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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851–875 of 30631

  • SevereFDA (Drugs)·D-0491-2026·2026-05-06

    Systane Lubricant Eye Gel Recalled Due to Sterility Concerns

    Alcon Research LLC is recalling Systane Lubricant Eye Gel Night Gel (10g) distributed nationwide due to FDA inspection observations regarding lack of assurance of sterility that may impact product quality.

    Product
    SYSTANE — SYSTANE (HYPROMELLOSE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2016-2026·2026-05-06

    Medline Medical Procedure Kits with Neuro Sponges Recalled

    Medline is recalling multiple medical procedure kits containing Neuro Sponges due to higher-than-expected endotoxin levels that may render the product out-of-specification.

    Product
    Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. OPEN HEART CDS PART A, Medline Kit Number/SKU CDS840402AI; 2. OPEN HEART CDS, Medline Kit Number/SKU CDS984890V; 3. RR-NEURO VASCULAR PACK-LF, Medline Kit Number/SKU DYNJ0394874L; 4.
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1771-2026·2026-05-06

    Boston Scientific Cardiac Pacemakers Require Software Update

    Boston Scientific is expanding a software advisory for ACCOLADE family pacemakers and cardiac resynchronization therapy devices. Updated software (Brady SMR6) is now available to address identified issues.

    Product
    Boston Scientific Cardiac Resynchronization Therapy (CRT)labeled as: 1. VALITUDE CRT-P EL, Model Number U125; 2. VALITUDE CRT-P EL MRI, Model Number U128; 3. VISIONIST CRT-P EL, Model Number U225; 4. VISIONIST CRT-P EL, Model Number U226; 5. VISIONIST CRT-P EL MRI, Mod
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1947-2026·2026-05-06

    AIDBAG First Aid Kits with Recalled Blood Glucose Meters Recalled

    North American Rescue LLC. is recalling AIDBAG first aid kits containing McKesson TRUE Metrix PRO blood glucose meters that display an E-5 error code incorrectly, potentially delaying appropriate patient treatment.

    Product
    AIDBAGs are first aid kits of convenience composed of individually labeled devices designed as specialty first aid kits designed for the appropriate level provider to evaluate and treat patients at the point-of-injury / point-of-illness. The original manufacturer labeling, includ
    Category
    Medical Device
    Distribution
    2 states
  • SevereFDA (Devices)·Z-1984-2026·2026-05-06

    Immy Myco DDR Trident Neutralization Buffer B Recalled for Potential Contamination

    Immuno-Mycologics, Inc. is recalling Immy Myco DDR Trident Bulk Neutralization Buffer B (60 X 30 mL, Lot F5061154) because the product may contain contaminants. The buffer is used for clinical specimen processing for Mycobacterium spp. diagnosis.

    Product
    Immy, Myco DDR Trident, Bulk Neutralization Buffer B (60 X 30 mL), REF: TBPN67-60 For processing of clinical specimens for Mycobacterium spp. diagnosis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0499-2026·2026-05-06

    Optase Dry Eye Drops Recalled for Lack of Sterility Assurance

    Scope Health is recalling Optase Dry Eye Intense Drops (Glycerin 0.2%) due to lack of assurance of sterility. The product is distributed nationwide.

    Product
    OPTASE — OPTASE (GLYCERIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2043-2026·2026-05-06

    Medline IV Start and Securement Kits Recalled for Non-Sterile Alcohol Prep Pads

    Medline Industries is recalling multiple IV start and securement kits nationwide because they contain non-sterile Webcol Large Alcohol Prep Pads due to discovery of a bacterial contaminant during sterilization testing.

    Product
    Medline or Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: 1. NEONATAL IV START KIT (Centurion), Medline Kit SKU IV8310E; 2. IV SECUREMENT KIT (Centurion), Medline Kit SKU IVS1700; 3. IV START KIT (Centurion), Medline Kit SKU IV
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2026-2026·2026-05-06

    Medline Medical Procedure Kits Recalled for Higher Endotoxin Levels

    Medline Industries is recalling medical procedure kits containing neuro sponges worldwide because testing found higher-than-expected endotoxin levels, indicating products may be out-of-specification.

