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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8951–8975 of 27636

  • HighFDA (Devices)·Z-1011-2025·2025-01-29

    Baxter Continu-Flo Solution Set with Duo-Vent Spike recalled for inverted clamps

    Baxter is recalling specific lots of Continu-Flo Solution Sets due to potentially inverted side clamps that render the tubing unusable. Distribution included eight US states.

    Product
    Baxter Continu-Flo Solution Set with Duo-Vent Spike, REF UC8519
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0422-2025·2025-01-29

    Frozen Buttered Vegetables Recall Due to Undeclared Milk Allergen

    Lidl's frozen buttered vegetables are recalled because the product labels do not disclose milk as an ingredient. Approximately 35,320 units distributed across nine states are affected.

    Product
    Buttered Vegetables KEEP FROZEN NET WT 10.5 OZ (300g) INGREDIENTS: CARROTS, PEAS, CALIFLOWER, CORN, BUTTER, SUGAR, SALT, CORN STARCH, PARSLEY MAY CONTAIN WHEAT. DISTRIBUTED BY LIDL USA, LLC. 3500 S. CLARK STREET, ARLINGTON, VA 22202 UPC 4 056489 122876
    Category
    Food
    Distribution
    10 states
  • HighFDA (Devices)·Z-0976-2025·2025-01-29

    BD Pyxis Med 4000 Auxiliary Drawer and Door Failures Delay Medication Access

    CareFusion 303, Inc. is recalling 5 units of the BD Pyxis Med 4000 Auxiliary medication dispensing system due to drawer and door failures that may delay access to medications. Three failure modes identified: door latch failure, cable ribbon damage, and magnet falling out.

    Product
    BD Pyxis Med 4000 Auxiliary (AUX), REF 314
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1004-2025·2025-01-29

    BD PCR Cartridges for MAX System signal drift in select lots

    Specific lots of BD PCR Cartridges used with the MAX System may experience signal drift, potentially affecting diagnostic accuracy. BD has initiated a recall of 516,435 affected units worldwide.

    Product
    BD PCR Cartridges used with MAX System. Model Number: 437519
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0974-2025·2025-01-29

    BD Pyxis MedStation 4000 Medication Cabinet Drawer and Door Failures

    CareFusion 303 is recalling 5,056 BD Pyxis MedStation 4000 AUX units worldwide due to drawer and door failures that may delay medication access. Failures include door latch failure, cable ribbon damage, and magnet falling out.

    Product
    BD Pyxis MedStation 4000 AUX, REF 306
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1010-2025·2025-01-29

    Baxter Clearlink system solution sets recalled for clamp defect

    Baxter Healthcare is recalling specific lots of Clearlink System Solution Sets with inverted clamps that render the tubing unusable. The affected units are distributed nationwide in eight U.S. states.

    Product
    Baxter Clearlink System Solution Set with Duo-Vent Spike, REF 2R8538
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1006-2025·2025-01-29

    Diagnostic analyzer software may fail to alert users to expired reagents

    VITROS XT 7600 Integrated System software may not warn users when Signal Reagent Packs expire, risking inaccurate or missing test results.

    Product
    Brand Name: VITROS Product Name: VITROS XT 7600 Integrated System Model/Catalog Number: 6844461 (New), 6272222 (Certified), 6904003 (China) Software Version: version 3.8.0 or higher Product Description: In vitro diagnostic chemistry analyzer. FDA 3 letter product code: JJE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1007-2025·2025-01-29

    VITROS 3600 Diagnostic System May Fail to Alert Users to Expired Reagents

    The VITROS 3600 Immunodiagnostic System may not properly alert users when Signal Reagent Packs expire, risking use of expired products and potentially inaccurate test results. Affected systems worldwide should be checked for this software issue.

    Product
    Brand Name: VITROS Product Name: VITROS 3600 Immunodiagnostic System Model/Catalog Number: 6802783 (New), 6802914 (Certified/Refurbished), 6904000 (China) Software Version: version 3.8.0 or higher Product Description: In vitro diagnostic chemistry analyzer. FDA 3 letter pr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1001-2025·2025-01-29

    Olympus Thunderbeat Hand Instruments Recalled for Probe Tip Damage and Breaking

    Olympus is recalling Thunderbeat hand instruments because probe tips can be damaged or break, and pads can detach during use. No injuries have been reported.

