The Recall Desk

Archive

November 2022 recalls

456 recalls were announced in November 2022.

What the numbers show

Critical
8
Severe
101
High
296
Moderate
47
Low
4

Of the 456 recalls this month scored against our rubric, 2% are Critical, 22% are Severe.

301–400 of 456

  • HighFDA (Devices)·Z-0161-2023·2022-11-09

    Surgical Cataract Packs with Compromised Breather Pouch Seals Recalled

    Medline recalls 708 Bausch + Lomb cataract surgical packs due to breather pouch seal defects that could compromise sterility of surgical instruments.

    Product
    BAUSCH + LOMB CATARACT PACK, REF VAL001CPMEA. Convenience kit used in surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0168-2023·2022-11-09

    Pediatric Vision Scanner Battery Pack Poses Fire Risk

    Rebiscan is recalling Blinq Pediatric Vision Scanners (Model BQ830) because the battery pack may vent and catch fire if a cell voltage drops below 2.5V.

    Product
    Blinq Pediatric Vision Scanner-Pediatric Vision Scanner-intended for automated detection of misalignment of the visual axes using polarized light. Model Number BQ830
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0163-2023·2022-11-09

    Medline LINQ Surgical Trays Recalled for Compromised Pouch Seals

    Medline has recalled LINQ TRAY surgical kits with breather pouch seal openings that could compromise sterility. The recall affects 40 kits distributed nationwide; no injuries have been reported.

    Product
    MEDLINE LINQ TRAY, REF DYNJ65880A. Convenience kit used in medical/surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0158-2023·2022-11-09

    Surgical Cataract Pack Recalled Due to Compromised Sterile Packaging

    Medline Industries is recalling 300 units of Bausch + Lomb Cataract Packs due to breather pouches with seal openings that may compromise sterility. The affected surgical kits were distributed nationwide.

    Product
    BAUSCH + LOMB CATARACT PACK, REF VAL009CTSGA. Convenience kit used in surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0159-2023·2022-11-09

    Surgical eye kits recalled for breached sterile pouches

    Medline Industries recalls Bausch + Lomb eye muscle surgical kits due to breached breather pouches that may compromise sterility. The affected kits (Lot 22DBN366) were distributed nationwide.

    Product
    BAUSCH + LOMB EYE MUSCLE, REF VAL036EMESB. Convenience kit used in surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0179-2023·2022-11-09

    Allen Life Assist Beach Chair Adhesive Cure Failure Recall

    Baxter Healthcare is recalling the Allen Life Assist Beach Chair due to adhesive on fasteners that may not cure correctly, potentially compromising the device's mechanical integrity during surgical procedures.

    Product
    Allen Life Assist Beach Chair, BCSSP-BEACH CHAIR , REF A-91501, #104002. For use with orthopaedic procedures using the Fowlers or beach chair position.
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-0176-2023·2022-11-09

    Baxter Neurosurgical Headrest Recalled Due to Defective Adhesive

    Baxter Healthcare is recalling C-Flex Polar Head Positioning Device neurosurgical headrests because adhesive on fasteners may not cure correctly, potentially compromising mechanical integrity and holding force.

    Product
    C-Flex Polar Head Positnr-Device Only, SSP-NEUROSURGICAL HEADREST, REF A-70701, #103001,
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-0178-2023·2022-11-09

    Beach Chair Clamp Shoulder Positioner recalled for adhesive curing failure

    Baxter Healthcare recalls Beach Chair Clamp shoulder positioner components because adhesive on the fasteners may not cure properly, potentially reducing the device's mechanical integrity during surgical procedures.

    Product
    Beach Chair Clamp, BEACH CHAIR SHLDER POSITIONER CMPT, REF A-90013, #800104. Component to position and support the patients head in surgical procedures.
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-0147-2023·2022-11-09

    Fogarty Biliary Balloon Probes recalled for latex deterioration

    Edwards Lifesciences is recalling Fogarty Biliary Balloon Probes due to confirmed latex deterioration in pouches. The recall affects 26,560 units distributed worldwide.

    Product
    Fogarty Biliary Balloon Probes Model Number: 410235FP 410405FP 410236FP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0171-2023·2022-11-09

    BD Trucount Tubes for Blood Testing Recall Due to Label Detachment

    Becton, Dickinson is recalling BD Trucount Tubes due to partial label detachment that can cause tubes to stick together or create automation errors. The defect stems from an adhesive supplier change and affects 52,570 units.

    Product
    BD Trucount Tubes (Cat. No. 340334), used for determining absolute counts of leucocytes in blood. BD Trucount tubes are designed for use with in vitro diagnostic products such as BD Tritest reagents, and a suitably equipped flow cytometer. BD Trucount tubes can be used with the B
    Category
    Medical Device
    Distribution
    43 states
  • HighFDA (Food)·F-0081-2023·2022-11-09

    Brie en Croute with Raspberry Recalled for Potential Listeria Contamination

    Kabobs Acquisition Inc. is recalling Brie en Croute with Raspberry (Lot PM22J07) due to potential Listeria monocytogenes contamination. The product was distributed to one distributor in Georgia.

    Product
    BRIE EN CROUTE WITH RASPBERRY
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0128-2023·2022-11-09

    Hood Cottage Cheese with Pineapple Recalled for Possible Plastic Contamination

    HP Hood LLC is recalling Hood Fat Free Cottage Cheese with Pineapple, 16 oz containers for possible plastic contamination. Affected products have best-by dates from October 24, 2022 through December 12, 2022.

    Product
    Hood Fat Free Cottage Cheese with Pineapple, 16 oz
    Category
    Food
    Distribution
    39 states
  • HighFDA (Food)·F-0093-2023·2022-11-09

    Bella Cucina Artichoke Lemon Pesto Recalled for Undeclared Milk Allergen

    Bella Cucina Artful Food is recalling Artichoke Lemon Pesto in three sizes because the label does not declare milk as an ingredient. The product was distributed to all U.S. states, Canada, and Italy.

