects approximately 211,228 cases distributed across 20 U.S. states and Canada.

    Product
    "Shredded Lettuce" (salad product) packed in 8oz., 14oz., 16oz., and 5lb. packages
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Food)·F-0534-2022·2022-02-02

    Fresh Express Caesar Bacon Salad Recalled for Listeria Risk

    Fresh Express Inc is recalling Caesar Bacon salad products (9.9oz., 10.3oz., and 14.6oz. packages) due to potential Listeria monocytogenes contamination. The affected products were distributed to domestic and Canadian wholesalers.

    Product
    "Caesar Bacon" (salad product) packed in 9.9oz., 10.3oz., and 14.6oz. packages
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Food)·F-0564-2022·2022-02-02

    Fresh Express Italian Balsamic Kit Salad Recall for Listeria Risk

    Fresh Express Inc is recalling Italian Balsamic Kit salad products due to potential Listeria monocytogenes contamination. The affected 10.5 oz packages were distributed to wholesalers in 20 U.S. states and Canada.

    Product
    "Italian Balsamic Kit" (salad product) packed in 10.5oz. packages
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Food)·F-0550-2022·2022-02-02

    Fresh Express Chopped Southwest Salad Recalled for Listeria Contamination Risk

    Fresh Express Inc is recalling Chopped Southwest salad in 10.3oz packages due to potential Listeria monocytogenes contamination. The recall affects 40,867 cases distributed to domestic and Canadian distributors.

    Product
    "Chopped Southwest" (salad product) packed in 10.3oz. packages
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Food)·F-0577-2022·2022-02-02

    Organic Caesar Salad Recalled for Potential Listeria Contamination

    Fresh Express Inc is recalling 9.8oz packages of Organic Caesar salad due to potential contamination with Listeria monocytogenes. The product was distributed to 110 domestic and 3 foreign distributors.

    Product
    "Organic Caesar" (salad product) packed in 9.8oz. packages
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Food)·F-0546-2022·2022-02-02

    Fresh Express Chopped Kale Salad Recalled for Listeria Risk

    Fresh Express Inc is recalling 3,277 cases of Chopped Kale Pecan Cranberry salad (9.5oz packages, codes Z324–Z350) due to potential Listeria monocytogenes contamination. The product was distributed to domestic and Canadian distributors.

    Product
    "Chopped Kale Pecan Cranberry" (salad product) packed in 9.5oz. packages
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Food)·F-0524-2022·2022-02-02

    American Salad Product Recalled for Listeria Contamination Risk

    Fresh Express Inc is recalling American-brand salad products in 11oz. and 24oz. packages due to potential Listeria monocytogenes contamination. Products were distributed across 20 U.S. states and Canada.

    Product
    "American" (salad product) packed in 11oz. and 24oz. packages
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Drugs)·D-0407-2022·2022-02-02

    Mitomycin-C Injectable Syringes Recalled for Sterility Assurance Failure

    Edge Pharma is recalling Mitomycin-C 40 mg/40 mL single-dose syringes (NDC 05446-1416-01) nationwide due to lack of assurance of sterility. Approximately 860 syringes are affected.

    Product
    Mitomycin-C, 40mg/40mL (1mg/mL), 40 mL per syringe, Single Dose Syringe for Intravesical Use, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1416-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0535-2022·2022-02-02

    Caesar Lite Salad Recalled for Potential Listeria Contamination

    Fresh Express Inc is recalling 12,835 cases of Caesar Lite salad product (9.8 oz packages) due to potential contamination with Listeria monocytogenes. The affected product was distributed to domestic and Canadian distributors.

    Product
    "Caesar Lite" (salad product) packed in 9.8oz. packages
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Food)·F-0547-2022·2022-02-02

    Fresh Express Chopped Kit Poppyseed Recalled for Listeria Risk

    Fresh Express Inc. is recalling approximately 11,668 cases of "Chopped Kit Poppyseed" salad products due to potential contamination with Listeria monocytogenes. The products were distributed to retailers and distributors in 20 U.S. states and Canada.

    Product
    "Chopped Kit Poppyseed" (salad product) packed in 11.7oz. packages
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Food)·F-0604-2022·2022-02-02

    Sweet Dijon Onion Salad Recalled for Listeria Contamination Risk

    Fresh Express Inc is recalling Sweet Dijon Onion salad products in 7.6oz. packages due to potential Listeria monocytogenes contamination. The product was distributed to retailers across 20 US states and Canada.