    Product
    Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,20 cm, Front-actuated Grip Type S Model Number: TB-0520FCS Catalog Number/Product Code: N5423930 Software Version: N/A Product Description: Thunderbeat instrument is a
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1017-2025·2025-01-29

    Randox Lipoprotein (a) assay distributed without required FDA clearance

    Randox Lipoprotein (a) assay for Roche Cobas c501 analyzers was distributed without required FDA 510(k) or PMA regulatory clearance. The diagnostic test kits lack formal validation for their claimed measurements.

    Product
    Randox Lipoprotein (a) - In vitro diagnostic (IVD) use as Randox Lipoprotein (a) assay on automated analysers. Catalog Number: LP3403
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1013-2025·2025-01-29

    Wolf-Pak Dressing Change Kits Recalled Due to Package Defects

    Trinity Sterile is recalling Wolf-Pak Dressing Change Kits (lot #600018) due to potential holes in the package that could compromise product sterility. The recall affects 1,980 units distributed in Maryland, Pennsylvania, Tennessee, and Texas.

    Product
    Brand Name: Wolf-Pak Product Name: Dressing Change Kit with Transparent Dressing & 3mL CHG One Step Applicator CS/30 Model/Catalog Number: DC3077LF Software Version: N/A Product Description: Dressing change kit, case of 30, lot #600018, 66 cases affected. Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1018-2025·2025-01-29

    Randox Lipoprotein (a) Diagnostic Assay Lacks FDA Clearance, Recalled

    Randox Laboratories is recalling 33 Randox Lipoprotein (a) diagnostic kits nationwide. The assay's claims for use on Roche Cobas c501 analyzers lack required FDA clearance or approval.

    Product
    Randox Lipoprotein (a) - In vitro diagnostic (IVD) use as Randox Lipoprotein (a) assay on automated analysers. Catalog Number: LP2757
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0988-2025·2025-01-29

    CardioMEMS HF Pressure Measurement System Recalled for Inaccurate Readings

    St. Jude Medical is recalling the CardioMEMS HF Pressure Measurement System due to a cloud data migration that caused the system to revert to an outdated configuration, resulting in inaccurate pulmonary artery pressure readings.

    Product
    CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM CardioMEMSTM HF System Patient Electronics System (PES) REF CM1100 Merlin.net Patient Care Network (PCN) Heart Failure Web Application (Which interfaces with CardioMEMSTM HF System Patient Electronics System (PES) and CardioMEMSTM HF S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0989-2025·2025-01-29

    CardioMEMS Heart Failure Monitoring System Cloud Migration Causes Inaccurate Pressure Readings

    St. Jude Medical recalled 431 CardioMEMS HF pressure measurement systems after a cloud data migration reverted systems to outdated configuration, causing inaccurate pulmonary artery pressure readings.

    Product
    CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM CardioMEMSTM HF System Hosptial Electronics System (PES) REF CM3000 Merlin.net Patient Care Network (PCN) Heart Failure Web Application (Which interfaces with CardioMEMSTM HF System Patient Electronics System (PES) and CardioMEMSTM HF
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0990-2025·2025-01-29

    Microvention Headway Microcatheter Recall Due to Incomplete Packaging Seal

    Microvention is recalling Lot #0000629846 of the Headway 17 Advanced Straight Microcatheter due to incomplete seals in inner packaging that could compromise sterility. The affected lot was distributed outside the U.S.

    Product
    Microvention, Headway" 17 Advanced Straight Microcatheter with Hydrophilic Coating, REF: MC172150SX-CN, Sterile R, Rx Only, Lot# 0000629846
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0985-2025·2025-01-29

    Medtronic Recalls EOPA Arterial Cannula Models for Labeling Errors

    Medtronic Perfusion Systems is recalling EOPA Arterial Cannula models 77418 and 77422 due to incorrect labeling on seven manufacturing lots. Approximately 930 units were distributed worldwide.