    Product
    Bella Cucina Artful Food Artichoke Lemon Pesto Net Wt. 3.5 oz (100g) UPC 6 19193 00232 8, Net Wt. 17 oz (xxxg) UPC 6 19193 00132 1 & Net Wt. 23 oz (652g) UPC 6 1913 00130 7 in glass jar, Manufactured by Bella Cucina Artful Food Atlanta, GA 30310
    Category
    Food
    Distribution
    45 states
  • HighFDA (Food)·F-0124-2023·2022-11-09

    Hood Cottage Cheese Recalled for Possible Plastic Contamination

    HP Hood is recalling Hood Cottage Cheese with Cucumber & Dill (16 oz) because the product may contain plastic foreign objects. Consumers should not eat the recalled product.

    Product
    Hood Cottage Cheese with Cucumber & Dill, 16 oz
    Category
    Food
    Distribution
    39 states
  • HighFDA (Food)·F-0097-2023·2022-11-09

    Bella Cucina Dried Cherry and Almond Biscotti Recalled for Undeclared Milk and Wheat

    Bella Cucina Artful Food is recalling Dried Cherry and Almond Biscotti because the label fails to indicate the presence of milk and wheat allergens. Consumers with allergies to these ingredients should not consume the product.

    Product
    Bella Cucina Artful Food Dried Cherry and Almond Biscotti Net Wt. 6 oz (170g) bag, UPC 6 19193 00019 5 Distributed by Bella Cucina Artful Food Atlanta, GA 30310
    Category
    Food
    Distribution
    45 states
  • HighFDA (Food)·F-0122-2023·2022-11-09

    Cottage Cheese Products Recalled Due to Possible Plastic Contamination

    HP Hood LLC is recalling multiple cottage cheese brands (Hannaford, Hood, Market Basket, Weis) due to possible plastic fragments in the products. The recall affects 391,824 cases distributed across 38 states.

    Product
    Hannaford Fat Free Cottage Cheese, 16 oz and 24 oz; Hood Fat Free Cottage Cheese, 16 oz; Market Basket Fat Free Cottage Cheese, 16 oz and 24 oz; Weis Fat Free Cottage Cheese, 24 oz
    Category
    Food
    Distribution
    39 states
  • HighFDA (Food)·F-0082-2023·2022-11-09

    Domino and C&H Sugar recalled for potential metal wire contamination

    Domino Foods Inc is recalling Domino and C&H Granulated Pure Cane Sugar (Easy Baking Tub) due to potential contamination with metal wire from a broken screen. The recalled product was distributed to distribution centers in 22 states.

    Product
    Domino and C&H Granulated Pure Cane Sugar Easy Baking Tub packaged in 3.5lb plastic tubs 6 tubs per case
    Category
    Food
    Distribution
    22 states
  • HighFDA (Food)·F-0104-2023·2022-11-09

    Bella Cucina Sweet Pumpkin Pesto fails to declare milk allergen

    Bella Cucina Sweet Pumpkin Pesto (6 oz jars, UPC 6 19193 00144 4) does not indicate milk on the label, posing a risk for consumers with milk allergies. The product was distributed across most US states, Canada, and Italy.

    Product
    Food Sweet Pumpkin Pesto Net Wt. 6 oz (169g) jar, UPC 6 19193 00144 4 Manufactured by Bella Cucina Artful Food Atlanta, GA 30310
    Category
    Food
    Distribution
    45 states
  • HighFDA (Food)·F-0102-2023·2022-11-09

    Bella Cucina Sweet Pepper Pesto recalled due to undeclared milk allergen

    Bella Cucina Artful Food Sweet Pepper Pesto is being recalled because the label does not declare milk as an ingredient. Consumers with milk allergies could experience a serious allergic reaction.

    Product
    Bella Cucina Artful Food Sweet Pepper Pesto Net Wt. 3 oz (84.5g) jar, UPC 6 19193 00233 5 Manufactured by Bella Cucina Artful Food Atlanta, GA 30310
    Category
    Food
    Distribution
    45 states
  • HighFDA (Drugs)·D-0047-2023·2022-11-09

    Papaverine HCL Stock Solution Recalled Due to Sterility Assurance Failure

    Pharmacy Plus, Inc. dba Vital Care Compounder is recalling Papaverine HCL Stock Solution 30mg/ml vials due to lack of sterility assurance. FDA inspection found the product was produced in a manner that cannot guarantee sterility.

    Product
    PAPAVERINE HCL STOCK SOLUTION 30MG/ML SOLUTION, 10 mL vial, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
    Category
    Drug
    Distribution
    4 states
  • HighFDA (Drugs)·D-0055-2023·2022-11-09

    Sterile Talc Powder Recalled Due to Sterility Assurance Failure

    Pharmacy Plus, Inc. is recalling sterile talc powder vials after FDA inspection found the manufacturing process cannot guarantee sterility. The product was distributed in Alabama, Louisiana, Mississippi, and Tennessee.

    Product
    TALC, STERILE POWDER, 5 GM vial, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
    Category
    Drug
    Distribution
    4 states
  • HighFDA (Drugs)·D-0050-2023·2022-11-09

    Phentolamine Injectable Drug Recalled Due to Sterility Concerns

    Pharmacy Plus recalls Phentolamine 10MG/ML injection due to lack of guaranteed sterility during production. Affected lots distributed to AL, LA, MS, and TN.

    Product
    PHENTOLAMINE 10MG/ML INJECTION, 10MG/ML SOLUTION, 10 mL vial, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
    Category
    Drug
    Distribution
    4 states
  • HighFDA (Drugs)·D-0034-2023·2022-11-09

    Laureth-9 Injectable Solution Recalled for Lack of Sterility Assurance

    A compounded Laureth-9 injectable solution has been recalled after the FDA found the manufacturing process could not guarantee sterility. The recalled product (lot 66513) was distributed in AL, LA, MS, and TN.

    Product
    LAURETH-9 INJ 2% Solution, 30 ML vial, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
    Category
    Drug
    Distribution
    4 states
  • HighFDA (Drugs)·D-0054-2023·2022-11-09

    Pharmacy Plus Eye Solution Recalled for Sterility Assurance Issues

    Pharmacy Plus is recalling SERUM TEARS IN NSAL 20% Ophthalmic Solution due to lack of assurance of sterility. FDA inspection found the manufacturing process could not guarantee the product's sterility.

