The Recall Desk

Severity 4 of 5

Severe recalls

The hazard poses a serious risk of illness, injury, or structural failure. 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.

801–825 of 32252

  • SevereFDA (Devices)·Z-2378-2026·2026-06-24

    Arrow PICC and delta kits contain recalled supplier drugs

    Arrow PICC and PICC/Delta kits are being recalled because they contain lidocaine, bupivacaine and 0.9% sodium chloride subject to a supplier recall. 3,481 units affected.

    Product
    Description/REF: PI PICC: 3: 6FR x 55CM w CHG/ DLX-35563-HPKC; AGBA PICC: 2L 5.5 FR X 45 CM/ASK-44552-ABKB; AGBA PICC/DELTA KIT: 5.5 FR X 55 CM/ASK-45552-MHBV; AGBA PICC: 1L 4.5FR x 55CM w Biopatch/DLX-45541-HPKB; PICC/DELTA KIT: 2L 5.5 FR X 50 CM/ASK-45052-MC; AGBA PI PICC KIT…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2383-2026·2026-06-24

    Arrow pacing and PSI kits contain drugs from a recalled supplier

    Arrow Pacing/PSI kits, 5 Fr two-lumen, are being recalled because they contain lidocaine, bupivacaine and 0.9% sodium chloride subject to a supplier recall. 95 units affected.

    Product
    Description/REF: PACING/PSI KIT: 5 FR 2L/ASK-07155-MGU
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2364-2026·2026-06-24

    Arrow access trays and StimuCath kits contain recalled supplier drugs

    Arrow access trays and StimuCath safety kits are being recalled because they contain lidocaine, bupivacaine and 0.9% sodium chloride subject to a supplier recall. 205,685 units affected.

    Product
    Description/REF: ACCESS TRAY/ASK-04001-SUH-S; ACCESS TRAY/ASK-04001-VM1; STIMUCATH SFTY KIT: 19G CTH, 17Gx4CM NDL/AB-19604-KS; STIMUCATH SFTY KIT: 19G CTH, 17Gx8CM NDL/AB-19608-KS; STIMUCATH SFTY KIT: 20G CTH, 18Gx8CM NDL/AB-20608-KS; STIMUCATH KIT: 19G CATH, 17G x 9CM…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2360-2026·2026-06-24

    Automated Impella Controller software error affects left ventricular support devices

    Automated Impella Controllers are being recalled because of a potential software error when used with left ventricular Impella devices. 10,297 units are affected.

    Product
    Automated Impella Controller (AIC), for use with left heart support blood pump. Labeled as the following with corresponding Product Codes: 1. Impella Controller, Packaged, AU; Product Code: 0042-0000-AU. 2. Impella Controller, Packaged, CA; Product Code: 0042-0000-CA.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2385-2026·2026-06-24

    Arrow access trays and PSI kits contain recalled supplier drugs

    Arrow access trays and PSI kits are being recalled because they contain lidocaine, bupivacaine and 0.9% sodium chloride subject to a supplier recall. 426,041 units are affected.

    Product
    Description/REF: ACCESS TRAY/GU-04020; PSI KIT: 8.5 FR/AK-09803-CDC; PSI KIT: 9 FR/AK-09903-CDC; PSI KIT: 8.5 FR X 4 IN (10 CM)/ASK-09810-PCMH1; PSI KIT: 9 FR X 10 CM/ASK-09903-KH; PSI KIT: 9 FR X 10 CM/ASK-09903-PHP1; PSI KIT: 9 FR X 4 IN (10 CM)/ASK-09903-UPA; PSI KIT: 9 FR X…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2363-2026·2026-06-24

    Arrow paracentesis kits contain drugs from a recalled supplier

    Arrow paracentesis kits, REF AK-00376 and ASK-00376-VCU, are being recalled because they contain lidocaine, bupivacaine and 0.9% sodium chloride subject to a supplier recall. 50,724 units affected.

    Product
    PARACENTESIS KIT, REF: AK-00376, ASK-00376-VCU
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2395-2026·2026-06-24

    Arrow PICC access trays contain drugs from a recalled supplier

    The Arrow PICC Access Tray, REF ASK-04001-CG1, is being recalled because it contains lidocaine, bupivacaine and 0.9% sodium chloride subject to a supplier recall. 360 units affected.

    Product
    Description/REF: PICC ACCESS TRAY/ASK-04001-CG1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2382-2026·2026-06-24

    Arrow drainage and thoracentesis kits contain recalled supplier drugs

    Arrow drainage and thoracentesis kits are being recalled because they contain lidocaine, bupivacaine and 0.9% sodium chloride subject to a supplier recall. 444,943 units are affected.

