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.

101–125 of 50460

  • HighFDA (Devices)·Z-3224-2026·2026-09-30

    Maquet PowerLED 300 Concealed Lighting System Recalled for Detachment Risk

    Maquet is recalling 667 PowerLED 300 Concealed Lighting Systems because the spring arm may detach and fall, posing a potential injury risk.

    Product
    PowerLED 300 Concealed Lighting System (PWD30+SF W K3 SPRING ARM A2 FC3 50-100nm) Model Numbers: 1. ARD568474114A, 2. ARD567501286;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3251-2026·2026-09-30

    Abiomed Recalls Automated Impella Controllers Due to Firmware and Software Defects

    Abiomed is recalling 3,322 Automated Impella Controllers worldwide due to firmware and software defects that affect pressure signal accuracy and system reliability.

    Product
    Automated Impella Controller (AIC) with the below product descriptions and corresponding Product Codes. 1. Impella Controller, Packaged, CA; Product Code: 0042-0000-CA. 2. Impella Controller, Packaged, EU; Product Code: 0042-0000-EU. 3. Impella Controller, Packaged…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3230-2026·2026-09-30

    Medline Instrument Channel Brush Kits Recalled for Sharp Edges

    Medline is recalling Healthmark Instrument Channel Brush kits due to potential sharp edges that could cause cuts, abrasions, or infection.

    Product
    Medline convenience kits containing Healthmark Instrument Channel Brushes. SINUS PACK DYNJ48258D and SINUS PACK DYNJ48258F.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3219-2026·2026-09-30

    Midmark IQvitals Zone Recalled for Inaccurate Blood Pressure Readings

    Midmark Corporation is recalling 20 IQvitals Zone units because a performance issue may cause inaccurate blood pressure readings when using the Linear Deflation Method.

    Product
    Midmark IQvitals Zone, automatically and noninvasively measures systolic and diastolic blood pressure, pulse rate, temperature (temporal), and oxygen saturation (SpO2) for adult and pediatric patients, Model Number: 1-200-0350 with Kit Number: 4-000-0722
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-1389-2026·2026-09-30

    Elegant Foods Recalls Pecorino Toscano Cheese Due to Listeria Risk

    Elegant Foods, LLC is recalling Pecorino Toscano D.O.P. STAGIONATO cheese wheels in Wisconsin due to potential Listeria contamination from cooler condensation.

    Product
    Pecorino Toscano D.O.P. STAGIONATO cheese wheels. Product of Italy. Each cheese wheel is approximately 3-4 lbs. Wheels contain a wax rind. Keep Refrigerated. Produced by Soc. Cooperativa Val D'Orcia Aocieta Agricola
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-3268-2026·2026-09-30

    Medline Neurological Surgery Kits Recalled for Endotoxin Variability

    Medline is recalling 234 neurological surgery kits nationwide due to potential endotoxin variability that may cause adverse health reactions.

    Product
    Medline Convenience Kits: 1) MAJOR NEURO VCH, Catalog Number: DYNJ39218I; 2) NEURO PACK-LF, Catalog Number: DYNJ41246F; 3) CRANIOTOMY PACK (CRSJE)227-LF, Catalog Number: DYNJ47487A; 4) MAJOR NEURO PACK, Catalog Number: DYNJ57233J; 5) NEURO, Catalog Number: DYNJ82388A…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3220-2026·2026-09-30

    Midmark IQvitals Zone Recalled for Inaccurate Blood Pressure Readings

    Midmark Corporation is recalling 33 IQvitals Zone units because a performance issue may cause inaccurate blood pressure readings when using the Linear Deflation Method.

    Product
    Midmark IQvitals Zone, automatically and noninvasively measures systolic and diastolic blood pressure, pulse rate, temperature (temporal), and oxygen saturation (SpO2) for adult and pediatric patients, Model Number: 1-200-0360 with Kit Number: 4-000-0724
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3259-2026·2026-09-30

    New York Embroidery Studio Recalls Isolation Gowns for Liquid Barrier Failure

    New York Embroidery Studio is recalling 5,400 Trinity Non-Surgical Isolation Gowns because they do not consistently meet minimum liquid-barrier performance requirements.

