The Recall Desk

Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

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201–225 of 247

  • 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-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-1927-2026·2026-04-29

    Sequencing Agent SEQ0067 Component Recalled for Potential False-Positive Results

    Foundation Medicine is recalling Sequencing Agent SEQ0067, a component of the FoundationOne CDx test, due to a possible increase in phasing that could result in false-positive BARD1 splice site indel artifact variants.

    Product
    Sequencing Agent SEQ0067, component of FoundationOne CDx (F1CDx)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-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-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-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-1874-2026·2026-04-29

    AccuVu Angiographic Catheter, Omni Flush, Non-Braided Defect Recall

    Angiodynamics recalls AccuVu Angiographic Catheters due to a manufacturing defect that may prevent guidewires from passing through the catheter hub. The affected devices were distributed worldwide.

    Product
    AccuVu Angiographic Catheter, Omni Flush, Non-Braided, With 21 R/O Markers; ACCU-VU OF 4F X 70CM 035 NB 6SH 21 R/O 1CM; Catalog No.: 13709704; Product/UPN No.: H787137097045 (Box), H787137097040 (Pouch); Box Quantity: 5 pouches;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1915-2026·2026-04-29

    [pending] Pressure Injectable Arrowg+ard Blue Plus¿ Four-Lumen CVC Kit REF ASK-45854-PUPM1 UDI code: (01)1080

    Pending LLM rewrite. Source: FDA_DEVICE Z-1915-2026.

    Product
    Pressure Injectable Arrowg+ard Blue Plus¿ Four-Lumen CVC Kit REF ASK-45854-PUPM1 UDI code: (01)10801902159578(17)270531(11)251205(10)33F25M0011 The Arrowg+ard technology is intended to provide protection against catheter-related bloodstream infections (CRBSIs). It is not int
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1923-2026·2026-04-29

    Oxoid Agglutinating Sera Salmonella 9-0 Serotyping Classification Error

    Remel Europe Ltd. is recalling specific lots of Oxoid Agglutinating Sera, Salmonella 9-0 due to cross-reactivity that may misidentify Salmonella 9-O serotypes as 2-O serotypes in laboratory testing.

    Product
    Oxoid Agglutinating Sera, Salmonella 9-0 R30957301
    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 ane
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1864-2026·2026-04-29

    Soft-Vu Angiographic Catheter Cobra Non-Braided Manufacturing Defect

    Angiodynamics, Inc. recalls Soft-Vu Angiographic Catheter, Cobra (1), Non-Braided devices due to a manufacturing defect that may prevent guidewires from passing through the catheter hub.

    Product
    Soft-Vu Angiographic Catheter, Cobra (1), Non-Braided; SOFT-VU CB1 4F X 100CM 038 NB 0SH; Catalog No.: 10714017; Product/UPN No.: H787107140175 (Box), H787107140170 (Pouch); Box Quantity: 5 pouches;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1928-2026·2026-04-29

    Central Line Dressing Kit containing non-sterile alcohol prep pads recalled

    LSL Healthcare's Central Line Dressing Kit (Model 2717H) is being recalled because it contains Webcol Large Alcohol Prep Pads that were found to be non-sterile. The kits were distributed nationwide in Maryland, Illinois, and Minnesota.

    Product
    LSL Healthcare, Central Line Dressing Kit, Model/Catalog Number: 2717H
    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-1904-2026·2026-04-29

    Olympus OER-ELITE Endoscope Reprocessor Connecting Tubes Recall

    Olympus Corporation of the Americas is recalling OER-ELITE Endoscope Reprocessor Connecting Tubes (Model MAJ-2116) because the Version 2 reprocessor connecting tube lock levers may fail prematurely.

    Product
    OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2116.
    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-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-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-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-1933-2026·2026-04-29

    LSL Healthcare Wound Closure Tray Model 7554 Recalled for Non-Sterility

    LSL Healthcare is recalling its Wound Closure Tray (Model 7554) distributed nationwide to Maryland, Illinois, and Minnesota because the kits contained non-sterile Webcol Large Alcohol Prep Pads.

    Product
    LSL Healthcare Wound Closure Tray, Model/Catalog Number: 7554
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1872-2026·2026-04-29

    AccuVu Angiographic Catheter recall due to manufacturing defect

    Angiodynamics is recalling AccuVu Angiographic Catheters due to a manufacturing defect that may prevent a guidewire from passing through the catheter hub. The defect could interfere with proper device function during medical procedures.

    Product
    AccuVu Angiographic Catheter, Omni Flush, Non-Braided, With 2 R/O Markers; ACCU-VU OF 4F X 70CM 035 NB 6SH 2 R/O 2CM; Catalog No.: 13709005; Product/UPN No.: H787137090055 (Box), H787137090050 (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