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.

12626–12650 of 53082

  • HighFDA (Devices)·Z-2097-2023·2023-07-12

    Teleflex Pilling Surgical Retractor Recalled for Incomplete Cleaning Instructions

    Teleflex recalls the Pilling LOWSLEY PROSTATIC TRACTOR STR due to incomplete pre-cleaning instructions in the product manual. The issue affects 32 units distributed nationwide and internationally.

    Product
    Pilling LOWSLEY PROSTATIC TRACTOR STR, REF 243201; retractor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2056-2023·2023-07-12

    TrackMaster Treadmill Control Malfunction Can Cause Unexpected Acceleration

    Full Vision's TrackMaster treadmill can experience drive PCB malfunctions causing unexpected stopping, reversal, and acceleration. The malfunction affects 264 units distributed worldwide.

    Product
    TRACKMASTER, TREADMILL GE T2100-ST1 110VV, MODEL NUMBER 317-07926GE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2064-2023·2023-07-12

    Surgical drill guides may bend and produce metal shavings during use

    T.A.G. MEDICAL PRODUCTS CORPORATION is recalling Betta Link LG Reusable ProngED Guides used in orthopedic surgery because the guides may bend when force is applied, creating metal shavings that could injure patients.

    Product
    Betta Link LG Reusable ProngED Guide - Intended for use in soft tissue to bone fixation in the repair of the natural ligament or tendon disruption or to assist in reconstruction surgeries. Part Number: 110045156
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1228-2023·2023-07-12

    Gelato Boy Chocolate Chunk Gelato Recalled for Undeclared Milk

    Gelato Boy is recalling Chocolate Chunk Gelato frozen dessert because it contains undeclared milk, which poses a risk to consumers with milk allergies.

    Product
    Gelato Boy Chocolate Chunk Gelato, frozen dessert, 24 month shelf life, paper cup and lid. 14 FL OZ, UPC: 853457008002, distributed by Gelato Boy, 5401 Western Ave., Boulder, CO 80301
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-2094-2023·2023-07-12

    BD Pyxis CII Safe Dispensing Cabinets Recalled for Electrical Current Leakage

    BD Pyxis CII Safe automated dispensing cabinets may leak excessive electrical current when connected to multi-socket power strips, risking electric shock and system downtime.

    Product
    BD Pyxis CII Safe, Software: V7, REF: 107-96, 107-97, 107-97-201; BD Pyxis CII Safe, Software: V7, REF: 107-223, 107-224, 111-191, 111-192, 111-193, 111-194, 111-195, 111-196, 111-197, 111-198; BD Pyxis CII Safe, Software: V8, 111-199-01, 111-200-01, 111-201-01, 111-202-01…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2082-2023·2023-07-12

    Dermal repair scaffold recalled due to endotoxin testing failures

    TEI Biosciences is recalling 10,159 units of PriMatrix Ag Meshed dermal repair scaffolds due to testing failures that cannot verify endotoxin levels. Procedures for testing bacterial toxin levels during manufacturing quality control were found to be flawed.

    Product
    PriMatrix Ag Meshed; Dermal Repair Scaffold; Rx Only; Sizes 10x12 cm (2:1), 10x25 cm (2:1), 20x25 cm (1:1), 4x4 cm (2:1), 6x6 cm (2:1), 8x12 cm (2:1), 8x8 cm (2:1).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1225-2023·2023-07-12

    Wegmans Single Serve Snack Tray Recalled Due to Undeclared Allergens

    Wegmans single serve snack trays (5.7oz) are being recalled due to undeclared almonds and/or wheat allergens. Consumers with allergies to these ingredients should not consume them and should return them to the retailer.

    Product
    Wegmans single serve snack tray (5.7oz) packaged in a clear square plastic packaging with fruit, almonds and cheese 6 trays per case
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-2106-2023·2023-07-12

    Ventilator Instructions for Use Contain Translation Error in Korean Materials

    Korean-language instructions for Trilogy Evo ventilators contain a mistranslation where 'invasive' was incorrectly rendered as 'noninvasive.' This error could lead to improper device configuration by Korean-speaking users.

