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.

2326–2350 of 52932

  • HighFDA (Drugs)·D-0263-2026·2026-01-21

    Alka Seltzer recalled over insanitary conditions at a distribution center

    Gold Star Distribution is recalling Alka Seltzer over CGMP deviations, citing insanitary conditions including rodent exposure and activity at its distribution center.

    Product
    Alka Seltzer, a) Original, 2 tablets per packet in 58 count box, UPC: 815556020033, 016500514473, b) Plus Cold & Flu, 2 tablets per packet in 36 count box, UPC: 016500594932
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0279-2026·2026-01-21

    TUMS antacid tablets recalled over insanitary conditions at a distribution center

    Gold Star Distribution is recalling TUMS antacid tablets over CGMP deviations, citing insanitary conditions including rodent exposure and activity at its distribution center.

    Product
    TUMS a) Assorted, 12 Ct.; b) Extra Strength (EX) Assorted Berries, 12-count #1194A *05/27; c)Extra Strength (EX) Assorted Fruit, 12-count, #1194C *03/27
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0396-2026·2026-01-21

    Pink rose pound cakes recalled because soy was not on the label

    Ukrop's Homestyle Foods is recalling 61 pound cakes with buttercream icing and pink roses because the label did not include soy, which was used in the product.

    Product
    Ukrop's 6" Pound Cake with Buttercream Icing/Pink Roses NET WT 44 OZ (2.75lb/1.25kg) CONTAINS: Egg, Milk, Wheat Made in a production area that also uses soy and tree nuts. UPC 7 22515 91452 7 Ukrop's Homestyle Foods, LLC Richmond, VA 23230
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1042-2026·2026-01-21

    Angioplasty balloon catheters recalled over inflation and deflation difficulty

    Boston Scientific is recalling 21 Coyote over-the-wire PTA balloon dilatation catheters over the potential for inflation and deflation difficulty during use in the peripheral vasculature.

    Product
    Boston Scientific Coyote OVER-THE-WIRE PTA Balloon Dilation Catheter, 4F, 1) 2.5mm x120mm, 150 cm, UPM/Model No. REF H74939186251210; 2) 3.5mm x120mm, 150 cm, UPM/Model No. REF H74939186351210; Catheter, Angioplasty, Peripheral, Transluminal
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1100-2026·2026-01-21

    Arterial blood sampling kits recalled over a crack on the syringe collar

    ICU Medical is recalling 64,290 Pulsator Arterial Blood Sampling Kits because syringes may have a crack on the collar, which may lead to blood leakage and repeated draws.

    Product
    Pulsator Arterial Blood Sampling Kit, Item Numbers 4044EG-1 4080P-2 4084P-1 4080PE 4080PG
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0258-2026·2026-01-21

    Testosterone pellets recalled over a lack of assurance of sterility

    Advanced Pharmaceutical Technology is recalling 22,843 TESTO-100 testosterone pellets over a lack of assurance of sterility and potential microbial contamination.

    Product
    TESTO-100 CIII (testosterone 100 mg), 10 Sterile Pellets per carton, Rx only, Manufactured by: Advanced Pharmaceutical Technology, 132 South Central Avenue, Elmsford, NY 10523, NDC# 57377-100-01
    Category
    Drug
    Distribution
    4 states
  • HighFDA (Devices)·Z-1099-2026·2026-01-21

    Circulatory support blood pumps recalled over locking into the motor

    Thoratec is recalling 8,399 CentriMag blood pump products after reports that the pump may not fit or lock securely into the motor using the screw-in locking feature.

    Product
    CentriMag Blood Pump, REF: 102953, 201-20003, 201-90010, 201-90016; CentriMag RVAD HDE KIT, REF: 104318; CentriMag Pre-connected Pack, REF: CMAEK00; CentriMag VAD KIT, REF: 201-51006, 201-51007, 201-90001 201-90001T; Blood Pump with CentriMag Acute Circulatory Support System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1095-2026·2026-01-21

    Coagulation reagent recalled over potential for microbial contamination

    Instrumentation Laboratory is recalling 7,720 units of a coagulation reagent used for evaluating the intrinsic pathway and monitoring heparin therapy over potential microbial contamination.

    Product
    The product is used for the evaluation of the intrinsic coagulation pathway, APTT substitution test and the monitoring of heparin therapy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0261-2026·2026-01-21

    Frozen raw shrimp recalled over elevated levels of chloramphenicol

    AZ Gems is recalling 1,099 cases of Member's Mark Jumbo Raw Shrimp over elevated levels of chloramphenicol.