    Product
    Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. NEURO BASIN PACK-LF, Medline Kit Number/SKU DYNJ0532910L; 2. NEURO BASIN PACK-LF, Medline Kit Number/SKU DYNJ39461J; 3. PK-MAD,SPINE, Medline Kit Number/SKU DYNJ58060I; 4. PK-MAD,SPI
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2005-2026·2026-05-06

    epoc BGEM BUN Test Card for epoc Blood Analysis System

    Siemens Healthcare Diagnostics is recalling epoc BGEM BUN Test Cards due to risk of inaccurate pH and carbon dioxide readings that could lead to inappropriate or missed treatment of acid-base disorders.

    Product
    epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System; Siemens Material Number (SMN): 10736515;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2011-2026·2026-05-06

    Medline medical procedure kits recalled for out-of-specification endotoxin levels

    Medline Industries is recalling medical procedure kits containing Neuro Sponges for spinal fusion due to higher-than-expected endotoxin levels that may be out-of-specification.

    Product
    Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: SPINAL FUSION, Medline Kit Number/SKU CDS860017AG
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2001-2026·2026-05-06

    Abbott i-STAT Blood Gas Cartridges Reporting Inaccurate pH and PCO2 Results

    Abbott Point Of Care Inc. is recalling approximately 7.6% of i-STAT G3+, i-STAT EG6+, and i-STAT EG7+ blood gas cartridges due to a manufacturing issue causing falsely high PCO2 and low pH readings, which may lead to unnecessary or harmful clinical interventions.

    Product
    i-STAT G3+ cartridge; List Number: 03P78-26;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2028-2026·2026-05-06

    Centurion Surgical ENT Prep Kits with Medline Neuro Sponges Recalled

    Medline Industries is recalling Centurion Surgical ENT Prep Kits (Medline Neuro Sponges) due to higher-than-expected endotoxin levels that may render the product out-of-specification. Approximately 3,000 kits have been distributed worldwide.

    Product
    Centurion medical procedure kits, containing Medline Neuro Sponges, labeled as follows: SURGICAL ENT PREP KIT, Medline Kit Number/SKU MNS11715
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2034-2026·2026-05-06

    Medline medical procedure kits with neuro sponges recalled for endotoxin

    Medline Industries is recalling medical procedure kits containing neuro sponges after internal review identified higher-than-expected endotoxin levels. In-market product may be out-of-specification for endotoxin.

    Product
    Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. SPINE PROCEDURES PACK-LF, Medline Kit Number/SKU DYNJ0751220P; 2. ENSEMBLE RACHIS-LF, Medline Kit Number/SKU DYNJ47568B; 3. UROLOGY ROBOTIC, Medline Kit Number/SKU DYNJ55555B; 4. UROLOG
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2030-2026·2026-05-06

    Medline Microdisectomy Kits Recalled for High Endotoxin Levels

    Medline is recalling Microdisectomy Packs containing Neuro Sponges due to higher-than-expected endotoxin levels found during an internal review. The affected products may be out-of-specification for endotoxin.

    Product
    Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. MICRODISECTOMY PACK, Medline Kit Number/SKU DYNJ80585B; 2. MICRODISECTOMY PACK, Medline Kit Number/SKU DYNJ80585C; 3, MICRODISECTOMY PACK, Medline Kit Number/SKU DYNJ80585D.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2033-2026·2026-05-06

    Medline medical procedure kits recalled for elevated endotoxin levels

    Medline Industries is recalling medical procedure kits containing Neuro Sponges due to higher-than-expected endotoxin levels found on the products. Affected kits were distributed worldwide.

    Product
    Medline medical procedure kits, containing Medline Neuro Sponges (961 in total), NEURO,
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2044-2026·2026-05-06

    Medline Centurion Medical Kits Recalled for Non-Sterile Alcohol Prep Pads

    Medline Industries is recalling Centurion medical convenience kits containing Webcol Large Alcohol Prep Pads after Cardinal Health determined the pads are non-sterile due to bacterial contamination discovered during sterilization testing.