    Product
    EOPA Arterial Cannula, Model Numbers 77422 (22 Fr) and 77418 (18 Fr)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0994-2025·2025-01-29

    Olympus Thunderbeat Hand Instrument Probe Tips May Break or Detach

    Olympus is recalling the Thunderbeat surgical hand instrument because the probe tips are being damaged or breaking. The recall affects 34,325 units distributed in the US and internationally.

    Product
    Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: Thunderbeat Front-Actuated Grip Type S Model Number: TB-0545FCS Catalog Number/Product Code: R5000688 Software Version: N/A Product Description: Thunderbeat instrument is a sterile, sing
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0966-2025·2025-01-29

    Otological Ventilation Tubes Recalled for Lack of FDA Premarket Clearance

    Adept Medical Ltd is recalling Otological Ventilation Tubes (T-Tube 9mm, Silicone) distributed without FDA 510(k) premarket notification clearance. Approximately 6,280 units were distributed in the US and internationally.

    Product
    Otological Ventilation Tube - T-Tube 9mm - Silicone; Product Code: NZ3309;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0417-2025·2025-01-29

    Cal Yee Farms Fruit Basket Recalled for Undeclared Almonds

    Cal Yee Farms Fruit Basket (50-oz) is being recalled due to undeclared almonds. The product was distributed to 2 retail stores in California and through online and phone orders to California and Pennsylvania.

    Product
    Cal Yee Farms Fruit Basket (50-oz)
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-0973-2025·2025-01-29

    BD Pyxis MedStation 4000 Medication Dispenser Recalled for Door Failures

    BD Pyxis MedStation 4000 medication dispensers are recalled due to drawer and door failures that may delay medication access. The recall affects 13,055 units distributed worldwide.

    Product
    BD Pyxis MedStation 4000 Main, REF 303
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0972-2025·2025-01-29

    BD Pyxis MedStation ES AUX medication dispenser drawer and door failures

    The BD Pyxis MedStation ES AUX medication dispenser may experience drawer and door failures due to latch, cable, or magnet defects, potentially delaying access to medications. Approximately 39,615 units are affected worldwide.

    Product
    BD Pyxis MedStation ES AUX, REF 324
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0999-2025·2025-01-29

    Olympus Thunderbeat Surgical Instrument Recalled for Damaged Probe Tips

    Olympus is recalling the Thunderbeat 5 mm surgical hand instrument due to damaged or broken probe tips and pads. The defect may affect surgical function and device performance.

    Product
    Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,45 cm,Front-actuated Grip Type S Model Number: TB-0545FCS Catalog Number/Product Code: N5423430 Software Version: N/A Product Description: Thunderbeat instrument is a s
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0996-2025·2025-01-29

    Olympus Thunderbeat Surgical Hand Instruments Recalled for Probe Damage

    Olympus Corporation is recalling Olympus Thunderbeat front-actuated surgical hand instruments (Model TB-0535FCS) due to damaged or breaking probe tips and pad detachment. Approximately 128,608 units distributed outside the US are affected.

    Product
    Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,35 cm, Front-actuated Grip Type S Model Number: TB-0535FCS Catalog Number/Product Code: N5423730 Software Version: N/A Product Description: Thunderbeat instrument is a
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·25103·2025-01-23

    NQDTPBOR Multi-Purpose Helmets Recalled Due to Head Injury Risk

    NQDTPBOR multi-purpose helmets for teens do not comply with federal bicycle safety standards for impact protection, stability, labeling, and certification. The recalled helmets, sold on Amazon from May to August 2024, can fail to protect wearers in a crash.

    Product
    NQDTPBOR Multi-Purpose Helmets
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·25102·2025-01-23

    Children's Holiday Pajama Sets recalled due to flammability violation

    Duluth Trading recalls about 22,400 children's holiday pajama sets that violate federal flammability regulations for sleepwear, posing a risk of burn injuries to children.

    Product
    Children's Holiday Pajama Sets
    Category
    Consumer Product
    Distribution
    Distributed nationwide