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.

7626–7650 of 88183

  • HighFDA (Devices)·Z-1916-2025·2025-06-18

    Medical Device Convenience Kits Recalled for Ethylene Oxide Residual Contamination

    American Contract Systems, Inc. is recalling convenience kits containing cast padding due to elevated ethylene oxide and ethylene chlorohydrin residuals that may cause loss of functionality and delay treatment.

    Product
    LOWER EXTREMITY, Model: NCEX20I; LOWER EXTREMITY, Model: NCEX20J; TOTAL KNEE PACK, Model: NCTK31K; TOTAL KNEE PACK, Model: NCTK31L All convenience kits contain Specialist Blend Cast Padding, Item: QTX30-322NS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1965-2025·2025-06-18

    iBOT PMD Personal Mobility Device Software Update Recall

    Mobius Mobility LLC is recalling 442 units of the iBOT PMD (Personal Mobility Device) with software version 01.05.24 due to a software issue that could cause the device to tip over during Balance Mode operation.

    Product
    iBOT PMD with software version 01.05.24. Personal Mobility Device.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0040-2025·2025-06-18

    Tortilla Products Recalled for Undeclared Soy Allergen

    Tortilleria Xpress Inc is recalling multiple tortilla products due to undeclared soy allergen. Consumers with soy allergies who purchased these products should not consume them.

    Product
    Tortilla de mesa with 12 units per package, Tortilla Pirata with 10 units per package, Tortilla cruda especial with 20 units per package, Tortilla Cruda Pirata with 20 units per package
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1957-2025·2025-06-18

    KWIK-STICK Quality Control Kit for Culture Media Swab Mix-Up

    Microbiologics Inc is recalling KWIK-STICK quality control kits because products were packaged with incorrect microorganism swabs, which may lead to delayed diagnosis of patient samples in clinical laboratories.

    Product
    KWIK-STICK, Quality control kit for culture media, Catalog Numbers 01065K, Oligella urethralis derived from ATCC¿ 17960; 0621K, Staphylococcus aureus derived from NCTC 12493
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1974-2025·2025-06-18

    BD TEXIUM Closed Male Luer Devices Recalled for Leaking Interface Risk

    BD TEXIUM closed male luer drug transfer devices may leak at the interface between the closed male luer component and the needle-free connector, potentially causing procedure delays, treatment interruptions, hazardous drug exposure, and medication underdosing.

    Product
    BD TEXIUM CLOSED MALE LUER WITH FEMALE CAP, REF: 10012241; BD TEXIUM (China), REF: 10012241 CHINA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1948-2025·2025-06-18

    Solana Bordetella Complete Assay Kit Recalled for False Positive Results

    Ortho-Clinical Diagnostics is recalling the Solana Bordetella Complete Assay Kit (Model M308) because it may produce false positive results for Bordetella parapertussis at a rate of up to 16.7%.

    Product
    Brand Name: Solana¿ Bordetella Complete Assay Product Name: Solana Bordetella kit Model/Catalog Number: M308 Software Version: not applicable Product Description: One sales unit (kit) contains materials for 48 tests. One kit contains 48 tubes of 1.45 mL Process Buffer and…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1962-2025·2025-06-18

    Baxter Healthcare 2.5V Rechargeable Batteries for PocketScope Handles

    Baxter Healthcare is recalling 2.5V rechargeable batteries for Welch Allyn PocketScope handles due to potential short circuits that can cause excessive heat and user burns.

    Product
    2.5 V replacement rechargeable batteries for Hillrom WELCH ALLYN PocketScope handles, Product Code 72600
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1914-2025·2025-06-18

    Stryker Gamma4 Long Nail with incorrect left-nail geometry recalled

    Stryker GmbH is recalling a specific lot of Gamma4 Right Long Nails (Catalog Number 84250320S) because they were manufactured with left-nail geometry instead of right-nail geometry, which could affect surgical fit and function.

    Product
    Long Nail, RIGHT Gamma4 10x320mm x 125, component of the Gamma4 System. Catalog Number: 84250320S.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0929-2025·2025-06-18

    Gluten Free Vegan Peanut Butter Jam Cookie recalled for undeclared sesame

    Sweetheart USA, LLC is recalling Gluten Free Vegan Peanut Butter Jam Cookies because the product contains undeclared sesame, a common allergen. The recall affects 53 units distributed to 11 restaurants in Ohio.

