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.

11851–11875 of 22152

  • HighFDA (Food)·F-1131-2024·2024-04-17

    Caesar Salad Mislabeled as Garden Salad, Allergens Undeclared

    Taylor Farms Southwest recalled 150 units of chicken caesar salad mislabeled as garden salad, with undeclared allergens including egg, fish, and soy. Affected product was distributed in Arizona, Colorado, New Mexico, Nevada, Utah, and Texas.

    Product
    Family Size Garden Salad 17oz packaged in Flexible plastic combo 32 oz clamshell.
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-1482-2024·2024-04-17

    RayStation Software Use Error Could Cause Incorrect Radiation Dose Calculations

    RayStation radiation therapy planning software versions 8B through 2024A contain a use error that can incorrectly select silicon material for silicone gel polymer implant dose calculations, potentially resulting in incorrect radiation doses.

    Product
    RayStation Software Version Numbers version numbers 8B, 9A, 9B, 10A, 10B, 11A, 11B, 12A, 12B, 2023B, 2024A including some service packs.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1516-2024·2024-04-17

    PEG feeding tube with blocked connector may impede placement procedure

    Boston Scientific's EndoVive 20Fr PEG Kit may have a blocked connector that prevents the guidewire from advancing during placement, potentially causing complications including bleeding and aspiration.

    Product
    EndoVive 20Fr Push Standard PEG Kit (Box 2)-Indicated for enteral nutrition directly into the stomach in both pediatric and adult patients who are unable to consume nutrition by conventional means. UPN: M00568211
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1508-2024·2024-04-17

    Nucleic Acid Isolation Device Recall: EZ2 Connect MDx-IVD Heater Failure

    Qiagen Sciences is recalling 168 units of the EZ2 Connect MDx-IVD nucleic acid isolation device due to insufficient welding that causes heater cable embrittlement and device malfunction, resulting in sample loss during testing.

    Product
    EZ2 Connect MDx-IVD Designed to perform automated isolation and purification of nucleic acids in molecular diagnostic and/or molecular biology applications. Model Number: 9003230
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1132-2024·2024-04-17

    Egg Salad Sandwich Recalled for Undeclared Fish Allergen Mislabeling

    Tuna salad sandwiches were mislabeled as egg salad, creating an undeclared fish allergen risk for consumers. The recall affects 551 units distributed to institutions and retailers across ten states.

    Product
    Egg salad sandwich packaged in clamshell for individual sale. 7.22oz (205g) UPC 766375938415
    Category
    Food
    Distribution
    10 states
  • HighFDA (Devices)·Z-1488-2024·2024-04-17

    Medline SwivAssist Bed Assist Bars Recalled for Safety Standard Non-Compliance

    Medline is recalling 79 Bed Assist Bars that failed to comply with federal safety standards for adult portable bed rails. The products were manufactured after the compliance deadline.

    Product
    Bed Assist Bars, labeled as follows: a) Medline SwivAssist Bar, Model Number MDS6800SWIV (case of 3), b) Medline SwivAssist Bar, Model Number MDS6800SWIVRH (individual)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0437-2024·2024-04-17

    FDA Recalls Rifampin Capsules 300mg Nationwide for Subpotency

    Lupin Pharmaceuticals recalls Rifampin Capsules USP 300mg nationwide due to subpotency—the drug contains less active ingredient than labeled. Affected lot: A201064, expiring March 2024. 26,352 bottles involved.

    Product
    Rifampin Capsules USP, 300mg, 30-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited Aurangabad 431 210 India, NDC 6818-0659-06
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1121-2024·2024-04-17

    Nicomex Tequesquite recalled due to elevated lead contamination

    Nicomex Inc. is recalling Nicomex Tequesquite seasoning (1.5 oz) due to elevated lead levels. Approximately 192 units were distributed to retailers in New Jersey and New York.

    Product
    Nicomex Tequesquite, Net Wt. 1.5oz (42.52gms), UPC: 8 8467810180 7. Packaged in a plastic bag.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-1122-2024·2024-04-17

    Ground cinnamon bulk product recalled due to elevated lead levels

    Tasty-Sawa ground cinnamon in 55.11-pound bags distributed in Florida, Georgia, North Carolina, Trinidad and Tobago, and Guyana is being recalled due to elevated lead levels. Consumers should stop using this product immediately.

