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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3526–3550 of 39824

  • HighFDA (Devices)·Z-2153-2025·2025-07-30

    Medline labor triage kits contain ChloraPrep applicators with open seals

    Medline LABOR TRIAGE KIT convenience kits are being recalled because they contain BD ChloraPrep Clear 1 mL Applicators that may exhibit an open seal, which may breach sterility. 960 units affected.

    Product
    Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as: LABOR TRIAGE KIT, REF DYKM1564
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-2171-2025·2025-07-30

    Stryker StrykeFlow irrigator with tip may leak solution into handpiece

    The Stryker StrykeFlow Disposable Suction/Irrigator with Disposable Tip is being recalled because irrigation solution may leak into the handpiece and battery pack, causing it to malfunction.

    Product
    Stryker, StrykeFlow REF: 0250070520 / 2, Disposable Suction/Irrigator with Disposable Tip
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2142-2025·2025-07-30

    Ellik Evacuator male connector tubing has conflicting sterilization instructions in Japan

    The Tubing for Male Connector 194, Ellik Evacuator, model 190-4, is being recalled because of discrepancies between the Japanese language package insert sterilization instructions and the manufacturer's IFU.

    Product
    Tubing for Male Connector 194, Ellik Evacuator. Model Number: 190-4. 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-2140-2025·2025-07-30

    Green endoscope silicone seals have conflicting sterilization instructions in Japan

    Green Silicone Seals for Accessories, reusable 0-7 FR, model CS-G7, are being recalled because of discrepancies between the Japanese language package insert sterilization instructions and the manufacturer's IFU.

    Product
    Green Silicone Seal for Accessories, Reusable Silicone Seal 0 - 7 FR. Model Number: CS-G7. The reusable silicone seals fit over the biopsy port of endoscopes to seal off the working channel. Some contain a lumen which allows instruments to be passed through the seal and mini
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2157-2025·2025-07-30

    EasiSlush sterile slush solution missed a quarterly gamma sterilization dose audit

    Bridge to Life EasiSlush is being recalled because quarterly dose audits monitoring the gamma sterilization process were not completed on time for three lots in the first quarter of 2024. 4,528 units affected.

    Product
    Bridge to Life EasiSlush, (Sodium Chloride Solution for Sterile Slush Preparation) (0.9% Sodium Chloride Irrigation, USP), Part Number REF BTLE-1250
    Category
    Medical Device
    Distribution
    16 states
  • 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-2145-2025·2025-07-30

    Ellik Evacuator locking adapter has conflicting sterilization instructions in Japan

    The Ellik Evacuator Adapter, Locking, model 190-NRS, is being recalled because of discrepancies between the Japanese language package insert sterilization instructions and the manufacturer's IFU. 5 units affected.

    Product
    Ellik Evacuator Adapter, Locking. Model Number: 190-NRS. 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-2139-2025·2025-07-30

    Reusable endoscope silicone seals have conflicting sterilization instructions in Japan

    Blue Silicone Reusable Silicone Seals 6-12 FR, model CS-B612, are being recalled because of discrepancies between the Japanese language package insert sterilization instructions and the manufacturer's IFU.

    Product
    Blue Silicone, Reusable Silicone Seal 6 - 12 FR. Model Number: CS-B612. The reusable silicone seals fit over the biopsy port of endoscopes to seal off the working channel. Some contain a lumen which allows instruments to be passed through the seal and minimize or prevent fl
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2146-2025·2025-07-30

    Ellik Evacuator non-locking cone has conflicting sterilization instructions in Japan

    The Cone with Male Tubing, Non-Locking, Ellik Evacuator, model 191-NRS, is being recalled because of discrepancies between the Japanese language package insert sterilization instructions and the manufacturer's IFU.

    Product
    Cone with Male Tubing, Non-Locking, Ellik Evacuator. Model Number: 191-NRS. 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-2163-2025·2025-07-30

    ACUVUE OASYS MAX multifocal daily lenses have bubbles and voids

    ACUVUE OASYS MAX 1-Day MULTIFOCAL contact lenses are being recalled because of defects, specifically bubbles and voids, identified during standard finished goods testing. 114,165 lenses affected.

    Product
    ACUVUE¿ OASYS MAX 1-Day MULTIFOCAL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2144-2025·2025-07-30

    Ellik Evacuator latex bulb has conflicting sterilization instructions in Japan

    The Ellik Latex Bulb, model 194-2, is being recalled because of discrepancies between the Japanese language package insert sterilization instructions and the manufacturer's IFU. 48 units affected.

    Product
    Ellik Latex Bulb, Ellik Evacuator. Model Number: 194-2. 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-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
  • 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
  • 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-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-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-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-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-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-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