    Product
    Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: DERMATOLOGY SHAVE KIT, Medline Kit SKU SK395
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2023-2026·2026-05-06

    Medline Medical Procedure Kits with Neuro Sponges Recalled for Endotoxin

    Medline Industries is recalling three medical procedure kits containing Neuro Sponges due to higher-than-expected endotoxin levels identified during internal review. The affected kits may be out-of-specification for endotoxin.

    Product
    Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. ENDOSCOPIC SKULL BASE, Medline Kit Number/SKU DYNJ58648J; 2. ENT ENDO SINUS WILMINGTON PACK, Medline Kit Number/SKU DYNJ66447; 3. ENDOSCOPIC SKULL BASE, Medline Kit Number/SKU DYNJ90836
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1987-2026·2026-05-06

    DePuy Synthes ATTUNE Revision Hinge Femoral Component Sterility Recall

    DePuy Synthes is recalling one lot of ATTUNE Revision Hinge Femoral components (left size 7, part number 150450107) due to external sterile packaging adhered to internal packaging, potentially compromising product sterility.

    Product
    Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 7 CEM. Part Number: 150450107.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2038-2026·2026-05-06

    Medline Medical Procedure Kits Recalled for High Endotoxin Levels

    Medline is recalling certain medical procedure kits containing neuro sponges because they may have higher-than-expected endotoxin levels, indicating out-of-specification product in the market.

    Product
    Medline medical procedure kits, containing Medline Neuro Sponges (4077 in total), LAMINECTOMY, CRANI, etc.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1991-2026·2026-05-06

    Depuy Synthes ATTUNE Revision Hinge Femoral Knee Component Recall

    Depuy Synthes is recalling 3 units of the ATTUNE Revision Hinge Femoral (Right, Size 5, Cemented) knee implant due to external sterile packaging adhered to internal sterile packaging, potentially compromising product sterility.

    Product
    Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 5 CEM. Part Number: 150450205.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1999-2026·2026-05-06

    Abbott i-STAT EG7+ Blood Gas Cartridges Reporting Inaccurate Results

    Abbott Point Of Care is recalling approximately 7.6% of specific i-STAT EG7+ cartridge lots due to a manufacturing issue causing falsely high pCO2 and low pH readings. Inaccurate results could lead clinicians to make unnecessary or harmful medical interventions.

    Product
    i-STAT EG7+ cartridge; List Number: 03P76-25;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2042-2026·2026-05-06

    Medline Centurion Medical Convenience Kits Recalled for Non-Sterility

    Medline Industries is recalling Centurion medical convenience kits containing Webcol Large Alcohol Prep Pads due to discovery of non-sterile product contaminated with Paenibacillus phoenicis bacteria during sterilization testing.

    Product
    Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: LATEX FREE GENERAL PURPOSE TRAY, Medline Kit SKU 75670
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2013-2026·2026-05-06

    Medline Medical Procedure Kits with Neuro Sponges Recalled

    Medline Industries is recalling medical procedure kits containing Neuro Sponges due to higher-than-expected endotoxin levels that may be out of specification. The kits were distributed worldwide.

    Product
    Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. NEURO PACK, Medline kit number/SKU DYNJ64479; 2. CRANIO/NEURO/SPINE, Medline kit number/SKU DYNJ901072D.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·H-0677-2026·2026-05-06

    [pending] 52USA brand POPPING BOBA; PASSION FRUIT FLAVOR; Net wt: 7 lb (3.2kg); Ingredients Drinking water, fr

    Pending LLM rewrite. Source: FDA_FOOD H-0677-2026.

    Product
    52USA brand POPPING BOBA; PASSION FRUIT FLAVOR; Net wt: 7 lb (3.2kg); Ingredients Drinking water, fructose syrup, food additives (hydroxypropyl distarch phosphate (E1442), calcium lactate (E327), DL-malic acid (E296), sodium alginate (E401), citric acid (E330), carrageenan (EE407
    Category
    Food
    Distribution
    1 state