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.

19051–19075 of 50407

  • HighFDA (Devices)·Z-2601-2021·2021-10-06

    Patient lift devices may lose ability to maintain horizontal positioning during transfers

    Hill-Rom LikoStretch Mod 600 IC patient lift devices may fail to maintain patients in a horizontal position while lifting, potentially causing patients to slide or fall.

    Product
    LikoStretch Mod 600 IC Model Number: 3156065 LikoStretch Mod 600 IC, Wide Model Number: 3156065B (obsolete since 12JUN2020) - The combination of this products allows the user to easily adjust/control the center of gravity during lift of patient.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2586-2021·2021-10-06

    Operating room table rotational lock may fail to maintain position

    The rotational lock on certain operating room tables may fail to secure the table position. This could cause the table to move unexpectedly during diagnostic or surgical procedures.

    Product
    Operating room table - Product Usage: intended for use during diagnostic examinations, radiologic procedures or surgical procedures to support and position a patient.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1022-2021·2021-10-06

    Little Debbie Mini Nutty Buddy Cookie Bites Undeclared Tree Nut Allergen

    Mckee Foods Corporation is recalling Little Debbie Mini Nutty Buddy Cookie Bites Sandwich Cookies due to an undeclared tree nut allergen that poses a risk to consumers with tree nut allergies.

    Product
    Little Debbie Mini Nutty Buddy Cookie Bites Sandwich Cookies 2.5oz plastic packaging 72 pouches per case
    Category
    Food
    Distribution
    4 states
  • HighFDA (Devices)·Z-2597-2021·2021-10-06

    Patient lift device may lose horizontal positioning control, creating fall risk

    The OctoStretch with Stretch Leveller may lose its ability to keep patients horizontal during lifting, risking patient falls. 440 units were distributed worldwide.

    Product
    OctoStretch with Stretch Leveller - The combination of this products allows the user to easily adjust/control the center of gravity during lift of patient. Model Number: 3156056
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2561-2021·2021-10-06

    Fluid management system control unit display freeze during hysteroscopic procedures

    A software defect in the Covidien HysteroLux fluid management system causes the display to freeze at a specific volume threshold during hysteroscopic surgery, creating risk of improper fluid accounting and potential circulatory complications.

    Product
    Covidien HysteroLux Fluid Management System Control Unit, REF: 72205000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2603-2021·2021-10-06

    Corin TriFit TS Orthopedic Implant Recall Due to Packaging Damage and Sterility Loss

    Corin Ltd is recalling Corin TriFit TS orthopedic implants due to packaging damage that may cause sterility loss and device contamination. The affected devices were shipped in July 2021 to multiple US states.

    Product
    Corin TriFit TS, Size 8, Standard Tapered Stem, REF 694.0008, Sterile.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2579-2021·2021-10-06

    PAS-PORT Proximal Anastomosis Device recalled for deployment failure risk

    Aesculap Implant Systems is recalling the PAS-PORT Proximal Anastomosis Device because the implant may fail to deploy successfully, potentially requiring additional medical intervention during surgery.

    Product
    PAS-PORT PROXIMAL ANASTOMOSIS DEVICE US Catalog Number: FG-000001-13
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2558-2021·2021-10-06

    Outlook Pump Add-On Set Recalled for Potential Leakage and Under-Delivery

    B. Braun Medical is recalling the Outlook Pump Add-On Set due to potential leakage that may delay medication delivery and cause incomplete dosing. The affected units could increase the risk of bloodstream infections.

    Product
    Outlook Pump Add-On Set-single use, for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: V7400
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2543-2021·2021-10-06

    Carotid and Gelsoft vascular patches recalled for incorrect instructions

    Vascutek vascular patches were distributed with rest-of-world instructions instead of U.S. instructions. The 159 units distributed to Puerto Rico and Guam have incorrect Instructions for Use for U.S. use.