    Product
    "Sweet Dijon Onion" (salad product) packed in 7.6oz. packages
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Food)·F-0592-2022·2022-02-02

    Fresh Express Romaine Chopped Salad Recalled for Listeria Risk

    Fresh Express Inc is recalling Romaine Chopped salad in 32oz. and 2lb. packages due to potential Listeria monocytogenes contamination. The recall affects approximately 9,741 cases distributed across 20 U.S. states and Canada.

    Product
    "Romaine Chopped" (salad product) packed in 32oz. and 2lb. packages
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Food)·F-0537-2022·2022-02-02

    Chef Salad Bowl Products Recalled for Potential Listeria Contamination

    Fresh Express Inc is recalling Chef Salad Bowl products due to potential contamination with Listeria monocytogenes. The recall affects 6.2oz packages distributed to domestic and Canadian distributors.

    Product
    "Chef Salad Bowl" (salad product) packed in 6.2oz. packages
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Food)·F-0560-2022·2022-02-02

    Green & Crisp Salad Product Recalled for Listeria Contamination Risk

    Fresh Express Inc is recalling Green & Crisp salad in 11oz packages due to potential Listeria monocytogenes contamination. The recall affects 26,695 cases distributed across multiple US states and Canada.

    Product
    "Green & Crisp" (salad product) packed in 11oz. packages
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Drugs)·D-0404-2022·2022-02-02

    Lidocaine HCL / Bupivacaine HCL Sterile Ophthalmic Solution Lacks Sterility Assurance

    Edge Pharma is recalling a sterile ophthalmic injectable solution because the manufacturer cannot guarantee that the product remains sterile. The recall affects approximately 1,202 syringes distributed nationwide.

    Product
    Lidocaine HCL / Bupivacaine HCL (contains Hyaluronidase 15 units/mL), Sterile Ophthalmic Solution for Injection (PF), 2%/0.375%, 8 mL per syringe, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1548-18
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0549-2022·2022-02-02

    Fresh Express Chopped Pomegranate Salad Recalled for Listeria

    Fresh Express Inc is recalling Chopped Pomegranate salad in 10.3 oz packages due to potential Listeria monocytogenes contamination. The product was distributed to retailers and distributors across 20 U.S. states and Canada.

    Product
    "Chopped Pomegranate" (salad product) packed in 10.3oz. packages
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Drugs)·D-0427-2022·2022-02-02

    Vancomycin HCl IV Injection Recalled Due to Sterility Assurance Concerns

    Edge Pharma is recalling Vancomycin HCl in 0.9% Sodium Chloride Injection due to lack of assurance of sterility. The recall affects approximately 749 bags distributed nationwide.

    Product
    Vancomycin HCl in 0.9% Sodium Chloride Injection, USP, 1,750mg/500mL, Single Use Bag for IV Injection (Preservative Free), 500 mL pre-filled bag, Rx Only, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446 NDC 05446-1459-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0558-2022·2022-02-02

    Farmer's Garden Salad Recalled for Potential Listeria Contamination

    Fresh Express Inc is recalling Farmer's Garden 9oz. salad packages due to potential contamination with Listeria monocytogenes. The product was distributed to multiple domestic and Canadian distributors.

    Product
    "Farmer's Garden" (salad product) packed in 9oz. packages
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Drugs)·D-0416-2022·2022-02-02

    Edge Pharma Phenylephrine HCl IV Injection Sterility Assurance Recall

    Edge Pharma is recalling Phenylephrine HCl 1mg/10mL single-use syringes for IV injection due to lack of assurance of sterility. The recall affects 6,535 vials distributed nationwide.

    Product
    Phenylephrine HCl, 1mg/10mL (0.1mg/mL), 10 mL per syringe, Single Use Syringe for IV Injection, Edge Pharma, LLC, 856 Hercules Dr, Colchester, VT 05446 NDC 05446-1544-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0545-2022·2022-02-02

    Fresh Express Chopped Kale Recall for Listeria Contamination Risk

    Fresh Express Inc is recalling Chopped Kale salad products in 11.9oz. and 12.2oz. packages due to potential Listeria monocytogenes contamination. The recall affects products distributed across multiple U.S. states and Canada.

    Product
    "Chopped Kale" (salad product) packed in 11.9oz. and 12.2oz. packages
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Food)·F-0563-2022·2022-02-02

    Italian Salad Product Recalled for Listeria Contamination Risk

    Fresh Express Inc is recalling Italian salad in 9oz. packages due to potential Listeria monocytogenes contamination. The affected product was distributed to retailers across the United States and Canada.

    Product
    "Italian" (salad product) packed in 9oz. packages
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Food)·F-0593-2022·2022-02-02

    Romaine Garden Salad Recalled for Potential Listeria Contamination

    Fresh Express Inc is recalling Romaine Garden salad in 12oz. packages due to potential contamination with Listeria monocytogenes. The product was distributed to domestic and Canadian distributors across multiple states.

