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.

10626–10650 of 88183

  • HighFDA (Devices)·Z-0249-2025·2024-11-06

    Surgical patties and strips recalled for endotoxin contamination

    Integra LifeSciences is recalling surgical patties and strips due to higher-than-expected endotoxin levels in raw materials. The contamination may have resulted in out-of-specification finished products.

    Product
    SURG STRP 1/4X6 Model/Catalog Number: 801450. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous system, during surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0079-2025·2024-11-06

    Reser's Chicken Quesadilla Meal Kit Recalled for Listeria Contamination

    Reser's Fine Foods is recalling Bistro 28 Chicken Quesadilla Express Meal Kits distributed across 30 states due to potential Listeria monocytogenes contamination in the cooked chicken.

    Product
    Item 407121, UPC 13454 38496, Bistro 28 Chicken Quesadilla Express Meal Kit. Make 3 Quesadilla. Ready in 4 MIN. Net wt. 22.5 oz (1 LB 6.5 OZ) 638g. Distributed by Fresh Creative Foods, Vista, CA. Case GTIN 10013454384968, Case UPC 13454 38496, Bistro 28 Chicken Quesadilla…
    Category
    Food
    Distribution
    30 states
  • HighFDA (Devices)·Z-0252-2025·2024-11-06

    Surgical Patties and Strips Recalled for Endotoxin Contamination

    Integra LifeSciences is recalling surgical patties and strips due to higher-than-expected endotoxin levels in raw material, which may result in out-of-specification endotoxin in finished products.

    Product
    SURG STRP 1X6-200 Model/Catalog Number: 801453. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous system, during surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0080-2025·2024-11-06

    Bistro 28 Chicken Burrito Bowl Express Meal Kit recalled for Listeria

    Reser's Fine Foods is recalling Bistro 28 Chicken Burrito Bowl Express Meal Kits distributed across 31 states due to Listeria monocytogenes contamination in the cooked chicken. No illnesses have been reported.

    Product
    Item 407119, UPC 13454 38494, Bistro 28 Chicken Burrito Bowl Express Meal Kit. Ready in 5 MIN. Net wt. 25 oz (1 LB 9 OZ) 788g. Distributed by Fresh Creative Foods, Vista, CA. Case GTIN 10013454384944, Case UPC 13454 38494, Bistro 28 Chicken Burrito Bowl Express Meal Kit.…
    Category
    Food
    Distribution
    30 states
  • ModerateFDA (Devices)·Z-0283-2025·2024-11-06

    West Pharmaceutical Recalls Vial2Bag Advanced Devices Due to Sterile Barrier Risk

    West Pharmaceutical Services is recalling Vial2Bag Advanced 20mm Admixture Devices because heat exposure during shipping may have compromised the sterile barrier.

    Product
    Brand Name: Vial2Bag Advanced¿ Product Name: Vial2Bag Advanced¿ 20mm Admixture Device Model/Catalog Number: 6070030 Software Version: Not applicable Product Description: The Vial2Bag Advanced 20mm Admixture Device is a single use, fluid transfer device that allows for the…
    Category
    Medical Device
    Distribution
    33 states
  • ModerateFDA (Devices)·Z-0260-2025·2024-11-06

    Surgical tracking device patient labels show incorrect expiration date

    Patient label stickers on Insight Base Flex tracking device snaps have incorrect expiration dates. The stickers show manufacturing date instead of actual expiration date, though the correct date appears on carton and pouch labels.

    Product
    Product Name: Insight Base Flex - 8, Ref 608-3TX; The device consists of a sterile Snap that includes reflective features that facilitate imaging of the (attached) instrument using instrument tracking technology when used with a compatible tracking system. Each TrackX¿ Snap has…
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-0271-2025·2024-11-06

    King LTSD Oropharyngeal Airway Recalled for Pediatric Indication Exemption

    King Systems Corp. dba Ambu, Inc. is recalling 42,605 units of King LTSD Oropharyngeal Airways due to exceeding 510(k) exemption limitations.

    Product
    KING LTSD,SIZE 2,W/SUCTION PORT STERILE-Inserted into a patient s pharynx through the mouth to provide patent airway. Model/Catalog Number: KLTSD422
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0070-2025·2024-11-06

    International Delight Peppermint Mocha Mislabeled as Zero Sugar Product Recall

    DANONE US LLC is recalling Home Alone International Delight Peppermint Mocha Zero Sugar beverages because the product is labeled as zero sugar but actually contains sugar. The recall affects 1,799 cases distributed across multiple states.

