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.

15901–15925 of 27263

  • HighFDA (Devices)·Z-2181-2023·2023-07-26

    Medline Probe Cover Kits Recalled for Inadequate Seam Barriers

    Medline is recalling probe cover kits with ultrasound gel due to inadequate barriers at the seams that may compromise sterility during diagnostic ultrasound procedures.

    Product
    Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) BLOCK SUPPLIES NDL CNTR, Model Number DYNJRA1755; b) VNUS TEST KIT CFP-LF, Model Number DYNJTESTCFP4; c) ULTRASOUND PIV BUNDLE, Model Number IV8635D; d) ULTRASOUND GUIDED PIV KIT, Model
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1276-2023·2023-07-26

    Fry Daddy's Original Party Mix recalled for undeclared walnut

    Fry Daddy's Original Party Mix is recalled due to undeclared walnut. Approximately 10,343 retail units were distributed in Michigan with sell-by dates from June 1, 2023 through December 31, 2023.

    Product
    Fry Daddy's Original Party Mix 3.75oz and 12oz bags UPCs 860007991509 and 850047648006. 12 bags per wholesale case
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1290-2023·2023-07-26

    Frozen Salmon Spread Recalled for Incomplete Allergen Labeling

    Kenai Red Fish Company is recalling Frozen Wild Alaska Smoked Salmon Spread due to incomplete allergen labeling. The label does not properly declare the presence of salmon and anchovies, major fish allergens that could affect consumers with fish allergies.

    Product
    Frozen Wild Alaska Smoked Salmon Spread packaged in 6 oz. (net weight) rigid plastic tubs. Product packed in 10 units per case. Product is labeled in part, "***KENAI*RED FISH COMPANY***WILD ALASKA SMOKED SALMON SPREAD KEEP FROZEN - STIR & REFRIGERATE AFTER OPENING Ingredients: W
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2206-2023·2023-07-26

    Medline O.R. Scissors Recalled Due to Sterile Packaging Compromise Risk

    Medline is recalling approximately 189,221 surgical scissors because they were manufactured without a tip protector, allowing them to break through sterile packaging and compromise product sterility.

    Product
    Medline O.R. Scissors, S/B, Sterile, 5.5, Model #DYND04000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2158-2023·2023-07-26

    Medline Ultrasound Probe Covers Recalled for Inadequate Seam Barriers

    Medline Industries is recalling approximately 23,938 units of sterile ultrasound probe cover kits distributed worldwide from December 2017 to May 2023 due to inadequate barriers at seams that could compromise sterility during diagnostic ultrasound procedures.

    Product
    Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) NERVE BLOCK ACCESSORY PACK, Model Number DYNJRA1220; b) PERI NEURO BLOCK PACK-LF, Model Number DYNJRA1773; c) PERI NEURO BLOCK PACK-LF, Model Number DYNJ51107B; d) PERI NEURO BLOCK PAC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2200-2023·2023-07-26

    Medline Ultrasound Probe Covers Recalled for Inadequate Seam Barrier

    Medline Industries is recalling 70,648 ultrasound probe cover kits used in diagnostic and interventional procedures due to inadequate barriers at the seams.

    Product
    Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) ARTERIAL LINE START KIT , Model Number ART920; b) ULTRASOUND GUIDED PIV KIT , Model Number BSIPIV1005; c) ULTRASOUND GUIDED IV START KIT W/SHIELD , Model Number BSIPIV1006; d) PIV BSI
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2182-2023·2023-07-26

    Medline Probe Cover Kits Recalled Due to Inadequate Seam Barrier

    Medline is recalling Probe Cover Kits (Models CVI4325 and DT13351A) distributed worldwide from December 2017 to May 2023. The probe covers may have inadequate barrier protection at the seams, posing a contamination risk during diagnostic ultrasound procedures.

    Product
    Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) UNIVERSAL INSERTION TRAY, Model Number CVI4325; b) PPE BUNDLE KIT, Model Number DT13351A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2170-2023·2023-07-26

    Medline Ultrasound Probe Cover Kits Recalled for Inadequate Seam Barriers

    Medline is recalling probe covers used in ultrasound procedures that may have inadequate seam barriers. No illnesses have been reported.