    Product
    SERUM TEARS IN NSAL 20% OPTH SOLUTION, 3 mL droptainers, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
    Category
    Drug
    Distribution
    4 states
  • HighFDA (Drugs)·D-0057-2023·2022-11-09

    Voriconazole ophthalmic solution recalled for sterility concerns

    Pharmacy Plus, Inc. (Vital Care Compounder) is recalling Voriconazole Ophthalmic Solution 2% because FDA inspection found manufacturing processes cannot guarantee the product's sterility.

    Product
    VORICONAZOLE OPTH SOLUTION 2% STERILE SOLN, 10 ML droptainer, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
    Category
    Drug
    Distribution
    4 states
  • HighFDA (Drugs)·D-0024-2023·2022-11-09

    Buprenorphine and Naloxone Sublingual Tablets Recalled for Foreign Substance

    Sun Pharmaceutical is recalling buprenorphine and naloxone sublingual tablets (8 mg/2 mg) due to a foreign substance. Affected lots DNC1129A and DNC1740A were distributed nationwide.

    Product
    BUPRENORPHINE AND NALOXONE — BUPRENORPHINE AND NALOXONE (BUPRENORPHINE AND NALOXONE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0027-2023·2022-11-09

    Acetylcysteine Eye Drops Recalled for Sterility Assurance Issues

    Acetylcysteine ophthalmic solution 5% from Vital Care Compounder is recalled due to manufacturing deficiencies that cannot ensure product sterility. The affected product was distributed in Alabama, Louisiana, Mississippi, and Tennessee.

    Product
    ACETYLCYSTEINE OPTH 5% Solution, 15 mL droptainers, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
    Category
    Drug
    Distribution
    4 states
  • HighFDA (Drugs)·D-0042-2023·2022-11-09

    Pharmacy Plus Injectable Drug Recall Due to Sterility Assurance Failure

    Pharmacy Plus, Inc. recalled a compounded injectable medication (56 vials) due to manufacturing processes that cannot guarantee product sterility. Distributed in Alabama, Louisiana, Mississippi, and Tennessee.

    Product
    PAPAVERINE / PHENTOLAMINE / PROSTAGLANDIN 150MG / 2.5MG / 50MCG SOLUTION, 5 mL vials, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
    Category
    Drug
    Distribution
    4 states
  • HighFDA (Drugs)·D-0052-2023·2022-11-09

    Prostaglandin E1 Injection Recalled Due to Sterility Assurance Concerns

    Pharmacy Plus, Inc. dba Vital Care Compounder is recalling Prostaglandin E1 Injection Solution after FDA inspection found the products were manufactured in a manner that cannot guarantee sterility.

    Product
    PROSTAGLANDIN E1 INJECTION SOLUTION 500MCG/ML SOLUTION, 1 ML vials, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
    Category
    Drug
    Distribution
    4 states
  • HighFDA (Drugs)·D-0032-2023·2022-11-09

    Cyclosporin 0.07% Ophthalmic Solution Recalled Due to Sterility Concerns

    Pharmacy Plus recalls 67 bottles of Cyclosporin 0.07% ophthalmic solution across four states due to manufacturing process that cannot guarantee sterility.

    Product
    CYCLOSPORIN 0.07% OPTH 0.07% Solution in 10 mL bottles, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
    Category
    Drug
    Distribution
    4 states
  • HighFDA (Drugs)·D-0039-2023·2022-11-09

    Mitomycin Injection Recalled Due to Lack of Sterility Assurance

    Vital Care Compounder is recalling 185 syringes of Mitomycin Injection due to lack of sterility assurance discovered during FDA inspection. The product cannot guarantee sterility.

    Product
    MITOMYCIN INJECTION 0.375 mg/mL SYR, 0.375 mg/mL solution, 1 mL syringe, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
    Category
    Drug
    Distribution
    4 states
  • HighFDA (Devices)·Z-0167-2023·2022-11-09

    NICU PICC Insertion Bundle Recalled for Breather Pouch Seal Defects

    Medline Industries recalls NICU PICC insertion bundles (50 kits) due to openings in breather pouch seals that compromise sterile barrier integrity. This Class II recall affects units distributed across the United States.

    Product
    CENTURION MEDICAL PRODUCTS NICU PICC INSERTION BUNDLE W/O, REF CVI4470. Convenience kit used in medical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0164-2023·2022-11-09

    Medline Dental Pack Recall Due to Breather Pouch Seal Defect

    Medline is recalling Dental Pack surgical kits (Lot 22DBE139) because breather pouches have openings in their seals that could compromise sterility. Affected units were distributed to healthcare facilities in eight US states.

    Product
    MEDLINE DENTAL PACK, REF DYNJ66983. Convenience kit used in medical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0169-2023·2022-11-09

    Cardiac Navigation Catheter Recalled for Cellulose Fiber Contamination

    Johnson & Johnson is recalling 91 THERMOCOOL SMARTTOUCH SF cardiac catheters nationwide due to manufacturing defects introducing cellulose fibers into the irrigation system. The contamination may prevent proper flushing, reduce cooling capability, or cause clotting complications.

    Product
    THERMOCOOL SMARTTOUCH SF Bi-Directional Navigation Catheter, REF: D-1348-05-S. Used for catheter-based cardiac electrophysiological mapping (stimulation and recording) and, in conjunction with an RF generator, for cardiac ablation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0177-2023·2022-11-09

    Allen Spine Positioner Components Recalled for Adhesive Curing Defect

    Baxter Healthcare is recalling Allen Standard Starburst spine positioning components due to adhesive that may not cure correctly, potentially compromising mechanical holding force in surgical head positioning devices.

    Product
    Allen Standard Starburst, Mayfield/Doro, STANDARD SPINE POSITIONERS CMPT, REF A-70710, #800103. Component to position and support the patients head in surgical procedures.
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-0165-2023·2022-11-09

    Medline Radiology Procedure Pack Breather Pouches Recalled for Seal Defects

    Medline is recalling 240 Radiology Procedure Packs because some breather pouches show seal openings that could compromise sterility. The affected kits were distributed nationwide.

    Product
    MEDLINE RADIOLOGY PROCEDURE PACK, REF DYNJ67150A. Convenience kit used in medical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0105-2023·2022-11-09

    Bella Cucina Pizza Mix Recalled for Undeclared Wheat Allergen

    Bella Cucina Tradizionale Pizza and Foccacia Mix is being recalled because the label does not declare wheat, a common allergen. Consumers with wheat allergies could experience allergic reactions.

