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.

1376–1400 of 88106

  • HighFDA (Devices)·Z-2789-2026·2026-07-29

    Medline Convenience Kits Recalled Over Bacillus Contamination

    Medline Industries, LP is recalling 398 medical convenience kits that may be contaminated with low levels of Bacillus species. The recall affects specific SKUs distributed across multiple US states.

    Product
    Medline medical convenience kits labeled as: 1) SHOULDER PACK, Medline Kit SKU DYNJ39590O; 2) SHOULDER PACK, Medline Kit SKU DYNJ88566; 3) MAJOR ORTHO KIT, Medline Kit SKU DYNJ911535.
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Devices)·Z-2787-2026·2026-07-29

    Medline Convenience Kits Containing Bard Silastic Foley Catheters Recalled Due to Surface Contamination

    Medline Industries, LP is recalling 980 Medline convenience kits containing Bard Silastic Foley Catheters because excess raw material on the catheter surface may be harmful.

    Product
    Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16, 18, 20) 5cc balloons. KIT ROBOTICS UROLOGY PROSTATE DYKMBNDL116G
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2779-2026·2026-07-29

    Medline Bard Silastic Foley Catheter Kits Recalled Due to Surface Contamination

    Medline is recalling 980 Bard Silastic Foley Catheter kits due to increased raw material on the catheter surface that may be harmful.

    Product
    Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16, 18, 20) 5cc balloons. KIT ROBOTICS UROLOGY PROSTATE DYKMBNDL116I
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2781-2026·2026-07-29

    Medline Urology Robotic Procedure Packs Recalled Due to Catheter Surface Contamination

    Medline Industries, LP is recalling 980 Medline convenience kits containing Bard Silastic Foley Catheters because excess raw material on the catheter surface may be harmful.

    Product
    Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16, 18, 20) 5cc balloons. UROLOGY ROBOTIC PROCEDURE PACK DYNJ0945779U
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0711-2026·2026-07-29

    LEVOTHYROXINE SODIUM Tablets Recalled Due to Subpotent Drug Content

    Major Pharmaceuticals is recalling LEVOTHYROXINE SODIUM 150 mcg tablets because some batches contain less active ingredient than labeled, potentially reducing thyroid hormone effectiveness.

    Product
    LEVOTHYROXINE SODIUM — LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2776-2026·2026-07-29

    Olympus High Flow Insufflation Unit UHI-4 Recalled Due to Display and Air Delivery Failure

    Olympus Corporation of the Americas is recalling the Olympus High Flow Insufflation Unit (Model UHI-4) because the front panel display may turn off unexpectedly, causing air delivery to cease.

    Product
    Olympus High Flow Insufflation Unit - UHI-4. Model Number: UHI-4
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2770-2026·2026-07-29

    Penumbra System RED 68 Reperfusion Catheter Recall Due to Fracture Risk

    Penumbra, Inc. is recalling its RED 68 Reperfusion Catheter due to manufacturing issues that may cause the device to fracture during use.

    Product
    Penumbra System RED 68 Reperfusion Catheter REF: RED68KIT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2794-2026·2026-07-29

    Flexible Hystero-Fiberscope Kits Recalled Due to Expired Sterile Seals

    Karl Storz Endoscopy is recalling 45 Flexible Hystero-Fiberscope Kits that contain expired Single Use Endoscopic Seals, which could compromise sterility assurance during gynecological procedures.

    Product
    Flexible Hystero-Fiberscope Kits REF: 11264BBU1, 11264BBUK1, that contain expired Single Use Endoscopic Seal: GYN, REF: 26153EAU/1.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2783-2026·2026-07-29

    Medline Convenience Kits Containing Bard Silastic Foley Catheters Recalled Due to Surface Material

    Medline Industries, LP is recalling 980 Medline convenience kits containing Bard Silastic Foley Catheters because excess raw material on the catheter surface may be harmful.

    Product
    Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16, 18, 20) 5cc balloons. PROSTATE ROBOTIC DYNJ901822B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2777-2026·2026-07-29

    Emano Flow Uroflowmetry App Recalled Over Biased Flow Estimates

    Emano Metrics is recalling 685 units of the Emano Flow smartphone-based acoustic uroflowmetry app (v2.0.0) because recordings captured at 48,000 Hz were processed by models trained on 44,100 Hz audio, producing systematically biased urinary flow rate and voided volume estimates.

    Product
    Emano Flow with software version v2.0.0 GS1 GTIN code: 199874903484 Emano Flow is a smartphone-based acoustic uroflowmetry system. Software-only device that measures urinary flow rate and voided volume from the acoustic signal of urination. No physical components.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2778-2026·2026-07-29

    MiniMed Go App Recalled Due to Missed Insulin Alerts

    Medtronic is recalling its MiniMed Go app because a software bug can prevent insulin dose alerts during nighttime, potentially leading to missed doses and hyperglycemia.

    Product
    MiniMed Go App, Model: MMT-8600 (iOS), MMT-8601 (Android)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2785-2026·2026-07-29

    Medline Convenience Kits Containing Bard Silastic Foley Catheters Recalled Due to Surface Contamination

    Medline Industries, LP is recalling 980 Medline convenience kits containing Bard Silastic Foley Catheters because excess raw material on the catheter surface may be harmful.

