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.

10001–10025 of 27206

  • ModerateFDA (Drugs)·D-0640-2024·2024-08-28

    HAND-I-SAN Hand Sanitizer Recalled for Manufacturing Process Deviation

    HAND-I-SAN No-Rinse Hand Sanitizer is being recalled due to manufacturing process deviations involving the use of non-sterile water in production. The product was distributed nationwide and to Canada.

    Product
    HAND-I-SAN, No-Rinse Hand Sanitizer (75% Isopropyl Alcohol), packaged in a) 3.78L (1-gallon jug packaged in a case of 4x1 gallon jugs), b) 18.92L (5-gallon pail), c) 208.19L (55-gallon drum), and d) 1040.98L (275-gallon tote), ZEE Company 3401 Cummings Road, Chattanooga, TN, 374
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2687-2024·2024-08-28

    Dental Digital Analog Products Recalled for Out-of-Specification Rotation

    Preat Corp is recalling 185 dental digital analog products due to out-of-specification rotation affecting inspection accuracy. The devices are used in dental laboratories for visual inspection of abutments and restorations.

    Product
    Multiple Digital Analog Products labeled as: NobelBiocare Tri-Lobe-compatible 6.0mm Digital Analog, REF 9000703 Straumann Tissue-Level-compatible WN Digital Analog, REF 9001303 3i Certain-compatible 5.0mm Digital Analog, REF 9001903 3i Certain-compatible 6.0mm Digital Analog,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2710-2024·2024-08-28

    Medline Procedure Kits Recalled Due to Dimensional Fitting Issues

    Medline is recalling 160 medical procedure kits due to a dimensional variation that may make them difficult to fit into their outer canister. No injuries have been reported.

    Product
    Medline medical procedure kits labeled as follows: a) TURNOVER KIT, REF DYKC1289F
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2691-2024·2024-08-28

    Clinical Chemistry Analyzer Software Issue Causes Delayed Results

    Beckman Coulter clinical chemistry analyzers have a software issue that delays diagnostic results after processing 250 racks. Affected units experience buffer errors and result delays.

    Product
    DxC 500 AU Clinical Chemistry Analyzer, REF C63520 is an automated chemistry analyzer that measures analytes in samples, in combination with appropriate reagents, calibrators, quality control (QC) material and other accessories. This system is for in vitro diagnostic use only.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2713-2024·2024-08-28

    Medline Medical Procedure Kits Recalled for Dimensional Variation Affecting Outer Canister Fit

    Medline Industries is recalling certain C-Section surgical kits due to dimensional variations that could cause difficulty fitting into the outer canister. The recall affects 1,753 units distributed worldwide.

    Product
    Medline medical procedure kits labeled as follows: a) C-SECTION CDS, REF CDS983998C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2709-2024·2024-08-28

    Medline medical procedure kits recalled due to dimensional variation

    Medline Industries is recalling 1,700 medical procedure kits due to a dimensional variation that may cause fitting difficulty into the outer canister. The affected kits were distributed in the US and internationally.

    Product
    Medline medical procedure kits labeled as follows: a) KIT CANISTER SUCT W 12FT, REF DYKM2169
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2639-2024·2024-08-28

    C-Flow Bag Decanter Packaging Defects Prompt Sterile Barrier Recall

    Microtek Medical Inc. recalls C-Flow Bag Decanters (10,366 cases) due to pin holes and tears in sterile barrier packaging discovered during quality testing. The defects could allow bacterial contamination.

    Product
    C-Flow Bag Decanter, REF 2000S. Packaged on a form, fill and seal machine with a poly/Tyvek material then placed 50 products to a case (cs).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0642-2024·2024-08-28

    FDA recalls Timolol Maleate eye drops due to defective bottle cap

    FDC Limited recalls Timolol Maleate Ophthalmic Solution nationwide because the bottle cap spike becomes lodged in the nozzle, preventing patients from dispensing the medication. No illnesses have been reported.