    Product
    Bella Cucina Artful Food Tradizionale Pizza and Foccacia Mix Net Wt. 15 oz 422g can, Manufactured by Bella Cucina Artful Food Atlanta, GA 30310
    Category
    Food
    Distribution
    45 states
  • HighNHTSA·22V832000·2022-11-09

    Motorhome interior step tread may detach, increasing fall injury risk

    Holiday Rambler and Fleetwood motorhomes (2022–2023) have interior step treads that may be improperly secured and can detach when stepped on, creating a fall hazard.

    Product
    FLEETWOOD — FLEETWOOD, HOLIDAY RAMBLER BOUNDER, INVICTA, VACATIONER, FORTIS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·22V830000·2022-11-09

    2023 Volkswagen ID.4 electric motor coolant leak risk

    Volkswagen is recalling 2023 ID.4 vehicles due to improper electric motor sealing assembly that may allow coolant to leak into the high-voltage system, risking loss of vehicle control and unintended airbag deployment.

    Product
    VOLKSWAGEN — VOLKSWAGEN ID.4
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0103-2023·2022-11-09

    Preserved Lemon Cream Recalled for Undisclosed Milk Allergen

    Bella Cucina Artful Food is recalling its Preserved Lemon Cream because the label does not indicate the presence of milk, posing a risk to consumers with milk allergies.

    Product
    Bella Cucina Artful Food Preserved Lemon Cream Net Wt. 6 oz (169g) jar, UPC 6 19193 00045 4 Manufactured by Bella Cucina Artful Food Atlanta, GA 30310
    Category
    Food
    Distribution
    45 states
  • HighFDA (Food)·F-0094-2023·2022-11-09

    Pesto Recall: Undisclosed Milk Allergen Not Listed on Label

    Bella Cucina Artful Food Arugula & Pine Nut Pesto jars do not properly disclose milk on the label despite containing the allergen. The FDA Class II recall affects multiple lot numbers distributed nationwide and internationally.

    Product
    Bella Cucina Artful Food Arugula & Pine Nut Pesto Net Wt. 6 oz (169g) jar, UPC 6 19193 00145 1 Manufactured by Bella Cucina Artful Food Atlanta, GA 30310
    Category
    Food
    Distribution
    45 states
  • HighFDA (Drugs)·D-0049-2023·2022-11-09

    Prescription Injectable Medication Recalled for Sterility Assurance Failure

    Pharmacy Plus, Inc. recalled a prescription injectable medication (Papaverine/Phentolamine/Prostaglandin) because FDA inspection found the product was produced in a manner that cannot guarantee sterility. Lot 65976 (BUD 10/27/2022) was distributed in AL, LA, MS, and TN.

    Product
    PAPAVERINE/PHENTOLAMINE/PROSTAGLANDIN INJ 150MG/5MG/10MCG/VIAL SOLUTION, 5 ML vial, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
    Category
    Drug
    Distribution
    4 states
  • HighFDA (Drugs)·D-0028-2023·2022-11-09

    FDA Recalls Vital Care Autologous Tears Serum Due to Sterility Assurance Failure

    Vital Care Compounder's Autologous Tears Serum Full Strength has been recalled due to manufacturing defects that cannot assure product sterility. The product was distributed in Alabama, Louisiana, Mississippi, and Tennessee.

    Product
    AUTOLOGUS TEARS SERUM SOLN FULL STRENGTH, 3 mL droptainers, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
    Category
    Drug
    Distribution
    4 states
  • HighFDA (Food)·F-0099-2023·2022-11-09

    Bella Cucina Porcini & Parmesan Pesto Recalled for Missing Milk Allergen Labeling

    Bella Brands is recalling multiple lots of Bella Cucina Porcini & Parmesan Pesto because milk is not indicated on the product label, creating a risk for consumers with milk allergies.

    Product
    Bella Cucina Artful Food Porcini & Parmesan Pesto Net Wt. 6 oz (169g) jar, UPC 6 19193 00146 8 Manufactured by Bella Cucina Artful Food Atlanta, GA 30310
    Category
    Food
    Distribution
    45 states
  • HighFDA (Food)·F-0121-2023·2022-11-09

    Cottage Cheese with Pineapple Recalled for Plastic Contamination

    HP Hood LLC is recalling multiple brands of cottage cheese with pineapple due to possible plastic contamination. Products with best-by dates between October 24 and December 12, 2022 were distributed across 38 states.

    Product
    Food Club Cottage Cheese with Pineapple, 16 oz; Hannaford Cottage Cheese with Pineapple, 16 oz; Hood Cottage Cheese with Pineapple, 16 oz and 24 oz; Market Basket Cottage Cheese with Pineapple, 16 oz; Penn Maid Cottage Cheese with Pineapple, 16 oz;
    Category
    Food
    Distribution
    39 states
  • HighFDA (Food)·F-0096-2023·2022-11-09

    Bella Cucina Death By Chocolate Cookies Recalled for Undeclared Milk and Wheat

    Bella Cucina Artful Food is recalling Death By Chocolate Cookies because the labels do not declare milk and wheat, which are common allergens. Consumers with allergies to these ingredients are at risk.

    Product
    Bella Cucina Artful Food Death By Chocolate Cookies Net Wt. 6 oz (170g) bag, UPC 6 19193 00020 1 Distributed by Bella Cucina Artful Food Atlanta, GA 30310
    Category
    Food
    Distribution
    45 states
  • HighFDA (Food)·F-0101-2023·2022-11-09

    Bella Cucina Sun-Dried Tomato Pesto Recalled for Undeclared Milk Allergen

    Bella Cucina Artful Food sun-dried tomato pesto is being recalled because the label does not indicate the presence of milk, a major allergen. Consumers with milk allergies are at risk.

    Product
    Bella Cucina Artful Food Sun-Dried Tomato Pesto Net Wt. 3 oz (84.5g) jar, UPC 6 19193 00213 7 Manufactured by Bella Cucina Artful Food Atlanta, GA 30310
    Category
    Food
    Distribution
    45 states
  • HighFDA (Drugs)·D-0030-2023·2022-11-09

    Ceftazidime Intravitreal Solution Recalled for Sterility Assurance Failure

    Vital Care Compounder is recalling Ceftazidime intravitreal injection solutions due to manufacturing conditions that cannot guarantee product sterility. Affected lots were distributed to patients in Alabama, Louisiana, Mississippi, and Tennessee.

