The Recall Desk

Severity 4 of 5

Severe recalls

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

What “severe” means here

Severity 4 (Severe) recalls have a real, documented risk of significant injury, hospitalization, or property damage even if no deaths have been reported. The agency classification is FDA Class II with hospitalization reports, USDA Class I, or a structural vehicle defect. These need attention quickly — not five-alarm urgency but not something to put off. Examples include allergen mislabeling on common allergens for products eaten by children, drug potency out of specification by a margin that could cause measurable harm, and vehicle defects affecting braking or steering.

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.

1751–1775 of 4878

  • SevereFDA (Devices)·Z-0075-2024·2023-10-25

    Olympus High-Flow Insufflation Unit Model UHI-4 Recalled for Cardiac Complications

    Olympus recalls the UHI-4 High-Flow Insufflation Unit used in laparoscopic surgery after reports of patients experiencing cardiac arrhythmias and short cardiac arrests during procedures. Incidents may result from over insufflation of the abdominal cavity.

    Product
    Olympus High-Flow Insufflation Unit, Model UHI-4. For laparoscopic surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0029-2024·2023-10-18

    Hemodialysis machines recalled for potential printed circuit board contamination

    Fresenius Medical Care is recalling 733 2008T Hemodialysis Systems without CDX due to potential PCBA leaching from tubing. This FDA Class I recall affects units distributed nationwide.

    Product
    2008T Hemodialysis System without CDX
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0007-2024·2023-10-18

    Syringes with Luer Lock Recalled for Blood Backfill and Foreign Material Risk

    Fresenius Medical Care is recalling 3ML syringes with Luer Lock due to potential blood backfill leakage and foreign material contamination. The recall affects 124,773 boxes distributed nationwide.

    Product
    3ML Syringe Luer Lock with needle 20GX1, Part Number 15-03ML-0, 100 per box, 24 boxes per case
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0005-2024·2023-10-18

    FDA Recalls Fresenius 10mL Luer Lock Syringes Due to Leakage and Foreign Material

    Fresenius Medical Care is recalling 10mL syringes nationwide due to potential blood backfill leakage and foreign material. The recall affects 124,773 boxes of the devices.

    Product
    10ML SYRINGE LUER LOCK W/OUT NEEDLE, Part Number 15-R010-0, 100 per box, 12 boxes to a case
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0033-2024·2023-10-18

    Hemodialysis machines recalled for potential PCBA leaching from tubing

    Fresenius Medical Care is recalling 733 units of 2008T HD hemodialysis machines nationwide due to potential PCBA leaching from tubing. The FDA classified this as a Class I recall.

    Product
    2008T HD SYS. CDX W/BIBAG BLUESTAR
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0031-2024·2023-10-18

    Medical device manufacturer recalls hemodialysis machines for potential PCBA leaching

    Fresenius Medical Care is recalling 733 units of the 2008T GEN 2 Bibag hemodialysis machine due to potential printed circuit board assembly material leaching from tubing. All affected units were distributed domestically.

    Product
    2008T GEN 2 Bibag without CDX
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0006-2024·2023-10-18

    10ML Syringe Luer Lock Recalled for Potential Blood Backfill Leakage

    Fresenius Medical Care is recalling 124,773 boxes of 10ML Syringe Luer Lock syringes due to potential blood backfill leakage and foreign material contamination.

    Product
    10ML SYRINGE LUER LOCK W/NEEDLE, Part Number 15-10ML-0, 100 per box, 12 boxes per case
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0007-2024·2023-10-18

    LuLu Chinese Express Korean Noodles Recalled for Undeclared Egg Allergen

    LuLu Chinese Express Korean Noodles (Japchae) with Vegetables are being recalled due to undeclared egg allergen. The 54 containers distributed in Missouri may pose a health risk to consumers with egg allergies.

