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.

19751–19775 of 50413

  • HighFDA (Devices)·Z-2086-2021·2021-07-28

    Medical dialysis concentrates recalled for freezing temperature exposure

    Fresenius Medical Care recalls Citrasate and NaturaLyte hemodialysis acid concentrates due to exposure to freezing temperatures during refrigerated truck transport. The affected products were distributed exclusively to Texas.

    Product
    Citrasate Liquid Acid Concentrate and NaturaLyte Liquid Acid Concentrate are each intended to be used as one component in the preparation of dialysate in a 3-stream proportioning hemodialysis machine according to a physician s prescription. Both concentrates are formulated for…
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2130-2021·2021-07-28

    Exactech Connexion GXL hip implant liners risk edge-loading and wear

    Exactech Connexion GXL acetabular polyethylene liners used in hip replacements may experience edge-loading and premature wear in certain patients due to implant configuration or surgical positioning. Approximately 89,050 units were distributed nationwide.

    Product
    Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 138-22-XX, Novation GXL 10 deg Liner, G00, 22mm ID. Orthopedic hip implant component.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2080-2021·2021-07-28

    Multiple Brands of Cotton Pads Recalled for Mold Contamination Risk

    Medline Industries is recalling multiple brands of cotton pads and rounds due to potential mold contamination. The affected products were distributed nationwide and internationally for use in cosmetic and personal care applications.

    Product
    Cotton Rounds/Pads under the following brand names: 1. BEAUTY 360 Extra Large Premium Cotton Ovals - two textures soft and strong 100 count; 2. BEAUTY 360 Premium Cotton Rounds - two textures soft and strong 240 count; 3. BEAUTY 360 Patterned Basic Cotton Rounds…
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2113-2021·2021-07-28

    Exactech Connexion GXL hip implant liners recalled due to premature wear risk

    Exactech is recalling 89,050 Connexion GXL hip implant liners distributed nationwide due to a risk of edge-loading and premature wear in certain patient implant configurations.

    Product
    Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 104-32-XX, MCS +5GXL Liner 5/15 DEG and MCS GXL Liner 5/15 DEG. Orthopedic hip implant component.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0783-2021·2021-07-28

    Pow Pow Powders Mocha Latte Recall for Undeclared Milk Allergen

    San Diego Coffee, Tea and Spice is recalling Pow Pow Powders Mocha Latte because the product lacks ingredient and allergen labeling and contains undeclared milk.

    Product
    Pow Pow Powders: A standard of Quality Mocha Latte; NET Wt. 3.50 lb. (1.59kg) Ingredients: Sugar, Non-Dairy Creamer (coconut oil, Corn Syrup Solids, Sodium Caseinate (a milk derivative), Sodium Citrate, Mono and Diglycerides, Salt and sodium Aluminosilicate), Non-Fat Dry Milk…
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0782-2021·2021-07-28

    Pow Pow Powders Spice Chai Recall: Undeclared Milk Allergen

    San Diego Coffee, Tea and Spice is recalling Pow Pow Powders Spice Chai because the product lacks required ingredient and allergen labeling, with milk present but undeclared. Consumers with milk allergies are at risk.

    Product
    Pow Pow Powders: A standard of Quality Spice Chai; NET Wt. 3.50 lb. (1.59kg) Ingredients: Sugar, Non-Dairy Creamer (coconut oil, Corn Syrup Solids, Sodium Caseinate (a milk derivative), Sodium Citrate, Mono and Diglycerides, Salt and sodium Aluminosilicate), Non-Fat Milk…
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2099-2021·2021-07-28

    Medical Device Calibration Standard Assigned Incorrectly in NEFA CAL Kit

    Randox Laboratories recalls NEFA CAL IVD calibration standard kits (Batch 544642) due to incorrectly assigned calibration values that could cause measurement errors up to 8% in quality control and patient test results.

    Product
    NEFA CAL (Non-Esterified Fatty Acids)- IVD Standard for measurement of NEFA Catalog Number: FA115
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2115-2021·2021-07-28

    Exactech Hip Implant Liners Recalled Due to Premature Wear Risk

    Exactech is recalling 89,050 Connexion GXL acetabular polyethylene hip implant liners due to risk of premature prosthesis wear in certain patient configurations and surgical positioning scenarios.