    Product
    Advil a) Ibuprofen, Dispenser Pack, 2 tablet packets in box containing 50 individual packets, UPC: 305730154895; b) PM, Ibuprofen, Dispenser Pack, 2 Caplet packets in box containing 50 packets, UPC: 305730164559
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0389-2026·2026-01-21

    Medium shrimp paste recalled after the product tested high for lead

    Gusto Group is recalling 7 cases of Klong Kone shrimp paste in the 16 oz medium size after the product tested high for lead.

    Product
    Shrimp Paste (Klong Kone) 'M' , 16 oz, 24 count , PLastic Jar, 24 packages/ case
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·H-0390-2026·2026-01-21

    Vaporizing chest rub recalled over insanitary conditions at a distribution center

    Gold Star Distribution is recalling Personal Care Vaporizing Chest Rub over CGMP deviations, citing insanitary conditions including rodent exposure and activity at its distribution center.

    Product
    DPA161 Shrimp Paste (Klong Kone) 'L' , 32 oz, 12 count , PLastic Jar, 12 packages / cases
    Category
    Drug
    Distribution
    2 states
  • HighFDA (Food)·H-0385-2026·2026-01-21

    Rice and pigeon peas recalled over undeclared soy in 2,078 units

    ASK Foods is recalling 2,078 units of Publix Rice & Pigeon Peas over an undeclared soy allergen.

    Product
    Publix Rice & Pigeon Peas, Net Wt 32 oz (2lb), Plastic tray with clear lid, black film, and a pre-printed label. 6 (2lb) containers per case .
    Category
    Food
    Distribution
    1 state
  • HighNHTSA·26V026000·2026-01-21

    Keystone Recalls Travel Trailers Due to Ramp Door Breakage Risk

    Keystone RV Company is recalling 2024-2026 Fuzion, Raptor, Redwood, and Voltage travel trailers because the ramp door may break away from the frame, increasing injury risk.

    Product
    KEYSTONE — KEYSTONE VOLTAGE, REDWOOD, RAPTOR, FUZION
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1058-2026·2026-01-21

    Children's NyQuil recalled over insanitary conditions at a distribution center

    Gold Star Distribution is recalling Children's NyQuil Cold & Flu over CGMP deviations, citing insanitary conditions including rodent exposure and activity at its distribution center.

    Product
    Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) ADMIN KIT, Medline kit SKU DYKS1339B; 2) ADMIN KIT, Medline kit SKU DYKS1339C; 3) QCASC WELCOME KIT, Medline kit SKU DYKS1359B; 4) ADMISSION KIT, Medline kit SKU DYKS
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1018-2026·2026-01-21

    MRI systems recalled over ice that may block magnet venting

    Canon Medical Systems is recalling 22 Vantage Titan 3T MRI systems because ice in the magnet venting system could lead to a helium vessel rupture during a quench.

    Product
    VANTAGE TITAN 3T Model MRT-3010/MEXL-3010
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1101-2026·2026-01-21

    Spinal tray syringes recalled over a crack on the syringe collar

    ICU Medical is recalling 64,290 Portex Spinal Trays because syringes may have a crack on the collar, which may lead to delayed or repeated blood draws and blood leakage.

    Product
    Portex Spinal Tray, Item No. A3729-24 A3595
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1096-2026·2026-01-21

    Surgical access port kits recalled over trays that may crack

    Intuitive Surgical is recalling 41,526 da Vinci SP Access Port Kits because the Access Port System tray may develop cracks, potentially resulting in a sterility breach.

    Product
    da Vinci SP, SP Access Port Kit, Large Incision Reference Numbers:430073 (2.7-4cm,SP1098, Box) & 430075 (2.7-7cm,SP1098,Box)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1057-2026·2026-01-21

    Levothyroxine tablets recalled after a bottle held the wrong strength

    Alvogen is recalling a lot of Levothyroxine Sodium Tablets, 150mcg, after a pharmacy reported a single bottle containing 88 mcg tablets instead of 150 mcg tablets.

    Product
    Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) PRE OP KIT, Medline kit SKU DYKS1093B; 2) PRE OP KIT, Medline kit SKU DYKS1124C; 3) PRE OP KIT, Medline kit SKU DYKS1128C; 4) PREOP KIT, Medline kit SKU DYKS1130B; 5) P
    Category
    Drug
    Distribution
    Distributed nationwide