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.

4926–4950 of 52939

  • HighFDA (Food)·F-0641-2025·2025-03-26

    Shredded Colby Jack cheese recalled for potential stainless steel fragments

    Great Lakes Cheese Co is recalling Happy Farms by ALDI Colby Jack shredded cheese due to potential stainless steel fragments. Affected products have best-by dates of July 13 or July 14, 2025.

    Product
    Happy Farms by ALDI Colby Jack (a blend of Colby & Monterey Jack finely shredded cheeses), Net Wt. 12 OZ (340g), packaged in flexible plastic stand-up pouches, 12 pouches per case, UPC 4061463330840, with Best By dates of July 13, 2025 and July 14, 2025. Dist. & sold exclusively
    Category
    Food
    Distribution
    4 states
  • HighFDA (Devices)·Z-1393-2025·2025-03-26

    Medline C-Section Procedure Kits Recalled for Defective Syringes

    Medline is recalling 456 C-section procedure kits containing plastic syringes affected by an FDA safety alert. The syringes may leak or break, posing a risk to patient health during surgical procedures.

    Product
    Medline procedure kits labeled as: 1) C SECTION, Pack Number DYNJ909098
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1369-2025·2025-03-26

    Sterile surgical drapes recalled due to potential packaging breach

    Medline Industries is recalling 220 Proxima Drape sterile surgical drapes nationwide due to a potential breach in pouch packaging that could compromise sterility.

    Product
    Proxima Drape labeled as UNIVERSAL DAVINCI ROBOTIC P. Sterile surgical drape.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1406-2025·2025-03-26

    Cranial Surgery Procedure Kit Recalled Over Sterility Assurance Failure

    American Contract Systems Inc is recalling 91 CRANI PACK cranial procedure kits because a critical component cannot be confirmed to meet sterility requirements, making them unsuitable for surgical use.

    Product
    CRANI PACK, Model/Catalog Number WECR41D, medical procedure kit.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1367-2025·2025-03-26

    Medline Proxima Sterile Surgical Drapes Recalled for Packaging Breach Risk

    Medline Industries is recalling Proxima Drape sterile surgical drapes due to potential packaging breach that could compromise sterility. The recall affects 16 units distributed nationwide.

    Product
    Proxima Drape labeled as FACE LIFT. Sterile surgical drape.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0651-2025·2025-03-26

    Chef's Line US Foods 3 Grain Burgers recalled for foreign bolt

    Chef's Line 3 Grain Burgers have been recalled due to a bolt found in the product. The affected cases were distributed to Illinois, Maryland, New Jersey, Pennsylvania, and Delaware.

    Product
    Chef's Line US Foods, 3 Grain 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 (Food)·F-0642-2025·2025-03-26

    emd Oysterettes Oyster Crackers Recalled for Metal Contamination

    Dairy State Foods Inc is recalling emd Oysterettes oyster crackers due to the possibility of metal contamination. Affected batches have date codes 34824 and 35324 and were distributed in Michigan.

    Product
    emd Oysterettes (oyster crackers in polypropylene film). 0.75 oz. Packed for and Distributed by emd, Detroit, MI 48212.
    Category
    Food
    Distribution
    1 state
  • 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-1350-2025·2025-03-26

    Laceration Tray Kits Recalled Due to Sterilization Assurance Failure

    American Contract Systems Inc recalls 690 laceration tray kits due to inability to confirm sterilization requirements were met. The trays may lack functionality and delay patient treatment.

    Product
    LACERATION TRAY , Model No SGLA07A SGLA07B-01 SGLA07B-02 SGLA07B
    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 (Devices)·Z-1340-2025·2025-03-26

    General Angio Pack Sterilization Assurance Cannot Be Confirmed

    American Contract Systems unable to confirm sterilization of 956 General Angio Pack kits distributed nationwide. Unsterile devices may lose functionality and delay patient treatment.

    Product
    GENERAL ANGIO PACK , Model Nos LLAP75G LLAP75G-01 LLAP75G-02 LLAP75G-03
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1397-2025·2025-03-26

    IV Catheter Valve Housing May Detach and Cause Leakage

    B. Braun Medical is recalling Introcan Safety 3 IV catheters because the valve housing may detach, causing fluid leakage. Approximately 28,200 units are affected.

    Product
    Introcan Safety 3 Closed IV Catheter 22 Ga. x 1 in., PUR, Winged. Passive safety IV catheter.
    Category
    Medical Device
    Distribution
    16 states
  • HighFDA (Food)·F-0644-2025·2025-03-26

    HOT ONES Verde hot sauce recalled for possible plastic contamination

    HOT ONES brand VERDE hot sauce by Heatonist is being recalled due to possible plastic foreign object contamination. Multiple sizes were distributed in North Carolina, Ohio, Indiana, and Illinois.

    Product
    HOT ONES brand VERDE, Los Calientes Hot Sauce, BY HEATONIST; 1 gallon, 5 oz, and 5 gallon sizes; UPC: 8-51444-00803-5
    Category
    Food
    Distribution
    4 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-1404-2025·2025-03-26

    CAPNOCHECK BCI Airway Adapter may break off, causing ventilation failure

    The CAPNOCHECK BCI Airway Adapter (Model BSR) may break when attached to a valve or tube, risking airway circuit failure and loss of ventilation. Approximately 175,994 units were recalled nationwide.

    Product
    CAPNOCHECK BCI Airway Adapter; Model Number BSR; Product Code WW1100
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0286-2025·2025-03-26

    Injectable Drug Recalled for Stability Issues at Expiration

    Amgen recalls 258,750 vials of Neupogen (filgrastim) injection due to stability concerns. Stability data shows products may be out of specification at expiration; patients should consult healthcare providers about affected lots.

    Product
    NEUPOGEN — NEUPOGEN (FILGRASTIM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0648-2025·2025-03-26

    Dried Longan Pulp Recalled for Elevated Sulfite Levels

    Growland Inc. is recalling Dried Longan Pulp products due to elevated sulfite levels. The affected product was distributed across seven states.

    Product
    Dried Longan Pulp- Made in China, 8oz(227g), GROWLAND INC. rear panel- Organic Planted, Store in cool and dry place, Made in Thailand; UPC# 8 513041 327262
    Category
    Food
    Distribution
    7 states
  • 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 (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 (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 (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 (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-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 (Drugs)·D-0279-2025·2025-03-26

    Cinacalcet Hydrochloride Tablets Recalled for Nitrosamine Impurity Above Safe Limits

    Slate Run Pharmaceuticals is recalling Cinacalcet Hydrochloride Tablets 60 mg for containing nitrosamine impurity above acceptable daily intake limits. The recall affects 2,444 bottles distributed nationwide.

    Product
    Cinacalcet Hydrochloride Tablets 60 mg, 30-count bottle, Rx only, Distr. by: Slate Run Pharma., LLC, Columbus, Ohio 43215, Mfg. by: Piramal Pharma Limited, Madhya Pradesh, India, NDC 70436-008-04
    Category
    Drug
    Distribution
    Distributed nationwide
  • 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