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.

19776–19800 of 50413

  • HighFDA (Devices)·Z-2125-2021·2021-07-28

    Exactech Connexion GXL hip implant liners recalled for premature wear risk

    Exactech is recalling 89,050 hip implant liners due to edge-loading and premature wear risk in a subset of patients with certain implant configurations.

    Product
    Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 136-22-XX, Novation GXL Liner, +5mm Lateralized, G00, 22mm ID. Orthopedic hip implant component.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2127-2021·2021-07-28

    Exactech Connexion GXL Hip Implant Liners Recall Risk of Premature Wear

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

    Product
    Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 136-32-XX, Novation GXL Liner, +5mm Lateralized, 32mm. Orthopedic hip implant component.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2083-2021·2021-07-28

    Drain Bag Set for Peritoneal Dialysis Exposed to Freezing During Transport

    A Drain Bag Set used in peritoneal dialysis was exposed to freezing temperatures due to refrigerated truck malfunction during distribution. The affected lot was distributed to Texas.

    Product
    The Drain Bag Set (tubings and flexible bags) is a passive, closed drainage system used as an optional receptacle during an APD treatment. The Drain Bag Set is used to collect effluent in bags rather than letting the effluent flow directly to a drain. The Drain Bag Set connects…
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2088-2021·2021-07-28

    Fresenius APD Luer-Lock Adapter Recalled Due to Freezing Temperature Exposure

    Fresenius Medical Care is recalling 5 cases of the APD Luer-Lock Adapter (Lot 20LR08111) distributed in Texas after exposure to freezing temperatures during truck transport. Freezing may have compromised device sterility and functionality.

    Product
    The Fresenius APD Luer-Lock Adapter, Catalog number 050-95018, is designed to connect a peritoneal dialysis bag equipped with a luer-lock connector to a Fresenius Automated Peritoneal Dialysis (APD) cycler set that uses the Fresenius Safe-Lock¿ connector (e.g., Liberty¿ cycler…
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2120-2021·2021-07-28

    Exactech Hip Implant Liners Recalled for Premature Wear Risk

    Exactech Connexion GXL acetabular polyethylene liners used in hip implants face premature wear risk in certain patient and implant configurations. Consult your orthopedic surgeon if you have this device.

    Product
    Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 132-22-XX, Novation GXL Liner, G00, 22mm ID; and Novation GXL Liner, Lipped Ant, 28mm. Orthopedic hip implant component.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2122-2021·2021-07-28

    Hip Implant Liners Recalled Due to Risk of Premature Wear

    Exactech Connexion GXL hip implant liners are being recalled due to a risk of edge-loading and premature prosthesis wear in patients with certain implant configurations and surgical positioning.

    Product
    Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 132-36-XX, Acumatch GXL 15 Degree Liner, 36mm, and Novation GXL Liner, Lipped Ant, 36mm; and Novation GXL Liner, Lipped, 36mm. Orthopedic hip implant component.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2114-2021·2021-07-28

    Hip implant liners recalled due to risk of premature wear

    Exactech is recalling 89,050 hip implant liners due to risk of edge-loading and premature wear in specific patient and surgical configurations affecting a subset of patients.

    Product
    Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 104-36-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 (Devices)·Z-2098-2021·2021-07-28

    SoftCytogenetics Software Recalled for Incorrect Test Result Transmission

    Soft Computer Consultants, Inc. is recalling SoftCytogenetics software (versions 4.1.11.20, 4.1.12.11, 4.1.15.6) distributed in CA, FL, MN, and NJ because it produces incorrect results for retested specimens that are transmitted to clinical information systems.

    Product
    SoftCytogenetics
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2094-2021·2021-07-28

    Infant Heel Warmer Units Recalled for Rupture and Chemical Splashing Risk

    Cardinal Health is recalling 926,425 infant heel warmers (SKU MH00002T) due to reports of pack rupture or leaking during activation. The heated liquid may splash into a user's eyes or onto an infant, potentially causing rash, burn, or inflammation.