    Product
    CEFTAZIDIME INTRAVITREAL 2.25MG/0.1ML Solution, 0.5 mL syringe, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
    Category
    Drug
    Distribution
    4 states
  • HighFDA (Devices)·Z-0180-2023·2022-11-09

    Surgical Positioning Clamp Adhesive May Fail to Cure Properly

    Baxter Healthcare is recalling Simple Clamp surgical positioning equipment because the adhesive may not cure properly, reducing mechanical integrity during use. Affected units were distributed across multiple US states and international locations.

    Product
    Simple Clamp, US/EURO Rails, UPPER EXTREMITY DISTRACTION CMPT, REF F-40018, #800101. To position, support and/or distract the patients hand, wrist, forearm, arm, and shoulder in surgical procedures.
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-0166-2023·2022-11-09

    Medline CVC Barrier Kit Recalled for Breached Pouch Seals

    Medline is recalling CVC barrier kits (Lot 22ABT774) due to breather pouches with seal openings that could compromise sterility of the surgical kit contents.

    Product
    MEDLINE CVC BARRIER KIT, REF DYNJ80485. Convenience kit used in medical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0175-2023·2022-11-09

    Operating Room Table With Defective Adhesive May Lose Mechanical Integrity

    Baxter Healthcare is recalling Allen Advance operating room tables because adhesive securing fasteners may not cure properly, potentially compromising mechanical integrity.

    Product
    Allen Advance Table, RSP-ADVANCE TABLE: a) REF A-71100-US, #107003, b) A-71101-EU, #107003. operating room table
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Food)·F-0100-2023·2022-11-09

    Bella Cucina Spinach Artichoke Bruschetta Spread Recalled for Undisclosed Milk

    Bella Cucina Artful Food is recalling Spinach Artichoke Bruschetta Spread because the label does not indicate milk. Consumers with milk allergies should not consume this product.

    Product
    Bella Cucina Artful Food Spinach Artichoke Bruschetta Spread Net Wt. 10 oz (286g) jar, UPC 6 19193 00501 5 Manufactured by Bella Cucina Artful Food Atlanta, GA 30310
    Category
    Food
    Distribution
    45 states
  • HighFDA (Food)·F-0095-2023·2022-11-09

    Bella Cucina Pastry Tarts Recalled for Undisclosed Milk Allergen

    Bella Cucina Artful Food is recalling Crostata Sweet Butter Pastry Tarts because the label fails to indicate the presence of milk, a major allergen. Affected units were distributed across all U.S. states and internationally.

    Product
    Bella Cucina Artful Food CROSTATA SWEET BUTTER PASTRY TARTS Net Wt. 2.6 oz (73g) box, Distributed by Bella Cucina Artful Food Atlanta, GA 30310 UPC 6 19193 00721 7
    Category
    Food
    Distribution
    45 states
  • HighFDA (Food)·F-0098-2023·2022-11-09

    Bella Cucina Fresh Basil Pesto Recalled for Undisclosed Milk Allergen

    Bella Cucina Artful Food is recalling Fresh Basil Pesto because the label does not disclose milk. The product may cause allergic reactions in consumers with milk allergies.

    Product
    Bella Cucina Artful Food Fresh Basil Pesto Net Wt. 3 oz (84.5g) bag, UPC 6 19193 00211 3 Manufactured by Bella Cucina Artful Food Atlanta, GA 30310
    Category
    Food
    Distribution
    45 states
  • HighFDA (Food)·F-0125-2023·2022-11-09

    Hood and Penn Maid Cottage Cheese Recalled for Possible Plastic Contamination

    HP Hood LLC is recalling Hood and Penn Maid cottage cheese with pineapple and cherry due to possible plastic foreign objects. Affected products have best-by dates between October 24, 2022 and December 12, 2022.

    Product
    Hood Cottage Cheese with Pineapple & Cherry, 16 oz; Penn Maid Cottage Cheese with Pineapple & Cherry, 16 oz
    Category
    Food
    Distribution
    39 states
  • HighFDA (Food)·F-0123-2023·2022-11-09

    Hood Cottage Cheese with Blueberries Recalled for Plastic Contamination

    HP Hood LLC is recalling Hood Cottage Cheese with Blueberries (16 oz) because the product may contain plastic pieces. Affected products have best-by dates between October 24, 2022 and December 12, 2022.

    Product
    Hood Cottage Cheese with Blueberries, 16 oz
    Category
    Food
    Distribution
    39 states
  • HighFDA (Food)·F-0131-2023·2022-11-09

    Lactaid Cottage Cheese Recalled for Plastic Foreign Objects

    HP Hood LLC is recalling Lactaid Cottage Cheese (16 oz) with best-by dates Oct 24 2022 to Dec 12 2022 due to possible plastic contamination. Consumers should discard or return affected products.

    Product
    Lactaid Cottage Cheese, 16 oz
    Category
    Food
    Distribution
    39 states
  • HighFDA (Food)·F-0129-2023·2022-11-09

    Hood Lowfat Cottage Cheese recalled due to plastic foreign objects

    HP Hood LLC is recalling Hood Lowfat Cottage Cheese (16 oz and 24 oz) with best-by dates Oct 24–Dec 12, 2022, because the product may contain plastic foreign objects.

    Product
    Hood Lowfat Cottage Cheese, 16 oz and 24 oz
    Category
    Food
    Distribution
    39 states
  • HighFDA (Food)·F-0127-2023·2022-11-09

    Hood Everything Bagel Cottage Cheese Recalled for Plastic Fragments

    HP Hood LLC is recalling Hood Everything Bagel Cottage Cheese due to the potential presence of plastic fragments. The recall affects approximately 391,824 cases distributed across 37 states with best-by dates from October 24 to December 12, 2022.

    Product
    Hood Everything Bagel Cottage Cheese, 16 oz
    Category
    Food
    Distribution
    39 states
  • HighFDA (Food)·F-0106-2023·2022-11-09

    Bella Cucina Walnut Sage Pesto recalled for undeclared milk allergen

    Bella Cucina Artful Food is recalling Walnut Sage Pesto because milk is present in the product but not declared on the label. Consumers allergic to milk should not consume this product.