    Product
    Description/REF: DRAINAGE KIT/AK-01600, DRAINAGE KIT/AK-01601, DRAINAGE KIT/ASK-01601-MM, THORACENTESIS KIT/AK-01000-T, THORACENTESIS KIT/AK-01000, THORACENTESIS KIT/ASK-01000-CHP, DRAINAGE KIT/ASK-01000-NW, THORACENTESIS KIT/ASK-01000-UPMS, PNEUMOTHORAX KIT/AK-01500…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2381-2026·2026-06-24

    Arrow 12 Fr hemodialysis kit contains drugs from a recalled supplier

    The Arrow two-lumen 12 Fr x 16 cm hemodialysis kit is being recalled because it contains lidocaine, bupivacaine and 0.9% sodium chloride subject to a supplier recall. 1,945 units affected.

    Product
    Description/REF: HEMODIALYSIS KIT: 2-LUMEN 12 FR X 16 CM/AK-12122-F
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2366-2026·2026-06-24

    Arrow pacing PSI kits contain drugs from a recalled supplier

    Arrow Pacing PSI kits are being recalled because they contain lidocaine, bupivacaine and 0.9% sodium chloride subject to a supplier recall. 15,915 units are affected.

    Product
    Description/REF: PACING PSI KIT: 6 FR/AI-06210-KS, PACING PSI KIT: 5 FR 2-L/AI-07155-KS, PACING PSI KIT: 5 FR 2L/ASK-07155-UPM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2457-2026·2026-06-24

    Impella CP sets may lose mechanical circulatory support from low purge pressure

    Impella CP Sets with SmartAssist are being recalled because a low purge pressure occurrence may cause persistent alarms and, in some cases, interruption or loss of circulatory support.

    Product
    Impella CP Set with SmartAssist. Product Codes: 1000080, 1000851, 0048-0014, 0048-0024-JP.
    Category
    Medical Device
    Distribution
    7 states
  • SevereFDA (Food)·H-0953-2026·2026-06-24

    White cheddar popcorn seasoning made with Salmonella-recalled milk powder

    Fireworks Popcorn White Cheddar Seasoning is being recalled because it was made with recalled California Dairies milk powder due to Salmonella. 1,407 jars are affected.

    Product
    White Cheddar Seasoning packed in the following sizes and configurations: 1. Net Wt. 1.2 oz (34g) Distributed by: Fireworks Popcorn, Division of Jonco Industries, Milwaukee, WI 53218. Sold in a Fireworks Popcorn, Natural American Popcorn Popping & Toppings gift set.…
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Devices)·Z-2374-2026·2026-06-24

    Arrow AHDC catheter kits contain drugs from a recalled supplier

    Arrow AHDC three-lumen catheter kits are being recalled because they contain lidocaine, bupivacaine and 0.9% sodium chloride subject to a supplier recall. 4,270 units affected.

    Product
    Description/REF: AHDC KIT: 3-L 12 FR X 16 CM/AK-12123-PCDC; AHDC KIT: 3-L 12 FR X 20 CM/AK-15123-PCDC; AHDC KIT: 3-L 12 FR X 20 CM/CDC-15123-XP1A; AHDC KIT: 3-L 12 FR X 25 CM/CDC-16123-XP1A; AHDC KIT: 3-L 12 FR X 25 CM/CDC-16123-XPN1A; AHDC AGB U-BEND KIT: 2-L 12 FR X 20…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2376-2026·2026-06-24

    Arrow central venous catheter kits contain drugs from a recalled supplier

    Arrow central venous catheter kits are being recalled because they contain lidocaine, bupivacaine and 0.9% sodium chloride subject to a supplier recall. 308,263 units affected.

    Product
    Description/REF: CVC/PSI KIT: 2 LUMEN 8 FR X 6 IN/ASK-42802-PLH; CVC KIT: 3-LUMEN 12 FR X 16 CM/AK-12123-F; CVC KIT: 3-LUMEN 12 FR X 20 CM/AK-15123-F; 3L CVC KIT: 7 FR X 16 CM/ASK-12703-PMAH; 3L PI CVC KIT: 7 FR X 16 CM/ASK-12703-PNM; 3L CVC KIT: 7 FR X 16 CM/ASK-12703-PUMH…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2373-2026·2026-06-24

    Arrow hemodialysis catheter kits contain drugs from a recalled supplier

    Arrow two-lumen hemodialysis kits are being recalled because they contain lidocaine, bupivacaine and 0.9% sodium chloride subject to a supplier recall. 15,425 units affected.

