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.

23576–23600 of 88183

  • HighFDA (Food)·F-1372-2022·2022-07-06

    Walnut Product Misidentified as Nutritional Yeast Due to Labeling Error

    Honey Heaven Wholesale Inc is recalling 48 bags of walnut product labeled as Nutritional Yeast due to mislabeling. The misidentification poses a potential allergen risk to consumers with tree nut allergies.

    Product
    The content inside package is walnut but was mis-labeled as Nutritional Yeast and packaged in a stand up plastic pouch. Net Weight: 0.6lb (272g). UPC: 616316762060 The label is read in parts: "***Brand Name: Hummingbird ***Organic Nutritional Yeast Large Flake***".
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1386-2022·2022-07-06

    BBQ Sauce Mislabeled as Vegan Despite Containing Fish Allergen

    Blue Kuna BBQ Sauce labeled as vegan contains anchovies (fish), a common allergen. This mislabeling poses a risk to consumers with fish allergies.

    Product
    Blue Kuna Taste of Devil's Night Heat Infused BBQ Sauce, 16 oz
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1291-2022·2022-07-06

    Stryker INFINITY Resect Guide Recalled for Incorrect Color Coding

    Wright Medical is recalling 35 units of the Stryker INFINITY Resect Guide for INBONE Talus (Model #33620254) due to incorrect color coding. The color coding error could lead to misidentification and improper use during ankle surgery.

    Product
    Stryker INFINITY Resect Guide for INBONE Talus, Size 4, Model #33620254, non-sterile, an instrument used with the INFINITY Total Ankle System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1306-2022·2022-07-06

    NaviCare Nurse Call System Cancels Patient Calls During Wireless Use

    The NaviCare Nurse Call system software (versions 3.9.100-3.9.300) has a wireless integration defect causing patient calls to be canceled when answered on wireless phones. The issue affects 283 installations in the US and Canada.

    Product
    NaviCare Nurse Call/Voalte Nurse Call
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1307-2022·2022-07-06

    Yukon Straight Rod spinal implants recalled for discoloration and contamination

    K2M Inc. is recalling certain Yukon Straight Rod spinal implants due to discoloration from trace amounts of inorganic phosphorous compound. The contaminated devices may cause mild irritation or adverse tissue reactions.

    Product
    Yukon Straight Rod 4.0 x120mm; Cat# 7601-540120. Used to provide immobilization and stabilization of spinal segments.
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-1310-2022·2022-07-06

    FDA Recalls TEG 5000 Fibrinogen Reagent Kits Due to Outdated Reference Ranges

    Haemonetics Corporation is recalling TEG 5000 Functional Fibrinogen Reagent kits because the reference ranges in the instructions have shifted. Clinicians using these outdated ranges could misdiagnose patients or fail to provide necessary treatment.

    Product
    TEG 5000 Functional Fibrinogen Reagent, Item No. 07-034
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1308-2022·2022-07-06

    Surgical Light Paint Particles May Fall Into Operating Field

    Paint particles may detach from VOLISTA StandOP Surgical Lights and fall into the operating field during surgery, risking infection and organ irritation. Getinge Usa Sales Inc is recalling 337 affected units in the United States.

    Product
    VOLISTA StandOP Surgical Light, Product Code/Part Numbers ARD568811901 VLT600SF AIM STP ARD568811911 VLT600SF AIM STP ARD568811961 VLT600DF AIM STP ARDVST229000A VST60SF AIM ARDVST229001A VST60DF AIM ARDVST229002A VST66SF AIM ARDVST229003A VST66DF AIM ARDVST229034A…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1384-2022·2022-07-06

    Wilton Rainbow Sprinkles Mix recalled for milk contamination

    Wilton Industries recalled 16,281 units of Wilton Rainbow Sprinkles Mix due to milk contamination. The affected lots are 21005Z and 21111Z.

    Product
    Wilton Rainbow Sprinkles Mix net wt 5.92 oz. item number 710-0-0627
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1305-2022·2022-07-06

    Laparoscopic irrigator recalled for inability to provide irrigation

    Davol, Inc. is recalling the HydroSurg Plus Laparoscopic Irrigator because the device cannot provide irrigation as intended. The recall affects 4,390 units in the US and 390 in Canada.

    Product
    HydroSurg Plus Laparoscopic Irrigator with Nezhat-Dorsey SmokEvac Trumpet Valve, 33cm Tip and Cojoined Suction and Irrigation Tubing, Catalog Number 0026870
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1387-2022·2022-07-06

    PurAqua Belle Vie Sparkling Water Recalled for Undeclared Caffeine

    PurAqua Belle Vie Sparkling Water with Ashwagandha contains undeclared caffeine. The product was distributed to 17 states and poses potential risk for caffeine-sensitive consumers.