    Product
    Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) BREAST BIOPSY KIT, Model Number DYNDA1224B; b) U/S CORE BIOPSY KIT, Model Number DYNDH1121C; c) BIOPSY PACK, Model Number DYNDH1124; d) REVAMP BIOPSY TRAY, Model Number DYNDH1147A; e
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2212-2023·2023-07-26

    UFSK Treatment Chair 500 XLE Seat Drive Failure Risk

    The UFSK Treatment chair 500 XLE's electrical seat drive may wear unexpectedly, causing the chair to fail to hold position while the patient is seated in an inclined position. Healthcare facilities should contact the manufacturer regarding affected units.

    Product
    UFSK Treatment chair 500 XLE- Treatment chair for positioning and support of the patient during diagnostic and therapeutic treatments of temporary to short-term duration, especially in ophthalmology Art.no. / REF no.: 15000004 Art.no. / REF no.: 15000006
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0939-2023·2023-07-26

    Famotidine tablets recalled for carton labeling error on strength

    Glenmark Therapeutics is recalling famotidine 20 mg tablets after some cartons were labeled with a side label indicating 10 mg instead. The medication inside is correct; only the external carton label is mislabeled.

    Product
    FAMOTIDINE — FAMOTIDINE (FAMOTIDINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0924-2023·2023-07-26

    Loteprednol Etabonate Eye Drops Recalled for Out-of-Specification Potency

    Sun Pharmaceutical recalls Loteprednol Etabonate eye drops due to out-of-specification unit dose content in certain lots. Affected bottles may contain incorrect potency levels.

    Product
    LOTEPREDNOL ETABONATE — LOTEPREDNOL ETABONATE (LOTEPREDNOL ETABONATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2146-2023·2023-07-26

    Aesculap Surgical Needle Recalled for Incorrect Product Code Marking

    Aesculap Implant Systems is recalling Aesculap Surgical Needles (MD610) because they are etched with an incorrect product code. The needles are marked MD611 when they should be marked MD610.

    Product
    Aesculap Surgical Needle, straight, 3 1/2", (90 mm), 13GA, width: 2,400 mm, non-sterile, reusable Article Number: MD610
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0927-2023·2023-07-26

    FDA Recalls Phenylephrine HCl IV Solution Over Manufacturing Contamination

    Advanced Compounding Solutions is recalling 82 bags of phenylephrine HCl intravenous solution due to potential contamination from manufacturing facility violations. No illnesses have been reported.

    Product
    PHENYLephrine HCl 10mg added to 0.9% Sodium Chloride 250mL, 250 mL IV Bag @60 Total volume), RX only, Advanced Compounding Solutions, 4 Constitution Way Ste L Woburn, MA 01801-1042, NDC: 71546-450-25;
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0925-2023·2023-07-26

    Prescription drug recall: Fingolimod capsules fail dissolution specifications

    Ascend Laboratories is recalling 2,652 bottles of Fingolimod capsules nationwide because they failed to meet dissolution specifications, potentially affecting medication effectiveness.

    Product
    FINGOLIMOD — FINGOLIMOD (FINGOLIMOD HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2214-2023·2023-07-26

    Ultrasound reporting software recalled by manufacturer for software issue

    Digisonics has voluntarily recalled OBView ultrasound reporting software versions 4.8.2 SP6 through 4.8.3 due to a software issue. The recall affects 32 units distributed across multiple U.S. states and Aruba.

    Product
    Digisonics OBView Versions 4.8.2 SP6 - 4.8.3, Ultrasound reporting software
    Category
    Medical Device
    Distribution
    19 states
  • CriticalFDA (Food)·F-1240-2023·2023-07-19

    Jumbo Deviled Crabs recalled for undeclared milk and sesame allergens

    SANTOS FROZEN FOODS is recalling Jumbo Deviled Crabs (6oz packages) because they contain undeclared milk and sesame seeds. Consumers with allergies or sensitivities to these allergens should not consume this product.

    Product
    Jumbo Deviled Crabs, 6oz
    Category
    Food
    Distribution
    0 states
  • CriticalFDA (Drugs)·D-0921-2023·2023-07-19

    Artificial Tears Eye Drops Recalled for Bacterial Contamination

    Delsam Pharma's Artificial Tears eye drops are being recalled nationwide due to bacterial contamination found in unopened bottles. Consumers should stop using affected products immediately.

