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.

2926–2950 of 88106

  • HighFDA (Devices)·Z-1871-2026·2026-04-29

    Angiodynamics Soft-Vu Angiographic Catheter Kumpe Recall

    Angiodynamics is recalling Soft-Vu Angiographic Catheter, Kumpe devices due to a manufacturing defect that may prevent guidewire passage through the catheter hub.

    Product
    Soft-Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 40CM 035 NB 0SH; Catalog No.: 10734301; Product/UPN No.: H787107343015 (Box), H787107343010 (Pouch); Box Quantity: 5 pouches;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1913-2026·2026-04-29

    Arrow Epidural Catheter Kits Recalled Due to Adhesive Manufacturing Defect

    Arrow International is recalling FlexTip Plus Epidural Catheter and FlexBlock Continuous Peripheral Nerve Block Catheter Kits due to incorrect manufacturing of liquid adhesive. The recall affects 190 units distributed nationwide.

    Product
    FLEXTIP PLUS EPIDURAL CATHETER;FLEXBLOCK CONTINOUS PERIPHERAL NERVE BLOCK CATHETER KIT/SET REF ASK-05502-BSM UDI code: (01)10801902209853(17)270831(11)251210(10)33F25K0409 The Arrow Epidural Catheter kit permits access to the epidural space for administration of epidural…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1920-2026·2026-04-29

    IV Administration Sets from Windstone Medical for Infusion Pump Systems

    Windstone Medical Packaging is recalling Custom Convenience Kits Pre Op Kit units due to potential backflow of medication between IV containers and risk of priming failure in gravity and pump administration sets.

    Product
    Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14994
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1808-2026·2026-04-29

    Handheld UV-C germicidal wand recalls for excessive radiation exposure

    Uvlizer handheld UV-C germicidal wands may expose users and nearby people to ultraviolet radiation at levels above international safety guidelines for skin and eye protection.

    Product
    The product is a handheld ultraviolet-C germicidal wand and contains a combination of five UV-A and UV-C LED lights. The product comes in two configurations: UV-C x 1; UV-A x 4, or UV-C x 2; UV-A x 3. The product has two peak emission wavelengths at 274 nm and 397 nm.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·H-0673-2026·2026-04-29

    El Mexicano horchata casera instant drink contains undeclared milk

    EL MEXICANO horchata casera Instant Horchata Drink is being recalled because of undeclared milk. The action covers 40,032 packages distributed across a large number of states.

    Product
    EL MEXICANO horchata casera Instant Horchata Drink NET WT 14oz (396g) INGREDIENTS: *** MILK SUBSTITUTE (WHEY *** LACTOSE *** DISTRIBUTED BY MARQUEZ BROTHERS INTERNATIONAL, INC. San Jose CA 95138 UPC: 042743190266 Item: 102284
    Category
    Food
    Distribution
    29 states
  • HighFDA (Devices)·Z-1861-2026·2026-04-29

    Angiodynamics Soft-Vu Angiographic Catheter Cobra Non-Braided Recall

    Angiodynamics is recalling specific lots of Soft-Vu Angiographic Catheter, Cobra (2), Non-Braided devices due to a manufacturing defect that may prevent guidewire passage through the catheter hub.

    Product
    Soft-Vu Angiographic Catheter, Cobra (2), Non-Braided; SOFT-VU CB2 4F X 65CM 038 NB 0SH; Catalog No.: 10714011; Product/UPN No.: H787107140115 (Box), H787107140110 (Pouch); Box Quantity: 5 pouches;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1938-2026·2026-04-29

    Diversatek Healthcare Viper Balloon Dilator Inflation Tag Labeling Error

    Diversatek Healthcare is recalling Viper 3-Stage Fixed Wire Balloon Dilators because the catheter inflation tag may contain incorrect part numbers and balloon diameter and pressure specifications.

    Product
    Diversatek Healthcare Viper¿ 3-Stage Fixed Wire Balloon Dilator, 6mm-7mm-8mm, REF 1204-08
    Category
    Medical Device
    Distribution
    19 states
  • HighFDA (Devices)·Z-1875-2026·2026-04-29

    AccuVu Angiographic Catheter recalled for guidewire passage defect

    Angiodynamics is recalling the AccuVu Angiographic Catheter (Pigtail, Non-Braided) due to a manufacturing defect that may prevent a properly sized guidewire from passing through the catheter hub's inner diameter.