    Product
    Trilogy Evo, Evo Clinical Korean (1137823) and Evo Caregiver Korean (1137853) Instructions for Use
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2091-2023·2023-07-12

    Aptio Storage and Retrieval Module firmware error may cause incorrect test results

    Siemens Aptio Automation Storage and Retrieval Module has a firmware error that may incorrectly associate test results to patient samples, potentially leading to incorrect patient results. Eighty-three units are affected worldwide.

    Product
    Aptio Automation Storage and Retrieval Module (SRM)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2105-2023·2023-07-12

    Stryker Infinity Alignment Frame Distal Sub-Assembly Recalled for Manufacturing Defect

    Wright Medical Technology is recalling the Stryker Infinity Alignment Frame Distal Sub-Assembly due to manufacturing defects that prevent proper assembly. The pin sleeve holes were manufactured too narrow, preventing insertion of pin sleeves and proper device configuration.

    Product
    Stryker Infinity Alignment Frame Distal Sub-Assembly, Catalog #33600020, non-sterile.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-1024-2023·2023-07-12

    Cricket Creek Farm Berkshire Bloom Cheese Recalled for Improper Pasteurization

    Cricket Creek Farm Berkshire Bloom Cheese has been recalled because it was not properly pasteurized. Batch #076 (140 units) was distributed in New York, Massachusetts, and Connecticut.

    Product
    Cricket Creek Farm brand Berkshire Bloom Cheese
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-1223-2023·2023-07-12

    Cargill Tripotassium Citrate Monohydrate Recalled for Potential Metal Contamination

    Cargill is recalling Tripotassium Citrate Monohydrate in 50 lb. bags due to potential metal contamination. The product was distributed to manufacturers and distributors across multiple states and Canada.

    Product
    Cargill Tripotassium Citrate Monohydrate packaged in 50 lb. paper bag. Product item: SKU 100105392, TPC GNLR 50LB BG KH FCC
    Category
    Food
    Distribution
    13 states
  • HighFDA (Drugs)·D-0895-2023·2023-07-12

    Losartan Potassium Tablets Recalled for Blue Plastic Contamination

    Strides Pharma Inc. is recalling Losartan Potassium Tablets, 25 mg, due to the presence of blue plastic pieces embedded in tablets from lot 7901903A. No illnesses or injuries have been reported.

    Product
    LOSARTAN POTASSIUM — LOSARTAN POTASSIUM (LOSARTAN POTASSIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2099-2023·2023-07-12

    BD Synapsys Informatics Solution risks patient data mis-association

    The BD Synapsys Informatics Solution may incorrectly associate patient demographic data under specific conditions when the system operates near capacity during rapid manual result processing.

    Product
    BD Synapsys Informatics Solution, Catalog Number 444150
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Devices)·Z-2080-2023·2023-07-12

    PriMatrix Ag Dermal Repair Scaffold Recalled for Endotoxin Testing Issues

    TEI Biosciences is recalling 1,689 units of PriMatrix Ag dermal repair scaffolds distributed nationwide due to potential endotoxin testing deficiencies. Testing procedures may not have been conducted reliably.

    Product
    PriMatrix Ag; Dermal Repair Scaffold; Rx Only; Sizes 10x12 cm, 10x25 cm, 20x25 cm, 4x4 cm, 6x6 cm, 8x12 cm, 8x8 cm.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2058-2023·2023-07-12

    Treadmill recalled for drive PCB malfunction causing unexpected acceleration

    Full Vision Inc recalls 95 TRACKMASTER GE T2100-ST2 treadmills with a defective drive PCB that may misread signals, causing the equipment to unexpectedly stop, reverse, or accelerate forward.

    Product
    TRACKMASTER, TREADMILL GE T2100-ST2 220V CHINA, MODEL NUMBER 317-07927GE CHINA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2086-2023·2023-07-12

    Medical procedure packs recalled for compromised package seals

    DeRoyal Industries is recalling 4,225 custom medical procedure packs nationwide because outer package seals may be open or compromised, potentially affecting sterility of the surgical materials inside.