    Product
    Delsam Pharma's ARTIFICIAL TEARS (Carboxymethylcellulose Sodium) Lubricant Eye Drops, 10 MG in 1 ml, 1%, 1/2 fl oz (15 ml) bottle, Distributed By: Delsam Pharma Llc, Bronx, New York 10467, NDC 72570 121 15.
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1236-2023·2023-07-19

    FDA Recalls Rader Farms Organic Fresh Start Smoothie for Hepatitis A

    Rader Farms Organic Fresh Start Smoothie, a frozen fruit and vegetable blend, has been recalled due to potential Hepatitis A contamination. The recall affects 62,380 bags distributed across 31 states.

    Product
    Rader Farms Organic Fresh Start Smoothie Blueberry, Strawberry, Raspberry, Kale, Spinach. Item # 1399671. Frozen, packed into 8oz. flexible plastic pouches and six 8oz pouches are packed into one flexible plastic bag. Net Wt. 48oz. UPC on retail bag: 8 84038 08326 2. A total
    Category
    Food
    Distribution
    32 states
  • CriticalFDA (Drugs)·D-0938-2023·2023-07-19

    Prescription albuterol inhalers recalled nationwide due to defective valve seals

    Cipla USA is recalling 278,538 albuterol sulfate inhalers nationwide with specific lot numbers due to defective valve gaskets that cause empty inhalers or medication leakage. Check your lot number and contact your healthcare provider if affected.

    Product
    ALBUTEROL SULFATE — ALBUTEROL SULFATE (ALBUTEROL SULFATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1242-2023·2023-07-19

    Multiple Pretzel Brands Recalled for Undeclared Milk Allergen

    Honey mustard pretzel products from multiple brands are being recalled due to potential undeclared milk. The recall affects 334,357 bags distributed nationwide.

    Product
    1. Hy-Vee Honey Mustard Braided Pretzels, 10oz poly bags, UPC: 75450-24309, 12 pack; 2. Dakota Style Honey Mustard Pretzel Kravings, 10oz poly bags, UPC 84872-60031, 12 pack and 6 pack; 3. Four Brothers Honey Mustard Pretzels, 10oz poly bags, UPC: 33147-89145, 12 pack; 4. Schn
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1234-2023·2023-07-19

    Frozen fruit blend recalled for potential Hepatitis A contamination

    Great Value Antioxidant Fruit Blend frozen berries are being recalled due to potential Hepatitis A contamination. The affected product was distributed across multiple states through Walmart, HEB, and Costco.

    Product
    Great Value Antioxidant Fruit Blend Strawberries, Blueberries, Raspberries, Pitted Dark Sweet Cherries and Pomegranate Arils. Item # 111097. Frozen, packed into flexible plastic bags. Net wt. 2lbs. 8oz. (40oz). UPC on retail bag: 0 78742 34615 1. A total of 6 sellable units (
    Category
    Food
    Distribution
    32 states
  • SevereFDA (Devices)·Z-2104-2023·2023-07-19

    Spectrum IQ Infusion System False Occlusion Alarm Correction Issued

    The FDA has issued a Class I correction for Baxter's Spectrum IQ Infusion System due to increased false upstream occlusion alarms following software updates. Approximately 19,861 units are affected nationwide.

    Product
    The Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1232-2023·2023-07-19

    Great Value Sliced Strawberries recalled for potential Hepatitis A contamination

    Walmart's Great Value Sliced Strawberries are being recalled due to potential Hepatitis A contamination. Approximately 28,650 bags distributed across 32 states are affected.

    Product
    Great Value Sliced Strawberries. Item # 107356. Frozen, packaged flexible plastic bags. Net wt. 4 lbs (64oz). UPC on retail bag: 0 78742 25387 9. A total of 6 sellable units (4lbs. each) are placed into a case for distribution to retailer. DISTRIBUTED BY: Walmart Inc. Bentonvi
    Category
    Food
    Distribution
    32 states
  • SevereFDA (Food)·F-1241-2023·2023-07-19

    Pretzel products recalled for undeclared milk allergen nationwide

    Dakota Style, Inc. is recalling salt and vinegar pretzel products nationwide because they may contain undeclared milk. Consumers with milk allergies should not consume these products.

    Product
    1. Hy-Vee Salt & Vinegar Braided Pretzels, 10 oz poly bags, UPC: UPC: 75450-27706, 12 pack; 2. Dakota Style Salt & Vinegar Pretzel Kravings, 4.5 oz poly bags, UPC: 84872-60030, 6 pack; 3. Dakota Style Salt & Vinegar Pretzel Kravings, 10 oz poly bags, UPC 84872-60018, 12 pack, 4
    Category
    Food
    Distribution
    Distributed nationwide