    Product
    Gluten Free Vegan Peanut Butter Jam Cookie, Net Wt. 3.5 oz (200g), packaged individually in plastic
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1949-2025·2025-06-18

    Tecfen Medical 15 degree Stab Knife sterility assurance recall

    Tecfen Medical is recalling its 15 degree Stab Knife (Model QKN1501) due to sterility assurance concerns. The ophthalmic knife is used in eye surgeries and was distributed in the US and internationally.

    Product
    Brand Name: Tecfen Medical Product Name: 15 degree Stab Knife Model/Catalog Number: QKN1501 Software Version: No software Product Description: This is an ophthalmic knife (manual) that is to be sterile (gamma radiation) and packaged individually in Tyvek 1059B. Stab knives…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1919-2025·2025-06-18

    Kendall SCD Blended Comfort Sleeves Recalled for Software Logic Error

    Cardinal Health is recalling Kendall SCD Blended Comfort Sleeves (Knee Length Small, SKU 84021B) due to incorrect software logic that may cause frequent E1 errors. The issue may delay treatment or therapy.

    Product
    Kendall SCD Blended Comfort Sleeves Knee Length Small - For use with Kendall SCD SmartFlow SKU 84021B Kendall SCD Small Comfort sleeves when used with the Kendall SCD Smartflow Controller
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-1925-2025·2025-06-18

    Digital Acquisition Box Electrode Placement Labels Applied Backwards

    Natus Neurology has recalled the OBM00002 OBM DAB (Digital Acquisition Box) because electrode placement labels were applied backwards. This may lead to misdiagnosis of seizure location in neonates monitored with the device.

    Product
    Brand Name: OBM00002 OBM DAB (Digital Acquisition Box) Product Name: OBM00002 OBM DAB (Digital Acquisition Box) Model/Catalog Number: OBM00002 OBM DAB (Digital Acquisition Box) Software Version: N/A Product Description: OBM00002 OBM DAB (Digital Acquisition Box) Component…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0017-2025·2025-06-18

    Rocky Road Ice Cream 1.5 qt with Mislabeled Tree Nut Allergen

    Unilever Manufacturing is recalling Rocky Road Ice Cream due to conflicting allergen labeling—the tub says "may contain tree nuts" while the lid declares almonds are present. Consumers with tree nut allergies may be at risk.

    Product
    Rocky Road Ice Cream packaged in a Breyer Chocolate Truffle Tub that says "may contain tree nuts" with a Breyers Rocky Road Ice Cream Lid that declares almonds as an ingredient. 1.5 qt
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-0934-2025·2025-06-18

    Instant Milk Tea Powder lacks milk allergen declaration

    R&M Trading LLC is recalling Instant Milk Tea Original Flavor because the label does not declare milk, despite containing whey powder and sodium caseinate, which are milk-derived ingredients.

    Product
    Instant Milk Tea Original Flavor, R&M Refresher brand, B0D71YHZX4, net wt. 1lb. Product is sold in 1-pack or 3-pack. Parent ASIN #B0D728CZWS 1-pack ASIN #B0D71YHZX4 3-pack ASIN #B0D72BLQRW Label declares Ingredients: Non-Dairy Creamer (Glucose Syrup, Vegetable Oil, Whey…
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1918-2025·2025-06-18

    Kendall SCD Comfort Sleeves Pediatric Knee Length Software Error Recall

    Kendall SCD Comfort Sleeves Knee Length Small Pediatric models may experience frequent E1 errors due to incorrect software logic, potentially delaying treatment or therapy.

    Product
    Kendall SCD Comfort Sleeves Knee Length Small, Pediatric - For use with Kendall SCD SmartFlow, SKU 84021P Kendall SCD Small Comfort sleeves when used with the Kendall SCD Smartflow Controller
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Food)·F-0935-2025·2025-06-18

    Instant Milk Tea Brown Sugar Powder recalled for undeclared milk allergen

    R&M Refresher brand Instant Milk Tea Brown Sugar Flavor is recalled because the ingredients contain milk (Whey Powder, Sodium Caseinate) but the label does not declare milk as an allergen.

    Product
    Instant Milk Tea Brown Sugar Flavor, R&M Refresher brand, B0D725TXQW, net wt. 1lb. Product is sold in 3-pack. Parent ASIN #B0D728CZWS 3-pack ASIN #B0D72FQVDR Ingredients: Non-Dairy Creamer (Glucose Syrup, Vegetable Oil, Whey Powder, Sodium Caseinate***). Product of China.…
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1920-2025·2025-06-18

    SOLTIVE Pro SuperPulsed Laser System surgical instrument thermal incident

    Olympus Corporation of the Americas is recalling the SOLTIVE Pro SuperPulsed Laser System due to risk of unexpected smoke, sparks, burning, or unsteady flames caused by fiber fracturing during clinical use.

