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.

9951–9975 of 27089

  • HighFDA (Devices)·Z-2619-2024·2024-08-21

    Surgical Lights Recalled for Possible Weld Defect and Frame Detachment

    DKK Dai-Ichi Shomei Co., Ltd. is recalling 822 Aurora surgical light heads due to a weld defect that could cause the light head to sag, crack, or detach during use.

    Product
    Aurora 2 Series, Aurora 7 lighthead; Models: AUR7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2569-2024·2024-08-21

    Merit Medical pericardiocentesis kits recalled for syringe defects

    Merit Medical convenience kits containing plastic syringes have been recalled nationwide. The syringes have quality issues including leaks and breakage that may pose a risk to patient health.

    Product
    Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: PC (Pericardiocentesis Tray - Fluid drainage tray), REF: PC101/B PC801 PC801/A PC802 PC802/A The Pericardiocentesis Kit is intended to withdraw fluid from
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2558-2024·2024-08-21

    Merit Medical Convenience Kits with Recalled Syringes Pose Quality Risks

    Merit Medical is recalling convenience kits containing syringes with quality defects including leaks and breakage that may pose patient safety risks in cardiac and vascular procedures.

    Product
    Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Custom Procedure Kit (Angiography/angioplasty kit), REF: K12T-10773 K12T-09284D K12T-10621 K12T-10800 K12T-12491 To support various vascular or cardiac dia
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1729-2024·2024-08-21

    Pariva Marinated Labneh Bites Recalled Due to Mold Contamination

    Pariva LLC is recalling Pariva Marinated Labneh Bites Za'atar (8 oz) due to potential mold contamination. The product was distributed in seven Northeast states with best-by dates in October or December 2024.

    Product
    Pariva Marinated Labneh Bites Za'atar; NET WT 8 OZ (225g); INGREDIENTS: YOGURT (CULTURED PASTEURIZED GRADE A MILK & CREAM, SKIM MILK, WHEY PROTEIN CONCENTRATE, SALT AND PECTIN), *SUNFLOWER OIL, *EXTRA VIRGIN OLIVE OIL, SESAME SEEDS, SPICES; CONTAINS: MILK, SESAME; Distributed by,
    Category
    Food
    Distribution
    7 states
  • ModerateFDA (Food)·F-1731-2024·2024-08-21

    Pariva Marinated Labneh Bites Recalled for Potential Mold Contamination

    Pariva LLC recalls Marinated Labneh Bites due to potential mold contamination. Approximately 4,261 units were distributed across seven states.

    Product
    Pariva Marinated Labneh Bites Rosemary Garlic; NET WT 8 OZ (225g); INGREDIENTS: YOGURT (CULTURED PASTEURIZED GRADE A MILK & CREAM, SKIM MILK, WHEY PROTEIN CONCENTRATE, SALT AND PECTIN), *SUNFLOWER OIL, *EXTRA VIRGIN OLIVE OIL, ROSEMARY SPICES; CONTAINS: MILK, Distributed by, Mayu
    Category
    Food
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-2580-2024·2024-08-21

    VITROS Folate Reagent Pack Recalled for Delayed Test Results

    Ortho-Clinical Diagnostics is recalling VITROS Folate Reagent Pack due to fibrinogen precipitation causing delayed test results. The recall affects 18,467 units distributed worldwide.

    Product
    VITROS Immunodiagnostic VITROS Folate Reagent Pack 1/2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1705-2024·2024-08-21

    Fox's u-bet Vanilla Syrup Recalled for Potential Microbiological Contamination

    SUBCO Foods is recalling Fox's u-bet Vanilla Flavored Syrup due to bloated bottles and elevated pH and water activity levels that indicate potential microbiological contamination and food-borne illness risk.

    Product
    Fox's u-bet Vanilla Flavored Syrup, 20oz, UPC 070216241016, 12 retail units per wholesale case
    Category
    Food
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-2545-2024·2024-08-21

    Discrete Chemistry Analyzer Recalled Due to Carousel Malfunction

    Beckman Coulter is recalling 59 units of its Access 2 Immunoassay System Analyzer due to misaligned index wheels causing carousel motion errors that disable the analyzer and cancel patient tests.