    Product
    Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 130-22-XX, Novation GXL Neutral Liner, G00, 22mm ID. Orthopedic hip implant component.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2107-2021·2021-07-28

    Suture Anchor Products Recalled Due to Improper Sterilization

    Arthrex is recalling 3,985 BioComposite SwiveLock C suture anchors due to improper sterilization from seal defects. The affected lots (12758314 and 13022357) were distributed nationwide.

    Product
    Suture Anchor, BioComposite SwiveLock C, 5.5 mm x 19.1 mm, Closed Eyelet, REF AR-2323BCC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2119-2021·2021-07-28

    Exactech Connexion GXL Hip Implant Liners Risk Premature Wear

    Exactech hip implant liners may experience premature wear and edge-loading in certain patient configurations, according to this Class II recall of 89,050 units distributed nationwide.

    Product
    Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 130-40-XX, Novation GXL Liner, Neutral, 40mm. Orthopedic hip implant component.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2082-2021·2021-07-28

    Hemodialysis concentrate recalled for freezing exposure during transport

    Fresenius Medical Care recalls Granuflo and Naturalyte hemodialysis concentrate affected by freezing temperatures during refrigerated truck transport. Freezing may compromise product sterility and safety.

    Product
    (1) 08-4078-BB BIBAG 650 GRAMS/BAG 16 BAGS/CASE (2) 08-4080-BB BIBAG 900 grams/bag 12 bags/case For patients with acute and chronic end stage renal disease going under PD in healthcare or home setting GRANUFLO & NATURALYTE: Concentrate is formulated to be used in…
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2129-2021·2021-07-28

    Exactech Hip Implant Liners Recalled for Premature Wear Risk

    Exactech Connexion GXL hip implant liners are recalled due to risk of edge-loading and premature wear in certain patient configurations. No injuries have been reported.

    Product
    Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 136-40-XX, Novation GXL Liner, +5mm Lateralized, 40mm. Orthopedic hip implant component.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2106-2021·2021-07-28

    Cell Marque MSH6 Antibody Recalled for Distribution Without FDA Clearance

    Cell Marque Corporation is recalling Cell Marque Antibodies, MSH6 (44), Mouse Monoclonal Antibody because the product was distributed as an in-vitro diagnostic device without FDA clearance.

    Product
    Cell Marque Antibodies, MSH6 (44), Mouse Monoclonal Antibody, REF: 287M-10, IVD, CE, GTIN: 00841683104513
    Category
    Medical Device
    Distribution
    18 states
  • HighFDA (Devices)·Z-2118-2021·2021-07-28

    Hip implant polyethylene liners recalled due to premature wear risk

    Exactech Connexion GXL acetabular liners used in hip implants are recalled due to risk of edge-loading and premature wear in patients with specific implant configurations and surgical positioning.

    Product
    Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 130-36-XX, Acumatch GXL 0 Degree Liner, 36mm; and Novation GXL Liner, Neutral, 36mm. Orthopedic hip implant component.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2090-2021·2021-07-28

    Fresenius Sterile Stay Safe Cap Recalled for Freezing Temperature Exposure

    Fresenius recalls 39 cases of Sterile Stay Safe Caps (lot numbers B1ZH191, B1ZI092) distributed to Texas due to exposure to freezing temperatures during refrigerated truck malfunction, which may have compromised product sterility.

    Product
    050-95012 Sterile Stay Safe Cap The Indications for Use/Intended Use for the Fresenius Sterile Stay Safe¿ Cap is equivalent to that for the Fresenius Stay Safe Cap and is as follows: Indications for Use Fresenius Sterile Stay Safe¿ Cap is intended to be used for closure of the…
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2093-2021·2021-07-28

    Laboratory Information System SoftGenomics Recalled for Displaying Incorrect Results

    SoftGenomics version 4.1.15.6, a laboratory information system used in clinical laboratories, has been recalled due to reports that the software displays incorrect results and PDF reports do not match the hospital information system.