    Product
    Infant Heel Warmer with Attachment Tab, Nonsterile, Active Product SKU MH00002T The infant heel warmer is activated at the point of care by squeezing the pouch. This mixes the substrates inside the pouch causing an exothermic chemical reaction, warming the pouch, which is…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2121-2021·2021-07-28

    Exactech GXL Acetabular Hip Implant Liners Recalled for Premature Wear Risk

    Exactech, Inc. is recalling 89,050 Connexion GXL and Novation GXL acetabular hip implant liners due to risk of edge-loading and premature prosthesis wear in certain patients. The risk depends on implant configuration and surgical positioning.

    Product
    Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 132-28-XX, Acumatch GXL 15 Degree Liner, 28mm; Novation GXL Liner, G0, 28mm ID; Novation GXL Liner, Lipped Ant, 28mm; and Novation GXL Liner, Lipped, 28mm. Orthopedic hip…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2087-2021·2021-07-28

    NaturaLyte Bicarbonate Concentrate Recalled After Freezing Temperature Exposure

    NaturaLyte Dry Bicarbonate Concentrate, used in hemodialysis machines to prepare dialysate, was recalled after exposure to freezing temperatures during transport. The affected lot (21ATBC004) was distributed to facilities in Texas only.

    Product
    NaturaLyte Dry Bicarbonate Concentrate is composed of sodium bicarbonate powder and is used as one component in the preparation of dialysate in a 3-stream proportioning hemodialysis machine according to a physician s prescription. NaturaLyte Dry Bicarbonate Concentrate is…
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2084-2021·2021-07-28

    Hemodialysis Acid Concentrates Recalled After Freezing Exposure During Transport

    Fresenius Medical Care is recalling Citrasate and GranuFlo Dry Acid Concentrates after freezing temperature exposure during refrigerated truck transport. Affected lots distributed in Texas should be discontinued immediately.

    Product
    Citrasate Dry Acid Concentrate and GranuFlo Dry 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 use in…
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2081-2021·2021-07-28

    Moderna COVID-19 Vaccine Administration Kits Recalled for Unsuitable Syringes

    McKesson is recalling 53,388 Moderna COVID-19 vaccine administration kits due to unsuitable 3mL syringes included in the kits. The affected kits were distributed May 4-24, 2021, and should not be used for vaccine administration.

    Product
    ANCILLARY ADULT 140-DOSE CONVENIENCE KIT, ITEM #1189482, for the administration of the Moderna COVID-19 vaccine convenience kit for the administration of the COVID-19 vaccine
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2091-2021·2021-07-28

    Backflush Brush Needles Recalled Due to Incorrect Gauge Labeling

    Dutch Ophthalmic USA is recalling Disposable Replacement Backflush Brush Needles (lot 3420011396) distributed in IL, IN, MO, and PA because the label incorrectly identifies the gauge as 20 gauge/0.9mm when the product is actually 23 gauge/0.6mm.

    Product
    Disposable Replacement Backflush Brush Needles (23 gauge/0.6mm)-for use in vitreoretinal surgery Product Number: labeled as 1281.B1D, product is 1281.B1D06
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-2101-2021·2021-07-28

    Stryker Cortoss Bone Augmentation Material Recalled for Temperature Storage Violation

    Stryker Spine recalled Cortoss Bone Augmentation Material due to a 12-hour temperature excursion at the distribution center that could have compromised product sterility and efficacy.

    Product
    Cortoss Bone Augmentation Material 10cc Cartridge, Catalog Number 2101-0010, GTIN 00808232000979
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·21172·2021-07-28

    Birkenstock Kids' Mogami Sandals Recalled for Choking Hazard

    Birkenstock USA has recalled Kids' Mogami Sandals in sizes 24-28 because a plastic rivet can detach from the ankle strap, posing a choking hazard for young children. No injuries have been reported.

