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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13051–13075 of 13816

  • HighFDA (Devices)·Z-2466-2021·2021-09-22

    BD Alaris Infusion Pump Buerette Set Connector Valve Occlusion Issues

    BD Alaris needle-free connector valves in Buerette Sets may develop occlusions, difficulty flushing, or flow issues that could delay patient therapy. The product was distributed worldwide across all US states and multiple countries.

    Product
    BD Alaris Pump Infusion Buerette Set Smallbore Tubing Smartsite Port (Burette) 3 SmartSite Y-Sites, REF: 2441-0006
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2470-2021·2021-09-22

    Arjo Disposable Repositioning Sling Recalled for Trip Hazard Risk

    Getinge recalled 46,085 Arjo Disposable Repositioning Sling units because the sling loop straps pose a trip hazard. The affected devices were distributed nationwide to healthcare facilities.

    Product
    Arjo Disposable Repositioning Sling, Model AHD001
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2478-2021·2021-09-22

    Medtronic HVAD Pump Implants: Driveline Cover May Impede Connector Access

    Medtronic HVAD Pump Implant Kits may require increased force to remove the driveline cover after strain relief repair, potentially making controller exchanges difficult and risking further repair damage.

    Product
    Medtronic HVAD Pump Implant Kits
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2457-2021·2021-09-22

    BD Syringe Set Needle-Free Connector Valves May Cause Therapy Delay

    BD Syringe Set needle-free connector valves may experience difficulty flushing, flow issues, or occlusions that could delay patient therapy. About 16,700 units have been distributed worldwide.

    Product
    BD Syringe Set 20 DP MIC TBG 0.2MF CKV Anti-Siphon SmartSite VLV Sensing Disc, REF: 10798696; BD Syringe Set 20 DP MIC TBG CKV Anti-Siphon SmartSite VLV Sensing Disc, REF: 10798703;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2459-2021·2021-09-22

    BD Alaris Infusion Pump Buerette Sets Needle-Free Connector Valve Issues

    BD Alaris Pump Infusion Buerette Sets with needle-free connector valves may experience flushing difficulties, flow issues, or occlusions that could delay therapy delivery. No illnesses or injuries have been reported.

    Product
    BD Alaris Pump Infusion Buerette Set 0.2 Micron Filter Smallbore Tubing SmartSite Port (Burette) SmartSite Y-Site, REF: 10015012; BD Alaris Pump Infusion Buerette Set Ball Valve Smallbore Tubing Smartsite Port (Burette) SmartSite Y-Site, REF: 10817920; BD Alaris Pump Infusion Bue
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2462-2021·2021-09-22

    BD Gravity Burette Set Needle-Free Connector Valves Recalled for Flow Issues

    CAREFUSION is recalling BD Gravity Burette Sets with needle-free connector valves that may develop flow restrictions and blockages, potentially delaying medication delivery. Approximately 29,130 units were distributed.

    Product
    BD Gravity Burette Set 60 DP 3 SmartSite VALVES BALL VALVE DRIP CHAMBER, REF: 10012564
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2443-2021·2021-09-22

    Hero Model 100 Smart Pill Dispenser Recalled for Software Dose-Prompting Error

    Hero Health is recalling the Model 100 smart pill dispenser due to a software defect causing the device to prompt users to take medication doses that have already been dispensed, creating overdose risk.

    Product
    The Hero Model 100 (H-100) is a system consisting of a smart pill dispenser and a medication management app.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2456-2021·2021-09-22

    FDA recalls BD burette sets for connector valve occlusion and flow defects

    BD Gravity Burette Sets and Add-On Burette Sets are being recalled due to needle-free connector valve defects that may cause flushing difficulties, flow problems, or complete occlusions, potentially delaying therapy. The recall affects approximately 77,802 units distributed worldwide.

