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.

20526–20550 of 50413

  • HighFDA (Devices)·Z-1512-2021·2021-05-05

    Donjoy Ultrasling Pro Arm Sling Recalled for Failed Rivet

    DJ Orthopedics is recalling Donjoy Ultrasling Pro arm slings because a rivet at the chafe tab failed, potentially compromising the device's ability to immobilize the arm.

    Product
    DONJOY REF:11-0471-9 ULTRASLING PRO ER/IR 15, UNIVERSAL, Rx ONLY, UDI: (01) 00190446683667 - Product Usage: intended for medical purposes to immobilize the arm, by means of a fabric band suspended from around the neck.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0457-2021·2021-05-05

    Twin City Foods Recalls Frozen Corn for Allergen Cross-Contact

    Twin City Foods is recalling Signature Select Golden Corn Sweet due to possible egg and wheat allergen cross-contact during packaging.

    Product
    Signature Select Golden Corn Sweet, frozen, packed in poly film bags. 12/16 oz. packages per case. UPC 2113009152. Signature Select Golden Corn Sweet, frozen, packed in poly film bags, 12/32 oz. packages per case. UPC 2113009021. Product of USA. Products is DISTRIBUTED BY…
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1503-2021·2021-05-05

    Trinity Biotech Captia Measles IgM Kit Recalled for Invalid Run Risk

    Clark Laboratories is recalling 80 kits of the Trinity Biotech Captia Measles IgM Kit because the positive control may run high, resulting in invalid runs and necessitating retesting.

    Product
    Trinity Biotech Captia Measles IgM Kit, Catalog No. 2326060 - Product Usage: intended for the qualitative detection of Measles igM antibodies in human serum of patients suspected of measles (rubeola) infection.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1499-2021·2021-05-05

    ConMed Infinity ACL Tibial Guides Recalled for Potential Misalignment

    ConMed Corporation is recalling three Infinity ACL Tibial Elbow and Tip Guides due to potential lateral misalignment that could affect surgical accuracy.

    Product
    KIT_INFINITY_BASE Custom Procedural Kit - Italy, containing Infinity ACL Tibial Elbow and Tip Guides product line, KTE100 and KTT100. For use in open and arthroscopic procedures for knee ligament reconstruction The procedural kits have no kit specific labeling. Each…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1506-2021·2021-05-05

    Datascope Cardiosave Hybrid IABP Recalled for Cybersecurity Vulnerabilities

    Datascope Corp. is recalling Cardiosave Hybrid IABP devices due to cybersecurity vulnerabilities in a TCP/IP software library that may cause loss of communication to hospital systems.

    Product
    Cardiosave Hybrid IABP - Product Usage: used to inflate and deflate intra-aortic balloons. It provides temporary support to the left ventricle via the principle of counterpulsation, Model Numbers 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-34, 0998-00-0800-35…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1513-2021·2021-05-05

    DJ Orthopedics Recalls Ultrasling Pro Arm Sling Due to Failed Rivet

    DJ Orthopedics is recalling Ultrasling Pro arm slings because a rivet at the chafe tab failed. The defect could compromise the device's ability to immobilize the arm.

    Product
    DONJOY REF:11-0472-9 ULTRASLING PRO ER/IR 30, UNIVERSAL, Rx ONLY, UDI: (01)00190446683674 - Product Usage: intended for medical purposes to immobilize the arm, by means of a fabric band suspended from around the neck.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·21125·2021-05-05

    CPSC Recalls Kolcraft Inclined Sleeper Accessories Due to Suffocation Risk

    CPSC is recalling Kolcraft inclined sleeper accessories due to a risk of infant suffocation. Consumers should stop using the accessory immediately and contact Kolcraft for a refund or voucher.

    Product
    Inclined sleeper accessory included with Kolcraft Cuddle 'n Care 2-in-1 Bassinet & Incline Sleepers and Preferred Position 2-in-1 Bassinet & Incline Sleepers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0355-2021·2021-05-05

    Grace Healthcare Recalls Compressed Oxygen Cylinders Due to Manufacturing Deviations

    Grace Healthcare Medical, Inc. is voluntarily recalling 35,838 compressed oxygen cylinders nationwide due to cGMP deviations. The recall was initiated in April 2021.