    Product
    LuLu Chinese Express Korean Noodles (Japchae) w/ Vegetables. Net Wt 16oz.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Devices)·Z-0030-2024·2023-10-18

    2008T Hemodialysis System recalled for potential PCBA leaching from tubing

    Fresenius Medical Care is recalling 733 units of the 2008T Hemodialysis System due to potential leaching of printed circuit board material from machine tubing. Patients using affected devices should contact their healthcare provider.

    Product
    2008T Hemodialysis System w/Bibag
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0032-2024·2023-10-18

    Hemodialysis Machines Recalled Due to Potential PCBA Leaching

    Fresenius Medical Care is recalling 733 hemodialysis machines nationwide due to potential printed circuit board material leaking from tubing.

    Product
    2008T HD SYS. CDX BLUESTAR
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0042-2024·2023-10-18

    FDA recalls BREXAFEMME tablets due to cross-contamination with ezetimibe

    The FDA is recalling BREXAFEMME antifungal tablets due to potential cross-contamination with ezetimibe during manufacturing, with two lot numbers distributed nationwide.

    Product
    BREXAFEMME (Ibrexafungerp) tablets 150 mg, 4 count cartons, Rx Only, Manufactured for and distributed by SCYNEXIS, Inc., Jersey City, NJ 07302 NDC 75788-115-04
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0035-2024·2023-10-18

    Hemodialysis Systems Recalled for Potential PCBA Tubing Leaching

    Fresenius Medical Care is recalling 733 hemodialysis machines nationwide due to potential leaching of circuit board material from tubing. Affected equipment may contaminate blood or dialysate during treatment.

    Product
    2008T HD SYS. W/O CDX W/BIBAG BLUESTAR
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0034-2024·2023-10-18

    Hemodialysis machines recalled due to potential circuit board material leaching

    Fresenius Medical Care is recalling 733 units of 2008T hemodialysis systems nationwide due to potential leaching of printed circuit board assembly material from tubing. No illnesses or injuries have been reported.

    Product
    2008T HD SYS. W/O CDX BLUESTAR
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0002-2024·2023-10-11

    Arrow ErgoPack central venous catheter recalled for incorrect labeling

    ARROW INTERNATIONAL is recalling 180 units of the Arrow ErgoPack Complete CVC catheter (Lot 33F23B0723) distributed in the US because the product code and product name were incorrectly listed on the kit's label.

    Product
    Arrow ErgoPack Complete, Pressure Injectable Arrowg+ard Blue Plus¿ Four-Lumen CVC, REF CDC-42854- PCN1A; catheter, intravascular, therapeutic, long-term greater than 30 days
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0001-2024·2023-10-11

    Arrow PICC Catheters Recalled for Incorrect Product Label Information

    Arrow International recalled 1,173 PICC line units due to incorrect product code and name on packaging labels. Affected lot 33F23B0781 was distributed in the US.

    Product
    Arrow ErgoPack, Pressure Injectable Arrowg+ard Blue Advance Two-Lumen PICC pre-loaded with Arrow VPS Precision Stylet, REF CDC-45552-VPS2; Catheter: Percutaneous Implanted Long-Term Intravascular Catheter Stylet: Diagnostic Intravascular Catheter
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0003-2024·2023-10-11

    Arrow Central Venous Catheter Recalled for Incorrect Lidstock Labeling

    Arrow International is recalling 380 units of its Arrowg+ard Blue Plus Four-Lumen central venous catheter (model CDC-45854-P1A, lot 13F22L0806) due to incorrect product code and name listed on the package lidstock.

    Product
    Arrow Pressure Injectable Arrowg+ard Blue Plus¿ Four-Lumen CVC, REF CDC-45854-P1A; catheter, intravascular, therapeutic, long-term greater than 30 days
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0004-2024·2023-10-11

    FDA Recalls Arrow PICC Catheters with Incorrect Product Code Labels

    Arrow INTERNATIONAL recalled 172 units of ErgoPack PICC catheters due to incorrect product code and product name labels. The error affected lot 13F22G0508 distributed in the US.

