The Recall Desk

Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means deaths or serious injuries are reported, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

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Any3+ (High and above)4+ (High and above)5+ (High and above)

Clear filters

9151–9175 of 40095

  • HighFDA (Devices)·Z-2600-2023·2023-09-27

    Stryker ACM Cement Mixing System nozzle may break during surgery

    Stryker is recalling ACM Systems due to potential breakage of the femoral nozzle applicator tip during use. This could cause device failure and leave components in the surgical site.

    Product
    Stryker ACM (Advanced Cement Mixing) System: ACM Kit w/ Femoral Breakaway Nozzle & Prox. Med. Press-Allows the user to mix bone cement with a constant high vacuum through the process Catalog Number: 0306-573-000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2603-2023·2023-09-27

    Orthopedic knee implant component lacks final sterilization before shipment

    Encore Medical recalls 20 DJO Surgical Empowr Knee tibia baseplate components that were not sterilized before shipment. If implanted, these components may cause infection requiring treatment or revision surgery.

    Product
    DJO Surgical: Empowr Knee, Universal Tibia Baseplate, 6R, REF: 352-02-106
    Category
    Medical Device
    Distribution
    26 states
  • HighFDA (Devices)·Z-2605-2023·2023-09-27

    Orthopedic hip stem implant recalled due to sterilization failure

    Encore Medical has recalled a hip stem orthopedic implant that was not sterilized before shipment. Non-sterile implants may cause infection if implanted, requiring treatment and potentially revision surgery.

    Product
    DJO Surgical: CLP Hip, Stem, Polished Neck, Lateral Offset Implant, Size#3, REF: 426-11-030
    Category
    Medical Device
    Distribution
    26 states
  • HighFDA (Devices)·Z-2614-2023·2023-09-27

    Abbott Cardiac Defibrillators Recalled for Bluetooth Circuit Component Failure

    Abbott recalled certain ICD and CRT-D devices manufactured before April 2022 due to a Bluetooth malfunction from a crystal component defect in the BLE circuit. The malfunction causes loss of Bluetooth communication, and in some cases, excessive power drain affecting battery longevity.

    Product
    Gallant VR Implantable Cardioverter Defibrillator: VR ICD REF CDVRA500Q Gallant DR Implantable Cardioverter Defibrillator: DR ICD REF CDDRA500Q Neutrino VR Implantable Cardioverter Defibrillator: NxT VR ICD REF CDVRA600Q Neutrino DR Implantable Cardioverter Defibrillator:
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2616-2023·2023-09-27

    PDS Plus Antibacterial Sutures Recalled for Tensile Strength Defect

    Ethicon is recalling PDS Plus Antibacterial sutures from specific lots that failed internal tensile strength testing. The defective sutures could fail during or after surgery, creating a risk of serious patient harm.

    Product
    PDS Plus Antibacterial (polydioxanone) Suture, Product Numbers PDP072H40, PDP259H50, PDP416H50, PDP441H50, PDP442H50, PDP489G50, PDP489H40, PDP497G51, PDP497H16, PDP497H40, PDP498H40, PDP502V05, PDP507V05, PDP510V05, PDP515V05, PDP662H50, PDP663H50, PDP684H40, PDP9615H40, PDP9625
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2612-2023·2023-09-27

    TyTek PneumoDart Decompression Device: Updated Instructions for Needle Placement

    Tytek Medical is updating instructions for the TyTek PneumoDart to better identify needle decompression risks and improve placement guidance. Approximately 22,026 units distributed before October 5, 2020 are affected.

    Product
    TyTek PneumoDart- Intended for introduction into the body to facilitate removal of air from the pleural cavity in patients with a tension pneumothorax Model Number: TM-317
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-2608-2023·2023-09-27

    Philips Patient Information Center iX Software Crashes Delay Patient Monitoring

    Philips Patient Information Center iX software versions 4.x may crash due to an Intel Graphics Driver error, causing a blank screen. Users must manually reboot the system, potentially delaying the detection of patient condition changes.

    Product
    Patient Information Center iX with Software Version Number 4.x in the following: (1) Patient Information Center iX Product Number: 866389; (2) Patient Information Center iX Expand Product Number: 866390; (3) PIC iX Essentials Product Number: 867093; (4) PIC iX Essential
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2606-2023·2023-09-27

    DJO Surgical Reverse Shoulder System Components Recalled Due to Missing Sterilization

    Reverse shoulder implant components were shipped without final sterilization, potentially leading to infection and possible revision surgery if implanted. Encore Medical is recalling 64 units distributed across the US and internationally.

