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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3576–3600 of 39948

  • ModerateFDA (Devices)·Z-2143-2025·2025-07-30

    Ellik Evacuator recalled over conflicting sterilization instructions in Japanese inserts

    The Ellik Evacuator, model 194, is being recalled because of discrepancies between the Japanese language package insert sterilization instructions and the manufacturer's IFU. 11 units are affected.

    Product
    Ellik Evacuator. Model Number: 194. The Ellik Evacuator and adapter accessories are compatible with Gyrus ACMI Elite and Elite 2 Resection Sheaths.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2141-2025·2025-07-30

    Ellik Evacuator glass body has conflicting sterilization instructions in Japan

    The Glass Body for the 194 Ellik Evacuator, model 190A, is being recalled because of discrepancies between the Japanese language package insert sterilization instructions and the manufacturer's IFU.

    Product
    Glass Body For 194 Ellik Evacuator. Model Number: 190A. The Ellik Evacuator and adapter accessories are compatible with Gyrus ACMI Elite and Elite 2 Resection Sheaths.
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2102-2025·2025-07-23

    i-view video laryngoscopes may be faulty because of depleted batteries

    The i-view video laryngoscope is being recalled because of the potential for faulty devices as a result of depleted batteries. 2,152 pieces are affected.

    Product
    i-view video laryngoscope. Model Number: 8008000. The i-view video laryngoscope is indicated to facilitate laryngoscopy.
    Category
    Medical Device
    Distribution
    17 states
  • SevereFDA (Devices)·Z-2095-2025·2025-07-23

    Baxter SIGMA Spectrum V6 infusion pumps may carry incorrect software version

    Baxter SIGMA Spectrum Infusion Pump V6 units are being recalled because certain pumps may have an incorrect version of software. 14 units are affected.

    Product
    Baxter SIGMA Spectrum Infusion Pump V6, Model Number 35700BAX
    Category
    Medical Device
    Distribution
    10 states
  • SevereFDA (Devices)·Z-2096-2025·2025-07-23

    Baxter SIGMA Spectrum V8 infusion pumps may carry incorrect software version

    Baxter SIGMA Spectrum Infusion Pump V8 units are being recalled because certain pumps may have an incorrect version of software. 28 units are affected.

    Product
    Baxter SIGMA Spectrum Infusion Pump V8, Model Number 35700BAX2
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Devices)·Z-2120-2025·2025-07-23

    VITROS Performance Verifier I lots can cause quality control drift

    VITROS Chemistry Products Performance Verifier I is being recalled because quality control drift can occur with certain cholinesterase slide lots, which could produce erroneous patient results.

    Product
    Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products Performance Verifier I Model/Catalog Number: 806 7324 Software Version: Not Applicable Product Description: VITROS Chemistry Products Performance Verifier is an assayed control used to monitor perfo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2118-2025·2025-07-23

    NIO-A intraosseous device stabilizer may not release properly after insertion

    The NIO-A NIO Intraosseous Device Adult is being recalled because a manufacturing error means the built-in stabilizer may not be released properly after deployment and insertion. 7,056 US units affected.

    Product
    Brand Name: NIO-A Product Name: NIO Intraosseous Device Adult Model/Catalog Number: 105000603 Software Version: N/A Product Description: NIO devices are a spring-based, automatic intra-osseous access device supplied Sterile and single use. Indicated for Intra-osseous access t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2116-2025·2025-07-23

    SwabCap disinfecting caps may have an incomplete seal allowing alcohol evaporation

    SwabCap Disinfecting Caps for needlefree connectors are being recalled because an incomplete seal may let isopropyl alcohol evaporate, which may result in inadequate disinfection. 1,445,600 units affected.

    Product
    SwabCap Disinfecting Cap for Needlefree Connectors: SwabSleeve, REF: SCXT3-5-2000; SwabCap, 200-ct. Box, REF: SCXT3-2000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2111-2025·2025-07-23

    BLS DIODE laser projectors shipped without a working remote interlock connector

    BLS laser light show projectors, models DIODE 1000, 2000 and 3000, are being recalled because the remote interlock connector required by federal regulation was not installed or was not wired. 10 units affected.

