The Recall Desk

Severity 3 of 5

High recalls

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

What “high” means here

Severity 3 (High) recalls have a known hazard but no confirmed illness, injury, or property damage in the source text. The risk is theoretical-but-real: a pathogen pre-emptively pulled from shelves before anyone got sick, an allergen mislabeling on an uncommon allergen, a precautionary correction on a device that hasn't yet malfunctioned in the field. Most allergen recalls land here, as do most preventive food recalls based on routine sampling. You should still stop using the product, but you don't need to panic.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

926–950 of 21623

  • 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-1807-2026·2026-04-29

    Ultraviolet-C Germicidal Wand Recalled for Unsafe UVC Radiation Exposure

    Uvlizer handheld UV-C wands may expose users and bystanders to ultraviolet-C radiation levels above international safety limits during normal use, posing risk of skin and eye injury.

    Product
    The product is a handheld ultraviolet-C germicidal wand and contains two low-pressure mercury bulbs with a peak emission wavelength at 254 nm.
    Category
    Medical Device
    Distribution
    0 states
  • 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 ane
    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-1836-2026·2026-04-29

    [pending] Medline Kits: 1) MTS LEFT HEART KIT-CAROLINAS HOS, Model Number: 60021775; 2) DBD-MTS LHK BHS BAP

    Pending LLM rewrite. Source: FDA_DEVICE Z-1836-2026.

    Product
    Medline Kits: 1) MTS LEFT HEART KIT-CAROLINAS HOS, Model Number: 60021775; 2) DBD-MTS LHK BHS BAPTIST. LOUISVI, Model Number: 60022026; 3) MTO LEFT HEART KIT SUMMA BARBERT, Model Number: 60022673; 4) MTS LH KIT-UNIV OF MIAMI PG, Model Number: 60030817; 5) MTS LEFT HEART
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1877-2026·2026-04-29

    Medline Convenience Kits With Syringes Recalled for Unapproved Design Changes

    Medline Industries is recalling Convenience Kits containing 10mL polycarbonate colored syringes due to unapproved design changes made outside of FDA 510(k) clearance. The recall affects 270,311 units distributed nationwide and internationally.

    Product
    Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes ADULT CATH PACK-LF DYNJ38395G ANGIO DRAPE PACK (ADLUG)642-LF DYNJ47665F DYNJ47665G ANGIO KIT PACK DYNJ83746 DYNJ83746A ANGIO PACK DYNJ30565G DYNJ51239C DYNJ66631A DYNJ6920
    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-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-1866-2026·2026-04-29

    Angiodynamics Soft-Vu Angiographic Catheter Guidewire Blockage Risk

    Angiodynamics is recalling the Soft-Vu Angiographic Catheter, Kumpe, Non-Braided 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 100CM 038 NB 0SH; Catalog No.: 10714021; Product/UPN No.: H787107140215 (Box), H787107140210 (Pouch); Box Quantity: 5 pouches;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-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 (Food)·H-0682-2026·2026-04-29

    [pending] Kirkland Signature Traditional Madeleines 12 Count/net wt. 18oz., Item #2000012, UPC 000020000127. P

    Pending LLM rewrite. Source: FDA_FOOD H-0682-2026.

    Product
    Kirkland Signature Traditional Madeleines 12 Count/net wt. 18oz., Item #2000012, UPC 000020000127. Plastic clamshell container is packed with 9 pieces of Filled Heart Madeleines. Distributed by Costco Wholesale Corp. Seattle, WA. Label of recalled package is read in part: TRAD
    Category
    Food
    Distribution
    8 states
  • HighFDA (Devices)·Z-1894-2026·2026-04-29

    LeadCare Plus Blood Lead Test Kit Recalled for Unexpectedly Elevated Results

    Magellan Diagnostics is recalling LeadCare Plus Blood Lead Test Kits (Catalog Number 82-0004) because they may produce falsely elevated lead results when used with certain third-party micro-collection devices, potentially causing delayed testing and unnecessary follow-up testing.

    Product
    LeadCare¿ Plus Blood Lead Test Kit; Catalog Number: 82-0004; The LeadCare¿ Plus kit is provided with the following materials: " Sensors (4 containers of 24 each; 96 tests) " Treatment Reagent Tubes (4 packages of 24 each; 96 tests) " Calibration Button (1 @) " Lead Contro
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1854-2026·2026-04-29

    Olympus Thunderbeat II Shears Ultrasonic Mode distal tip detachment risk

    Olympus is recalling Thunderbeat II Shears (5mm, 45cm) because the distal tip component may detach during use, potentially causing patient harm.

    Product
    Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 45cm. Model Number: TB2-0545FC.
    Category
    Medical Device
    Distribution
    0 states
  • 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 (Devices)·Z-1929-2026·2026-04-29

    LSL Healthcare Central Line Dressing Change Kit Recalled for Non-Sterility

    LSL Healthcare is recalling its Standard Central Line Dressing Change Kit (Model 2717J) because the included Webcol Large Alcohol Prep Pads were found to be non-sterile.

    Product
    LSL Healthcare, Standard Central Line Dressing Change Kit, Model/Catalog Number: 2717J
    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-1912-2026·2026-04-29

    Arrow Percutaneous Sheath Introducer Catheter Recall Due to Adhesive Defect

    Arrow International is recalling 115 units of its percutaneous sheath introducer with 7.5–8 Fr catheter because the liquid adhesive was incorrectly manufactured by a supplier. The product is used for venous access and central circulation catheterization.

    Product
    PERCUTANEOUS SHEATH INTRODUCER with 7.5 - 8 Fr. Catheter REF ASK-09903-MGH3 UDI code: (01)10801902159127(17)270331(11)251203(10)33F25J0352 The Arrow¿ percutaneous sheath introducer permits venous access and catheter introduction to the central circulation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-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