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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3551–3575 of 39987

  • HighFDA (Devices)·Z-2138-2025·2025-07-30

    Natus brain monitor breakout box shows right side impedance under left

    The Natus Brain Monitor Breakout Box is being recalled after two complaints that the left side labeling showed impedance for the right side. 27 units are affected.

    Product
    Natus Brain Monitor Breakout Box, Part Number 021911; full-montage standard electroencephalograph
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-2152-2025·2025-07-30

    Estrone RIA kits give falsely increased results from a bovine albumin lot

    Estrone RIA kits are being recalled because a specific lot of bovine serum albumin used to manufacture the coated tubes caused falsely increased assay results. 496 units are affected.

    Product
    Estrone RIA, REF: DSL8700. Estrone RIA is an IVD used for the quantitative measurement of estrone in human serum and plasma.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2154-2025·2025-07-30

    Medline IV start lab draw kits contain ChloraPrep with open seals

    Medline IV START KIT LAB DRAW-SH convenience kits are being recalled because they contain BD ChloraPrep Clear 1 mL Applicators that may exhibit an open seal, which may breach sterility. 184 units affected.

    Product
    Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as: IV START KIT LAB DRAW-SH, REF CDS860014P
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-2156-2025·2025-07-30

    Medline C-section prep kits contain ChloraPrep applicators with open seals

    Medline C-SECTION PREP convenience kits are being recalled because they contain BD ChloraPrep Clear 1 mL Applicators that may exhibit an open seal, which may breach sterility. 48 units affected.

    Product
    Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as: C-SECTION PREP, REF DYNJ32702B
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-2155-2025·2025-07-30

    Medline blood culture kits contain ChloraPrep applicators with open seals

    Medline blood culture convenience kits are being recalled because they contain BD ChloraPrep Clear 1 mL Applicators that may exhibit an open seal, which may breach sterility. 15,700 units affected.

    Product
    Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as: 1) BLOOD CULTURE KIT, REF DYNDH1462B; 2) BLOOD CULTURE KIT, REF DYNDH1622C; 3) BLOOD CULTR KT DIVRSN DEVICE, REF DYNDH1866.
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-2132-2025·2025-07-30

    Discovery MR750w gradient coils can produce acoustic noise above the limit

    GE HealthCare Discovery MR750w 3.0T MR systems are being recalled because gradient coils can produce acoustic levels exceeding the 99 dB limit set by IEC 60601-2-33 during scanning.

    Product
    Discovery MR750w 3.0T
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2130-2025·2025-07-30

    SIGNA Architect gradient coils can produce acoustic noise above the limit

    GE HealthCare SIGNA Architect MR systems are being recalled because gradient coils can produce acoustic levels exceeding the 99 dB limit set by IEC 60601-2-33 during scanning.

    Product
    SIGNA Architect
    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-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-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-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-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-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-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-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
  • 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