    Product
    Birkenstock Kids' Mogami Sandals Sizes 24-28
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0788-2021·2021-07-28

    Heidi's Brownies Recalled for Undeclared Soy Allergen

    Heidi's Brownies are being recalled because soy lecithin is listed in the ingredients but soy is not mentioned in the allergen declaration on the label, posing a risk to people with soy allergies.

    Product
    Heidi's Brownies is packaged in saran wrap in a plastic bag with a twist tie, 3 oz (85g). Label is read in parts: "***Heidi's ~~~ Brownies ~~~ *Malted barley wheat flour, cane sugar, water, chocolate chips (unsweetened chocolate, sugar, dextrose, soy lecithin (an…
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0785-2021·2021-07-28

    Pow Pow Powders Hot Cocoa Mix Recalled for Undeclared Milk Allergen

    San Diego Coffee, Tea and Spice is recalling Pow Pow Powders hot cocoa mix because the product lacks ingredient and allergen labeling, with undeclared milk present in the formulation.

    Product
    Pow Pow Powders: A standard of Quality Hot Cocoa Mix; 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), Cocoa (processed with alkali) Non-Fat Dry…
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2103-2021·2021-07-28

    Knee Prosthesis Recall: Packaging Mixup May Cause Wrong Size Implantation

    Encore Medical recalls DJO Surgical EMPOWR 3D knee prosthetic components because packaging labels may not match the product inside, risking implantation of incorrect prosthesis sizes.

    Product
    DJO Surgical EMPOWR 3D Knee Tibial Insert - e-plus, REF: 341-12-711, Left Sz. 11 12mm, CE0086, Sterile H2O2, UDI: (01)00888912166980
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2100-2021·2021-07-28

    Cortoss Bone Augmentation Material Recalled Due to Storage Temperature Excursion

    Stryker Spine is recalling 559 units of Cortoss Bone Augmentation Material 5cc Cartridges due to a 12-hour temperature excursion at the distribution center. The affected lot may not meet required storage conditions.

    Product
    Cortoss Bone Augmentation Material 5cc Cartridge, Catalog Number 2101-0005, GTIN 00808232000962
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2133-2021·2021-07-28

    Hip implant acetabular liners recalled for edge-loading and premature wear

    Exactech Connexion GXL acetabular polyethylene liners for hip implants are recalled due to risk of edge-loading and premature wear in certain patient configurations and implant positions. Approximately 89,050 units distributed nationwide are affected.

    Product
    Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 132-32-XX, Acumatch GXL 15 Degree Liner, 32mm; Novation GXL Liner, Lipped Ant, 32mm; and Novation GXL Liner, Lipped, 32mm. Orthopedic hip implant component.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2109-2021·2021-07-28

    Stimulen Collagen Moisturizing Lotion recalled for sterilization audit failure

    Southwest Technologies Inc is recalling Stimulen Collagen Moisturizing Lotion, ST9555B (Lot 2104007) due to failure in the sterilization audit process. Approximately 2016 units were distributed to Malaysia.

    Product
    Stimulen Collagen Moisturizing Lotion, ST9555B
    Category
    Medical Device
    Distribution
    0 states
  • HighCPSC·21768·2021-07-27

    Oculus Quest 2 Removable Foam Facial Interfaces Due to Skin Irritation Risk

    Facebook Technologies is recalling about 4 million removable foam facial interfaces for Oculus Quest 2 virtual reality headsets because the foam can cause facial skin irritation and reactions. Consumers should stop using affected interfaces and contact the manufacturer for a free silicone replacement.

    Product
    Removable Foam Facial Interfaces for Oculus Quest 2 Virtual Reality Headsets
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·21V571000·2021-07-27

    Newmar Recreational Vehicles Recalled for Window Adhesive Failure

    Newmar is recalling select 2018-2021 recreational vehicles due to potential window adhesive failure. The vent portion of affected windows may detach, increasing crash and injury risk.

    Product
    NEWMAR — NEWMAR NEW AIRE, LONDON AIRE, ESSEX, VENTANA
    Category
    Vehicle
    Distribution
    Distributed nationwide