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.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means deaths or serious injuries are reported, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

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10301–10325 of 114055

  • HighFDA (Devices)·Z-1377-2025·2025-03-26

    Microstream CO2 Sampling Lines May Be Difficult to Disconnect From Breathing Tubes

    Microstream CO2 sampling lines and airway adapters may be difficult or impossible to disconnect from endotracheal tubes during clinical procedures, potentially causing treatment delays and unintended extubation with risk of serious complications.

    Product
    Microstream Instructions for Use and Part Number used with - Product Description, REF: FilterLine Sets & VitaLine Sets Adult/Pediatric, MQ04616 - MICROSTREAM FilterLine H Set Long Adult-Pediatric CO2 Sampling Line and Airway Adapter for Humid Environments, 007737; MICR
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1363-2025·2025-03-26

    Medline Proxima sterile surgical drapes recalled due to potential packaging breach

    Medline is recalling 1,482 units of Proxima sterile surgical drapes due to potential breaches in pouch packaging that could compromise sterility. No illnesses have been reported.

    Product
    Proxima Drape labeled as DRAPE C-SECTION W/ WINDOW; SHEET, DRAPE, SPLIT, ST,10/CS; DRAPE,LAPROSCOPY,CHOLE,W/TROUGH,ST,8/CS; DRAPE,LAPROSCOPY,CHOLE,W/TROUGH,ST,8/CS; DRAPE,ABDOMINAL,MAJOR,ST,8/CS; DRAPE,ABDOMINAL,MAJOR,ST,8/CS; DRAPE,SPLIT,CVMAX,6/CS; DRAPE,ORTHOMAX ,BAR,6/CS; DRA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1355-2025·2025-03-26

    Neuro IR Tray recalled over unconfirmed sterilization assurance

    American Contract Systems Inc is recalling Neuro IR Tray (Model WENI56J) due to inability to confirm sterilization assurance. Loss of functionality could delay or prolong treatment.

    Product
    NEURO IR TRAY , Model No WENI56J
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1370-2025·2025-03-26

    Surgical drapes recalled due to potential sterility breach in packaging

    Medline Industries is recalling Proxima Drape surgical drapes nationwide due to a potential breach in pouch packaging that could lead to loss of sterility. The recall affects 1,118 units distributed in the US.

    Product
    Proxima Drape labeled as ORTHO TRAUMA CDS, TOTAL KNEE AUX PACK, TOTAL HIP PACK, TOTAL HIP, TOTAL KNEE, SPINE. Sterile surgical drape.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1364-2025·2025-03-26

    Surgical Drape Packs Recalled for Potential Sterility Breach in Packaging

    Medline Industries is recalling Proxima Sterile Surgical Drape packs due to a potential breach in the pouch packaging that could lead to loss of sterility. The recall affects 1,490 units distributed nationwide.

    Product
    Proxima Drape labeled as PACK,BASIC,SIRUS,V,5/CS; PACK,BASIC IV,SIRUS,5/CS; PACK,SET UP,NO DRAPE,12/CS; PACK,SET UP,NO DRAPE,12/CS; PACK,SET UP,NO DRAPE,12/CS; PACK,SET UP,NO DRAPE,12/CS; PACK,SET UP,NO DRAPE,12/CS; PACK,UNIVERSAL II,SIRUS,7/CS; PACK,LAPAROTOMY,NO GOWN,10/CS; PAC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·25V190000·2025-03-26

    Micro Bird Recalls G5 School Buses for Missing Seat Reinforcements

    Micro Bird is recalling certain G5 school buses because seat reinforcement supports may be missing, which could cause seats to detach in a crash.

    Product
    MICRO BIRD — MICRO BIRD G5 SCHOOL BUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0280-2025·2025-03-26

    Prasugrel 5 mg Tablets Recalled Due to Failed Dissolution Specifications

    Mylan Pharmaceuticals is recalling specific lots of Prasugrel 5 mg tablets due to failed dissolution specifications. The affected tablets may not dissolve properly in the body.

    Product
    PRASUGREL — PRASUGREL (PRASUGREL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1376-2025·2025-03-26

    CO2 Sampling Lines May Fail to Disconnect During Neonatal Care

    Microstream CO2 sampling lines and airway adapters may be difficult or impossible to disconnect from endotracheal tubes, potentially delaying treatment or causing unintended extubation. The defect affects neonatal and pediatric patients worldwide.