    Product
    DJO Surgical: Reverse Shoulder System (RSP) Semi Humeral Socket Insert, 32mm, REF: 508-01-032; Baseplate, Glenoid HA-Coat, RSP, 6.5mm X 30mm, REF: 508-32-104; Reverse Shoulder System (RSP) Glenoid, Neutral Head W/ Retaining Screw, 36mm, REF: 508-36-101
    Category
    Medical Device
    Distribution
    26 states
  • HighFDA (Devices)·Z-2594-2023·2023-09-27

    SofTech Wheelchair Cushions Recalled for Defective Battery Overheating Risk

    Aquila Corporation is recalling 134 SofTech Pressure-Sensing Wheelchair Cushions with defective battery packs that can overheat, risking property damage and a possible injury. The affected units have been distributed nationwide in the US and internationally to Canada, Sweden, Romania, Australia, and the UK.

    Product
    SofTech Pressure-Sensing Wheelchair Cushions
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2592-2023·2023-09-27

    Sentec Membrane Changer components recalled for manufacturing defect

    SenTec AG recalls Membrane Changer components for the Sentec Digital Monitoring System due to a potential manufacturing defect that could affect measurement accuracy.

    Product
    Membrane Changer Single-Use, REF MC, each package contains 3 changers; Membrane Changer Reloadable, REF MC-R, each package contains 3 changers; and Membrane Changer Insert, REF MC-I, each package contains 5 inserts. All are components of the Sentec Digital Monitoring System (SDM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2613-2023·2023-09-27

    Prucka 3 Amplifier Power Supply May Fail and Cause Device Inoperability

    GE Medical Systems is recalling Prucka 3 Amplifiers and related field replaceable units used in CardioLab and ComboLab systems. A power supply diode may overheat and fail, causing the amplifier to stop working.

    Product
    Prucka 3 Amplifiers, Model P1801PA, and Field Replaceable Units (FRUs), Model 5875569, used with CardioLab AltiX and ComboLab AltiX.
    Category
    Medical Device
    Distribution
    17 states
  • ModerateFDA (Devices)·Z-2590-2023·2023-09-27

    Arrow ErgoPack PICC Catheters Recalled for Incorrect Product Labeling

    Arrow International is recalling 190 units of Arrow ErgoPack One-Lumen PICC catheters (Lot 13F22J0617) because the product code and product name were incorrectly printed on the kit packaging. The units were distributed nationwide.

    Product
    Arrow ErgoPack Pressure Injectable One-Lumen PICC, REF CDC-05541-HPK1A; catheter, intravascular
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2619-2023·2023-09-27

    MINISCAV Vacuum Pump Recalled for Inadequate Acceptance Documentation

    R A Medical Services has recalled 10 MINISCAV Vacuum Pump units distributed in Ohio due to inadequate documentation of the product acceptance activity during manufacturing.

    Product
    MINISCAV (tm) Vacuum Pump
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2611-2023·2023-09-27

    TyTek Tension Pneumothorax Access Kit Instructions Updated for Needle Decompression Safety

    Tytek Medical is updating instructions and visual guidance for its tension pneumothorax kit to clarify needle decompression risks and proper placement. The update affects 4,400 units distributed in the US and international locations.

    Product
    TyTek Tension Pneumothorax Access Kit TPAK10: 10 gauge, 3.25 inch- Intended for introduction into the body to facilitate removal of air from the pleural cavity in patients with a tension pneumothorax Model Number: TM-310
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-2622-2023·2023-09-27

    COOLIEF RF Generator recalls due to F100 and F101 fault complaints

    Avanos Medical is recalling 24 COOLIEF RF Generator units that have produced F100 and F101 faults. Units were distributed to 17 U.S. states and Brazil.

    Product
    COOLIEF RF Generator is an 80-watt Radio-Frequency (RF) Generator with four independent RF channels, allowing all RF channels to be activated individually or altogether. The system is controlled via a touch screen interface display that includes user controls, alarm messages, and
    Category
    Medical Device
    Distribution
    16 states
  • ModerateFDA (Devices)·Z-2627-2023·2023-09-27

    Epidural Anesthesia Sets Recalled Due to Incorrect Lid Stock Label

    B. Braun Medical is recalling approximately 3,440 Perifix® epidural anesthesia sets due to incorrect labeling of the lid stock. The mislabeled products were distributed to multiple U.S. states.

    Product
    Perifix¿ / Epidural anesthesia set, medicated
    Category
    Medical Device
    Distribution
    13 states
  • ModerateFDA (Devices)·Z-2609-2023·2023-09-27

    Chemistry Quality Control Material Recalled for Transcription Error in Instructions

    Randox Laboratories recalled Liquid Assayed Chemistry Control Premium Plus Level 3 due to incorrect standard deviation values in the product instructions. The error could affect patient result reporting, but the correct operating values remain available.