    Product
    Home Alone International Delight Peppermint Mocha Zero Sugar, 32oz plastic bottle, 6 bottles per case. Refrigerated.
    Category
    Food
    Distribution
    13 states
  • ModerateFDA (Devices)·Z-0272-2025·2024-11-06

    King LTSD Oropharyngeal Airway Recalled for Pediatric Indication Limitation

    King Systems Corp. is recalling 31,457 units of King LTSD oropharyngeal airways because the device exceeded 510(k) exemption limitations by introducing a new pediatric indication.

    Product
    KING LTSD,SIZE 2.5, W/SUCTION PORT STERILE-Inserted into a patient s pharynx through the mouth to provide patent airway. Model/Catalog Number: KLTSD4225
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0258-2025·2024-11-06

    17-OH Progesterone ELISA Kit Recalled for Labeling Discrepancy

    DRG International is recalling 504 units of its 17-OH Progesterone ELISA kit (Model EIA-1292) due to mismatched control acceptance ranges between the Certificate of Analysis and component labels, causing test failure.

    Product
    17-OH Progesterone ELISA 96 well kit- An enzyme immunoassay for the quantitative in vitro diagnostic measurement of 17-OH Progesterone (17-OHP) in serum or plasma Model/Catalog Number: EIA-1292
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0276-2025·2024-11-06

    KING LTSD Oropharyngeal Airway Kit Recalled for Unapproved Pediatric Use

    King Systems Corp. is recalling KING LTSD airway kits (Model KKLTSD4325) because they were marketed for pediatric use without FDA approval for that indication. Approximately 36,727 units were distributed nationwide.

    Product
    KING LTSD,SIZE 2.5, W/SUCTION PORT NON-STERILE KIT-Inserted into a patient s pharynx through the mouth to provide patent airway. Model/Catalog Number: KKLTSD4325
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0076-2025·2024-10-30

    Aespire 7900 Anesthesia Gas Machine Recalled Over Breathing Circuit Misconnection Risk

    Datex-Ohmeda has recalled 12,036 Aespire 7900 anesthesia gas machines worldwide due to potential risk of patient breathing circuit being mistakenly connected to the Auxiliary Common Gas Outlet port.

    Product
    Aespire 7900. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by medical professionals trained and qualified in the administration of general anesthesia.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0074-2025·2024-10-30

    Aespire 7100 Anesthesia Machines Recalled for Breathing Circuit Misconnection

    Datex-Ohmeda is recalling 20,097 Aespire 7100 series anesthesia machines because a patient breathing circuit can be mistakenly connected to the wrong outlet (ACGO port) instead of the intended connection point.

    Product
    Aespire 7100, 7100 (Variant), and Aespire 7100 S/5 Protiva configurations. These anesthesia gas machines are intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by medical professionals trained and qualified in the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0218-2025·2024-10-30

    Baxter TruSystem 7000 Operating Tables Recalled for Electrical Short-Circuits

    Baxter Healthcare is recalling 13 TruSystem 7000 operating tables because their batteries and connectors experienced electrical short-circuits and emitted smoke.

    Product
    Baxter Operating Table TruSystem 7000 U14 (MBW) V, Product code REF 2065386
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0075-2025·2024-10-30

    Aespire 100 anesthesia machine breathing circuit misconnection FDA recall

    Datex-Ohmeda Aespire 100 anesthesia machines are recalled due to potential misconnection of breathing circuit limbs to the Auxiliary Common Gas Outlet port, which could impair anesthesia or ventilation delivery.

    Product
    Aespire 100. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by medical professionals trained and qualified in the administration of general anesthesia.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0081-2025·2024-10-30

    Anesthesia Machine Recall Due to Patient Breathing Circuit Misconnection Risk

    Datex-Ohmeda Aisys anesthesia machines may allow patient breathing circuits to be incorrectly connected to the Auxiliary Common Gas Outlet, potentially affecting ventilation during anesthesia. Approximately 4,790 units worldwide are affected.