    Product
    AccuVu Angiographic Catheter, Pigtail, Non-Braided, With 21 R/O Markers; ACCU-VU PT 4F X 70CM 035 NB 10SH 21 R/O 1CM; Catalog No.: 13709804; Product/UPN No.: H787137098045 (Box), H787137098040 (Pouch); Box Quantity: 5 pouches;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1870-2026·2026-04-29

    Soft-Vu Angiographic Catheter Omni Flush Non-Braided Defect Recall

    Angiodynamics is recalling Soft-Vu Angiographic Catheters (Omni Flush, Non-Braided) due to a manufacturing defect that may prevent guidewires from passing through the catheter hub.

    Product
    Soft-Vu Angiographic Catheter, Omni Flush, Non-Braided; SOFT-VU OF 4F X 65CM 035 NB 6SH; Catalog No.: 10732301; Product/UPN No.: H787107323015 (Box), H787107323010 (Pouch); Box Quantity: 10 units;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1851-2026·2026-04-29

    Olympus Thunderbeat II Shears recall due to distal tip detachment

    Olympus Corporation of the Americas is recalling Olympus Thunderbeat II Shears (Model TB2-0520FC) because the distal tip component may detach during use.

    Product
    Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 20cm. Model Number: TB2-0520FC.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1906-2026·2026-04-29

    Olympus OER-ELITE Endoscope Reprocessor Connecting Tubes Recalled

    Olympus Corporation is recalling OER-ELITE Endoscope Reprocessor Connecting Tubes (Model MAJ-2118) due to potential premature failure of Version 2 reprocessor connecting tube lock levers. The recall affects 1,259 units distributed worldwide.

    Product
    OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2118.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1859-2026·2026-04-29

    Soft-Vu pigtail angiographic catheters may block the appropriately sized guidewire

    Soft-Vu Pigtail Angiographic Catheters are being recalled because a manufacturing defect may prevent an appropriately sized guidewire from passing through the catheter hub.

    Product
    Soft-Vu Angiographic Catheter, Pigtail, Non-Braided; SOFT-VU PT 4F X 65CM 038 NB 10SH; Catalog No.: 10714002; Product/UPN No.: H787107140025 (Box), H787107140020 (Pouch); Box Quantity: 10 pouches;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1930-2026·2026-04-29

    Foley Urine Collection Kit recalled for non-sterile alcohol prep pads

    LSL Healthcare is recalling its Foley Urine Collection Kit (Model 1555) because it contains Webcol Large Alcohol Prep Pads that are non-sterile. The kits were distributed nationwide in Maryland, Illinois, and Minnesota.

    Product
    LSL Healthcare, Foley Urine Collection Kit, Model/Catalog Number: 1555
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1868-2026·2026-04-29

    Soft-Vu Angiographic Catheter Headhunter recalled due to manufacturing defect

    Angiodynamics is recalling Soft-Vu Angiographic Catheter, Headhunter (1), Non-Braided devices because a manufacturing defect may prevent guidewires from passing through the catheter hub.

    Product
    Soft-Vu Angiographic Catheter, Headhunter (1), Non-Braided; SOFT-VU HH1 4F X 100CM 038 NB 0SH; Catalog No.: 10714040; Product/UPN No.: H787107140405 (Box), H787107140400 (Pouch); Box Quantity: 5 pouches;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1873-2026·2026-04-29

    AccuVu Angiographic Catheter Manufacturing Defect Recall Worldwide

    Angiodynamics is recalling AccuVu Angiographic Catheters worldwide due to a manufacturing defect that may prevent guidewires from passing through the catheter hub's inner diameter.

    Product
    AccuVu Angiographic Catheter, Straight Flush, Non-Braided, With 10 R/O Markers; ACCU-VU STR FL 4F X 100CM 035 NB 6SH 10 R/O 6@1CM 4@5CM; Catalog No.: 13709604; Product/UPN No.: H787137096045 (Box), H787137096040 (Pouch); Box Quantity: 5 pouches;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1862-2026·2026-04-29

    Soft-Vu Angiographic Catheter, Kumpe, Non-Braided manufacturing defect

    Angiodynamics is recalling Soft-Vu Angiographic Catheter, Kumpe, Non-Braided devices due to a manufacturing defect that may prevent guidewires from passing through the catheter hub.

    Product
    Soft-Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 65CM 038 NB 0SH; Catalog No.: 10714014; Product/UPN No.: H787107140145 (Box), H787107140140 (Pouch); Box Quantity: 5 pouches;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1922-2026·2026-04-29

    Beckman Coulter Access Total T4 Calibrator Recalled for Inaccurate Results

    Beckman Coulter is recalling Access Total T4 Calibrator lots because they produce falsely low patient results on DxI 600/800 instruments, potentially leading to unnecessary testing, delayed treatment for thyroid disorders, and incorrect dosing in pregnant patients.