    Product
    PurAqua Belle Vie SPARKLING WATER wellness RELAX 100mg ASHWAGANDHA PER 12 FL OZ STRAWBERRY CUCUMBER FLAVORED SPARKLING WATER WITH OTHER NATURAL FLAVORS 12 FL OZ (355mL) CAN UPC: 4099100315622
    Category
    Food
    Distribution
    17 states
  • HighFDA (Devices)·Z-1299-2022·2022-07-06

    Radiation therapy software shows misleading dose display in RayStation 11B

    RayStation 11B radiation therapy planning software has two display issues affecting Linear Energy Transfer values. These errors could lead to incorrect dose calculations if not identified during clinical review.

    Product
    RayStation 11B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1170-2022·2022-07-06

    Calcipotriene Scalp Solution Recalled Due to Defective Delivery System

    Akorn, Inc. is recalling Calcipotriene Topical Solution 0.005% (Scalp Solution) nationwide due to a defective delivery system that could prevent the product from dispensing properly.

    Product
    Calcipotriene Topical Solution, 0.005% (Scalp Solution), Rx only, 60 mL (2 fl. oz.) bottle, Manufactured by: HI-TECH PHARMACAL CO., INC., Amityville, N.Y. 11701. NDC: 50383-732-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1301-2022·2022-07-06

    IVUS Catheter Recall: Missing Contraindications in Instructions

    Volcano Corp is recalling Visions PV. 035 Digital IVUS Catheters because instructions for use do not include contraindications information. Healthcare providers should contact the manufacturer for complete safety documentation before use.

    Product
    Volcano Visions PV. 035 Digital IVUS Catheter REF 88901, PN: 300005384002 Rx Only, Sterile EO, CE 2797
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1302-2022·2022-07-06

    Digital IVUS Catheter Recalled for Missing Contraindication Information

    Volcano Corp is recalling 7,520 units of the Volcano Visions PV. 035 Digital IVUS Catheter due to missing contraindication information in the instructions for use. The IFU lacks details about situations where the device should not be used.

    Product
    Volcano Visions PV. 035 Digital IVUS Catheter REF 81234, PN: 300007367341 , Rx Only, Sterile EO, CE 2797
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1288-2022·2022-07-06

    FDA recalls MAC laryngoscope sets due to packaging error

    Baxter Healthcare Corporation is recalling MAC laryngoscope devices due to a packaging error. The recall affects 99 units distributed worldwide.

    Product
    #1 MAC F/O LARYNGOSCOPE; F/O Laryngoscope Set-MAC; F/O Laryngoscope Set-MAC W/LED
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1171-2022·2022-07-06

    Desmopressin Acetate Tablets recalled for manufacturing process deviations

    Glenmark Pharmaceuticals voluntarily recalls 36 bottles of Desmopressin Acetate Tablets (0.2 mg) due to manufacturing process deviations. The recall affected one distributor in Texas.

    Product
    Desmopressin Acetate Tablets, 0.2 mg, 100-count bottles, Rx Only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Colvale-Bardez, Goa 403513, India, NDC 16714-884-01
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1303-2022·2022-07-06

    Fresenius Optiflux 200NRe Dialyzers Recalled Due to Temperature Exposure

    Fresenius Medical Care is recalling 19 cases of Optiflux 200NRe dialyzers distributed in Pennsylvania after exposure to cold temperatures outside safe storage ranges. Affected lot number is 22AU04017.

    Product
    Optiflux 200NRe Dialyzer Finished Assy., Model no. 0500320E
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1339-2022·2022-06-29

    Peanut Butter Fudge Recalled Due to Potential Salmonella Contamination

    Calico Cottage Inc is recalling Peanuttiest Caramel Chocolate fudge nationwide because the peanut butter ingredient may be contaminated with Salmonella.

    Product
    1. PEANUTTIEST CARAMEL CHOCOLATE P-MADE(6SS)6LB NT WT - not consumer packaging, bulk carton
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1353-2022·2022-06-29

    Giai Phat Fried Featherback Fish Ball Recalled for Undeclared Egg

    Chaur Fong Inc. is recalling Giai Phat Fried Featherback Fish Ball (10 oz bags) because the product contains undeclared egg, a major allergen not disclosed on the label.