    Product
    Tasty-Sawa Cinnamon Ground, Net Wt. 55.11 lbs, paper bag (bulk), Country of Origin Vietnam
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-1495-2024·2024-04-17

    ConvaTec CarboFlex Wound Dressing Recalled for Failed Sterility Standards

    ConvaTec is recalling 63 market units of CarboFlex odor control dressings that fail to meet sterility assurance requirements. Affected lots were distributed in six states.

    Product
    ConvaTec CarboFlex, 15cm x 20cm, 6 in. x 8 in., Order No. 403204, Odor Control Dressing, Sterile. Packaged 1 dressing/immediate package, 5 packages/market unit.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1148-2024·2024-04-17

    Deluxe brand Macarons Party Edition recalled for undeclared allergens

    Lidl is recalling Deluxe Macarons Party Edition due to undeclared allergens. The packaging is labeled in a foreign language and does not identify wheat, soy, egg, milk, and tree nuts.

    Product
    Deluxe brand Macarons Party Edition 35 pieces 455g (35 x 13g) UPC:4056489365365 Product packaged in a cardboard/plastic container
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-1510-2024·2024-04-17

    Hillrom Welch Allyn Spot Vision Screener recalled for power cord insulation defect

    Hillrom Welch Allyn Spot Vision Screener VS100 units recalled due to power cord insulation that does not meet electrical safety standards. The affected devices may pose an electrical hazard to users.

    Product
    Hillrom Welch Allyn Spot Vision Screener VS100, marketed under the following models: a) SPOT VISION SCREENER,W/O CASE,PLUG2/EUR, VS100-2; b) SPOT VISION SCREENER,W/O CASE,PLUG4/UK, VS100-4; c) SPOT VISION SCREENER,W/O CASE,PLUG7/SA, VS100-7; d) SPOT VISION SCREENER,W/CAS
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1518-2024·2024-04-17

    da Vinci SP Surgical System Patient Cart Welds May Fail

    Intuitive Surgical recalled 53 da Vinci SP Surgical System Patient Carts due to inadequate welds in the instrument arm joints. These welds may cause tissue injuries, conversion to open surgery, or user pinching injuries.

    Product
    Patient Cart, Part: 380601, a component of the da Vinci SP Surgical System, Model: SP1098
    Category
    Medical Device
    Distribution
    21 states
  • HighFDA (Devices)·Z-1497-2024·2024-04-17

    Acetabular Bearing Components Recalled for Marketing Without FDA Clearance

    Synovo Production is recalling 1,681 acetabular bearing components that were marketed without FDA clearance.

    Product
    ACETABULAR BEARING (xx)MM I.D X (xx) O.D. UHMWPE 1020, STERILEEO, Reference Numbers: 01-02-4254 01-02-4456 01-02-4558 01-02-4760 01-02-4962 01-02-5164 01-02-5266
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1127-2024·2024-04-17

    Yellow onions recalled due to incomplete botulinum hazard analysis

    Pueblo Fruits is recalling 23 cases of yellow onions sold to a single restaurant in Albuquerque because the firm did not complete a hazard analysis for potential Clostridium botulinum growth in vacuum-sealed bags.

    Product
    Onion Yellow Med 3 Outer Rings 4-5 LB in a 5 LB ,vacuum sealed, clear plastic bag. Labeling: White paper label with the following information attached to the outside of plastic bag. Blake's (Richmond) Onion Yellow Med 3 Outer Rings 4-5 LB PO# 047981 Lot#787806-6883R5, 795046-3948
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1486-2024·2024-04-17

    Patient lift hanger bar may come loose, posing fall risks

    Certain patient lift models may have a hanger bar that could come loose during use, potentially causing patient falls. Approximately 10 units distributed to TX, IL, OK, and CA are affected.

    Product
    Altair 330 lbs w/o Hanger Bar, REF: 55200H-NA, 55220H-NA, and Roomer S 220 kg w/o Hanger Bar, REF: 55300H-NA, patient lifts
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1514-2024·2024-04-17

    PEG Feeding Tube Kit Recalled for Blocked Lumen Preventing Guidewire Advancement

    Boston Scientific is recalling 572 EndoVive PEG feeding tube kits due to a blocked lumen in the barb connector that may prevent guidewire advancement during placement, potentially requiring device exchange and increasing risk of complications.