    Product
    Arrow ErgoPack Pressure Injectable Arrowg+ard Blue Advance Three-Lumen PICC pre-loaded with Arrow VPS TipTracker Stylet, REF CDC-45563-TTS; catheter, intravascular, therapeutic, long-term greater than 30 days
    Category
    Medical Device
    Distribution
    0 states
  • SevereNHTSA·22V799000·2023-10-10

    CAN-AM Ryker Motorcycles Recalled for Loose Harnesses Causing Engine Stall

    CAN-AM is recalling 2019-2023 Ryker motorcycles because electrical harnesses in the front fenders may loosen and rub on the tire, causing a short circuit that can stall the engine while driving.

    Product
    CAN-AM — 2021 CAN-AM RYKER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·22V528000·2023-10-07

    2022 Ford F-53 Steering Wheel Attachment Bolt May Loosen

    Ford is recalling certain 2022 F-53 and F-59 motorhome and commercial chassis vehicles because the steering wheel attachment bolt may loosen and separate. This could result in loss of steering control and increased crash risk.

    Product
    FORD — 2022 FORD F-53
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·22V531000·2023-10-07

    Spartan RV Chassis Steering Gear Assembly Defect Recall

    Shyft Group is recalling certain 2022-2023 Spartan RV Chassis vehicles due to improperly assembled steering gears that may fracture, causing loss of steering control. Owners should contact the manufacturer for free inspection and replacement.

    Product
    SPARTAN — 2023 SPARTAN K1
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1662-2023·2023-10-04

    Kleina Bites frozen dessert recalled due to Listeria contamination risk

    Kleina Bites frozen dessert products may be contaminated with Listeria monocytogenes. Consumers in Ohio, New Jersey, and New York who purchased this product should not consume it.

    Product
    Kleina Bites; parve; 12 PACK / SINGLE; UPC: 0-91404-15148-1
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Food)·F-1656-2023·2023-10-04

    Ice cream sandwiches recalled for potential Listeria contamination

    Ice Cream House is recalling Double Fudge Sandwich ice cream products due to potential contamination with Listeria monocytogenes. Products are distributed in Ohio, New Jersey, and New York.

    Product
    Double Fudge Sandwich; dairy / parve; 6 PACK / SINGLE; UPC: 0-91404-15240-2
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Food)·F-1619-2023·2023-10-04

    Premium Sorbet 5-Liter Recall: Potential Listeria Contamination

    Ice Cream House recalls Premium Sorbet 5-liter products distributed in Ohio, New Jersey, and New York due to potential Listeria monocytogenes contamination.

    Product
    Premium Sorbet 5 Liter - All flavors; parve; 1 PACK; Food Service
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Food)·F-1676-2023·2023-10-04

    Ice Cream House Mini Roll Cake Assorted Recalled for Listeria Contamination

    Ice Cream House Mini Roll Cake Assorted products may be contaminated with Listeria monocytogenes. Affected products were distributed in Ohio, New Jersey, and New York.

    Product
    Mini Roll Cake Assorted; parve; 8 PACK / SINGLE; UPC: 0-91404-15350-8
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Food)·F-1606-2023·2023-10-04

    Frozen whole octopus recalled for Salmonella contamination

    CenSea Inc is recalling 281 cases of Central Seafoods frozen whole octopus due to Salmonella contamination detected during testing. Product distributed to OH, FL, GA, and IL.

    Product
    Central Seafoods 30# case of IQF whole octopus. Three item codes / GTIN numbers depending on size of individual octopus: Item 10400: 2-4 pound whole octopus, GTIN 1 00 70041 20007 0. Item 10432: 4-6 pound whole octopus, GTIN 1 00 70041 20008 7. Item 10460: 6-8 pound whole octo
    Category
    Food
    Distribution
    4 states