    Product
    SoftGenomics version 4.1.15.6 SoftGenomics is a laboratory workflow and information management system to be used in a clinical molecular or cytogenetics laboratory or medical research laboratory setting by knowledgeable and trained users. SoftGenomics is used to record and…
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2111-2021·2021-07-28

    Ultrasound Imaging Software Recalled for Inaccurate Measurement Estimates

    Caption Health recalled ultrasound imaging software version 1.2.0 due to a bug that includes unintended video frames in its analysis, potentially resulting in incorrect automated ejection fraction and image quality score estimates. The recall affects approximately 15 systems distributed across five U.S. states.

    Product
    Version: 1.2.0 (1.2.0+85ela410) Caption Health, Caption AI, Ultrasound Imaging System Application Software (GMDN: 40873), UDI: (01)00860003586303(10)1.2.0)
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-2131-2021·2021-07-28

    Exactech Hip Implant Liners Recalled Due to Premature Wear Risk

    Exactech is recalling certain acetabular polyethylene hip implant liners due to risk of edge-loading and premature wear in specific implant configurations and surgical positions.

    Product
    Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 138-28-XX, Acumatch GXL 15 Degree, +5 Lat Liner, 28mm; Novation GXL 10 Deg Liner, G0, 28mm; and Novation GXL Liner, 10 Deg Face, 28mm. Orthopedic hip implant component.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2089-2021·2021-07-28

    MTS Set dialysis accessory recalled for freezing temperature exposure during transport

    Fresenius is recalling MTS Sets distributed to Texas due to exposure to freezing temperatures from refrigerated truck malfunctions. This exposure may compromise the sterility of the device.

    Product
    The MTS Set is a single-use, sterile (EO), non-pyrogenic, optional accessory that provides additional connections/disconnections when used with a stay"safe compatible cycler set during acute and chronic PD treatment. The MTS Set utilizes the same PIN engagement technology used…
    Category
    Medical Device
    Distribution
    1 state
  • HighNHTSA·21V577000·2021-07-28

    2022 Kia Telluride Instrument Cluster Display May Go Blank

    Certain 2022 Kia Telluride vehicles have instrument cluster displays that may go blank after startup, potentially hiding critical driving information like speed and gear selection. Kia will update the software at no cost.

    Product
    KIA — KIA TELLURIDE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2092-2021·2021-07-28

    Blood heater-cooler devices recalled for water contamination and infection risk

    Gentherm's Hemotherm CE blood cooler/heater devices may harbor dangerous organisms including nontuberculous mycobacteria in their water systems that could aerosolize during cardiac surgery, risking patient infection.

    Product
    Hemotherm CE Dual Reservoir Cooler/Heater, Model 400CE, 115V Model, part no. 86022. Used to cool or warm blood during cardiopulmonary bypass procedures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·21V575000·2021-07-28

    Forest River Recalls 2021 Prime Time Tracer Trailers Due to Tail Light Defect

    Forest River is recalling 2021 Prime Time Tracer TRT22RBS recreational trailers because the tail light is located too close to the water heater exhaust, which may cause the light to fail.

    Product
    PRIME TIME — PRIME TIME TRACER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2104-2021·2021-07-28

    DJO Surgical EMPOWR 3D Knee Tibial Insert packaging may contain wrong implant size

    Packaging for DJO Surgical EMPOWR 3D Knee Tibial Insert knee prosthesis implants may be mislabeled, with 12mm packages potentially containing 16mm implants or vice versa, risking incorrect surgical implantation.

    Product
    DJO Surgical EMPOWR 3D Knee Tibial Insert - e-plus, REF: 341-16-711 Left Sz. 11 16mm, CE 0086, Sterile H2O2, UDI: (01)00888912167185
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2112-2021·2021-07-28

    Exactech Connexion GXL Hip Implant Liners Recalled for Premature Wear Risk

    Exactech Connexion GXL hip implant liners are being recalled due to risk of edge-loading and premature wear in certain surgical configurations. Approximately 89,050 units distributed nationwide may be affected.

    Product
    Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 104-28-XX, MCS +5GXL Liner 5/15 DEG and MCS GXL Liner 5/15 DEG. Orthopedic hip implant component.
    Category
    Medical Device
    Distribution
    Distributed nationwide