    Product
    Bella Cucina Artful Food Walnut Sage Pesto Net Wt. 6 oz (169g) glass jar, UPC 6 19193 00041 6 Manufactured by Bella Cucina Artful Food Atlanta, GA 30310
    Category
    Food
    Distribution
    45 states
  • HighFDA (Food)·F-0132-2023·2022-11-09

    Pasta Salad Products Recalled for Undeclared Cashew Allergen

    Craftology and Dutch Treat Foods pasta salads are recalled due to undeclared cashew allergen. The products were distributed in Michigan.

    Product
    Craftology This Is My Happy Place Handcrafted Pasta Salad 14oz clear plastic clamshell, UPC 8 55034 00649 4, 6 units per wholesale case. Dutch Treat Foods Sweet Pea Pasta Salad 10 pound case (2, 5 pound plastic bags per case), 20 pound and 30 pound buckets
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0119-2023·2022-11-09

    HP Hood Chive Cottage Cheese Recalled for Plastic Contamination

    HP Hood LLC is recalling chive cottage cheese sold under multiple store brands due to potential plastic contamination. Approximately 391,824 cases distributed across 37 states.

    Product
    Food Club Chive Cottage Cheese, 16 oz; Hannaford Chive Cottage Cheese, 16 oz; Hood Chive Cottage Cheese, 16 oz and 24 oz; Price Chopper Chive Cottage Cheese, 16 oz; Market Basket CChive Cottage Cheese, 16 oz
    Category
    Food
    Distribution
    39 states
  • HighFDA (Food)·F-0120-2023·2022-11-09

    Cottage Cheese Products Recalled for Possible Plastic Foreign Objects

    Multiple cottage cheese brands are recalled due to possible plastic foreign objects. The recall affects 391,824 cases distributed to 38 states.

    Product
    Hannaford Cottage Cheese, 16oz and 24 oz; Hood Country Style Cottage Cheese, 16 oz, 24 oz., 32 oz.; Hood Large Curd Cottage Cheese, 16 oz; IGA Cottage Cheese, 16 oz; IGA Large Curd Cottage Cheese, 16 oz; Market Basket Cottage Cheese, 16 oz, 24 oz; Weis Cottage Cheese, 16 oz and 2
    Category
    Food
    Distribution
    39 states
  • HighFDA (Drugs)·D-0037-2023·2022-11-09

    Injectable hormone medication recalled for sterility assurance failure

    Pharmacy Plus, Inc. dba Vital Care Compounder is recalling Medroxyprogesterone Acetate 300 mg/mL suspension due to lack of sterility assurance. The product was produced in a manner that cannot guarantee sterility of the injectable medication.

    Product
    MEDROXYPROGESTERONE ACETATE 300 MG/ML Suspension, 10 mL vial, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
    Category
    Drug
    Distribution
    4 states
  • HighFDA (Drugs)·D-0040-2023·2022-11-09

    Moxifloxacin Preservative-Free Eye Drops Recalled for Sterility Assurance Failure

    Pharmacy Plus, Inc. is recalling Moxifloxacin 0.15 mg/0.1 mL preservative-free eye drops in 1 mL syringes due to lack of assured sterility. FDA inspection found the manufacturing process could not guarantee the product's sterility.

    Product
    MOXIFLOXACIN PRESERVATIVE FREE SYR, 0.15 mg/0.1 mL, Sterile Solution, 1 mL syringes, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
    Category
    Drug
    Distribution
    4 states
  • HighFDA (Food)·F-0130-2023·2022-11-09

    Hood Lowfat Cottage Cheese with Peaches Recalled for Plastic Foreign Objects

    HP Hood LLC recalls Hood Lowfat Cottage Cheese with Peaches due to possible plastic foreign objects. Affected products have best-by dates between October 24, 2022 and December 12, 2022.

    Product
    Hood Lowfat Cottage Cheese with Peaches
    Category
    Food
    Distribution
    39 states
  • HighFDA (Drugs)·D-0033-2023·2022-11-09

    Glycerin Ophthalmic Drops Recalled Due to Sterility Manufacturing Concerns

    Pharmacy Plus, Inc. dba Vital Care Compounder is recalling Glycerin Ophthalmic Drops 98.5% Solution because manufacturing methods cannot guarantee the sterility of the product. Products affected are distributed in Alabama, Louisiana, Mississippi, and Tennessee.

    Product
    GLYCERIN OPHTHALMIC DROPS 98.5% Solution, 10 mL droptainer, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
    Category
    Drug
    Distribution
    4 states
  • HighFDA (Drugs)·D-0026-2023·2022-11-09

    Acetylcysteine eye drops recalled for sterility assurance defect

    Pharmacy Plus Inc. is recalling acetylcysteine 10% eye drop solution due to manufacturing issues that cannot guarantee sterility. Lot 66895 was distributed in Alabama, Louisiana, Mississippi, and Tennessee.

    Product
    ACETYLCYSTEINE OPTH 10% Solution, 15 mL droptainers, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
    Category
    Drug
    Distribution
    4 states
  • HighFDA (Drugs)·D-0043-2023·2022-11-09

    Pharmacy Compounded Injection Recalled for Sterility Assurance Failure

    Pharmacy Plus, Inc. dba Vital Care Compounder is recalling a compounded injectable medication because manufacturing did not ensure sterility. The product was distributed in Alabama, Louisiana, Mississippi, and Tennessee.

    Product
    PAPAVERINE / PHENTOLAMINE / PROSTAGLANDIN INJ 150MG/10MG/100MCG/ BOTTLE SOLUTION, 5 ML vial, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
    Category
    Drug
    Distribution
    4 states
  • HighFDA (Drugs)·D-0046-2023·2022-11-09

    Injectable Papaverine/Phentolamine Recalled Due to Sterility Assurance Failure

    Pharmacy Plus, Inc. is recalling 242 vials of papaverine/phentolamine injection because FDA inspection found the products were produced in conditions that cannot guarantee sterility. The affected lots were distributed to AL, LA, MS, and TN.