    Product
    The Instructions for Use (IFU) for: Carotid Patch and Gelsoft Patch vascular patches. FSN says Tapered Carotid Patch 920875t
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2596-2021·2021-10-06

    GE Healthcare anesthesia machine flow sensors may over-deliver anesthetic

    Flow sensors in GE Healthcare anesthesia machines built before June 2021 may have damaged tubing that leaks, potentially causing over-delivery of anesthetic to patients.

    Product
    Flow sensors that may be installed in the following GEHC anesthesia machines: (1) Aestiva MRI, GTIN 0080682102339; (2) Aestiva 7900; (3) Aestiva 7100; (4) Aespire System Carestation, S/5 Protiva Config., Aespire 100 Compact Wall Mount (Aespire 7100); (5) S/5 Aespire 7900…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2549-2021·2021-10-06

    Outlook Pump Measured Volume Solution Set recalled for cassette leakage

    B. Braun is recalling 940 units of Outlook Pump Measured Volume Solution Sets due to potential leakage in the cassette. The leakage could delay medication delivery, result in incomplete dosing, or lead to bloodstream infections.

    Product
    Outlook Pump Measured Volume Solution Set/ w/ Auto Shut-Off. Single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 375118
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2589-2021·2021-10-06

    Atrium ADVANTA VXT Vascular Graft may lack required radial support ring

    Atrium Medical Corporation is recalling 28 units of the Atrium ADVANTA VXT Vascular Graft because some packages may contain mismatched units lacking the radial support ring specified in labeling.

    Product
    Atrium ADVANTA VXT Vascular Graft, Part No. 22059, UDI 00650862220599 - Product Usage: intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·22003·2021-10-06

    ElliptiGO Arc Bicycles Recalled for Structural Frame Failure Risk

    ElliptiGO Arc bicycles are being recalled because the aluminum frame can break while riding, creating a fall hazard. Six minor injuries have been reported so far.

    Product
    ElliptiGO Arc bicycles
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2574-2021·2021-10-06

    NAMIC Angiographic Manifolds Recalled for Potential Sterile Barrier Compromise

    Medline Industries recalled 816,420 NAMIC Angiographic Manifolds due to potential microscopic pinholes in sterile pouches that could compromise device sterility. No injuries reported.

    Product
    NAMIC Manifolds. (1) NAMIC Angiographic MANIFOLD, Medium Pressure, REF 64038301, UPN H965640383011, 3 Valve Manifold, Off Star Handles, Ports on Right, Rx only, Sterile; (2) NAMIC Angiographic MANIFOLD, Medium Pressure, REF 64038303, UPN H965640383031, 3 Valve…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2545-2021·2021-10-06

    B. Braun Outlook Pump Sets recalled for potential leakage and infection risk

    B. Braun is recalling 585,576 Outlook Pump Sets due to potential leakage in the cassette portion. The defect may cause medication under-delivery and increase bloodstream infection risk.

    Product
    Outlook Pump Sets w/3 CARESITE Needle-Free Injection Sites: single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Material ID: 352413
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2581-2021·2021-10-06

    Dose Calibrator Software Bug May Cause Incorrect Isotope Measurements

    AtomLab 500Plus Dose Calibrator software versions 2.0.00–2.0.08 contain a bug that fails to remove dial settings when deleting custom isotopes, potentially causing incorrect dose calibrations and misadministration.

    Product
    AtomLab 500Plus Dose CalibratorSoftware 2.0.00 through Revision 2.0.08, inclusive Model: 086-332
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2590-2021·2021-10-06

    Mobile X-Ray System Recalled for Unexpected Column Motion During Parking

    GE Healthcare is recalling the AMX Navigate Mobile X-Ray System due to an unexpected column motion defect that occurs during parking operations. Three units distributed in the United States are affected.

    Product
    AMX Navigate Mobile X-Ray System
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2615-2021·2021-10-06

    Cardiosave Hybrid IABP may unexpectedly shut down on AC power

    The Cardiosave Hybrid Intra-Aortic Balloon Pump may unexpectedly shut down when running on AC power with one battery installed and the battery removed during charging. No injuries have been reported.