    Product
    Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16, 18, 20) 5cc balloons. RR-DAVINCI PROSTATE ACCESSORY DYNJ63392F
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-1187-2026·2026-07-29

    Won Ton Wrappers Recalled for Undeclared Food Color Additives

    Man Fon Inc. is recalling Won Ton Wrappers Extra Thin because they contain undeclared Yellow#5 and Yellow#6 color additives. The product was distributed to restaurants in California and some grocery stores in New Mexico.

    Product
    Man Fon Inc. Won Ton Wrappers Extra Thin; Net Wt. 10 oz; UPC# 757168 977315, Keep Refrigerated, Can be Frozen. Sold in 48 units (10oz)/case.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-2782-2026·2026-07-29

    Medline Convenience Kits Containing Bard Silastic Foley Catheters Recalled Due to Surface Material

    Medline Industries, LP is recalling 980 Medline convenience kits containing Bard Silastic Foley Catheters because excess raw material on the catheter surface may be harmful.

    Product
    Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16, 18, 20) 5cc balloons. NON MB DAVINCI LITHOTOMY SM PK DYNJT6105
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2767-2026·2026-07-29

    3mensio Workstation Software Recalled Due to Inaccurate Cardiovascular Measurements

    PIE Medical Imaging B.V. is recalling 3mensio Workstation (Vascular Fenestrated) software because it may provide inaccurate cardiovascular measurements under specific conditions.

    Product
    3mensio Workstation (Vascular Fenestrated) software
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2753-2026·2026-07-29

    Boston Scientific Recalls FARASTAR Ablation Generators Due to Catheter Incompatibility

    Boston Scientific is replacing specific FARASTAR PFA generators that are not compatible with the FARAPOINT PFA catheter. The FDA Class II recall affects 6 units distributed internationally.

    Product
    FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401; Percutaneous Cardiac Ablation Catheter
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Drugs)·D-0727-2026·2026-07-29

    Naropin Injection Recall Over Particulate Matter Contamination

    Fresenius Kabi is recalling 92,600 vials of NAROPIN (ropivacaine hydrochloride) injection, 0.5%, 10/2028, due to the presence of particulate matter, including hair, found in the product.

    Product
    NAROPIN — NAROPIN (ROPIVACAINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0722-2026·2026-07-29

    Rohto Cooling Eye Drops Recalled Due to Lack of Assurance of Sterility

    Rohto-Mentholatum (Vietnam) Co., Ltd. is recalling certain lots of Rohto Cooling Eye Drops because the company cannot assure the sterility of the product.

    Product
    ROHTO — ROHTO (NAPHAZOLINE HYDROCHLORIDE, POLYSORBATE 80)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2754-2026·2026-07-29

    FARADRIVE Steerable Sheath Clear IDE Recall for Air Embolism Risk

    Boston Scientific recalls 400 units of a cardiac catheter sheath due to potential air embolism risk from valve damage during preparation.

    Product
    FARADRIVE Steerable Sheath Clear IDE, used to facilitate access to the vasculature and into the chambers of the heart, Material Number 21C602, IFU Reference Number 51636751-01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0710-2026·2026-07-29

    Levothyroxine Sodium Tablets Recalled Due to Subpotent Drug Concerns

    Major Pharmaceuticals is voluntarily recalling Levothyroxine Sodium Tablets (125 mcg) because the medication may be subpotent.

    Product
    LEVOTHYROXINE SODIUM — LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0728-2026·2026-07-29

    Xylocaine Injection Recall Due to Hair Contamination

    Fresenius Kabi is recalling 93,250 vials of Xylocaine (lidocaine HCl) injection due to the presence of particulate matter, specifically hair found in the product.

    Product
    XYLOCAINE — XYLOCAINE (LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2784-2026·2026-07-29

    Medline Convenience Kits Containing Bard Silastic Foley Catheters Recalled Due to Surface Material Issues

    Medline Industries, LP is recalling 980 Medline convenience kits containing Bard Silastic Foley Catheters because excess raw material on the catheter surface may be harmful.

    Product
    Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16, 18, 20) 5cc balloons. ROBOTIC CDS980523M
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2788-2026·2026-07-29

    Medline Medical Convenience Kits Recalled Due to Potential Bacillus Contamination

    Medline Industries, LP is recalling specific Medline medical convenience kits because they may contain BD PurPrep 26 mL contaminated with low levels of Bacillus species.

    Product
    Medline medical convenience kits labeled as: 1) KIT PEDIATRIC OPEN HEART MOSES, Medline Kit SKU DYNJ910103B; 2) BASIC HEART CDS, Medline Kit SKU DYNJ910961A.
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Food)·H-1179-2026·2026-07-29

    Brooklyn Roasting Company Pasteurized Cold Brew Concentrate Recalled Due to Botulism Risk

    Brooklyn Roasting Works LLC is recalling Brooklyn Roasting Company Pasteurized Cold Brew Concentrate because ambient storage may lead to Clostridium botulinum toxin formation.

    Product
    Brooklyn Roasting Company Pasteurized Cold Brew Concentrate; 2.5gal; bag in a box distributed between 04/01/2026 and 06/20/2026.
    Category
    Food
    Distribution
    2 states