    Product
    BD Gravity Burette Set 60 DROP 1.2 MF 2 SmartSite VALVES BALL VALVE DRIP CHAMBER V/NV, REF: 10037031; BD Gravity Burette Set 20 DROP 1.2 Micron Filter 2 SmartSite VALVES BALL VALVE DRIP CHAMBER V/NV , REF: 10037032; BD GRAVITY BURETTE SET 60 DROP 2 Smartsite VALVES BALL DRIP CHAM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2449-2021·2021-09-22

    Pentax Upper GI Endoscopes and Colonoscopes: Updated Reprocessing Instructions

    Pentax Medical is updating reprocessing instructions for certain gastroscope and colonoscope models to ensure proper sterilization. Affected healthcare facilities should review and implement the updated instructions.

    Product
    Gastroscope Family # 1-Gastroscopes without a Water Jet Channel Models: EG-2790i, EG-1690K, EG-2490K, EG-2790K, EG27-i10; Gastroscope Family # 2- Gastroscopes with a Water Jet Channel Models: EG-2990i, EG-2990K, EG-3490K, EG29-i10; Gastroscope Family # 3-Gastroscopes with Two Ins
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2467-2021·2021-09-22

    BD SmartSite Needle-Free Connector Valves Recalled for Flow and Occlusion Issues

    CAREFUSION is recalling BD SmartSite needle-free connector valves due to difficulty flushing, flow issues, and occlusions that could delay therapy. Approximately 23.8 million units were distributed worldwide.

    Product
    BD SmartSite, REF: 2000E CHINA; BD SmartSite Connector, REF: 2000E-04; BD SmartSite J-LOOP Extension Set One Needle Free Valve, REF: 20021E7D; BD SmartSite Extension Set One Needle Free Valve Slip Luer, REF: 20037E7D; BD SmartSite Extension Set 3 Needle Free Valves, REF: 20038E7D
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2446-2021·2021-09-22

    Siemens radiation therapy software may lose treatment structure data

    Siemens syngo.CT software used in radiation therapy systems may lose treatment structure data during edit and reopen operations, sending incomplete treatment information to planning systems.

    Product
    syngo.CT VA20A, VA30A and VA40A in: syngo.via RT Image Suite / Sim&Go SOMATOM go.Now SOMATOM go.Up SOMATOM go.All SOMATOM go.Top SOMATOM go.Sim SOMATOM go.Open Pro and SOMATOM X.cite Material Numbers: 11061620 11061628 11061630 11061640 11061660 11061670
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2481-2021·2021-09-22

    Leica BOND Primary Antibody CDX2 Recalled for Performance Specification Issue

    Leica Microsystems recalls BOND Ready-To-Use Primary Antibody CDX2 (PA0375, Lot 69909) because the product may not perform as specified in its instructions for use. The recall affects 237 units distributed nationwide.

    Product
    BOND Ready-To-Use Primary Antibody CDX2 (EP25), REF PA0375
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2402-2021·2021-09-15

    Pipeline Flex Embolization Device Recalled for Potential Push Wire Fracture Risk

    Micro Therapeutics recalls Pipeline Flex Embolization Devices for potential push wire fractures in the delivery system during use. Device fractures in the Hypotube may result in malfunction during vascular procedures.

    Product
    Pipeline Flex Embolization Device
    Category
    Medical Device
    Distribution
    48 states
  • CriticalFDA (Devices)·Z-2392-2021·2021-09-15

    Eco-Med ultrasound gels and lotions recalled for bacterial contamination

    Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. are being recalled due to potential bacterial contamination. The FDA issued a Class I recall on August 18, 2021, advising health care providers to stop using all affected products.

    Product
    LiquaSonic Ultrasound Gel 5L, Model No. 001222
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2391-2021·2021-09-15

    FDA Recalls Ultrasound Gel for Risk of Bacterial Contamination

    Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. are being recalled due to the risk of bacterial contamination. Healthcare providers and consumers should stop using affected products.

    Product
    LiquaSonic Ultrasound Gel 250mL, Model No. 001205
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2377-2021·2021-09-15

    NORMOFLO Irrigation Warming Sets Recalled for Aluminum Leaching Risk

    Smiths Medical is recalling NORMOFLO Irrigation Warming sets (Models IR-40, IR-500, IR-600, IRI-600, IRI-600B, IR-700) due to potential aluminum leaching when used at lower flow rates with certain solutions and blood products. No illnesses have been reported.

