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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2751–2775 of 13446

  • ModerateFDA (Devices)·Z-2193-2025·2025-08-06

    Sprinter Cart Infusion Pole recalled for labeling non-compliance

    Maquet is recalling 7,754 Sprinter Cart and Sprinter Cart XL Infusion Poles worldwide due to labeling that does not comply with international electrical safety standards (IEC 60601-1). No injuries or illnesses have been reported.

    Product
    Sprinter Cart/Sprinter Cart XL Infusion Pole. Component used to hold 2 x 2 kg infusion bags.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2194-2025·2025-08-06

    LYFO-DISK Microbiological Quality Control Material May Fail to Function

    Microbiologics Inc is recalling LYFO-DISK quality control materials that may fail to properly recover the target microorganism, potentially compromising laboratory test validation procedures.

    Product
    LYFO-DISK, M. Canis Derived from ATCC 36299, packaged as: 1) REF 0894K (6-pack), 2) REF 0894P (2-pack)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2192-2025·2025-08-06

    Phasor Drill units recalled due to reverse battery orientation

    Phasor Drill neurosurgical units with reversed battery orientation are being recalled. The recall affects 1,064 units distributed across the United States and U.S. territories.

    Product
    Phasor Drill, REF: 2.70S, 3.20L, 4.50, 5.30, 6.35
    Category
    Medical Device
    Distribution
    29 states
  • HighFDA (Devices)·Z-2143-2025·2025-07-30

    Ellik Evacuator sterilization instructions discrepancy between languages

    Olympus recalls Ellik Evacuators due to discrepancies in sterilization instructions between Japanese product inserts and manufacturer documentation. Inconsistent sterilization procedures could affect device safety.

    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
  • HighFDA (Devices)·Z-2130-2025·2025-07-30

    MR System Gradient Coils May Exceed Acoustic Noise Safety Limits

    GE HealthCare is recalling SIGNA Architect MR system gradient coils that can produce acoustic noise exceeding 99dB during scanning, potentially surpassing international safety limits even with required hearing protection.

    Product
    SIGNA Architect
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2152-2025·2025-07-30

    Estrone RIA diagnostic kits recalled for falsely elevated test results

    Beckman Coulter recalls Estrone RIA kits due to manufacturing defects in coated tubes causing falsely elevated estrone measurements. Affected lots were distributed in North Carolina and internationally.

    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
    0 states
  • HighFDA (Devices)·Z-2163-2025·2025-07-30

    Johnson & Johnson recalls Acuvue Oasys Max contact lenses for manufacturing defects

    Johnson & Johnson Vision Care is recalling 114,165 Acuvue Oasys Max 1-Day Multifocal contact lenses due to bubbles and voids found during quality testing. The defects were identified during standard finished goods inspection.

    Product
    ACUVUE¿ OASYS MAX 1-Day MULTIFOCAL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2166-2025·2025-07-30

    Biofinity Toric Multifocal Contact Lens Recalled for Potential Sterility Issues

    CooperVision is recalling Biofinity Toric Multifocal Contact Lenses with potentially compromised blister seals that may render the lenses unsterile. Approximately 827 units are affected worldwide.

    Product
    Biofinity Toric Multifocal Contact Lens
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2132-2025·2025-07-30

    GE Discovery MR750w MRI System Gradient Coil Acoustic Noise Hazard

    GE HealthCare's Discovery MR750w 3.0T MRI systems can produce excessive acoustic noise from gradient coils during scanning, potentially exceeding safe hearing protection limits.

    Product
    Discovery MR750w 3.0T
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2170-2025·2025-07-30

    Stryker StrykeFlow Suction Irrigator Recalled for Potential Liquid Leakage

    Stryker is recalling its StrykeFlow suction/irrigator device due to potential irrigation solution leakage into the handpiece and battery pack, which could cause device malfunction.

    Product
    Stryker, StrykeFlow , REF: 0250070500, 2, Disposable Suction/Irrigator without Disposable Tip
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2139-2025·2025-07-30

    Reusable Endoscope Seals Recalled Due to Sterilization Instructions Discrepancy

    Olympus reusable silicone seals for endoscopes are recalled because Japanese-language package instructions differ from the official sterilization guidance. Users following the incorrect instructions may not properly sterilize the device.

    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
  • HighFDA (Devices)·Z-2171-2025·2025-07-30

    Stryker StrykeFlow Disposable Suction/Irrigator Malfunction Recall

    Stryker is recalling StrykeFlow disposable suction/irrigators because irrigation solution may leak into the handpiece and battery pack, causing potential device malfunction.

    Product
    Stryker, StrykeFlow REF: 0250070520 / 2, Disposable Suction/Irrigator with Disposable Tip
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2155-2025·2025-07-30

    Medline Convenience Kits with BD ChloraPrep Recalled for Open Seal

    Medline Convenience Kits containing BD ChloraPrep applicators are recalled for potential open seals that breach sterility and may cause patient infection. The 15,700 affected units were distributed to California, Florida, Pennsylvania, and Texas.