    Product
    Discrete photometric chemistry analyzer for clinical use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2638-2024·2024-08-21

    PICC Catheter Package Contains Wrong Length, Causing Procedural Delay

    Argon Medical Devices recalls PICC catheters that are mislabeled. Packages marked 26G/1.9Fr x 30cm actually contain 26G/1.9Fr x 50cm catheters, which could delay procedures.

    Product
    L-CATH PICC S/L Peripherally Inserted Central Catheter, 26Ga (1.9F) 0.60mm x 30cm, REF: 384539
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-2622-2024·2024-08-21

    Salivary Testosterone ELISA Quality Control Failure Invalidates Test Results

    DRG International is recalling Salivary Testosterone ELISA kits (Model SLV-3013) due to out-of-range quality controls that invalidate test runs and delay patient results. The recall affects 257 units distributed nationwide in six states.

    Product
    Product Name: Salivary Testosterone ELISA Model/Catalog Number: SLV-3013 Product Description: An enzyme immunoassay for the quantitative in vitro diagnostic measurement of free active testosterone in saliva.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0633-2024·2024-08-21

    Hydrocortisone & Acetic Acid Otic Solution Recalled for Potency and Impurity Failures

    Taro Pharmaceuticals recalled Hydrocortisone 1% & Acetic Acid 2% Otic Solution (lot AD12890) due to failed impurity specifications and lower-than-established active ingredient levels during stability testing.

    Product
    Hydrocortisone 1% & Acetic Acid 2% Otic Solution, 10 mL bottle, Rx only, Mfg by: Taro Pharmaceuticals, Inc., Brampton, Ontario, Canada L6T 1C1, Distributed by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-3007-01
    Category
    Drug
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-2442-2024·2024-08-14

    Medline Medical Procedure Kits Recalled Due to Defective Plastic Syringes

    Medline is recalling over 1.6 million medical procedure kits nationwide and internationally due to plastic syringe defects. The affected kits contain syringes with leaks, breakage, and quality issues that may pose risks to patient health.

    Product
    Medline procedure kits labeled as: 1) CONTINUOUS BLOCK, Pack Number DYNJRA0960C; 2) COMBINED SPINAL AND EPIDURAL, Pack Number DYNJRA1268C; 3) WAL- UNIVERSAL BLOCK TRAY, Pack Number DYNJRA1638C; 4) BASIC DIAGNOSTIC TRAY, Pack Number DYNJRA1928; 5) PREOP NERVE BLOCK TRAY
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1645-2024·2024-08-14

    Bazzini Raw Almond Butter Recalled for Undeclared Peanuts

    Bazzini LLC is recalling 684 jars of Bazzini Raw Almond Butter (Lot code 2E136) due to undeclared peanuts, posing a serious risk to peanut-allergic consumers. The affected product was distributed to retailers in New York.

    Product
    Bazzini Raw Almond Butter Net Wt. 16 oz (454g) UPC Code 7506284009. Packaged in clear plastic jars with plastic white lids. 12 jars per case
    Category
    Food
    Distribution
    1 state
  • CriticalFDA (Food)·F-1678-2024·2024-08-14

    Cubanelle Peppers from Wiers Farm Recalled for Listeria Contamination

    Wiers Farm is recalling specific lots of cubanelle peppers due to potential Listeria monocytogenes contamination. The affected products were distributed across 18 states.

    Product
    Wiers Farm - Cubanelle packaged in 16oz plastic bag - 10 bags in a case
    Category
    Food
    Distribution
    18 states
  • CriticalFDA (Devices)·Z-2446-2024·2024-08-14

    Puritan Bennett 500 Series Ventilators recalled due to volatile organic compound release

    Covidien recalls 34,642 Puritan Bennett 500 Series Ventilators due to release of volatile organic compound (2-propanol, 1,3-dichloro) from gas pathway components during prolonged use beyond 10 years.

    Product
    Puritan Bennett 500 Series Ventilators (Description/REF): PURITAN BENNETT 560 VENTILATOR/4096600, PURITAN BENNETT PB560 VENTILATOR EU-DIV/4096600-01, PURITAN BENNETT 560 VENTILATOR JAPAN/4096600-02, PURITAN BENNETT 560 VENTILATOR APAC/4096600-03, Puritan Bennett 560 Ventilat
    Category
    Medical Device
    Distribution
    34 states
  • CriticalFDA (Food)·F-1683-2024·2024-08-14

    Wiers Farm Organic Yellow Squash Recalled for Listeria Contamination

    Wiers Farm Inc is recalling organic yellow squash in 2-count trays due to Listeria monocytogenes contamination. The recall affects 54 cases distributed across 17 states.