    Product
    "Romaine Garden" (salad product) packed in 12oz. packages
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Food)·F-0528-2022·2022-02-02

    Baby Greens Salad Recalled Due to Potential Listeria Monocytogenes Contamination

    Fresh Express Inc is recalling 611 units of Baby Greens salad in 6oz packages due to potential Listeria monocytogenes contamination. The product was distributed to 110 domestic distributors across 20 states and Canada.

    Product
    "Baby Greens" (salad product) packed in 6oz. packages
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Food)·F-0586-2022·2022-02-02

    Organic Super Greens Salad Recalled for Listeria Contamination Risk

    Fresh Express Inc is recalling "Organic Super Greens" salad in 5oz and 16oz packages due to potential Listeria monocytogenes contamination. The recall affects 7,603 cases distributed to domestic and Canadian distributors.

    Product
    "Organic Super Greens" (salad product) packed in 5oz. and 16oz. packages
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Food)·F-0542-2022·2022-02-02

    Fresh Express Chopped Caesar Salad Recalled for Listeria Risk

    Fresh Express Inc is recalling "Chopped Caesar" salad in 9.4oz., 10.4oz., and 10.5oz. packages due to potential Listeria monocytogenes contamination. The product was distributed to domestic and Canadian distributors.

    Product
    "Chopped Caesar" (salad product) packed in 9.4oz., 10.4oz., and 10.5oz. packages
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Food)·F-0556-2022·2022-02-02

    Crisp Greens Salad Recalled for Potential Listeria Monocytogenes Contamination

    Fresh Express Inc is recalling Crisp Greens salad in 12oz. packages due to potential contamination with Listeria monocytogenes. The recall affects products distributed to domestic and Canadian distributors across 20 U.S. states.

    Product
    "Crisp Greens" (salad product) packed in 12oz. packages
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Food)·F-0527-2022·2022-02-02

    Fresh Express Avocado Ranch Salad Recalled for Listeria Risk

    Fresh Express Inc is recalling Avocado Ranch salad products in 9.7oz and 12.8oz packages due to potential Listeria monocytogenes contamination. The products were distributed to wholesalers across 20 U.S. states and Canada.

    Product
    "Avocado Ranch" (salad product) packed in 9.7oz. and 12.8oz. packages
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Food)·F-0567-2022·2022-02-02

    Fresh Express Leafy Romaine Salad Recalled for Listeria Contamination Risk

    Fresh Express Inc is recalling Leafy Romaine salad in 9oz. and 10oz. packages due to potential Listeria monocytogenes contamination. The product was distributed to multiple states and Canada.

    Product
    "Leafy Romaine" (salad product) packed in 9oz. and 10oz. packages
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Food)·F-0570-2022·2022-02-02

    Old Fashion Coleslaw Recalled for Listeria Contamination Risk

    Fresh Express Inc is recalling Old Fashion Coleslaw (14oz packages) due to potential Listeria monocytogenes contamination across 20 U.S. states and Canada.

    Product
    "Old Fashion Coleslaw" (salad product) packed in 14oz. packages
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Food)·F-0526-2022·2022-02-02

    Fresh Express Asian Avocado Salad Recalled for Listeria Risk

    Fresh Express Inc is recalling Asian Avocado salad products in 9.7oz packages due to potential contamination with Listeria monocytogenes. The recall affects approximately 1,053 cases distributed across multiple U.S. states and Canada.

    Product
    "Asian Avocado" (salad product) packed in 9.7oz. packages
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Food)·F-0603-2022·2022-02-02

    Fresh Express Sweet Butter Salad Recalled for Listeria Contamination

    Fresh Express Inc is recalling approximately 98,358 cases of "Sweet Butter" salad in 6oz. packages due to potential Listeria monocytogenes contamination. The product was distributed to retailers in 20 U.S. states and Canada.

    Product
    "Sweet Butter" (salad product) packed in 6oz. packages
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Drugs)·D-0421-2022·2022-02-02

    Sterile Ophthalmic Solution Lacks Assurance of Sterility

    Edge Pharma is recalling a sterile ophthalmic solution due to lack of assurance of sterility. The recall affects 2,562 syringes distributed nationwide.

    Product
    Phenylephrine HCl/Tropicamide/Cyclopentolate HCl/Ketorolac Sterile Ophthalmic Solution, 2.5%/0.25%/0.25%/0.125%, 0.5 mL syringe, Single Use Syringe, For Topical Ophthalmic Use, NDC 05446-0993-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighCPSC·22069·2022-02-02

    SureClose READYFIT 180° Hinge-Closer Sets Recalled for Drowning Hazard

    D&D Technologies is recalling about 1,500 SureClose READYFIT 180° hinge-closer sets because they can malfunction and fail to fully self-close gates, allowing unintended access to pools and posing injury and drowning hazards to young children.