    Product
    Microstream Instructions for Use and Part Number used with - Product Description, REF: FilterLine H Set & VitaLine H Set Infant/Neonatal, 006147 - MICROSTREAM FilterLine H Set Infant/Neonatal CO2 Sampling Line and Airway Adapter for Humid Environments, 006324; MICROSTREAM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1382-2025·2025-03-26

    Microstream Neonatal-Infant CO2 Filter Line May Be Difficult to Disconnect

    Microstream Neonatal-Infant Intubated CO2 Filter Lines may become difficult or impossible to disconnect from endotracheal tubes during clinical procedures, potentially delaying treatment and causing unintended extubation.

    Product
    Microstream Instructions for Use and Part Number used with - Product Description, REF: Microstream Adv. Infant Intubated, PT00134354 - Microstream Advance Neonatal-Infant Intubated CO2 Filter Line 2m/6.5ft Extended Duration, QMVIIH
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0639-2025·2025-03-26

    Domna's Bakery Baklava Recalled for Undeclared Milk Allergen

    Optima Foods is recalling Domna's Bakery 24 PC Baklava Tray distributed in New York because it contains undeclared milk. Consumers with milk allergies should not consume this product.

    Product
    Domna's Bakery 24 PC Baklava Tray 330043 8
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0659-2025·2025-03-26

    Vanilla shakes recalled due to potential Listeria contamination

    Lyons Magnus LLC is recalling Ready Care and Imperial brand vanilla shakes (4 oz) due to potential Listeria monocytogenes contamination. The affected products were distributed to long-term care facilities, skilled nursing homes, and hospitals across the U.S.

    Product
    Ready Care Vanilla Shake No Sugar Added (4 oz), UPC 10045796017365; Imperial Vanilla Shake No Sugar Added (4 oz), UPC 00074865927031
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-1365-2025·2025-03-26

    Sterile Surgical Drape Recalled Due to Potential Packaging Breach

    Medline Industries is recalling 114 units of Proxima Drape surgical drapes due to a potential breach in pouch packaging that could compromise sterility. Affected units were distributed nationwide.

    Product
    Proxima Drape labeled as ENT-PLASTICS PACK. Sterile surgical drape.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0645-2025·2025-03-26

    HOT ONES Hot Sauce Recalled for Possible Plastic Contamination

    HOT ONES brand ROJO hot sauce is recalled due to possible plastic contamination. The Karma Sauce Company is conducting a precautionary recall of products distributed in North Carolina, Ohio, Indiana, and Illinois.

    Product
    HOT ONES brand ROJO, Los Calientes Hot Sauce, BY HEATONIST; 5 oz size and 1 gallon sizes; UPC: 8-51444-00810-03
    Category
    Food
    Distribution
    4 states
  • HighFDA (Food)·F-0640-2025·2025-03-26

    Madras Curry Powder Recalled for Elevated Lead Levels

    Trong Food International is recalling Madras Curry Powder sold in three package sizes due to elevated lead contamination. All lots of the product have been included in the recall, which affected distributors in Maryland and Washington DC.

    Product
    Madras Curry Powder sold in 3 different package sizes. Recall has been expanded to include ALL LOTS. CA RI NI AN DO "KIM TU THAP", NET WT./ Poids NET (4oz.) 114 grams glass jar UPC# 39606001562 (4oz.) 114 grams plastic pouch UPC# 36906001544 (16oz.) plastic bottle UPC# 39606001
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-0650-2025·2025-03-26

    Chef's Line Black Bean Burgers Recalled for Foreign Object

    Chef's Line US Foods black bean burgers are being recalled because a bolt was found in the product. The recalled product was distributed to Illinois, Maryland, New Jersey, Pennsylvania, and Delaware.

    Product
    Chef's Line US Foods, Black Bean Burger, 36/4.25 oz., Product in a plastic bag in a cardboard box. approx. 36 pieces per case. Keep Frozen,
    Category
    Food
    Distribution
    5 states
  • HighFDA (Devices)·Z-1331-2025·2025-03-26

    Laparoscopy Surgical Packs Recalled Due to Unconfirmed Sterilization

    American Contract Systems Inc. is recalling 303 Laparoscopy Packs (Models CALS41F, CALS41F-01, CALS41G) because sterilization assurance requirements could not be confirmed. Unsterilized instruments may cause infection or delayed treatment.