    Product
    Liquid Assayed Chemistry Control Premium Plus Level 3, Catalog Number LAE4215
    Category
    Medical Device
    Distribution
    6 states
  • LowFDA (Devices)·Z-2591-2023·2023-09-27

    Arrow ErgoPack PICC catheter kits recalled for incorrect product labeling

    Arrow International recalled 177 ErgoPack PICC catheter kits because the product code and name were incorrectly listed on the packaging. No illnesses or injuries reported.

    Product
    Arrow ErgoPack, Pressure Injectable Two-Lumen PICC pre-loaded with Arrow VPS Stylet, REF CDC-35552-VPS; Catheter: Percutaneous, implanted, long-term intravascular catheter
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2509-2023·2023-09-20

    Abbott Proclaim DRG Implantable Pulse Generators cannot exit MRI mode

    Abbott Medical is recalling approximately 17,394 Proclaim DRG Implantable Pulse Generators worldwide due to reports that patients cannot exit MRI mode on affected devices. This malfunction may prevent normal device operation when mode-switching is needed.

    Product
    Proclaim DRG Implantable Pulse Generator REF 3664 Product Description: The implantable pulse generator (IPG) is an electronic device designed to be connected to one or more extensions or leads with up to 16 electrodes total. It is powered by a hermetically sealed battery with
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2506-2023·2023-09-20

    Proclaim XR 7 Implantable Pulse Generators unable to exit MRI mode

    Abbott Medical is recalling Proclaim XR 7 Implantable Pulse Generators due to a malfunction that prevents patients from exiting MRI (Magnetic Resonance Imaging) mode, potentially disrupting normal device operation and therapy delivery.

    Product
    Proclaim" XR 7 Implantable Pulse Generator REF 3662 (previously known as Proclaim" 7 Elite IPG) Product Description: The implantable pulse generator (IPG) is an electronic device designed to be connected to one or more extensions or leads with up to 16 electrodes total. It i
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2514-2023·2023-09-20

    FDA Recalls Medline Hudson RCI Addipak Inhalation Solution for Sterility Failure

    Medline Industries is recalling HUDSON RCI Addipak 5mL sterile saline inhalation solution due to sterility failure. Approximately 18,000 units were distributed nationwide; the product was intended for scrap but was inadvertently shipped to customers.

    Product
    HUDSON RCI Addipak, UNIT DOSE VIALS, 5mL Sterile 0.9% NaCl Solution for Inhalation USP. REF RHUD59U
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2510-2023·2023-09-20

    Abbott Infinity 5 Implantable Pulse Generator Patients Unable to Exit MRI Mode

    Some Abbott Infinity 5 implantable pulse generator patients report being unable to exit MRI mode on their devices. This Class I recall affects 5,932 devices distributed globally.

    Product
    Infinity 5 Implantable Pulse Generator REF 6660 Product Description: The implantable pulse generator (IPG) is an electronic device designed to be connected to one or more extensions or leads with up to 16 electrodes total. It is powered by a hermetically sealed battery within
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2505-2023·2023-09-20

    Proclaim XR 5 Implantable Pulse Generators Cannot Exit MRI Mode

    Abbott Medical recalled the Proclaim XR 5 Implantable Pulse Generator after patients reported being unable to exit MRI mode on their devices. Approximately 113,784 units were distributed worldwide.

    Product
    Proclaim XR 5 Implantable Pulse Genterator REF 3660 (previously known as Proclaim" 5 Elite IPG) Model 3660 Product Description: The implantable pulse generator (IPG) is an electronic device designed to be connected to one or more extensions or leads with up to 16 electrodes
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2450-2023·2023-09-20

    Mallinckrodt One-Way Valve Recalled Due to Potential Oxygen Flow Failure

    Mallinckrodt Manufacturing is recalling approximately 13,600 One-Way Valves used with ventilators due to risk of valve sticking and oxygen flow reduction. The Class I recall affects worldwide distribution.

    Product
    Mallinckrodt One-Way Valve, 22F x 22M, a) Part #91346 (1 piece) and b) Part #50412 (pack of 5) Used with ventilators.
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2508-2023·2023-09-20

    Proclaim Plus 7 Implantable Pulse Generator Cannot Exit MRI Mode

    Abbott Medical recalled Proclaim Plus 7 Implantable Pulse Generators due to a defect preventing patients from exiting MRI mode. This operational failure could compromise device functionality during or after magnetic resonance imaging procedures.

    Product
    Proclaim Plus 7 Implantable Pulse Generator REF 3672 Product Description: The implantable pulse generator (IPG) is an electronic device designed to be connected to one or more extensions or leads with up to 16 electrodes total. It is powered by a hermetically sealed battery w
    Category
    Medical Device
    Distribution
    Distributed nationwide