    Product
    Giai Phat Fried Featherback Fish Ball NET WT. 10 oz. (283g) Keep Product Refrigerated at 38F or Below/May Be Frozen Ingredients: Fish meat (may contain surimi (Japanese Threadfin Bream Fish, Sugar, Polyphosphate) Lady Fish and or Featherback Fish), Water, Tapioca Flour, Salt…
    Category
    Food
    Distribution
    3 states
  • CriticalFDA (Food)·F-1352-2022·2022-06-29

    Fish ball product recalled for undeclared egg allergen (FDA Class I)

    Giai Phat featherback fish balls are recalled for undeclared egg allergen. Products were distributed to California, Illinois, and Idaho.

    Product
    Giai Phat Featherback Fish Ball NET WT. 11 oz. (312g) Ingredients: Fish meat (may contain Surimi (Japanese Threadfin Bream, Sugar, Polyphosphate) Lady Fish and or Featherback Fish) Water, Tapioca Flour, Salt, Monosodium Glutamate, Garlic Powder, White Pepper, Baking Powder…
    Category
    Food
    Distribution
    3 states
  • CriticalFDA (Food)·F-1329-2022·2022-06-29

    Albertsons Deli Snack Peanut Butter & Trail Mix Recalled for Salmonella Risk

    Albertsons Companies is recalling Deli Snack Peanut Butter & Trail Mix products for potential Salmonella contamination. Affected products have sell-through dates on or before May 26, 2022.

    Product
    Deli Snack Peanut Butter & Trail Mix Combo. Product were available for purchase at the following banners: Albertsons, Carrs-Safeway, Eagle, Randalls, Safeway, Tom Thumb. Packaged in clear plastic square bottom and lid. Net wt. 9 oz.
    Category
    Food
    Distribution
    32 states
  • CriticalFDA (Food)·F-1354-2022·2022-06-29

    Frozen Cuttle Fish Balls Recalled for Undeclared Egg Allergen

    Giai Phat Cuttle Fish Balls (8 oz bags) are recalled due to undeclared egg. Approximately 335,401 bags were distributed in California, Illinois, and Idaho.

    Product
    Giai Phat Cuttle Fish Ball NET WT. 8 oz. (227g) Keep Frozen Open Package Before Thawing Item # 31108 Ingredients: Cuttle Fish, Surimi (Japanese Threadfin Bream Fish, Sugar, Polyphosphate), Water, Tapioca Flour, Salt, Monosodium Glutamate, Garlic Powder, White Pepper, Baking…
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Food)·F-1333-2022·2022-06-29

    Ready-to-Eat Peanut Butter Snack Recalled for Potential Salmonella Contamination

    Albertsons Companies LLC is recalling Ready Meals Quad Peanut Butter Apple Celery Pretzel products due to potential Salmonella contamination. The products were sold at multiple retail banners nationwide with sell-through dates up to May 24, 2022.

    Product
    Ready Meals Quad Peanut Butter Apple Celery Pretzel. Product were available for purchase at the following banners: Albertsons, Andronico's Community Markets, Carrs-Safeway, Eagle, Jewel-Osco, Lucky, Pak 'N Save, Randalls, Safeway, Tom Thumb, Vons. Packaged in clear plastic…
    Category
    Food
    Distribution
    32 states
  • SevereFDA (Food)·F-1355-2022·2022-06-29

    Frozen Giai Phat Shrimp Balls Recalled for Undeclared Egg Allergen

    Giai Phat Shrimp Ball packages may contain undeclared egg allergen, posing a risk to consumers with egg allergies. The FDA Class I recall affects 335,401 bags distributed to California, Illinois, and Idaho.

    Product
    Giai Phat Shrimp Ball NET Wt. 7 oz. (198g) Keep Frozen Open Packaging Before Thawing Item #30108 Ingredients: Shrimp (surimi), Water, Tapioca Flour, Salt, Sugar, Monosodium, Glutamate, Garlic Powder, White Pepper, Baking Powder, Spice, Sesame Oil, and Red #40 Food Color…
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Food)·F-1349-2022·2022-06-29

    Crabmeat recall due to possible Listeria monocytogenes contamination

    Irvington Seafood is recalling crabmeat products packaged in 16-ounce plastic cups due to possible Listeria monocytogenes contamination. Affected products were distributed in Alabama, Georgia, Louisiana, and Mississippi.

    Product
    Irvington Seafood Crabmeat: Jumbo, Lump, Finger, Claw packaged in 16oz plastic cups - 40lbs per case
    Category
    Food
    Distribution
    4 states