    Product
    PAPAVERINE / PHENTOLAMINE INJECTION 150MG / 5MG / VIAL SOLUTION, 10 mL vials, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
    Category
    Drug
    Distribution
    4 states
  • HighFDA (Drugs)·D-0051-2023·2022-11-09

    Prescription eye drops recalled due to sterility assurance defect

    Vital Care Compounder is recalling 378 droptainers of PRED ACETATE/GATIFLOXACIN eye drops distributed in AL, LA, MS, and TN due to inability to guarantee manufacturing sterility. No illnesses have been reported.

    Product
    PRED ACETATE / GATIFLOXACIN 1% / 0.5% SUSP, 10 mL droptainers, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
    Category
    Drug
    Distribution
    4 states
  • HighFDA (Drugs)·D-0031-2023·2022-11-09

    FDA Recalls Cefuroxime Intravitreal Injections for Sterility Defect

    Pharmacy Plus Inc. recalls 460 syringes of compounded Cefuroxime intravitreal solution distributed in Alabama, Louisiana, Mississippi, and Tennessee due to manufacturing sterility defect.

    Product
    CEFUROXIME INTRAVITREAL SYR 1MG/0.1ML Solution in 1 mL syringe, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
    Category
    Drug
    Distribution
    4 states
  • HighFDA (Drugs)·D-0038-2023·2022-11-09

    Methylcobalamin Injection Recalled for Lack of Sterility Assurance

    Pharmacy Plus, Inc. dba Vital Care Compounder is recalling 514 vials of methylcobalamin injection solution. FDA inspection found manufacturing conditions that do not assure sterility.

    Product
    METHYLCOBALAMIN PF 1 ML Injection Solution 5,000 MCG/ML Solution, 1 mL vials, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
    Category
    Drug
    Distribution
    4 states
  • HighFDA (Drugs)·D-0048-2023·2022-11-09

    Compounded Injectable Medication Recalled for Lack of Sterility Assurance

    Vital Care Compounder is recalling an injectable medication (Papaverine/Phentolamine/Prostaglandin) because FDA inspection found production methods cannot guarantee product sterility. The recalled lot was distributed in Alabama, Louisiana, Mississippi, and Tennessee.

    Product
    PAPAVERINE/PHENTOLAMINE/PROSTAGLANDIN INJ 150/5/50MCG / VIAL SOLUTION, 10 mL vials, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
    Category
    Drug
    Distribution
    4 states
  • HighFDA (Drugs)·D-0044-2023·2022-11-09

    Compounded Injectable Drug Recalled Due to Sterility Assurance Defect

    A compounded injectable medication containing papaverine, phentolamine, and prostaglandin was recalled after FDA inspection found it was not produced under conditions that guarantee sterility. The product was distributed in Alabama, Louisiana, Mississippi, and Tennessee.

    Product
    PAPAVERINE / PHENTOLAMINE / PROSTAGLANDIN INJ 75MG/2.5MG/50MCG/ BOTTLE SOLUTION, 5 ML vial, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
    Category
    Drug
    Distribution
    4 states
  • HighFDA (Drugs)·D-0041-2023·2022-11-09

    Compounded injectable medication recalled for lack of sterility assurance

    Pharmacy Plus Inc. (Vital Care Compounder) is recalling compounded PAP/PHEN/PROSTAG/ATROPINE injections distributed in four states due to manufacturing conditions that cannot guarantee product sterility.

    Product
    PAP/PHEN/PROSTAG/ATROPINE INJ 150MG/7.5MG/75MCG/1MG bottle solution, 5 mL vials, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
    Category
    Drug
    Distribution
    4 states
  • HighFDA (Drugs)·D-0053-2023·2022-11-09

    Semaglutide Injection Recalled Due to Sterility Assurance Deficiency

    The FDA is recalling semaglutide injection from Vital Care Compounder for lack of assurance of sterility. The recall affects specific lots distributed in Alabama, Louisiana, Mississippi, and Tennessee.

    Product
    SEMAGLUTIDE INJECTION 5MG/ML (0.25MG/0.05ML) SOLN, various amounts in unit dose vials, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
    Category
    Drug
    Distribution
    4 states
  • HighFDA (Drugs)·D-0029-2023·2022-11-09

    Compounded sterile drug solution recalled due to manufacturing sterility failure

    Vital Care Compounder is recalling Brilliant Blue G Solution due to inability to assure product sterility. The recall involves 86 vials (Lot 60448) distributed in Alabama, Louisiana, Mississippi, and Tennessee.

    Product
    BRILLIANT BLUE G, 0.04% Solution, 2 mL vials, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
    Category
    Drug
    Distribution
    4 states
  • HighFDA (Drugs)·D-0056-2023·2022-11-09

    FDA Recalls Vancomycin Intravitreal Injections for Sterility Defect

    Pharmacy Plus Inc. is recalling vancomycin intravitreal eye injections due to FDA findings that sterility cannot be assured. The products were produced in a manner that does not guarantee they remain sterile.

    Product
    VANCOMYCIN INTRAVITREAL 1MG/0.1ML SOLUTION, 0.5 mL syringes, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
    Category
    Drug
    Distribution
    4 states
  • HighFDA (Drugs)·D-0036-2023·2022-11-09

    Lidocaine-Epinephrine Injectable Solution Recalled for Sterility Assurance Issues

    Vital Care Compounder is recalling 7 syringes of Lidocaine-Epinephrine solution due to lack of sterility assurance. FDA inspection found the products cannot be guaranteed to be sterile.

    Product
    LIDOCAINE EPINEPHRINE BUFFERED 2%/1:1000 Solution, 10 mL syringe, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
    Category
    Drug
    Distribution
    4 states
  • HighFDA (Drugs)·D-0045-2023·2022-11-09

    Injectable Drug Recalled Over Failure to Assure Product Sterility

    Vital Care Compounder is recalling a compounded injectable medication due to FDA findings that the manufacturing process failed to guarantee sterility. Two lots were distributed in Alabama, Louisiana, Mississippi, and Tennessee.

    Product
    PAPAVERINE / PHENTOLAMINE / PROSTAGLANDIN INJ 90MG/3MG/29.4MCG/ BOTTLE SOLUTION, 5 ML vial, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
    Category
    Drug
    Distribution
    4 states
  • HighFDA (Drugs)·D-0035-2023·2022-11-09

    Lidocaine/Phenylephrine Injectable Solution Recalled for Sterility Defect

    Pharmacy Plus Inc.'s Lidocaine/Phenylephrine injectable solution is recalled due to manufacturing process deficiencies that cannot guarantee product sterility. The recall affects 389 syringes distributed in Alabama, Louisiana, Mississippi, and Tennessee.

