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.

11076–11100 of 88183

  • HighFDA (Devices)·Z-3158-2024·2024-10-02

    Mobile X-Ray System Exposure Settings May Not Apply Correctly

    Fujifilm mobile x-ray systems may fail to apply configured exposure settings or default to adult chest imaging parameters. This could result in inappropriate radiation exposure levels.

    Product
    The device is a mobile x-ray system designed to work with Fujifilm's GOS and CsI scintillator FDR D-EVO2 (DR-ID) 12XXSE) family of digital x-ray detectors coupled.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1828-2024·2024-10-02

    Potato and Onion Vareniki Recalled Due to Undeclared Wheat

    M&P Food Productions is recalling Potato & Onion Vareniki due to undeclared wheat. Consumers with wheat allergies or celiac disease should not consume this product.

    Product
    Potato & Onion Vareniki; M&P Food Production; NET WT. 14oz; HANDMADE; Keep Frozen; DOUGH INGREDIENTS: Flour, eggs, water, oil (soybean), salt; FILLING INGREDIENTS: Potato, Fried Onion; UPC: 707163026167
    Category
    Food
    Distribution
    7 states
  • HighFDA (Devices)·Z-3297-2024·2024-10-02

    CooperSurgical Recalls Origio Sperm Wash Medium Due to Low Sodium Pyruvate

    CooperSurgical is recalling Origio Sperm Wash Medium because low sodium pyruvate levels could compromise gamete development.

    Product
    Origio Sperm Wash Medium Pack of Five 60ml bottles - Intended for washing of spermatozoa. Part Number: 84055060A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3215-2024·2024-10-02

    Siemens ACUSON Juniper ultrasound systems software unit conversion error

    Siemens is recalling ACUSON Juniper ultrasound systems that may perform incorrect unit conversions when configured with non-default settings, potentially producing measurements 10 times smaller than actual values and risking patient misdiagnosis.

    Product
    ACUSON Juniper 1.0, 1.5, 2.0, 2.5 Diagnostic Ultrasound Systems, REF: 11335791, with software. ACUSON Juniper Select 2.0, 2.5 Diagnostic Ultrasound Systems, REF: 11653093, with software.
    Category
    Medical Device
    Distribution
    42 states
  • HighFDA (Devices)·Z-3255-2024·2024-10-02

    Biodesign Fistula Plug Implants Recalled Due to Premature Expiration

    Cook Biotech is recalling Biodesign Fistula Plug C-FPS-0.2-2 implants because affected units expire before their labeled expiration dates. The defect could compromise product performance.

    Product
    Biodesign Fistula Plug C-FPS-0.2-2 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Order Number (GPN): G46374
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1824-2024·2024-10-02

    M&P Delicacies Pirozhki Pies Recalled for Undeclared Wheat and Milk

    M&P Delicacies Pirozhki (pies) are recalled due to undeclared wheat and milk in the product. Consumers with allergies to these ingredients should not consume the product.

    Product
    M&P Delicacies PIROZHKI (PIES) with Black Currant; INGREDIENTS: Flour, eggs, butter, vegetable oil, dry yeast, sugar, salt; Filling: Black currant, sugar, farina; 1 SERVING READY TO EAT; KEEP FROZEN
    Category
    Food
    Distribution
    7 states
  • HighFDA (Devices)·Z-3236-2024·2024-10-02

    Neuro Vascular Medical Kit Recalled for Sterilization Assurance Failure

    American Contract Systems recalls the Neuro Vascular ANKV91A medical convenience kit due to inability to confirm sterilization. Affected units were distributed across MO, MN, MA, OH, and NE.

    Product
    Neuro Vascular, ANKV91A; Medical convenience kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3242-2024·2024-10-02

    Nasal Sinus Pack Recalled Due to Sterilization Verification Failure

    American Contract Systems is recalling Nasal Sinus Pack units due to manufacturing control failures that prevent confirmation of sterilization. Affected units were distributed to multiple states.

    Product
    Nasal Sinus Pack, MTSN26B; Medical convenience kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3268-2024·2024-10-02

    FDA Recalls Esophageal Stent Systems for Potential Catheter Tip Detachment

    Boston Scientific's Wallflex and Agile esophageal stent systems are recalled due to the potential for delivery catheter tip detachment. The recall affects 146 units distributed worldwide.

    Product
    WALLFLEX FC ESO STENT RMV 23X105MM- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3269-2024·2024-10-02

    Boston Scientific Recalls WallFlex Esophageal Stent Systems Due to Catheter Tip Detachment

    Boston Scientific is recalling WallFlex and Agile esophageal stent systems because the delivery catheter tip may detach. The recall covers 176 units distributed worldwide.

    Product
    WALLFLEX FC ESO STENT RMV 23X125MM- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1822-2024·2024-10-02

    M&P Food Products Frozen Blintzes Recalled for Undeclared Wheat

    M&P Food Products Cheese & Cherry Blintzes are recalled because they contain undeclared wheat. Consumers with wheat allergies should not consume this product.

    Product
    M&P Food Products Cheese & Cherry Blintzes; Hand Made Russian Style; 6 Classic; NET WT. 14 OZ. (396g); KEEP FROZEN; INGREDIENTS: Flour, low fat milk; eggs, margarine; sugar, salt; FILLING INGREDIENTS: Farmer Cheese, cherries; Cheese & Cherry Blintzes Net Wt. 14 OZ. (396g) UPC…
    Category
    Food
    Distribution
    7 states
  • HighFDA (Food)·F-1833-2024·2024-10-02

    Pickled Garlic Product Recalled for Undeclared Fish Allergen

    Shiso Katsuo Ninniku pickled garlic products are being recalled due to an undeclared fish allergen. The recall affects 9,482 units distributed across seven states.