    Product
    Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Nos. 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0998-00-0800-45, 0998-00-0800-52, 0998-00-0800-53, 0998-00-0800-55, 0998-00-0800-65
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·21V777000·2021-10-06

    2021 Aluma trailers recalled for loose mounting bracket on trailer bed

    Aluma KLM recalls 2021 Aluma trailers for loose front latch rivet nuts that may cause the mounting bracket to disengage, tilting the trailer bed unexpectedly and increasing crash risk. Dealers will install replacement hardware free of charge.

    Product
    ALUMA — ALUMA ALUMA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2562-2021·2021-10-06

    LYMOL Medical Elite X Class Rigid Bronchoscope System — Updated reprocessing instructions not distributed

    Lymol Medical Corporation recalled the LYMOL Medical Elite X Class Rigid Bronchoscope System because updated reprocessing instructions issued November 15, 2020, were not sent to all consignees of the devices.

    Product
    LYMOL Medical Elite X Class Rigid Bronchoscope System, Part No. BD2410, BB2701, BB2702, BB2401, BB2402, BA2700, BT2000, BT2101, BT2103, BT2105, BT2106, BT2210, BT2201, BT2203, BT2205, BR2200, BP2200, BI2200, BR2000, BP2000, BI2999, BR2103, BP2103, BI2103, BR2101, BP2101, BI2101…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2552-2021·2021-10-06

    B. Braun Outlook IV Pump Sets Recalled Due to Leakage Risk

    B. Braun Medical is recalling Outlook pump IV sets used with specific infusion pumps due to leakage in the cassette portion. The defect may prevent proper medication delivery and pose a risk of bloodstream infection.

    Product
    OUTLOOK PUMP IV SET W/UNIVERSAL SPIKE-single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 474004
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2548-2021·2021-10-06

    Infusion Pump Sets Recalled for Leakage and Medication Under-Delivery Risk

    B. Braun Medical is recalling infusion pump sets that may leak, potentially causing delayed medication delivery, incomplete dosing, and bloodstream infections.

    Product
    10 drops/ml, Priming volume: 46ml, Length: 130 in.-single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 354216
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2584-2021·2021-10-06

    Operating Room Table Rotational Lock May Fail Due to Hardware Defect

    The rotational locking mechanism on certain ORT200/300 operating room tables may fail to lock or unlock due to a mechanical hardware defect. Affected tables have been distributed worldwide.

    Product
    Operating room table - Product Usage: intended for use during diagnostic examinations, radiologic procedures or surgical procedures to support and position a patient.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2611-2021·2021-10-06

    Corin Unity Knee Implant Components Recalled for Packaging Damage Risk

    Corin Ltd recalls two models of Unity Knee CS Insert implant components due to potential packaging damage that could compromise sterility or cause contamination. Affected devices were distributed in nine U.S. states in July 2021.

    Product
    Corin Unity Knee CS Insert, Size 5 / 9.0mm, Fixed Condylar Stabilised - UHMWPE, REF 1125182, Sterile, and Corin Unity Knee CS Insert, Size 8 / 10.0mm, Fixed Condylar Stabilised - UHMWPE, REF 1125243, Sterile, both are components of the Unity Total Knee System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2606-2021·2021-10-06

    Corin Trinity Liner hip implant components recalled due to packaging damage

    Corin Ltd is recalling specific Trinity Liner ECIMA hip implant components because packaging damage could compromise device sterility or cause contamination. Five units were distributed nationwide between July 22-26, 2021.

    Product
    Corin Trinity Liner ECIMA, diameter 40mm Neutral Offset, Taper Size 4, REF 322.04.640, Sterile; and Corin Trinity Liner ECIMA, diameter 36mm Neutral 4mm EPW, Taper Size 4 (Elevated Wall), REF 322.04.936, Sterile; both are components of the Trinity Acetabular System.
    Category
    Medical Device
    Distribution
    Distributed nationwide