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.

11851–11875 of 88183

  • HighFDA (Devices)·Z-2576-2024·2024-08-21

    Medical paracentesis procedure kits recalled for syringe leaks and breakage

    Merit Medical is recalling paracentesis procedure kits nationwide containing syringes with identified leaks and breakage. The defects may pose a risk to patient health during medical procedures.

    Product
    Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Safety Paracentesis Procedure Tray (Paracentesis Tray kit), REF: SPPT-100/D SPPT-5F-10/D SPPT-5F-10L/B SPPT-5F-10S SPPT-5F-12PL SPPT-5F-17PL SPPT-5F-7/D…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2621-2024·2024-08-21

    Surgical Lighting Equipment Recalled for Cracked Welds and Frame Detachment Risk

    Aurora Series surgical light heads are recalled due to cracked welds on the frame. The defects can cause the frame to sag, housing to crack, or the light head to detach.

    Product
    Aurora 4 Series, Aurora 7 lighthead; Models: AUA7 (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-2573-2024·2024-08-21

    Merit Medical Convenience Kits Recalled Due to Defective Syringes

    Merit Medical convenience kits containing recalled plastic syringes have quality issues including leaks and breakage that may pose risks during vascular and cardiac procedures. Approximately 5,700 affected kits were distributed nationwide.

    Product
    Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Custom Procedure Kit (Angiography/Angioplasty kit), REF: OPT0242-00 S1279-01 S2953 S2960 S6002 To support various vascular or cardiac diagnostic and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2586-2024·2024-08-21

    Heated Eye Mask Recalled Due to Detachable Wires and Burn Risk

    EYE COMFORT CARE LLC is recalling the UNclog Eye Mask due to safety clips that may allow wires to detach, potentially causing electrical shorts and burn injuries.

    Product
    Brand Name: UNclog Eye Mask Product Name: UNclog Eye Mask Model/Catalog Number: AG23JW24 Serial # ag22 Product Description: Heated eye mask Component: Heating unit, wire
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2571-2024·2024-08-21

    Merit Medical Convenience Kits with Recalled Syringes Pose Leak Risk

    Merit Medical is recalling 900 convenience kits containing plastic syringes due to identified leaks, breakage, and quality issues that may pose a risk to patient health.

    Product
    Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: SafeSheath CSG (Introducer Catheter), REF: FCL-069-00/A FCL-069-02/A FCL-069-03/A For the introduction of various types of pacing or defibrillator leads and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2572-2024·2024-08-21

    Merit Medical Convenience Kits with Defective Syringes Recalled

    Merit Medical convenience kits containing defective syringes are being recalled for 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: Prelude Prestige (Introducer Catheter), REF: PLP-2505/A PLP-2514/A PLP-2516/A The introduction of various types of pacing/defibrillator leads and catheters…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2574-2024·2024-08-21

    Merit Medical cardiac kits contain plastic syringes with quality defects

    Merit Medical convenience kits used in cardiac procedures contain plastic syringes with potential leaks and breakage. The defects were identified following an FDA Safety Alert issued March 19, 2024.

    Product
    Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Prelude SNAP (Introducer Catheter kit), REF: For the introduction of various types of pacing leads and catheters to the heart and coronary venous system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2583-2024·2024-08-21

    HeartMate 3 System Controller membrane may lift, risking fluid damage and device failure

    Thoratec LLC is recalling 694 HeartMate 3 System Controllers because the UI membrane may lift along the housing, allowing fluid entry that could damage internal circuits and cause loss of power or pump failure.

    Product
    HeartMate 3 System Controllers provided within the following HeartMate 3 Left Ventricular Assist System (LVAS) Implant Kits or distributed separately: HeartMate 3 LVAS Implant Kit, US, Model: 106524US; HeartMate 3 LVAS Implant Kit, OUS, Model: 106524INT; HeartMate 3 System…
    Category
    Medical Device
    Distribution
    42 states
  • HighFDA (Devices)·Z-2568-2024·2024-08-21

    Merit Medical convenience kits recalled for syringe leaks and breakage risks

    Merit Medical is recalling convenience kits containing syringes with quality defects including leaks and breakage. The recalled kits may pose a risk to patients undergoing vascular and cardiac procedures.

    Product
    Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K22C (Vein Tray Angiography kit), REF: K09T-11796F K12T-01558G K12T-01558H K12T-01822 K12T-01852L K12T-02006J K12T-02054 K12T-02091G K12T-02102B…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2585-2024·2024-08-21

    Medical Device Recall: BD Kiestra Urine Culture Software May Cause Inaccurate Results

    Becton Dickinson & Co. is recalling the BD Kiestra Urine Culture Application due to a software issue that may cause inaccurate bacterial colony counts. This could impact patient diagnosis and treatment decisions.

    Product
    BD Kiestra Urine Culture Application Powered by BD Synapsys Informatics Solution; Catalog (Ref): 444900;
    Category
    Medical Device
    Distribution
    17 states
  • HighFDA (Food)·F-1702-2024·2024-08-21

    Full Circle Frozen Dessert Recalled for Undeclared Cashew Allergen

    Full Circle Coconut Milk Chocolate Almond Crunch frozen dessert is recalled due to undeclared cashews. Product labels show mismatch: carton states 'coconut milk' but top states 'cashew milk,' and product contains cashew milk.

    Product
    FULL CIRCLE market COCONUTMILK CHOCOLATE ALMOND CRUNCH NON0DAIRY FROZEN DESSERT 16 FLOZ (1PT) 473 mL UPC 0 36800 46964 8 DISTRIBUTED BY TOPCO ASSOCIATES LLC ELK GROVE VILLAGE, IL 60007
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-2584-2024·2024-08-21

    Cepheid Sample Collection Device May Leak Causing Cross-Contamination Risk

    Cepheid specimen collection devices may leak after patient samples are inserted, creating risk of biohazard exposure and false positive test results. Affected devices are distributed in medical testing facilities worldwide.

    Product
    Cepheid, Sample Collection Device, Part: 900-0370
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2578-2024·2024-08-21

    Merit Medical convenience kits with recalled plastic syringes may leak or break

    Convenience kits from Merit Medical Systems containing recalled plastic syringes have identified 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: Customer Procedure Kit (Angiography/Angioplasty kit), REF: K09T-01138 K09T-04484A K09T-04757F K09T-04835H K09T-07256D K09T-07588B K09T-07611K K09T-07649K…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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 (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 (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 (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…
    Category
    Food
    Distribution
    7 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-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 (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-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
  • 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…
    Category
    Medical Device
    Distribution
    34 states
  • 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