    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
    0 states
  • HighFDA (Devices)·Z-2168-2025·2025-07-30

    Medtronic CareLink SmartSync Devices Abort Button Software Defect Limits Therapy Cancellation

    Medtronic CareLink SmartSync Patient Connectors have a software defect where the Abort button operates only in a limited time window during induction tests, potentially preventing users from canceling high voltage therapy delivery.

    Product
    Medtronic CareLink SmartSync Patient Connector, Model Number 24967 with the following software components: 1. Cobalt Crome application, Software Model Number D00U005; 2. Claria Amplia Compia application, Software Model Number D00U009; 3. Evera MRI application, Software M
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2154-2025·2025-07-30

    Medline Convenience Kits with BD ChloraPrep Applicators Recalled Over Sterility Concerns

    Medline Convenience Kits containing BD ChloraPrep Clear applicators are being recalled due to potential open seals in packaging that could compromise sterility and lead to infection.

    Product
    Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as: IV START KIT LAB DRAW-SH, REF CDS860014P
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2165-2025·2025-07-30

    Biofinity XR Toric Contact Lenses Recalled for Sterility Concerns

    CooperVision is recalling Biofinity XR Toric contact lenses due to potential sterility issues caused by incomplete or leaking seals on lens blisters, which may introduce contamination.

    Product
    Biofinity XR Toric Contact Lens
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2142-2025·2025-07-30

    Ellik Evacuator Tubing Recalled Due to Sterilization Instruction Discrepancies

    Olympus is recalling tubing for the Ellik Evacuator due to discrepancies between sterilization instructions in Japanese language package inserts and the manufacturer's Instructions for Use.

    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
  • HighFDA (Devices)·Z-2169-2025·2025-07-30

    Medtronic CareLink SmartSync Device Manager software abort button defect recall

    Medtronic is recalling CareLink SmartSync Device Manager software versions due to a defective abort button. The abort button does not properly stop induction testing, limiting users' ability to cancel high voltage therapy delivery.

    Product
    Medtronic CareLink SmartSync Device Manager, Model Number 24967A with the following software components: 1. Cobalt Crome application, Software Model Number D00U005; 2. Claria Amplia Compia application, Software Model Number D00U009; 3. Evera MRI application, Software Mod
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2156-2025·2025-07-30

    Medline Convenience Kits Recalled for Potential Sterility Breach Risk

    Medline Convenience Kits containing BD ChloraPrep Clear applicators are recalled due to potential open seals on packaging that may compromise sterility and lead to infection risk during surgical procedures.

    Product
    Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as: C-SECTION PREP, REF DYNJ32702B
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2153-2025·2025-07-30

    Medline Convenience Kits with BD ChloraPrep recalled due to sterility breach risk

    Medline Convenience Kits containing BD ChloraPrep applicators are being recalled due to potential open seals that could breach sterility and increase infection risk. The recall affects 960 units distributed in California, Florida, Pennsylvania, and Texas.

    Product
    Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as: LABOR TRIAGE KIT, REF DYKM1564
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2146-2025·2025-07-30

    Ellik Evacuator surgical device sterilization instructions differ between language versions

    Olympus is recalling Ellik Evacuator Model 191-NRS due to discrepancies between sterilization instructions in Japanese-language product inserts and the manufacturer's English Instructions For Use. Sterilization instruction discrepancies may affect proper device preparation before use.

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

    Brain Monitor Recall for Incorrect Left-Right Data Labeling

    Natus Brain Monitor devices are being recalled due to labeling errors where the left side display shows impedance data for the right side. Two complaints have been received; no injuries reported.

    Product
    Natus Brain Monitor Breakout Box, Part Number 021911; full-montage standard electroencephalograph
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-2131-2025·2025-07-30

    MRI Gradient Coils Produce Excessive Acoustic Noise During Scanning

    GE HealthCare is recalling certain SIGNA Architect AIR MRI systems because gradient coils can produce acoustic noise exceeding 99dB during scanning, surpassing safe limits even with required hearing protection.

    Product
    SIGNA Architect AIR
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2141-2025·2025-07-30

    Ellik Evacuator Glass Body Sterilization Instruction Discrepancy Recall

    Olympus recalls Model 190A Ellik Evacuator glass bodies due to discrepancies between sterilization instructions in Japanese and English product materials. Healthcare facilities should verify correct sterilization procedures with the manufacturer.

    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
  • HighFDA (Devices)·Z-2137-2025·2025-07-30

    Endosee System Convenience Kits recalled for non-sterile iodine pouches

    CooperSurgical is recalling 475 units of Endosee System Convenience Kits with IV Tube due to non-sterile iodine pouches labeled as sterile. The kits were distributed nationwide to healthcare facilities.

    Product
    Endosee System Convenience Kit with IV Tube. Model Number: ES-TRAY-IV. Endosee System Convenience Kit with IV Tube.
    Category
    Medical Device
    Distribution
    Distributed nationwide