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.

4876–4900 of 52939

  • HighCPSC·25201·2025-03-27

    NFH Iron Dietary Supplement Bottles Lack Required Child-Resistant Packaging

    About 17,660 NFH iron dietary supplement bottles lack child-resistant packaging required by federal law, posing a poisoning risk to young children. No injuries have been reported.

    Product
    NFH Iron SAP, NFH Heme Iron SAP and NFH Prenatal SAP bottles
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighCPSC·25199·2025-03-27

    APOTHEKE Pumpkin Ginger Scented Candles Recalled for Fire and Burn Hazards

    APOTHEKE's Pumpkin Ginger 3-wick candles can overheat and break their glass containers, posing fire and burn hazards. About 640 units were sold at Crate & Barrel from June 2024 through January 2025.

    Product
    APOTHEKE's Pumpkin Ginger 3-Wick Scented Candles
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·25197·2025-03-27

    Cra-Z-Art Gemex and Gel2Gem Jewelry Kits Recalled for Chemical Irritation Risk

    LaRose Industries is recalling about 224,100 Cra-Z-Art Gemex and Gel2Gem jewelry kits because the resin liquid can cause skin, eye, and respiratory irritation in children when inhaled, touched, or ingested.

    Product
    Cra-Z-Art Gemex/Gel2Gem Jewelry Kits
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·25202·2025-03-27

    Wooden dressers recalled for tip-over and entrapment hazards

    George Oliver wooden dressers sold on Wayfair.com are unstable without proper wall anchoring, posing tip-over and entrapment hazards. About 220 units were sold; no injuries reported.

    Product
    George Oliver Dressers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • 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-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 (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-1403-2025·2025-03-26

    Shoulder Prosthesis Stem Excess Material Prevents Proper Surgical Assembly

    Zimmer Orthopedics recalls shoulder prosthesis models due to excess material in the taper that prevents proper surgical assembly. Five complaints reported.

    Product
    Comprehensive Shoulder Stem, Comprehensive Micro Stem, Comprehensive Mini Stem; uncemented shoulder prosthesis, Model Nos. 113605, 113606, 113607, 113627
    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 (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-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-1358-2025·2025-03-26

    Vascular Pack Sterilization Assurance Requirements Cannot Be Confirmed

    American Contract Systems cannot confirm Major Vascular Pack surgical kits were properly sterilized. Sterilization assurance failure could result in loss of functionality and delayed patient treatment.

    Product
    MAJOR VASCULAR PACK , Model No UTMV78X-01 UTMV78Y UTMV78Y-01 UTMV78X-01 UTMV78Y-02
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1352-2025·2025-03-26

    Laparoscopy Surgical Packs Recalled Due to Unconfirmed Sterilization

    American Contract Systems Inc is recalling 237 laparoscopy surgical packs because sterilization assurance could not be confirmed. The packs may experience loss of functionality and require treatment delays.

    Product
    LAPAROSCOPY PACK , Model No SFLA02A SFLA02B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0652-2025·2025-03-26

    Chef's Line 3 Grain Slider Buns Recalled for Foreign Material

    Chef's Line US Foods 3 Grain Slider buns are being recalled due to foreign material (a bolt) found in the product. Approximately 8,107 cases were distributed to IL, MD, NJ, PA, and DE.

    Product
    Chef's Line US Foods, 3 Grain Slider , 54/1.8 oz., Product in a plastic bag in a cardboard box. approx. 54 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-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 (Devices)·Z-1407-2025·2025-03-26

    Synapse PACS Software incorrect patient age calculation for infants

    FUJIFILM's Synapse PACS Software versions 7.4.x incorrectly calculates patient age for infants under 3 months, potentially affecting clinical decisions. 104 units recalled in US and internationally.

    Product
    Synapse PACS Software Version 7.4.x; Software Versions: 7.4.000, 7.4.001, 7.4.010, 7.4.100, 7.4.110, 7.4.200.
    Category
    Medical Device
    Distribution
    30 states
  • HighFDA (Devices)·Z-1388-2025·2025-03-26

    DxI 9000 Access Immunoassay Analyzer Encoder Wheel Misalignment

    Beckman Coulter is recalling the DxI 9000 Access Immunoassay Analyzer (206 units) because an encoder wheel misalignment on the motor shaft can cause the instrument to stop and delay patient test results.

    Product
    DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-1351-2025·2025-03-26

    EAR PACK Medical Device Recalled Over Unconfirmed Sterilization

    American Contract Systems Inc is recalling 51 kits of the EAR PACK Model SFEA12A because the manufacturer could not confirm sterilization requirements were met, which could cause device malfunction and delayed treatment.

    Product
    EAR PACK , Model No SFEA12A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1400-2025·2025-03-26

    VERICIS Merge Cardio Medical Device Software Measurement Data Consistency Issue

    VERICIS Merge Cardio cardiovascular imaging software may display measurement values in patient reports that do not match original measurements when measurements are remeasured or manually edited. This affects 66 units distributed in the United States.

    Product
    VERICIS, Merge Cardio, Model/Catalog Number: Version 11.x, Software Version: 11.0.2, 11.0.3, 11.0.4, 11.1, 11.1.1; The VERICIS is an integrated cardiovascular information system classified as a picture archiving and communications system.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Drugs)·D-0289-2025·2025-03-26

    FDA Recalls Subpotent CURAD Alcohol Prep Pads Nationwide

    Medline Industries is recalling CURAD Alcohol Prep Pads nationwide because they are subpotent. The recalled pads are sterile, medium, 2-ply alcohol prep pads distributed nationally.

    Product
    CURAD ALCOHOL PREP PADS — CURAD ALCOHOL PREP PADS (ISOPROPYL ALCOHOL)
    Category
    Drug
    Distribution
    Distributed nationwide