    Product
    Laser light show projectors manufactured by BLS, Model DIODE 1000/2000/3000.
    Category
    Other
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2119-2025·2025-07-23

    NIO+ intraosseous device stabilizer may not release properly after insertion

    The NIO Intraosseous Device Adult is being recalled because a manufacturing error means the built-in stabilizer may not be released properly after deployment and insertion. 516 US units affected.

    Product
    Brand Name: NIO+ Product Name: NIO Intraosseous Device Adult Model/Catalog Number: 105000908 Software Version: N/A Product Description: NIO devices are a spring-based, automatic intraosseous access device supplied Sterile and single use. Indicated for Intraosseous access to t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2125-2025·2025-07-23

    EMPOWR 3D knee 10mm tibial inserts were packaged with wrong implant

    EMPOWR 3D Knee Tibial Insert E-PLUS units, catalog number 341-10-711, are being recalled because of a packaging discrepancy in which incorrect tibial inserts were packaged. 20 units affected.

    Product
    Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEETM INS, 11L 10MM, VE Model/Catalog Number: 341-10-711 Software Version: NA Product Description: Enovis" knee devices are intended for treatment of patients who are candidates for knee arthroplasty p
    Category
    Medical Device
    Distribution
    18 states
  • HighFDA (Devices)·Z-2122-2025·2025-07-23

    VITROS CHE slides can cause quality control drift with performance verifiers

    VITROS Chemistry Products CHE Slides are being recalled because quality control drift can occur with certain Performance Verifier lots, which could produce erroneous patient results.

    Product
    VITROS Chemistry Products CHE Slides; Catalog Numbers: (1) 191 4605 (300 slides), (2) 800 4707 (90 slides);
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2115-2025·2025-07-23

    Access Vitamin B12 reagent lot can give erroneously low or high results

    Access Vitamin B12 Reagent lot 439850 is being recalled after complaints of erroneous results, which may lead to a delayed or improper diagnosis or repeat testing. 10,000 units are affected.

    Product
    Access Vitamin B12 Reagent, Catalog Number 33000, Lot Number 439850
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2123-2025·2025-07-23

    VITROS CHE slides sold in Japan can cause quality control drift

    VITROS Chemistry Products CHE Slides supplied in Japan are being recalled because quality control drift can occur with certain Performance Verifier lots, which could produce erroneous patient results.

    Product
    VITROS Chemistry Products CHE Slides (Japan); Catalog Numbers: (1) 684 4074 (90 slides), (2) 684 4138 (300 slides);
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2121-2025·2025-07-23

    VITROS Performance Verifier II lots can cause quality control drift

    VITROS Chemistry Products Performance Verifier II is being recalled because quality control drift can occur with certain cholinesterase slide lots, which could produce erroneous patient results.

    Product
    Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products Performance Verifier II Model/Catalog Number: 8231474 Software Version: N/A Product Description: VITROS Chemistry Products Performance Verifier is an assayed control used to monitor performance on V
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2112-2025·2025-07-23

    BLS laser show projectors shipped without a working remote interlock connector

    BLS laser light show projectors, models CLUB 1000, 2000 and 4000, are being recalled because the remote interlock connector required by federal regulation was not installed or was not wired. 12 units affected.

    Product
    Laser light show projectors manufactured by BLS, Model CLUB 1000/2000/4000.
    Category
    Other
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2126-2025·2025-07-23

    EMPOWR 3D knee tibial inserts were packaged with the wrong implant

    EMPOWR 3D Knee Tibial Insert E-PLUS units are being recalled because of a packaging discrepancy in which incorrect tibial inserts were packaged. 20 units are affected.

    Product
    Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEETM INS, 11L 12MM, VE Model/Catalog Number: 341-12-711 Software Version: NA Product Description: Enovis" knee devices are intended for treatment of patients who are candidates for knee arthroplasty p
    Category
    Medical Device
    Distribution
    18 states
  • HighFDA (Devices)·Z-2113-2025·2025-07-23

    BLS PURE laser projectors shipped without a working remote interlock connector

    BLS laser light show projectors, models PURE 5000 and PURE 10000, are being recalled because the remote interlock connector required by federal regulation was not installed or was not wired. 3 units affected.