    Product
    Wiers Farm - Organic Yellow Squash packaged into 2 count trays - cases dependent on customer
    Category
    Food
    Distribution
    18 states
  • CriticalFDA (Food)·F-1695-2024·2024-08-14

    Wiers Farm Tomatillos Recalled Due to Listeria Monocytogenes Contamination

    Wiers Farm is recalling 1,467 cases of tomatillos due to Listeria monocytogenes contamination. Affected lot numbers 240705-240712 were distributed across 17 states.

    Product
    Wiers Farm - Tomatillos packaged in 1lb cartons - case size dependent on customer
    Category
    Food
    Distribution
    18 states
  • CriticalFDA (Food)·F-1651-2024·2024-08-14

    Shelled walnuts recalled due to Listeria contamination

    Stutz Packing Company is recalling 2,538 cases of shelled walnuts due to Listeria contamination. The affected product was distributed in Texas and Arizona.

    Product
    Shelled Walnuts 1lb package in plastic flexible packaging. 24 packages per case
    Category
    Food
    Distribution
    2 states
  • CriticalFDA (Food)·F-1677-2024·2024-08-14

    Wiers Farm Poblano Peppers recalled for Listeria contamination

    Wiers Farm Inc is recalling Poblano peppers in 16oz bags due to Listeria monocytogenes contamination. The product was distributed across multiple states.

    Product
    Wiers Farm - Poblano packaged in 16oz plastic bag - 10 bags in a case
    Category
    Food
    Distribution
    18 states
  • CriticalFDA (Food)·F-1671-2024·2024-08-14

    Palmer Candy and Meijer Popcorn Products Recalled for Salmonella

    Palmer & Company is recalling Palmer Candy Drizzled Caramel Corn and Meijer Drizzled Caramel Popcorn Snack Bowls due to potential Salmonella contamination. Products were distributed nationwide in the United States and Canada.

    Product
    1. Palmer Candy Drizzled Caramel Corn, Item 19271, Net Wt. 16/5oz tubs, UPC 77343 19271 2. Meijer Drizzled Caramel Popcorn Snack Bowl, Net Wt. 12oz, UPC 60236 18830, 8/12oz case
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1699-2024·2024-08-14

    Wiers Farm Red Cabbage Recalled for Listeria Contamination

    Wiers Farm Inc is recalling specific lots of red cabbage in 1lb cartons due to Listeria monocytogenes contamination. The affected product was distributed across 16 states.

    Product
    Wiers Farm - Red Cabbage packaged in 1lb cartons - case size dependent on customer
    Category
    Food
    Distribution
    18 states
  • SevereFDA (Food)·F-1654-2024·2024-08-14

    Al'Fez Natural Tahini Recalled for Potential Salmonella Contamination

    Al'Fez Natural Tahini in 5.6oz glass jars is being recalled due to potential Salmonella contamination. The recall affects 3,522 cases distributed nationwide.

    Product
    Al'Fez Natural Tahini in 5.6oz glass jars, UPC 711464506778
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1658-2024·2024-08-14

    Urge! and Casey's Caramel Pretzels Recalled for Potential Salmonella

    Palmer & Company is recalling Urge! Caramel Swirl Pretzels and Casey's Caramel Swirl Coated Pretzels nationwide due to potential Salmonella contamination.

    Product
    1. Urge! Caramel Swirl Pretzels, White Fudge Coated Pretzel Twists Drizzled in Caramel, Net Wt. 6oz, UPC 39779 00417, 8/6oz case 2. Casey's Caramel Swirl Coated Pretzels, Net Wt. 4 oz., UPC 98437 26082, 6/4oz case
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1693-2024·2024-08-14

    Wiers Farm Pickling Cucumbers Recalled for Listeria Contamination

    Wiers Farm Inc is recalling pickling cucumbers due to Listeria monocytogenes contamination. The recall affects 31 cases distributed across multiple states.

    Product
    Wiers Farm - Pickling Cucumber packaged in 1lb cartons - carton size dependent on customer
    Category
    Food
    Distribution
    18 states