    Product
    Shiso Katsuo Ninniku (Pink Pickled Garlic), Net WT 5.2 OZ (147g). Products of China; Imported By Niitakaya U.S.A. Inc., Motebello, CA 90640 ITEM No. 3700
    Category
    Food
    Distribution
    7 states
  • HighFDA (Devices)·Z-3239-2024·2024-10-02

    Medical Cath Lab Pack Recalled Due to Sterilization Assurance Failure

    American Contract Systems is recalling Cath Lab Pack CECL02P medical kits because an inoperable chart recorder caused humidity readings to be out-of-specification, preventing confirmation that sterilization requirements were met.

    Product
    Cath Lab Pack, CECL02P; Medical convenience kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3233-2024·2024-10-02

    Bilateral Tubal Ligation Pack Recalled for Unconfirmed Sterilization

    American Contract Systems, Inc. is recalling the Bilateral Tubal Ligation Pack (Lot 2405102) due to inability to confirm proper sterilization following a chart recorder malfunction.

    Product
    Bilateral Tubal Ligation Pack, FHBT3T; Medical convenience kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3270-2024·2024-10-02

    Wallflex and Agile Esophageal Stents Recalled for Catheter Tip Detachment Risk

    Boston Scientific recalls Wallflex FC and Agile Esophageal Stent Systems due to the potential for delivery catheter tip detachment during use. Approximately 145 units are affected worldwide.

    Product
    WALLFLEX FC ESO STENT RMV 23X155MM- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1834-2024·2024-10-02

    Imported Pickled Garlic Recalled for Undeclared Fish Allergen

    Niitakaya USA Inc is recalling Miso Katsuo Ninniku pickled garlic because it contains undeclared fish allergen. Consumers with fish allergies should not consume this product.

    Product
    Miso Katsuo Ninniku (Pickled Garlic), Net WT 5.2 OZ (147g) Products of China; Imported By Niitakaya U.S.A. Inc., Motebello, CA 90640 ITEM No. 3701
    Category
    Food
    Distribution
    7 states
  • HighFDA (Devices)·Z-3298-2024·2024-10-02

    Origio Sperm Wash Medium Recalled for Low Sodium Pyruvate Concentration

    CooperSurgical is recalling Origio Sperm Wash Medium due to low sodium pyruvate concentration. The deficiency could compromise gamete development in assisted reproductive procedures.

    Product
    Origio Sperm Wash Medium Pack of Five 60ml bottles - Intended for washing of spermatozoa. Part Number: 84055060D
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3230-2024·2024-10-02

    American Contract Systems Recalls Open Shoulder Medical Convenience Kits

    American Contract Systems is recalling 12 Open Shoulder medical convenience kits because a faulty chart recorder prevented verification of sterilization requirements.

    Product
    Open Shoulder, LWOS39L; Medical convenience kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3219-2024·2024-10-02

    Karl Storz Hopkins Telescope Recalled for Unapproved Reprocessing Instructions

    Karl Storz Hopkins Telescope 6 endoscopes are being recalled because the instructions for use contain reprocessing procedures not reviewed or approved by the FDA. Affected units should not be used until corrected instructions are provided.

    Product
    Karl Storz - Endoskope , REF: 27093AA Hopkins Telescope 6, Rx only, CE 0123
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1821-2024·2024-10-02

    54th St Blackened Sauce Recalled for Undeclared Soy Allergen

    54th St Blackened Sauce is being recalled because soy allergen is present in the product but missing from the label's Contains statement. Consumers with soy allergies should not consume it.

    Product
    54th St Blackened Sauce, 9lb bags - 4 bags per case.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-3278-2024·2024-10-02

    FDA Recalls Esophageal Stent Systems Due to Delivery Catheter Tip Detachment Risk

    Boston Scientific recalled 364 esophageal stent systems due to potential delivery catheter tip detachment during placement procedures. No injuries have been reported. Affected patients and providers should contact the manufacturer.

    Product
    WALLFLEX ESOPHAGEAL FC 23/28MMX10CM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3231-2024·2024-10-02

    Day Surgery General Pack medical kit recalled for sterilization concern

    American Contract Systems recalled 280 units of its Day Surgery General Pack due to humidity control failures that prevent confirmation of adequate sterilization.

    Product
    Day Surgery General Pack, FHGE18T; Medical convenience kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3293-2024·2024-10-02

    Boston Scientific Agile Esophageal Over-the-Wire Stent System recalled for catheter tip detachment

    Boston Scientific is recalling the Agile Esophageal Over-the-Wire Stent System due to potential for delivery catheter tip detachment. Seven affected units distributed worldwide are identified by lot numbers 32889020 and 33178844.

    Product
    AGILE ESO FC RMV 23MM X 6.2CM IN 18.5 FR-Agile Esophageal Partially Covered (PC) and Fully Covered (FC) OTW Stent System is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3210-2024·2024-10-02

    AVS Anchor-C Cervical Cage Instructions for Use Labeling Correction

    Stryker Spine recalled the electronic Instructions for Use revision 5 for the AVS Anchor-C Cervical Cage System because specific indications language for the US and Canada was inadvertently removed.

    Product
    AVS Anchor-C Cervical Cage System Instructions For Use (IFU)- eIFU (revision 5)-Indicated for anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3225-2024·2024-10-02

    Karl Storz Nephroscope Recall Due to Unapproved Reprocessing Instructions

    Karl Storz Endoscope nephroscopes (REF: 27840KA) are being recalled because their instructions for use contain reprocessing methods that have not been reviewed or approved by the FDA for safety and efficacy.

    Product
    Karl Storz - Endoskope , REF: 27840KA, Nephroscope for MIP L, Rx only, CE 0123
    Category
    Medical Device
    Distribution
    Distributed nationwide