    Product
    New York Embroidery Studio Trinity Non-Surgical Isolation Gown, AAMI PB70 Level 2, X-Large. Model Number: NYES100-2. Packaged in inner packs of 10 and 100 gowns per shipping case.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3254-2026·2026-09-30

    Cardinal Health Recalls Presource Convenience Kits Due to Potential Seal Defects

    Cardinal Health is recalling 17,503 Presource Convenience Kits because applicator packaging may have open or incomplete seals, posing a risk of infection.

    Product
    Presource Convenience Kits: 1) KIT, PRE OP , Catalog Number: AMN548616A; 2) KIT, NICU ADMIT NEW HAN , Catalog Number: BA1DH0116B; 3) KIT, PRE PROCEDURE , Catalog Number: IVSJV8302E; 4) KIT, IV SUPPLIES , Catalog Number…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3246-2026·2026-09-30

    Olympus BiCOAG Hemostasis Probe Recalled for Ceramic Tip Detachment Risk

    Olympus is recalling 2,142 BiCOAG Hemostasis Probes because a manufacturing error may cause the ceramic tip to detach.

    Product
    Olympus BiCOAG Hemostasis Probe 7Fr Coaxial Connector. Model/Catalog Number: CD-B620LA.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·26V629000·2026-09-30

    Greenpower Recalls EV Star Buses Due to Software Error

    Greenpower is recalling 94 EV Star buses because a software error may allow the vehicle to move while the wheelchair lift is deployed.

    Product
    GREENPOWER — GREENPOWER EV STAR MOBILITY PLUS BUS, EV STAR BUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3218-2026·2026-09-30

    Midmark IQvitals Zone Recalled for Inaccurate Blood Pressure Readings

    Midmark Corporation is recalling 153 IQvitals Zone units because a performance issue may cause inaccurate blood pressure readings when using the Linear Deflation Method.

    Product
    Midmark IQvitals Zone, automatically and noninvasively measures systolic and diastolic blood pressure, pulse rate, temperature (temporal), and oxygen saturation (SpO2) for adult and pediatric patients, Model Number: 1-200-03300 with Kit Number: 4-000-0624
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3226-2026·2026-09-30

    SeaSpine Mariner Deformity Spinal Device Recall Due to Thread Depth Issue

    SeaSpine Orthopedics is recalling 270 units of the Mariner Deformity Extended Polyaxial Head because the proximal thread depth is out of design specification.

    Product
    SeaSpine Mariner Deformity Product Name: Extended Polyaxial Head, Attached Gimbal, 12mm REF: MD1-300010-12
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3258-2026·2026-09-30

    Intervascular Recalls Cardioroot Woven Collagen Coated Vascular Grafts

    Intervascular is recalling Cardioroot Woven Collagen Coated Vascular Grafts because the product failed to meet acceptance criteria for Integral Water Permeability.

    Product
    Cardioroot Woven Collagen Coated Vascular Graft; Model Numbers: 1. HEWROOT0024, 2. HEWROOT0026, 3. HEWROOT0028, 4. HEWROOT0030, 5. HEWROOT0032, 6. HEWROOT0034;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-1392-2026·2026-09-30

    United Sugar Recalls Powdered Sugar Due to Potential Wheat Kernel Contamination

    United Sugar Producers and Refiners is recalling specific batches of powdered sugar due to potential wheat kernel contamination. The product was distributed in eight states.

    Product
    Powdered Sugar, Packaged in the following configurations: 1. United 6X, Net Wt. 50 lbs. (22.68kg), Item Number 810087. UPC 7 85921-07090 4. Distributed by: United Sugar Producers & Refiners, Minneapolis, MN 55439. 2. Crystal Sugar, Net Wt. 25 lbs. (11.3 kg), Item…
    Category
    Food
    Distribution
    8 states
  • HighFDA (Devices)·Z-3267-2026·2026-09-30

    Medline Craniotomy Kits Recalled for Potential Endotoxin Variability

    Medline is recalling 486 craniotomy convenience kits due to potential endotoxin variability that may cause adverse health reactions.

    Product
    Medline Convenience Kits: 1) MFC CRANIOTOMY PACK, Catalog Number: DYNJT8784; 2) SLUH CRANIOTOMY PACK-LF, Catalog Number: DYNJ0369348Q; 3) SLUH CRANIOTOMY PACK-LF, Catalog Number: DYNJ0369348R; 4) SLUH CRANIOTOMY PACK-LF, Catalog Number: DYNJ0369348S; 5) SLUH CRANIOTOMY…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3231-2026·2026-09-30

    Biomerieux VITEK 2 AST-N461 Test Kit Recalled for Card Pouch Damage

    Biomerieux Inc is recalling VITEK 2 AST-N461 test kits due to card pouch damage that may cause false resistant results, potentially leading to less effective antibiotic treatments.

