The Recall Desk

Agency

U.S. Food and Drug Administration

The FDA regulates food, drugs, biologics, medical devices, and tobacco. We aggregate Class I, II, and III enforcement actions across its three recall streams.

Visit the official FDA site →

About FDA recalls

The FDA is the single biggest source of US product recalls by volume. Its enforcement workload splits into three streams — Foods (everything from infant formula to leafy greens to nutritional supplements), Drugs (prescription medicines, over-the-counter products, and active pharmaceutical ingredients), and Medical Devices (everything from implants to home blood-pressure monitors). The Recall Desk ingests all three from the openFDA enforcement endpoint every six hours.

FDA classifies every recall as Class I, II, or III. Class I means there is a reasonable probability that using the product will cause serious health consequences or death — these are the recalls you should treat as urgent. Class II means the product may cause temporary or medically reversible harm. Class III means the product is unlikely to cause adverse health consequences but still violates FDA rules. We map these classifications into our 1–5 severity score using the rubric on the methodology page.

Medical-device recalls are the highest-volume stream by far — software-update letters, calibration corrections, and IFU updates all show up in enforcement reports alongside genuine hazard recalls. We try to surface the severe ones first, but when in doubt, click through to the FDA notice itself for the clinical detail.

21901–21925 of 88183

  • 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 (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-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 (Devices)·Z-0151-2023·2022-11-09

    Boston Scientific EMBLEM S-ICD Subcutaneous Defibrillators Software Defect Causes Battery Display Error

    Boston Scientific is recalling 7 EMBLEM S-ICD Model A209 subcutaneous defibrillators due to a software defect that displays inaccurate battery capacity information. Patients may not realize when their device's battery requires replacement.

    Product
    EMBLEM S-ICD, Subcutaneous Implantable Defibrillators, Model A209, sterile.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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 (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 (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 (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 (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-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 (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-0155-2023·2022-11-09

    Surgical Eye Kit Pouches Recalled for Seal Defects

    Medline recalls Bausch + Lomb Eye surgical kits due to breather pouches with openings in the seal. Affected kits were distributed to healthcare facilities nationwide; unopened kits should not be used.

    Product
    BAUSCH + LOMB EYE PACK, REF LYN003EYSPA. Convenience kit used in surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-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
  • 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 (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 (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 (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-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-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 (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 (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 (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 (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 (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