    Product
    LIDOCAINE/PHENYLEPHRINE PF SYR 1%/1.5% Solution, 3 mL syringes, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
    Category
    Drug
    Distribution
    4 states
  • HighFDA (Devices)·Z-0162-2023·2022-11-09

    Medline Lithotomy Sterile Surgical Kit Recalled for Compromised Breather Pouch Seal

    Medline is recalling 96 sterile surgical kits (REF DYNJ50099C, Lot 22DBL482) distributed nationwide due to complaints of openings in breather pouches that compromise sterility and increase contamination risk.

    Product
    MEDLINE LITHOTOMY, REF DYNJ50099C. Convenience kit used in medical/surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0152-2023·2022-11-09

    Implantable Defibrillator Software Error Causes Inaccurate Battery Display

    Boston Scientific's EMBLEM MRI S-ICD implantable defibrillators contain a software defect with an incorrect manufacturing date that causes inaccurate battery capacity display. The recall affects 142 devices distributed worldwide.

    Product
    EMBLEM MRI S-ICD, Subcutaneous Implantable Defibrillator, Model A219, sterile.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0174-2023·2022-11-09

    BD Nexiva IV Catheter May Leave Needle Tip Exposed During Withdrawal

    The BD Nexiva Closed IV Catheter System tip shield may separate prematurely during needle withdrawal, leaving the needle tip exposed. This affects 56,080 units distributed across multiple U.S. states.

    Product
    BD Nexiva Closed IV Catheter System - Single Port REF 383516 20 GA X1.0o in (1.1 x 25 mm) 61 mL/min (3660 mL/hr)
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Devices)·Z-0150-2023·2022-11-09

    STRATAFIX Absorbable Sutures Recalled for Wrong Needle Type

    Ethicon recalls STRATAFIX absorbable sutures after discovering some packages contain the wrong needle type. The PS-1 cutting edge needle instead of the intended SH taper point needle may cause more tissue trauma than anticipated.

    Product
    STRATAFIX SPIRAL PGA-PCL UNI UD 20CM USP2-0(M3) S/A SH. indicated for use in soft tissue approximation where the use of absorbable sutures is appropriate. Product No.: SXMD1B405-12
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0025-2023·2022-11-09

    Ranibizumab eye implant recalled for non-functioning delivery system

    Genentech is recalling Susvimo ocular implants (452 units nationwide) due to manufacturing defects in the drug delivery system. A few patients have experienced non-functioning implants.

    Product
    SUSVIMO — SUSVIMO (RANIBIZUMAB)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0173-2023·2022-11-09

    BD Multitest 6-Color TBNK tubes recalled for partial label detachment

    BD Multitest 6-Color TBNK tubes are being recalled due to partial label detachment. The defect can cause tubes to stick together or lead to automation errors when used with the flow cytometer's automated loader.

    Product
    BD Multitest 6-Color TBNK with optional BD Trucount Tubes (Cat. No. 662995), for use with BD FACSLyric, BD FACSCanto II, and BD FACSCanto flow cytometers to determine the percentages and absolute counts of human lymphocyte subsets in peripheral whole blood for immunophenotyping.
    Category
    Medical Device
    Distribution
    43 states
  • HighNHTSA·22V828000·2022-11-04

    Forest River Recalls 2022-2023 East to West Alta Travel Trailers

    Forest River is recalling 2022-2023 East to West Alta travel trailers because side marker lights may not reflect light as intended, reducing visibility.

    Product
    EAST TO WEST — EAST TO WEST ALTA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·23034·2022-11-03

    BLACK+DECKER Garment Steamers Recalled for Burn Hazard from Hot Water

    Empower Brands recalls about 518,500 BLACK+DECKER Model HGS011 Easy Garment Steamers because they can expel, spray, or leak hot water during use, posing a burn hazard. The company has received 241 reports of hot water expelling, including 32 reports of burn injuries.

    Product
    BLACK+DECKER Model HGS011 Easy Garment Steamers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·23033·2022-11-03

    Tangame Busy Toy Houses Recalled for Lead Paint and Phthalate Violations

    Tangame Busy Houses, wooden activity toy cubes sold on Amazon, contain lead paint on a zipper, lead in a plastic phone cord, and phthalates in a horn bulb, exceeding federal safety bans. No injuries have been reported.

    Product
    Tangame Busy Houses
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·23032·2022-11-03

    FUUL Lamp Oil Recalled for Non-Child-Resistant Packaging and Labeling Failures

    FHS Retail is recalling about 1,700 units of FUUL 1.9L Pure Liquid Paraffin Lamp Oil because the packaging is not child-resistant and the label omits mandatory safety information required by federal law. The product can cause fatal chemical pneumonia or lung damage if ingested.

    Product
    FUUL 1.9L Pure Liquid Paraffin Lamp Oil
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·23036·2022-11-03

    Clarks Women's Navy Canvas Shoes Recalled for Chemical Hazard

    Clarks Americas is recalling three styles of women's navy canvas shoes sold from February to October 2022 because prolonged contact with the shoe material can expose wearers to toxic chemicals benzidine and/or dimethoxybenzidine.

    Product
    Breeze Ave, Breeze Shore and Breeze Step women's shoes in navy colors
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·23709·2022-11-03

    Rad Power Bikes RadWagon 4 Electric Cargo Bikes Recall

    Rad Power Bikes is recalling about 29,300 RadWagon 4 electric cargo bikes because the tires can unexpectedly go flat or separate, risking falls and crashes. The firm has received 137 reports of tire failures and eight injury reports.

    Product
    RadWagon 4 Electric Cargo Bikes
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·23031·2022-11-03

    Bolt Foldable Children's Scooters Recalled for Excessive Lead Paint

    Anker Play Products is recalling about 5,000 Bolt Foldable Children's Scooters sold at discount stores from March through May 2022. The paint contains lead levels exceeding the federal ban, creating a lead poisoning hazard for young children.

    Product
    Bolt Foldable Children's Scooters
    Category
    Consumer Product
    Distribution
    Distributed nationwide

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