    Product
    VITEK 2 AST-N461 TEST KIT, GRAM NEGATIVE SUSCEPTIBILITY TESTING - AUTOMATED, Reference Number 424811
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3217-2026·2026-09-30

    Midmark IQvitals Zone Recalled for Inaccurate Blood Pressure Readings

    Midmark Corporation is recalling IQvitals Zone devices because a performance issue may cause inaccurate blood pressure readings when using the Linear Deflation Method.

    Product
    Midmark IQvitals Zone, automatically and noninvasively measures systolic and diastolic blood pressure, pulse rate, temperature (temporal), and oxygen saturation (SpO2) for adult and pediatric patients, Model Number: 1-200-0320 with Kit Number: 4-000-0622
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3265-2026·2026-09-30

    Medline Neurological Sponges Recalled for Potential Endotoxin Variability

    Medline is recalling 695 convenience kits containing neurological sponges due to potential endotoxin variability that may cause adverse health reactions.

    Product
    Medline Convenience Kits: 1) PEDS SINUS PACK, Catalog Number: DYNJ02516G; 2) SINUS PACK-LF, Catalog Number: DYNJ0342705J; 3) NASAL-LF, Catalog Number: DYNJ40094G; 4) ENT PACK, Catalog Number: DYNJ50699F; 5) EENT PACK, Catalog Number: DYNJ83219
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0854-2026·2026-09-30

    MENOW Sunscreen Powder Recalled for cGMP Deviations in California

    Shantou Qiwei Industrial Co., Ltd is voluntarily recalling 2,970 units of MENOW Sunscreen Pressed Powder SPF35 PA+++ in California due to cGMP deviations.

    Product
    MENOW SUNSCREEN PRESSED POWDER SPF35 PA+++, Net content, 9g/0.32 oz, Manufactured by: Shantzu Qiwei Industry Co. Ltd, Add: Quiwei Building, Yingloinguan, Xiashan, Chaonan district, Shantou City, Guangdong Province, China
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Devices)·Z-3269-2026·2026-09-30

    Medline Neurological Surgery Kits Recalled for Endotoxin Variability

    Medline Industries is recalling 4,013 neurological surgery kits due to potential endotoxin variability that may cause adverse health reactions.

    Product
    Medline Convenience Kits: 1) ANTERIOR SPINE PACK, Catalog Number: DYNJT10197; 2) CRANIOTOMY #IMF 56646-LF, Catalog Number: DYNJVB91001; 3) CRANIOTOMY PACK-LF, Catalog Number: DYNJ0369348O; 4) SLUH CRANIOTOMY PACK-LF, Catalog Number: DYNJ0369348P; 5) LAMINECTOMY PACK-LF…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3255-2026·2026-09-30

    Cardinal Health Recalls Presource Convenience Kits Due to Seal Defects

    Cardinal Health 200, LLC is recalling Presource Convenience Kits because applicator packaging may have open or incomplete seals, posing a risk of infection.

    Product
    Presource Convenience Kits: 1) KIT, USGPIV , Catalog Number: PVMHIVMHD; 2) KIT, USGPIV , Catalog Number: PVMHIVM14; 3) KIT, USGPIV , Catalog Number: PVMHIVM15
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·26V626000·2026-09-30

    Starcraft Super Lite Maxx Travel Trailer Recall for Water Tank Fasteners

    Starcraft RV is recalling 2022-2024 Super Lite Maxx travel trailers because fasteners may fail, causing the fresh water tank to detach and create a road hazard.

    Product
    STARCRAFT RV TT — STARCRAFT RV TT SUPER LITE MAXX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·26V623000·2026-09-29

    RAM Recalls 2026 Ram 1500 Vehicles for Tire Pressure Sensor Defect

    Chrysler is recalling 2026 Ram 1500 vehicles because tire pressure sensors may fail to detect low pressure or illuminate the warning light, increasing crash risk.

    Product
    RAM — RAM 1500
    Category
    Vehicle
    Distribution
    Distributed nationwide