    Product
    TIMOLOL MALEATE — TIMOLOL MALEATE (TIMOLOL MALEATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2699-2024·2024-08-28

    Medical Device Liner Recalled for Dimensional Variation Affecting Fit

    Medline Industries has recalled 316,125 units of its MED-SOFT Single Liner with Solidifier due to a dimensional variation that may cause difficulty when inserting the product into the outer canister.

    Product
    1,5L MED-SOFT SINGLE LINER WITH SOLIDIFIER, REF OR1920PG
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1707-2024·2024-08-21

    Freshire Farms jalapenos recalled for potential Listeria monocytogenes contamination

    Freshire Farms jalapenos packaged in 8-ounce bags are being recalled due to potential contamination with Listeria monocytogenes. The recall affects 2,298 cases distributed across nine states.

    Product
    Freshire Farms - Jalapenos packaged in plastic bags at 8oz, 18 bags per case
    Category
    Food
    Distribution
    0 states
  • CriticalFDA (Food)·F-1709-2024·2024-08-21

    Green peppers recalled due to potential Listeria contamination

    RS Hanline and Company Inc is recalling Freshire Farms green peppers due to potential Listeria monocytogenes contamination. The recall affects 850 cases distributed across nine states.

    Product
    Freshire Farms - Green Peppers packaged in plastic bags containing 3 peppers, 16 bags per case
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-1732-2024·2024-08-21

    Lunds & Byerlys Fresh Guacamole Dip Recalled for Listeria Contamination

    Metro Produce Distributors is recalling Lunds & Byerlys Fresh Guacamole Dip due to potential Listeria monocytogenes contamination. The affected product has a Use By date of 02-AUG-24 and was distributed in Minnesota.

    Product
    Lunds & Byerlys Fresh Guacamole Dip, Net Wt 14 oz (396g). UPC 0 72431-66072 6. Keep Refrigerated.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Devices)·Z-2449-2024·2024-08-21

    Plum 360/A+ Spare Battery Defect Causes Accelerated Capacity Loss

    ICU Medical is recalling 130,826 units of Plum 360/A+ spare batteries due to a manufacturing defect that causes earlier-than-expected battery capacity loss and reduced runtime.

    Product
    Plum 360/A+ spare batteries. Item Number: SUB0000864.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2543-2024·2024-08-21

    RMU-2000 Automated Chest Compression Device Recalled Due to Motor Failure

    Defibtech is recalling the RMU-2000 Automated Chest Compression Device because a motor defect may cause the device to stop delivering compressions, potentially delaying critical therapy and resulting in patient injury or death.

    Product
    RMU-2000 Automated Chest Compression Device
    Category
    Medical Device
    Distribution
    5 states
  • SevereFDA (Food)·F-1736-2024·2024-08-21

    Lunds & Byerlys Deli Guacamole Recalled for Listeria Contamination

    Lunds & Byerlys Deli Guacamole (Item 85999, 56 oz) may be contaminated with Listeria monocytogenes. Twenty-eight units with a Use By date of 02-AUG-24 were distributed in Minnesota.

    Product
    Lunds & Byerlys Deli Guacamole, Item 85999. Net Wt 56 oz. Keep Refrigerated.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-1735-2024·2024-08-21

    Lunds & Byerlys Guacamole Dip Recalled for Listeria Risk

    Metro Produce Distributors is recalling 66 units of Lunds & Byerlys Pico de Gallo/Guacamole Dip distributed in Minnesota due to potential Listeria monocytogenes contamination. Consumers should not consume the product.

    Product
    Lunds & Byerlys Pico de Gallo / Guacamole Dip, Net Wt 18 oz (510g). UPC 0 72431-02993 6. Keep Refrigerated.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Devices)·Z-2447-2024·2024-08-21

    Plum 360 Infusion Battery Recall Due to Manufacturing Defect

    ICU Medical is recalling Plum 360 Infusion System replacement batteries due to a manufacturing defect that may cause loss of capacity and decreased runtime earlier than expected. Approximately 11,961 units were distributed worldwide.