    Product
    Oxygen, Compressed, USP UN 1072, packaged in cylinders labeled as: a) M6 Medical Gas Cylinder, b) C Medical Gas Cylinder; c) D Medical Gas Cylinder; d) E Medical Gas Cylinder; e) M Medical Gas Cylinder; f) H Medical Gas Cylinder, Rx only, Grace Healthcare 1418 31st Avenue…
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighCPSC·21123·2021-05-05

    TJX Recalls Infant Sleep Bags Due to Suffocation Risk

    TJX is recalling infant sleep bags sold at T.J. Maxx, Marshalls, and Sierra because the neck opening is too large, posing a suffocation risk.

    Product
    Infant Sleep Bags
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1490-2021·2021-05-05

    Boston Scientific Recalls Colpassist Vaginal Positioning Device Due to Sterility Risk

    Boston Scientific is recalling Colpassist Vaginal Positioning Devices due to potential pinholes that may compromise sterility and cause post-operative infection.

    Product
    Colpassist Vaginal Positioning Device - Product Usage: intended for use in general gynecological surgery to assist in the positioning and manipulation of the vagina during the procedure. Material No. M0068318210
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1491-2021·2021-05-05

    Boston Scientific Recalls Upsylon Y Mesh Kit Due to Sterility Concerns

    Boston Scientific is recalling Upsylon Y Mesh Kits because pinholes may breach the sterile barrier, potentially rendering the device non-sterile and causing post-operative infection.

    Product
    UpsylonTM Y Mesh Kit with Colpassist Vaginal Positioning Device - Product Usage: intended for use as a bridging material for sacrocolposuspension/sacrocolpopexy (laparotomy, laparoscopic or robotic approach Material No.M0068318220 Individually packaged Upsylon Y Mesh (UPN…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·21V321000·2021-05-05

    Volkswagen Recalls 46 Internal-Use Vehicles for Regulatory Compliance Concerns

    Volkswagen is recalling 46 internal-use vehicles sold without confirmation of compliance with federal safety standards. The vehicles may have been modified and could fail to meet safety requirements.

    Product
    VOLKSWAGEN — VOLKSWAGEN GOLF R, CC, E-GOLF, GOLF
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V318000·2021-05-05

    2021 and 2020 Porsche Cayenne passenger airbag may fail to deploy

    Porsche is recalling certain 2020-2021 Cayenne models because the passenger seat heating element may not be installed, preventing proper airbag calibration and risking airbag deployment failure.

    Product
    PORSCHE — PORSCHE redundant CAYENNE E-HYBRID, CAYENNE E-HYBRID, CAYENNE GTS, CAYENNE S
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0350-2021·2021-05-05

    CareFusion Recalls ChloraPrep Antiseptic Applicators Due to Fungal Growth Risk

    CareFusion 213, LLC is recalling ChloraPrep With Tint antiseptic applicators because fungal growth may breach package integrity at labeled storage conditions.

    Product
    ChloraPrep With Tint 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Non-Sterile Solution - Hi-Lite Orange, 0.10 fl. oz. (3 ml) each, 25 applicators in carton, applicator is sterile if package is intact. CareFusion El Paso, TX 79912, NDC 054365-400-11…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·21V319000·2021-05-05

    Spartan RV Chassis fuel rail may leak, increasing fire risk

    Shyft Group recalls 2017-2022 Spartan RV Chassis K2 and K3 models. A fuel rail defect may cause leaks that pose a fire risk when an ignition source is present.

    Product
    SPARTAN — SPARTAN K2, K3
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1518-2021·2021-05-05

    Omnia Soft Tissue Punch Recalled Due to Inadequate Sterilization

    Omnia SRL is recalling dental soft tissue punches because the contract manufacturer reported inadequate sterilization processes at their facility since 2016.

    Product
    Omnia Soft Tissue Punch is a dental instrument designed to remove with precision a circular section of oral soft tissue (e.g., gum, palatal mucosa) during dental surgery, typically to allow access to a site for drilling and dental/orthodontic implant placement without the use of…
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-1517-2021·2021-05-05

    Philips Recalls Xper Flex Cardio Monitors Due to Performance Issues

    Philips is recalling Xper Flex Cardio monitors due to software issues that may cause display delays, freezing, or incorrect data.

    Product
    Philips Xper Flex Cardio (FC2010, Procedure Room and FC2020, Bedside Monitor) devices - intended for use by professional healthcare providers for complete physiologic/hemodynamic monitoring Service numbers associated with FC2010: Xper Flex Cardio 2010 Rev A 453564241901…
    Category
    Medical Device
    Distribution
    Distributed nationwide