    Product
    LAPAROSCOPY PACK, Model No. CALS41F, CALS41F-01, CALS41G
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1335-2025·2025-03-26

    Cystoscopy Kit Recalled for Sterilization Assurance Verification Failure

    American Contract Systems Inc is recalling CYSTO PACK cystoscopy kits because the company cannot confirm sterilization assurance requirements were met. Possible loss of functionality could delay or prolong patient treatment.

    Product
    CYSTO PACK , Model N. HKCY31A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0287-2025·2025-03-26

    FDA Recalls Prasugrel Tablets for Failed Dissolution Specifications

    Golden State Medical Supply Inc. is recalling 2,601 bottles of Prasugrel 5 mg tablets due to failed dissolution specifications. The tablets may not dissolve properly, potentially affecting drug absorption.

    Product
    PRASUGREL — PRASUGREL (PRASUGREL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1389-2025·2025-03-26

    Candida ID Antigen recalled for reduced sensitivity, potential false negatives

    Immuno-Mycologics' Candida ID Antigen may have reduced sensitivity, causing false negative diagnostic results. Lot F4171005 has been distributed worldwide including CA and OK.

    Product
    Candida ID Antigen, REAG, AG, REF C50110, Vol 1 mL REF ID1001, Immy Fungal Antigens, Positive Controls, & Immunodiffusion (ID) plates for use in the ID test, RX only, IVD, CE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0291-2025·2025-03-26

    FDA Recalls Super-Potent Levothyroxine Sodium Tablets Due to Potency Deviation

    Mylan Institutional is recalling 1,068 cartons of levothyroxine sodium 125 mcg tablets (Lot 3115773) distributed nationwide due to out-of-specification potency. The tablets contain higher-than-specified amounts, potentially resulting in excessive doses.

    Product
    LEVOTHYROXINE SODIUM — LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0649-2025·2025-03-26

    Chocolate Peanut Butter Protein Balls Recalled for Undeclared Allergens and Food Additives

    Prep'd CDA LLC is recalling Chocolate Peanut Butter Protein Balls due to undeclared soy lecithin and undeclared food color additives. Consumers with soy allergies should not consume the product.

    Product
    Chocolate Peanut Butter Protein Balls. Product has expected life of 2 weeks and does not require refrigeration. Product is packaged in sets of 2 protein balls into resealable plastic baggies. Net Wt. 78 grams.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1357-2025·2025-03-26

    General Laparoscopic Pack Recall Due to Unconfirmed Sterilization

    American Contract Systems Inc is recalling 534 kits of General Laparoscopic Pack-LF surgical instruments because sterilization assurance could not be confirmed. This could result in loss of functionality and treatment delays.

    Product
    GENERAL LAPAROSCOPIC PACK-LF , Model No UTGL53S-06 UTGL53S-07 UTGL53S-08
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1332-2025·2025-03-26

    DR DIULUS Injection Pack Models Recalled for Sterilization Assurance Issues

    American Contract Systems Inc is recalling 1,200 DR DIULUS Injection Pack kits because the manufacturer cannot confirm sterilization assurance requirements were met. This may result in loss of functionality and treatment delays.

    Product
    DR DIULUS INJECTION PACK, Model Nos. CCDU12C CCDU12D CCDU12D-01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0278-2025·2025-03-26

    Cinacalcet Hydrochloride Tablets Recalled for Nitrosamine Impurity

    Slate Run Pharmaceuticals is recalling Cinacalcet Hydrochloride Tablets 30 mg due to nitrosamine impurity above acceptable daily intake limits. 56,790 bottles were distributed to 8 wholesalers nationwide.

    Product
    Cinacalcet Hydrochloride Tablets 30 mg, 30-count bottle, Rx only, Distr. by: Slate Run Pharma., LLC, Columbus, Ohio 43215, Mfg. by: Piramal Pharma Limited, Madhya Pradesh, India, NDC 70436-007-04
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1399-2025·2025-03-26

    VERICIS Merge Cardio may display inconsistent measurement data in clinical reports

    The VERICIS Merge Cardio system may display inconsistent cardiovascular measurements in patient reports when specific workflows are used. This could affect clinical decisions based on the reported data.

    Product
    VERICIS, Merge Cardio, Model/Catalog Number: Version 10.x, Software Version: 10.0, 10.1.1.1, 10.1.2, 10.2.0, 10.2 P2 , 10.3; The VERICIS is an integrated cardiovascular information system classified as a picture archiving and communications system.
    Category
    Medical Device
    Distribution
    0 states