    Product
    SureClose® READYFIT 180° Hinge-Closer Sets
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0528-2022·2022-02-02

    MAGEC 1 System Recalled for Post-Implantation Component Fractures

    The MAGEC 1 System implantable medical device is being recalled due to documented post-implantation fractures of an internal metallic component. The recall affects approximately 3,056 units manufactured before March 26, 2015 and distributed worldwide.

    Product
    MAGEC 1 System
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-0617-2022·2022-02-02

    G&C Foods Gouda Cheese Recall for Undeclared Wheat

    G&C Food Distributors & Brokers Inc. is recalling Gouda cheese that may contain undeclared wheat. The product was distributed to food service facilities in Connecticut, New Jersey, New York, Pennsylvania, and Tennessee.

    Product
    GOUDA CHEESE; INGREDIENTS: CULTURED PASTEURIZED MILK, SALT, ENZYMES, ANNATTO COLOR; Distributed By: G&C Foods; ALLERGEN: MILK; CONTAINS: 1 BAG; Product is for Food Service Only; KEEP REFRIGERATED
    Category
    Food
    Distribution
    5 states
  • HighFDA (Drugs)·D-0397-2022·2022-02-02

    Ceftazidime Sterile Ophthalmic Solution Lacks Sterility Assurance

    Edge Pharma is recalling Ceftazidime sterile ophthalmic solution for intraocular injection due to lack of assurance of sterility. The recall affects 168 syringes distributed nationwide.

    Product
    Ceftazidime, Sterile Ophthalmic Solution for Injection, Preservative Free (11.25 mg/0.5 mL (22.5 mg/mL), 0.5mL single use syringe for Intraocular Injection, Edge Pharma, LLC, 656 Hercules Dr., Colchester, VT 05446, NDC 05446-0733-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighCPSC·22066·2022-02-02

    Children's Robes Recalled for Flammability Standards Violation

    BAOPTEIL-branded children's robes sold on Amazon fail to meet federal flammability standards for children's sleepwear, posing a burn hazard. About 3,800 units sold from December 2019 through August 2021 are affected.

    Product
    Children's Robes
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0405-2022·2022-02-02

    Methacholine Challenge Test Kit Recalled for Lack of Sterility Assurance

    Edge Pharma, LLC is recalling Methacholine Challenge 5-Syringe Test Kits nationwide due to lack of assurance of sterility. The sterile inhalation solution may not meet sterility standards.

    Product
    Methacholine Challenge 5-Syringe Test Kit, Sterile Inhalation Solution, Preservative Free, 3 mL per syringe,(NDC 05446-1600-05), Kit includes; individual syringe: Methacholine Chloride,16 mg/mL (contains 48 mg) NDC 05446-1241-01; Methacholine Chloride 4 mg/mL (contains 12mg)…
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0517-2022·2022-02-02

    Diagnostic Imaging Angiography System Software Defects Recalled by Siemens

    Siemens is recalling 23 Artis icono angiography systems due to four software defects that could disable imaging, corrupt images, and cause unexpected shutdowns during patient procedures.

    Product
    Artis icono floor with software VE20C-diagnostic imaging angiography system Model: 11327700
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0515-2022·2022-02-02

    Siemens Diagnostic Angiography System Recalled for Multiple Software Defects

    Siemens is recalling its Artis pheno diagnostic angiography system (12 units) due to four software defects that may prevent imaging, corrupt images, or cause unintended shutdowns during clinical use.

    Product
    Artis pheno with software VE20C- diagnostic imaging angiography system Model: 10849000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0516-2022·2022-02-02

    Artis icono diagnostic imaging system software defects recalled nationwide

    Siemens is recalling 72 units of Artis icono biplane diagnostic imaging systems nationwide due to four software issues that could disable x-ray capability, corrupt diagnostic images, or cause unexpected shutdowns during procedures.

    Product
    Artis icono biplane with software VE20C-diagnostic imaging angiography system Model: 11327600
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0526-2022·2022-02-02

    Footrest accessory recalled for missing friction rubber block

    FDA recalls Intelli-C footrest accessories due to missing friction rubber blocks in the clamping mechanism. The defect may cause the footrest to slip during use.

    Product
    1. Footrest ( use exclusively in combination with Intelli-C devices) 2. Shoulder support ( use exclusively in combination with Intelli-C devices)
    Category
    Medical Device
    Distribution
    10 states

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