    Product
    EndoVive 20Fr Push Standard PEG Kit w/ENFit (Box 2)-Indicated for enteral nutrition directly into the stomach in both pediatric and adult patients who are unable to consume nutrition by conventional means. UPN: M00509051
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1129-2024·2024-04-17

    Whitley's Peanut Factory Deluxe Nut Mix recalled for undeclared allergens

    Whitley Peanut Factory is recalling Deluxe Nut Mix due to undeclared allergens (peanuts, milk, soy, wheat, and sesame) not listed on the product label. Consumers with allergies should not consume this product.

    Product
    Whitley's Peanut Factory, Deluxe Nut Mix, 12oz (340g), Electrolytic tin-plated cans, with paper label. 12-pack case boxes.
    Category
    Food
    Distribution
    28 states
  • HighFDA (Devices)·Z-1517-2024·2024-04-17

    EndoVive 20 Fr Feeding Tube May Obstruct During Placement

    Boston Scientific is recalling EndoVive 20 Fr feeding tubes due to potential blockage during placement that may prevent guidewire advancement. This could lead to procedure complications including bleeding, gastric leakage, or aspiration.

    Product
    EndoVive 20 Fr Safety PEG Push w/ENFit Kit (Box 2)-Indicated for enteral nutrition directly into the stomach in both pediatric and adult patients who are unable to consume nutrition by conventional means. UPN: M00509191
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1515-2024·2024-04-17

    Feeding tube kit recalled due to blocked connector preventing guidewire advancement

    Boston Scientific's EndoVive 20Fr PEG kit may have a blocked connector preventing proper guidewire advancement during placement, potentially requiring emergency intervention.

    Product
    EndoVive 20Fr Push Safety PEG Kit (Box 2)-Indicated for enteral nutrition directly into the stomach in both pediatric and adult patients who are unable to consume nutrition by conventional means. UPN: M00566471
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1487-2024·2024-04-17

    Medline Adult Portable Bed Rails Recalled for Safety Standard Failures

    Medline is recalling certain lots of adult portable bed rails that were manufactured after the mandatory compliance date but failed to meet required safety standards, potentially posing a fall risk.

    Product
    Bed Assist Bars, labeled as follows: a) Medline, Model Number BA6800, b) Medline Martha Stewart, Model Number MDS6800BAMMS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1496-2024·2024-04-17

    Acetabular Fixation Cups Recalled for Marketing Without FDA Clearance

    Synovo Production is recalling 764 acetabular fixation cups marketed without FDA clearance or approval. These hip replacement components were distributed nationwide in Washington state.

    Product
    ACETABULAR FIXATION CUP, (xx)MM, 5 HOLE, Ti-6AI-4V ELI TiN CERAMIC W/PLASMA SPRAY, STERILEEO, Reference Numbers: 01-01-0554 01-01-0556 01-01-0558 01-01-0560 01-01-0562 01-01-0564 01-01-0566
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1144-2024·2024-04-17

    Squash casserole recalled for missing ingredient and allergen labeling

    Robeson Enterprises is recalling its Pies & Sides squash casserole due to missing ingredient list labeling. The product contains undisclosed allergens (milk, eggs, soy, fish, wheat).

    Product
    PIES & SIDES SQUASH CASSEROLE CONTAINS: MILK, EGGS, SOY, FISH, WHEAT PIES & SIDES MOUNT HOLLY, NC
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-1126-2024·2024-04-17

    SWAD Cinnamon Powder Recalled Due to Lead Contamination

    RAJA FOODS LLC is recalling SWAD BRAND CINNAMON POWDER (3.5 oz) after testing confirmed lead contamination. The affected batch should not be consumed.

    Product
    SWAD BRAND CINNAMON POWDER in clear plastic 3.5 OZ bags, UPC 0-51179-34280-4, 20 retail units per wholesale case
    Category
    Food
    Distribution
    15 states
  • HighFDA (Devices)·Z-1506-2024·2024-04-17

    Chromophare Surgical Light System recalled for insufficient mounting force

    Stryker Communications recalls Chromophare Surgical Light Systems due to insufficient mounting force that could compromise the equipment's stability in surgical environments.

    Product
    Chromophare Surgical Light System , REF CH00000001
    Category
    Medical Device
    Distribution
    0 states