    Product
    Replacement Battery List Number SUB0000864, found in Plum 360 Infusion System, List Number 30010. Product description is PLUM 360 Infuser. OUS units marketed with the following descriptions: Bomba de infusi¿n Plum 360 compatible con el software ICU Medical MedNet, Plum 360 Inf
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1712-2024·2024-08-21

    Green Peppers Recalled Due to Potential Listeria Contamination

    RS Hanline and Company Inc is recalling green peppers due to potential Listeria monocytogenes contamination. The recall affects peppers distributed across nine states.

    Product
    Green Peppers packaged as whole 10lb carton, whole 20lb carton, whole 5lb carton
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-1708-2024·2024-08-21

    Freshire Farms Green Beans Recalled for Potential Listeria Contamination

    RS Hanline and Company Inc is recalling Freshire Farms Green Beans due to potential Listeria monocytogenes contamination. Approximately 1150 cases were distributed across nine states.

    Product
    Freshire Farms - Green Beans packaged in plastic bags at 1lb, 14 bags per case
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-1711-2024·2024-08-21

    Poblano Peppers Recalled Due to Potential Listeria Contamination

    RS Hanline and Company Inc is recalling Poblano peppers in multiple package formats due to potential Listeria monocytogenes contamination. The affected product was distributed across nine U.S. states.

    Product
    Poblano packaged as 5lb half sliced with 2 bags per case, 5lb fourth diced with 2 bags per case, 5lb half diced with 2 bags per case
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2448-2024·2024-08-21

    Plum A+ and Plum A+3 Infusion Pump Batteries Recalled for Capacity Loss Defect

    ICU Medical is recalling Plum A+ and Plum A+3 infusion pump batteries due to a manufacturing defect that may cause premature capacity loss and reduced runtime. Approximately 14,744 units were distributed worldwide.

    Product
    Replacement Battery List Number SUB0000594 and SUB0000864 found in Plum A+ & Plum A+3 Infusion Systems, Pump List Numbers: 11005, 11971, 12391, 12618, 20678, 20679, 20792, 60529, 12348, 11973. OUS units marketed with the following descriptions: Plum A+ Mednet TM Firmware New 1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1739-2024·2024-08-21

    Van Leeuwen Pumpkin Cinnamon Roll frozen dessert recalled for undeclared peanuts

    Van Leeuwen Ice Cream is recalling Pumpkin Cinnamon Roll non-dairy frozen dessert (14 oz) due to undeclared peanuts. The allergen poses serious risk to consumers with peanut allergies.

    Product
    VEGAN OAT; Van Leeuwen PUMPKIN CINNAMON ROLL; NON-DAIRY FROZEN DESSERT 14 oz, (414 ml); Est. Brooklyn 2008 ingredients: oat milk (water, oats) coconut cream, cane sugar, brown sugar, unbleached wheat flour, tapioca syrup, pumpkin puree, coconut oil, cocoa butter, water, ginger,
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-1740-2024·2024-08-21

    North Fish USA Recalls Cold Smoked Capelin Due to Botulism Risk

    North Fish USA is recalling Cold Smoked Capelin packages due to potential Clostridium botulinum contamination in uneviscerated fish. The affected products were distributed in Georgia and New York.

    Product
    Cold Smoked Capelin, 9-ounce packages, plastic trays, 34 packages per case (Best By Date:07.13.2024), 18 packages per case (Best Buy Date: 01.05.2025), UPC code4811527003360, Keep Frozen,UPC code 4811527003360
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-1733-2024·2024-08-21

    Lunds & Byerlys Spicy Guacamole Dip recalled due to Listeria contamination

    Metro Produce Distributors is recalling 121 units of Lunds & Byerlys Spicy Guacamole Dip because it may be contaminated with Listeria monocytogenes. The affected product was distributed in Minnesota.

    Product
    Lunds & Byerlys Spicy Guacamole Dip, Net Wt 10 oz (283g). UPC 0 72431-66128 0. Keep Refrigerated.
    Category
    Food
    Distribution
    1 state