    Product
    Aisys. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by medical professionals trained and qualified in the administration of general anesthesia.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0077-2025·2024-10-30

    Datex-Ohmeda Aespire View Anesthesia Machines Recalled for Connection Error Risk

    Datex-Ohmeda is recalling 10,338 Aespire View anesthesia machines due to a potential issue where a patient breathing circuit limb may be mistakenly connected to the Auxiliary Common Gas Outlet port.

    Product
    Aespire View. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by medical professionals trained and qualified in the administration of general anesthesia.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0046-2025·2024-10-30

    Life2000 Ventilator May Fail to Alarm on Low Gas Pressure

    Baxter Healthcare recalls Life2000 Ventilators due to potential Low Gas Pressure alarm failure. The alarm may not activate if the gas source isn't connected before therapy begins.

    Product
    Welch Allyn Life2000 Ventilation System, REF MS-01-0118, within exterior carton codes: 1) BT-20-0002, 2) BT-20-0002A, 3) BT-20-0002AP, 4) BT-20-0007, 5) BT-20-0011, and 6) RMS010118CP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0080-2025·2024-10-30

    Anesthesia gas machines pose risk of breathing circuit misconnection

    Avance CS2 and Avance CS2 Pro anesthesia machines may permit breathing circuit misconnection to the wrong gas outlet. Affected devices have the AGCO option and are distributed worldwide.

    Product
    Avance CS2 and Avance CS2 Pro. These anesthesia gas machines are intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by medical professionals trained and qualified in the administration of general anesthesia.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0083-2025·2024-10-30

    Aisys CS2 Anesthesia Machine Breathing Circuit Misconnection Hazard

    Datex-Ohmeda's Aisys CS2 anesthesia machine may pose a risk if a patient breathing circuit limb is mistakenly connected to the Auxiliary Common Gas Outlet port. Ninety-two units worldwide are affected in this FDA Class I recall.

    Product
    Aisys CS2 with Et Control. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by medical professionals trained and qualified in the administration of general anesthesia.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0079-2025·2024-10-30

    Amingo Anesthesia System: Risk of Breathing Circuit Misconnection to Auxiliary Outlet

    Datex-Ohmeda Amingo anesthesia systems may allow a patient breathing circuit to be mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) instead of the proper outlet. The potential misconnection affects all 77 units worldwide.

    Product
    Amingo. OUS only.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0078-2025·2024-10-30

    Anesthesia Gas Machine Recall: Breathing Circuit Misconnection Risk

    Datex-Ohmeda is recalling Avance anesthesia gas machines worldwide due to a potential hazard if a patient's breathing circuit is incorrectly connected to the Auxiliary Common Gas Outlet port during setup.

    Product
    Avance. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by medical professionals trained and qualified in the administration of general anesthesia.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0082-2025·2024-10-30

    Aisys CS2 Anesthesia Machine Recall: Breathing Circuit Misconnection Risk

    Datex-Ohmeda is recalling approximately 15,739 Aisys CS2 anesthesia machines worldwide. A breathing circuit limb may be mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) port instead of the intended connection point.

    Product
    Aisys CS2. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by medical professionals trained and qualified in the administration of general anesthesia.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0084-2025·2024-10-30

    Datex-Ohmeda Auxiliary Common Gas Outlet Conversion Kits Recalled

    Datex-Ohmeda is recalling 649 Auxiliary Common Gas Outlet (ACGO) conversion kits due to a potential issue if a patient breathing circuit limb is mistakenly connected to the ACGO port.

    Product
    Auxiliary Common Gas Outlet (ACGO) conversion/install kits sold under product names CONV KIT SCGO TO ACGO and ACGO ASSY FIELD INSTL. These kits are not affected specifically, however are included due to being purchased with or later used to convert to ACGO.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0054-2025·2024-10-30

    Lactaid Lactose Reduced Milk Recalled for Undeclared Almond Allergen

    HP Hood LLC is recalling Lactaid Lactose Reduced milk products because they may contain undeclared almond from almond milk. People with almond allergies face serious health risks.

    Product
    Lactaid Lactose Reduced milk 1. 96 oz Lactaid Whole Milk 2. 96 oz Lactaid 2% Milk 3. 96oz Lactaid 1% Milk 4. 96oz Lactaid Fat Free Milk (1607) 5. 96oz Lactaid 2% Calcium Enriched Milk (15567)
    Category
    Food
    Distribution
    27 states