    Product
    Brand Name: Powered Laser Surgical Instrument Product Name: SOLTIVE Pro SuperPulsed Laser System Model/Catalog Number: TFL-SLS, TFL-SLS-JA (Japan only); Product Description: SOLTIVE Laser Systems use technology to increase procedural efficiency and flexibility to…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1940-2025·2025-06-18

    Femoral Nail RIGHT T2 GTN 8x300 mm labeled incorrectly

    Stryker GmbH is recalling Femoral Nail RIGHT T2 GTN 8x300 mm devices because some lots were labeled as left or right but contained the opposite orientation.

    Product
    Femoral Nail, RIGHT T2 GTN 8x300 mm. Catalog Number: 1851-0830S.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·H-0042-2025·2025-06-18

    Supreme Produce Apple & PB Snack Cup Recalled for Plastic

    GBC Food Services is recalling Supreme Produce Apple & PB Snack Cup due to possible plastic foreign material in the product. Affected units were distributed in GA, MI, IN, and TN with Best By dates from 4/12/2025 to 5/6/2025.

    Product
    Supreme Produce Apple & PB Snack Cup. Net Wt: 8oz (226g). Keep Refrigerated. UPC 8 50065-403 1. GBC Food Services, 14043 Distribution Way, Farmers Branch, Texas
    Category
    Food
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-1926-2025·2025-06-18

    DxI 9000 Access Immunoassay Analyzer software version 1.20 recall

    Beckman Coulter is recalling certain DxI 9000 Access Immunoassay Analyzers due to incorrect motor/encoder and cable installation that causes error codes, prevents assays from running, and delays result generation.

    Product
    DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, running software versions 1.20
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1937-2025·2025-06-18

    BD BBL CultureSwab EZ Collection and Transport System Swabs Breakage

    BD BBL CultureSwab EZ Collection and Transport System (REF 220144) is being recalled because swabs may break during use. The recall affects units distributed nationwide in Maryland.

    Product
    BD BBL CultureSwab EZ Collection and Transport System, REF 220144, in vitro Diagnostic, SterileR, Rx Only
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·H-0015-2025·2025-06-18

    Comvita Manuka Honey Cordyceps recalled for faulty packaging seal

    Comvita Manuka Honey + Cordyceps is being recalled due to a leaking induction seal on the packaging. The defect affects approximately 2,730 units distributed across multiple states.

    Product
    Comvita branded Manuka Honey + Cordyceps for energy; made in New Zealand, Net Wt. 12 fl oz (355g); Barcode# 658196001037
    Category
    Food
    Distribution
    7 states
  • ModerateFDA (Food)·H-0014-2025·2025-06-18

    Comvita Manuka Honey Lion's Mane product recall packaging defect

    Comvita Manuka Honey + Lion's Mane for Focus is recalled due to a leaking induction seal on the packaging. Approximately 2,730 units distributed across multiple U.S. states are affected.

    Product
    Comvita branded Manuka Honey + Lion's Mane for Focus; made in New Zealand, Net Wt. 12 fl oz (355g); Barcode# 658196001020
    Category
    Food
    Distribution
    7 states
  • ModerateFDA (Food)·H-0016-2025·2025-06-18

    Comvita Manuka Honey + Reishi recalled for leaking induction seal

    Comvita Manuka Honey + Reishi is recalled due to a leaking induction seal on the packaging. The product may not be properly sealed.

    Product
    Comvita branded Manuka Honey + Reishi; made in New Zealand, Net Wt. 12 fl oz (355g); Barcode# 658196001013
    Category
    Food
    Distribution
    7 states
  • ModerateFDA (Drugs)·D-0469-2025·2025-06-18

    Cephalexin Oral Suspension Recalled for Failed Impurities Specifications

    Ascend Laboratories is recalling Cephalexin for Oral Suspension due to an out-of-specification result in impurity testing that identified Cephalexin Glucose Adduct during stability analysis.

    Product
    CEPHALEXIN — CEPHALEXIN (CEPHALEXIN)
    Category
    Drug
    Distribution
    Distributed nationwide