    Product
    Custom medical procedure packs labeled as: a) OPEN HEART TRACECART, REF '53-1941; b) CARDIAC CATH PACK, REF '89-10045; c) SHOULDER PACK, REF '89-10115; d) MINOR ORTHO PACK, REF '89-10213; e) TOTAL KNEE PACK PGYBK, REF '89-10505; f) ANTERIOR HIP PACK PGYBK, REF…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1229-2023·2023-07-12

    Pearl Milling Company Corn Meal Mix Recalled for Undeclared Milk

    Pearl Milling Company Self-Rising Yellow Corn Meal Mix bags may contain undeclared milk, posing a risk to people with milk allergies. Approximately 91,760 bags were distributed across multiple US states.

    Product
    Pearl Milling Company Self-Rising Yellow Corn Meal Mix Net Wt 80 oz (5 lb) UPC 3000057380 packaged in paper bag with printed label
    Category
    Food
    Distribution
    27 states
  • HighFDA (Devices)·Z-2072-2023·2023-07-12

    SurgiMend 2.0 Collagen Matrix Recalled for Endotoxin Testing Issues

    TEI Biosciences is recalling SurgiMend 2.0 collagen matrices nationwide due to possible out-of-specification endotoxin test results from issues with in-process and finished goods testing procedures.

    Product
    SurgiMend 2.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 5x6 cm, 6x12 cm, 10x15 cm, 16x20 cm, 13x25 cm, 25x40 cm, 20x30 cm, 20x20 cm, 20x25cm, 10x15cm Semi-Oval,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1226-2023·2023-07-12

    Wegmans snack trays recalled for undeclared almonds and wheat

    Wegmans single serve snack trays are being recalled due to undeclared almonds and/or wheat. Consumers with allergies to these ingredients should not consume the product.

    Product
    Wegmans single serve snack tray (4.1oz) packaged in a clear square plastic packaging with apples, cheese, pretzels, and peanut butter 6 trays per case
    Category
    Food
    Distribution
    2 states
  • HighNHTSA·23V477000·2023-07-12

    Jayco Seneca recreational vehicles recalled for windshield wiper linkage failure

    Jayco is recalling certain 2021-2022 Seneca recreational vehicles because the windshield wiper arms may fail, reducing driver visibility and increasing crash risk. Owners should contact Jayco customer service at 1-800-283-8267 for a free inspection and replacement.

    Product
    JAYCO — JAYCO, ENTEGRA SENECA, SENECA PRESTIGE, ACCOLADE XL, ACCOLADE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2069-2023·2023-07-12

    SurgiMend soft tissue collagen matrix recalled for endotoxin testing verification issues

    TEI Biosciences recalls 14,535 units of SurgiMend collagen matrices distributed nationwide due to potential endotoxin testing verification problems. Affected devices cannot be confirmed to meet endotoxin specifications.

    Product
    SurgiMend; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 1.0 5x6 cm, 1.0 6x12 cm, 1.0 10x10 cm, 1.0 10x15 cm, 1.0 10x20 cm, 1.0 16x20 cm, 1.0 13x25 cm, 1.0 4x16 cm, 1.0 3x3 cm, 1.0 4x7 cm, 1.0 4x12 cm, 1.0 6x16 cm, 1.0 25x40 cm, 1.0 20 x 30 cm, 1.0 8x16 cm, 1.0…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2054-2023·2023-07-12

    TrackMaster Treadmill Recalled for Drive PCB Malfunction Risk

    Full Vision Inc. is recalling 39 TrackMaster treadmills with a drive PCB malfunction that can cause unexpected stopping, reversal, or acceleration.

    Product
    TRACKMASTER, TREADMILL TMX428CP 110V, MODEL NUMBER 317-07928
    Category
    Consumer Product
    Distribution
    Distributed nationwide