    Product
    Access Total T4 Calibrator, Catalog No. 33805
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1907-2026·2026-04-29

    OER-ELITE Endoscope Reprocessor Connecting Tubes Lock Failure Recall

    Olympus Corporation of the Americas is recalling OER-ELITE Endoscope Reprocessor Connecting Tubes (Model MAJ-2119) due to potential premature failure of the Version 2 reprocessor connecting tube lock levers.

    Product
    OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2119.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0674-2026·2026-04-29

    El Mexicano agua fresca de horchata contains undeclared milk

    EL MEXICANO agua fresca de horchata Instant Horchata Drink is being recalled because of undeclared milk. The action covers 405,136 packages distributed across a large number of states.

    Product
    EL MEXICANO agua fresca de horchata Instant Horchata Drink NET WT 12oz (340g) INGREDIENTS: *** MILK SUBSTITUTE (WHEY *** LACTOSE *** DISTRIBUTED BY MARQUEZ BROTHERS INTERNATIONAL, INC. San Jose CA 95138 UPC: 042743190204 Item: 102279
    Category
    Food
    Distribution
    29 states
  • HighFDA (Devices)·Z-1860-2026·2026-04-29

    Soft-Vu Angiographic Catheter Angiodynamics Guidewire Passage Defect

    Angiodynamics is recalling Soft-Vu Angiographic Catheters (Berenstein, Non-Braided) due to a manufacturing defect that may prevent guidewires from passing through the catheter hub. The catheters were distributed worldwide including the US.

    Product
    Soft-Vu Angiographic Catheter, Berenstein, Non-Braided; SOFT-VU BER 4F X 65CM 038 NB 0SH; Catalog No.: 10714009; Product/UPN No.: H787107140095 (Box), H787107140090 (Pouch); Box Quantity: 5 pouches;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1857-2026·2026-04-29

    Soft-Vu Angiographic Catheter Kumpe Non-Braided manufacturing defect recall

    Angiodynamics is recalling Soft-Vu Angiographic Catheter Kumpe units due to a manufacturing defect that may prevent guidewires from passing through the catheter hub.

    Product
    Soft -Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 40CM 038 NB 0SH; Catalog No.: 10710013; Product/UPN No.: H787107100135 (Box), H787107100130 (Pouch); Box Quantity: 5 pouches;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1853-2026·2026-04-29

    Olympus Thunderbeat II shears 35 cm may shed a distal tip component

    Olympus is recalling Thunderbeat II Shears with Ultrasonic Mode, 5 mm and 35 cm, because a distal tip component may detach during use. 3,360 units are affected.

    Product
    Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 35cm. Model Number: TB2-0535FC.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1941-2026·2026-04-29

    Diversatek Viper Wire Guided Balloon Dilator Inflation Tag Incorrect

    Diversatek Healthcare is recalling Viper 3-Stage Wire Guided Balloon Dilators because the attached inflation tag may contain an incorrect part number with wrong balloon diameter sizes and inflation pressures.

    Product
    Diversatek Healthcare Viper¿ 3-Stage Wire Guided Balloon Dilator, 18mm-19mm-20mm, REF 1205-20
    Category
    Medical Device
    Distribution
    19 states
  • HighFDA (Devices)·Z-1858-2026·2026-04-29

    Soft-Vu Angiographic Catheter, Omni Flush, Non-Braided recalled for manufacturing defect

    Angiodynamics is recalling Soft-Vu Angiographic Catheters due to a manufacturing defect that may prevent guidewires from passing through the catheter hub. The defect affects 1,550 units distributed worldwide.

    Product
    Soft-Vu Angiographic Catheter, Omni Flush, Non-Braided; SOFT-VU OF 4F X 65CM 038 NB 6SH; Catalog No.: 10714001; Product/UPN No.: H787107140015 (Box), H787107140010 (Pouch); Box Quantity: 10 pouches;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1863-2026·2026-04-29

    Soft-Vu Angiographic Catheter Berenstein Non-Braided Device Recall

    Angiodynamics is recalling Soft-Vu Angiographic Catheters (Berenstein, Non-Braided) due to a manufacturing defect that may prevent the guidewire from passing through the catheter hub. The defect affects 1,030 units distributed worldwide.

    Product
    Soft-Vu Angiographic Catheter, Berenstein, Non-Braided; SOFT-VU BER 4F X 100CM 038 NB 0SH; Catalog No.: 10714016; Product/UPN No.: H787107140165 (Box), H787107140160 (Pouch); Box Quantity: 5 pouches;
    Category
    Medical Device
    Distribution
    Distributed nationwide