    Product
    NORMOFLO Irrigation Warming administration set (disposable), Models IR-40, IR-500, IR-600, IRI-600, IRI-600B, IR-700
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2376-2021·2021-09-15

    NORMOFLO Irrigation Fluid Warmer Recalled for Risk of Aluminum Leaching

    Smiths Medical recalls NORMOFLO Irrigation Fluid Warmer Models H-1100 and H-1129 (913 units) due to potential harmful aluminum leaching when used at lower flow rates with certain solutions and blood products.

    Product
    NORMOFLO Irrigation Fluid Warmer Models H-1100 and H-1129
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2403-2021·2021-09-15

    EV3 Pipeline Flex Embolization Device Recalled for Push Wire Fracture Risk

    Micro Therapeutics Inc. is recalling 16,169 EV3 Pipeline Flex Embolization Devices due to potential push wire fractures in the delivery system during use.

    Product
    EV3 Pipeline Flex Embolization Device with Flex Shield Technology
    Category
    Medical Device
    Distribution
    48 states
  • HighFDA (Devices)·Z-2413-2021·2021-09-15

    MRI device tabletop may fail to move completely in manual mode

    Philips Ingenia MRI tabletops may fail to move completely in manual mode, potentially delaying patient evacuation. The recall affects 144 units worldwide.

    Product
    Ingenia 1.5T S-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Model: 7813
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2414-2021·2021-09-15

    MRI Tabletop Movement Malfunction in Manual Mode Affects Philips Ingenia Systems

    Philips Ingenia 1.5T CX-a MRI systems may have a tabletop that fails to fully move in or out during manual operation, potentially delaying patient evacuation and treatment.

    Product
    Ingenia 1.5T CX-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models:
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2425-2021·2021-09-15

    Medical Device Test Kit Requires More Frequent Calibration Than Labeled

    Siemens Atellica IM BR 27.29 test kit requires calibration every 3 days instead of the labeled 10-day interval. The product's calibration performance does not meet its Instructions for Use specifications.

    Product
    Atellica IM BR 27.29 (BR) Assay 250 Test Kit- in vitro diagnostic use in the quantitative serial determination of cancer antigen CA 27.29 in human serum and plasma (EDTA) using the Atellica IM Analyzer. SMN: 10995477
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2424-2021·2021-09-15

    Atellica IM Diagnostic Test Kit Recalled for Calibration Interval Deficiency

    Siemens Healthcare recalls the Atellica IM BR 27.29 diagnostic test kit because it does not maintain the claimed 10-day calibration interval; the required interval has been shortened to 3 days to ensure accurate results.

    Product
    Atellica IM BR 27.29 (BR) Assay 50 Test Kit- in vitro diagnostic use in the quantitative serial determination of cancer antigen CA 27.29 in human serum and plasma (EDTA) using the Atellica IM Analyzer. SMN: 10995478
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2421-2021·2021-09-15

    MRI Tabletop Movement Failure May Delay Patient Evacuation and Treatment

    Philips MRI systems may fail to move the examination tabletop in manual mode, potentially delaying patient evacuation and medical treatment.

    Product
    SmartPath to dStream for XR and 3.0T-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or ext
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2418-2021·2021-09-15

    MRI Magnetic Resonance System Tabletop May Fail to Move in Manual Mode

    Philips Ingenia Elition S-a MRI systems may have tabletop movement failure in manual mode, potentially delaying patient evacuation from the scanner bore and treatment. This affects 64 units distributed worldwide.

    Product
    Ingenia Elition S-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models:
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2412-2021·2021-09-15

    Philips Ingenia 1.5T MRI tabletop malfunction may delay patient evacuation

    Philips is recalling 42 Ingenia 1.5T MRI systems because the tabletop may not fully move in or out in manual mode, potentially delaying patient evacuation and treatment.

    Product
    Ingenia 1.5T Evolution-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Mod
    Category
    Medical Device
    Distribution
    Distributed nationwide