    Product
    Laser light show projectors manufactured by BLS, Model PURE 5000/10000.
    Category
    Other
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2114-2025·2025-07-23

    NeuroSync EYE-SYNC headsets are inoperable and cannot be repaired

    NeuroSync EYE-SYNC systems containing Pico Neo 2 headsets are being recalled because eye syncing issues render the device inoperable and it cannot be repaired. 27 units are affected.

    Product
    NeuroSync EYE-SYNC containing Pico Neo 2 Headsets. Each unit consists of a Pico Neo 2 headset with embedded sensors, a paired Android tablet, and proprietary software, packaged in a portable field case. Eye-tracking headset system is intended for recording, viewing, and analyz
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2127-2025·2025-07-23

    Medtronic SmartSync software update removes an erroneous electrical reset message

    Medtronic SmartLink Software on the SmartSync Patient Connector is being updated because the system could display an erroneous electrical reset message on interrogation when no reset had occurred. 3,909 units affected.

    Product
    Medtronic SmartLink Software loaded on SmartSync Patient Connector, Model Number 24967 with the following software components: 1. Azure Astra application, Software Model Number D00U003; 2. Percepta Serena Solara application, Software Model Number D00U004; 3. Cobalt Crome
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2124-2025·2025-07-23

    Culture media quality control kits contain the wrong bacterial organism

    KWIK-STIK and LYFO DISK quality control kits for culture media are being recalled because affected products contain Staphylococcus epidermidis instead of the expected Brevundimonas diminuta. 21 units affected.

    Product
    KWIK-STIK and LYFO DISK, quality control kit for culture media Catalog # 0805K and 0805L
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-2128-2025·2025-07-23

    Medtronic CareLink SmartSync software update removes an erroneous reset message

    Medtronic SmartLink software on the CareLink SmartSync Device Manager is being updated because the system could display an erroneous electrical reset message on interrogation when no reset had occurred. 5,418 units affected.

    Product
    Medtronic SmartLink software loaded on CareLink SmartSync Device Manager, Model Number 24967A with the following software components: 1. Azure Astra application, Software Model Number D00U003; 2. Percepta Serena Solara application, Software Model Number D00U004; 3. Cobal
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2032-2025·2025-07-16

    Hillrom LikoScale patient lift components may falsely latch and detach

    Hillrom LikoScale components used with patient lift adapter kits are being recalled because the Q-link 13 may allow false latching of the quick-release hook. 9,839 units are affected.

    Product
    Hillrom LikoScale component, Product Code 3156232, used with the following adapter kits for patient lifts: 1) LikoScale 200 Accessory - Product Code 3156225; 2) LikoScale 350 Accessory - Product Code 3156228; 3) LikoScale 400 Accessory - Product Code 3156226.
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2080-2025·2025-07-16

    Optisite OPTI16 arterial cannulas may have wire protruding from the body

    Edwards Optisite OPTI16 Arterial Cannulas are being recalled after complaints of a 3 mm to 4 mm section of wire exposed or protruding from the outside of the cannula body. 27,022 units affected.

    Product
    Brand Name: Optisite Arterial Cannula Product Name: Optisite Arterial Cannula Model/Catalog Number: OPTI16 Software Version: N/A Product Description: Cardiac cannula. The Edwards OptiSite Arterial Perfusion Cannluae provides or establishes arterial perfusion in the extracorpo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2083-2025·2025-07-16

    FEM-FLEX II femoral arterial cannulas may have wire protruding from body

    Edwards FEM-FLEX II Femoral Arterial Cannulas are being recalled after complaints of a 3 mm to 4 mm section of wire exposed or protruding from the outside of the cannula body. 847 units affected.

    Product
    Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII016AS Software Version: N/A Product Description: The Edwards FEMFLEXII Femoral Perfusion Cannluae provides or establishes arterial perfusion in the extracorporeal circuit for d 6 hours.
    Category
    Medical Device
    Distribution
    Distributed nationwide