    Product
    Description/REF: HEMODIALYSIS KIT: 2-LUMEN 8 FR X 11 CM/AK-11802-F; HEMODIALYSIS KIT: 2-LUMEN 12 FR X 16 CM/AK-22122; HEMODIALYSIS KIT 2L: 14 FR X 15CM AGB/AK-22142-CDC; HEMODIALYSIS KIT 2L: 14 FR X 20CM AGB/AK-25142-CDC; HEMODIALYSIS KIT: 2L 14 FR X 15 CM/ASK-22142-UMD…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·26V399000·2026-06-23

    GM Recalls 2025-2026 Savana and Express for Steering Nut Issue

    General Motors is recalling 2025-2026 GMC Savana and Chevrolet Express vehicles because a steering gear nut may be loose, risking loss of control.

    Product
    GMC — GMC, CHEVROLET SAVANA, EXPRESS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·26563·2026-06-18

    Arrogantf Spa Drain Covers Recalled Over Entrapment and Drowning Hazards

    Arrogantf spa drain covers sold on Amazon violate federal safety standards and pose entrapment and drowning hazards. Consumers should stop using them immediately and contact the importer for a refund.

    Product
    Arrogantf Spa Drain Covers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereCPSC·26562·2026-06-18

    GOPO Toys pull string teething toys reported to cause choking incidents

    About 70,410 GOPO Toys pull string teething toys are being recalled after three reports of the silicone strings reaching the back of a child's throat, causing respiratory distress or choking.

    Product
    GOPO TOYS Pull String Teething Toys
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·H-0941-2026·2026-06-17

    Whole Foods vegetarian minestrone soup contains undeclared shrimp allergen

    Whole Foods Market Kitchens Vegetarian Minestrone Soup, 24 oz, is being recalled because it contains undeclared shrimp. 562 cases, or 4,496 units, are affected.

    Product
    Individual Unit Label (both lid and front of cup): Whole Foods Market Kitchens Minestrone Soup, VEGETARIAN NET WT 24 OZ (1 Lb 8OZ) 680g. Case Label: Whole Foods Global Minestrone Soup 702505, KEEP REFRIGERATED, Distributed by Whole Foods Market Austin, TX 78703. Eight (8)/ 24…
    Category
    Food
    Distribution
    18 states
  • SevereFDA (Food)·H-0939-2026·2026-06-17

    HH Fresh enoki mushrooms tested positive for Listeria monocytogenes

    HH Fresh Trading Corp. enoki mushrooms, 150 g, are being recalled after imported enoki mushrooms tested positive for Listeria monocytogenes. 120 cases are affected.

    Product
    HH Fresh Trading Corp. (branded) ENOKI MUSHROOM; Premium Quality; Net WT/ Poids Net 150g(5.29oz) Distributed by HH Fresh Trading Exported by JIA YANG INTERNATIONAL ENTERPRISES CO., LTD. Produced by Green Farm (Taiwan) UPC: 4711498860002
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0620-2026·2026-06-17

    Beekeeper's Naturals saline nasal spray recalled for microbial contamination

    Beekeeper's Naturals Saline Nasal Spray with propolis and xylitol, 1 fl oz, is being recalled for microbial contamination of non-sterile products. 1,680 bottles are affected.

    Product
    BEEKEEPER'S NATURALS Saline Nasal Spray, Sinus Congestion Rinse, Made with Propolis + Xylitol, 1 FL OZ (30 mL) per bottle, Manufactured For: Beekeeper's Naturals USA Inc., Covina, CA 91789.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0595-2026·2026-06-17

    Gas-X Extra Strength softgels contaminated with propylene glycol machine coolant

    Gas-X Extra Strength simethicone 125 mg softgels are being recalled because of contamination with a diluted propylene glycol-based coolant leaked from a machine during packaging.

    Product
    Gas-X Extra Strength, SIMETHICONE 125 mg/ANTIGAS, packaged in a) 120 SoftGels (UPC 3 00674 35041 9, b) 72 SoftGels (UPC 3 00439 00572 1), Distributed by: Haleon, Warren, NJ 07059.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0580-2026·2026-06-17

    Doxorubicin liposome injection vials contain glass particulate matter

    Doxorubicin Hydrochloride Liposome Injection, 50 mg/25 mL single-dose vials, is being recalled because of particulate matter identified as glass. 675 vials are affected.

    Product
    DOXORUBICIN HYDROCHLORIDE — DOXORUBICIN HYDROCHLORIDE (DOXORUBICIN HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide