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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7951–7975 of 40007

  • HighFDA (Devices)·Z-1076-2024·2024-02-21

    FDA Recalls Heart-Lung Machine Component Over Sterile Barrier Defect

    Maquet is recalling an HLS Set Advanced 5.0 component used in CARDIOHELP heart-lung machines due to a compromised sterile barrier that may cause infection. The recall affects 6,657 US units.

    Product
    Model No. BEQ-HLS 5050 USA, HLS Set Advanced 5.0, Product Code/Part Number 70106.9077. Used with the CARDIOHELP heart-lung machine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1078-2024·2024-02-21

    Skin Graft Carrier Recalled for Manufacturing Ratio Defect

    Zimmer Surgical Inc. is recalling 3:1 Dermacarrier skin graft carriers due to a manufacturing defect where the ridge pattern is 1.5:1 instead of 3:1, potentially causing tissue damage or additional grafting.

    Product
    3:1 Dermacarrier, Model Number 00219501300, skin graft carrier
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1088-2024·2024-02-21

    Philips CombiDiagnost R90 Fluoroscopy Display May Show Previous Patient Images

    Philips CombiDiagnost R90 fluoroscopy systems may display a previous patient's images during radiography examination, potentially showing different image content, format, and size that could affect imaging accuracy.

    Product
    CombiDiagnost R90 1.1 (709031)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1074-2024·2024-02-21

    Impella Catheters: Warnings Added for Potential Fiber Ingestion Risk

    Abiomed is adding safety warnings to Instructions for Use for all Impella catheter models to prevent fibers from entering the device, which could result in reduced flow. The warning applies to all Impella models distributed worldwide.

    Product
    Impella catheters - Intravascular micro axial blood pumps that support a patient's circulatory system. (1) Product Code 005042 - Impella 2.5 (2) Product Code 005062 - Impella 5.0 (3) Product Code 005082- Impella LD (4) Product Code 004334 - Impella RP (5) Product Code 0046-0035
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1068-2024·2024-02-21

    OriGen Biomedical Accessory Syringe Sets Recalled for Sterilization Incompatibility

    OriGen Biomedical is recalling 3,613 cases of accessory syringe sets due to design and material changes that caused loss of gamma sterilization compatibility, resulting in yellowed discoloration and unqualified product status.

    Product
    Accessory Sets Syringes: 6ml syringe with a female luer with 15cm sealed SCD tubing, REF: RF-T15, and 60ml syringe on a female luer with 15cm sealed SCD tubing, REF: 15-RF60-T
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Devices)·Z-1056-2024·2024-02-21

    Samsung GM85 Mobile X-ray System Welding Frame Defect Arm Fall Risk

    NeuroLogica is recalling 261 Samsung GM85 mobile x-ray systems due to a welding defect in the moving arm frame that could cause the arm to fall, risking bodily injury.

    Product
    Samsung Digital Diagnostic Mobile X-ray System, Model GM85.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1067-2024·2024-02-21

    Bone void filler recalled due to manufacturing process control issue

    Musculoskeletal Transplant Foundation recalled 50 units of AFT Allograft Filler Tubes in Minnesota due to an unqualified manufacturing filling process. The product may have extrudability issues causing extended surgery time.

    Product
    AFT (Allograft Filler Tube) Diverted Tube (3/4 Filled), Product Code 227005 (bone void filler)
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1071-2024·2024-02-21

    Olympus Duodenovideoscope Distal Cover may detach during gastrointestinal procedures

    Olympus Single Use Distal Cover MAJ-2315 may detach from duodenovideoscopes during gastrointestinal procedures, risking perforation, retained objects requiring urgent removal, burns, and airway obstruction.

    Product
    Single Use Distal Cover MAJ-2315 Used with: EVIS EXERA III Duodenovideoscope TJF-Q190V- designed to be attached to Olympus duodenovideoscopes to cover the distal end of the insertion tube and around the forceps elevator
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1083-2024·2024-02-21

    Portable X-ray system may move unexpectedly if improperly cleaned

    The MobileDiagnost wDR portable X-ray system may move unexpectedly if excessive liquid is used during cleaning. This affects 851 devices distributed nationwide.

    Product
    MobileDiagnost wDR, Model numbers 712001, 712002, 712004, 712006, and 712007
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1089-2024·2024-02-21

    global Medium embryo culture media recalled for potential development impairment

    CooperSurgical is recalling three specific lots of global Medium embryo culture media distributed to fertility clinics worldwide due to performance issues that may impair embryo development during culture.

    Product
    global Medium, Model Numbers LGGG-020 (20mL bottle), LGGG-050 (50mL bottle), LGGG-100 (100mL bottle). Intended use: Culture of human embryos from zygote to blastocyst, embryo transfer.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1066-2024·2024-02-21

    Bone Filler Tubes Recalled Due to Manufacturing Process Defect

    The FDA is recalling 89 AFT Bone Filler Tubes due to a manufacturing process defect that could cause extrudability issues during surgery. The filling process did not demonstrate adequate capability.

    Product
    AFT (Allograft Filler Tube) Straight Tube (1/2 Filled), Product Code 227010 (bone void filler)
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1069-2024·2024-02-21

    Captus 4000e Thyroid Uptake Systems spring failure poses fall risk

    Mirion Technologies recalls 467 Captus 4000e Thyroid Uptake Systems due to spring arm failure that can cause the collimator to fall, posing potential injury risk to patients and operators.

    Product
    Captus 4000e Thyroid Uptake Systems- Intended to be used by trained Nuclear Medicine Technologists or Nuclear Medicine Physicians to perform Thyroid Uptake Procedures. Models: 5430-30151, 5430-30152, and 5430-30154
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1087-2024·2024-02-21

    Philips CombiDiagnost R90 Fluoroscopy Device May Display Wrong Patient Images

    The Philips CombiDiagnost R90 fluoroscopy device may display a previous patient's radiography images during an examination, risking privacy violation and diagnostic errors in 86 affected units.

    Product
    CombiDiagnost R90 1.0 (709030)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1085-2024·2024-02-21

    Stryker Trevo Trak 21 Microcatheter Recalled for Unevaluated Intended Use

    Stryker, Inc. is recalling 63 units of the Trevo Trak 21 Microcatheter because the device instructions contain an intended use that has not been evaluated by the FDA.

    Product
    Stryker Neurovascular, Trevo Trak 21 Microcatheter, REF 90338, 0.021in X162cm
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1141-2024·2024-02-21

    HeartSine Samaritan PAD Defibrillators Recalled for Test Configuration Flaw

    HeartSine samaritan PAD defibrillators shipped in test configuration may have incorrect CPR timing and delayed or no therapy delivery in cardiac events. Users should stop using affected units and contact the manufacturer.

    Product
    HeartSine samaritan PAD (Public Access Defibrillator): Type/Catalog: SAM 350P/350-UNIT-US-10, 350-STR-US-10, 350-STR-UK-10; SAM 360P/360-STR-JA-10, 360-STR-DE-10, 360-STR-UK-10; SAM 450P/450-UNIT-US-08, ; SAM 500P/500-BAS-UK-10
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1084-2024·2024-02-21

    Stryker Neurovascular Trevo Pro Microcatheter Recalled for Unevaluated Use Statement

    Stryker is recalling the Trevo Pro 18 Microcatheter because its instruction manual contains an intended use that the FDA has not evaluated. The recall affects 11 units distributed across the United States.

    Product
    Stryker Neurovascular, Trevo Pro 18 Microcatheter, REF 90238 0.021in X150cm
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1086-2024·2024-02-21

    Quidel Sofia 2 Flu + SARS Test Kits Recalled for Incorrect Expiration Dates

    Quidel Corporation is recalling one lot of Sofia 2 Flu + SARS Antigen FIA diagnostic test kits due to incorrect expiration dates on packaging. Kits labeled to expire April 30 and May 31, 2025 actually expire September 12, 2024.

    Product
    The Sofia 2 Flu + SARS Antigen FIA employs immunofluorescence technology in a sandwich design that is used with Sofia 2 to detect nucleocapsid protein from influenza A, influenza B, and SARS-CoV-2. This test allows for the detection of SARS-CoV and SARS-CoV-2, but does not differ
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0857-2024·2024-02-14

    Cardinal Health Monoject Syringes Recalled Due to Manufacturing Changes

    Cardinal Health is recalling all sizes of Monoject sterile syringes—including Luer-Lock and Enteral syringes with ENFit connections—due to manufacturing and rebranding changes. Products distributed across the U.S. and Canada.

    Product
    Cardinal Health Monoject, 60 mL Syringe Luer-Lock Tip Soft Pack, REF 1186000777T
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0855-2024·2024-02-14

    Cardinal Health Monoject Syringe and Enteral Syringe Removal Due to Manufacturing Changes

    Cardinal Health is removing Monoject sterile syringes (Luer-Lock and Enteral with ENFit) from the market due to manufacturing and rebranding changes. Distribution affected US and Canada.

    Product
    Cardinal Health Monoject, 20 mL Syringe Luer-Lock Tip Soft Pack, REF 1182000777
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0842-2024·2024-02-14

    HeartMate Touch Communication System recalled for software pump operation defects

    Thoratec Corp. is recalling HeartMate Touch Communication Systems (1,560 units) due to software and controller defects causing unexpected LVAD pump starts or stops, potentially affecting patient safety.

    Product
    1. HeartMate Touch Communication System, REF HMT1100 2. HeartMate Touch Communication System, Rental REF HMT1100-R 3. HeartMate Touch Communication System, HMT1150 The HeartMate Touch Application is loaded onto a tablet and will provide a user interface with state-of-the-art
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0847-2024·2024-02-14

    Cardinal Health Monoject Enteral Syringes Recalled for Pump Incompatibility

    Cardinal Health Monoject enteral syringes (6, 12, 35, 60 mL) in Lot 230503 and 230701 have compatibility issues with certain feeding pumps and should not be used.

    Product
    Cardinal Health Monoject, 6ML Enteral Syringe (purple) Low Dose (LDT) - For Use with ENFit Connection System, REF 406SE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0859-2024·2024-02-14

    Cardinal Health Monoject Syringes Removal Due to Manufacturing Changes

    Cardinal Health is removing Monoject brand syringes due to manufacturing changes and rebranding efforts. The removal includes Luer-Lock and ENFit connection models distributed nationwide in the US and Canada.

    Product
    Cardinal Health Monoject, 3 mL Purple Enteral Syringe with Enfit Connection Sterile, REF 403SE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0930-2024·2024-02-14

    BrightView X Gamma Camera Detector May Fall, Causing Patient Injury

    Detectors in Philips BrightView X gamma cameras may fall unexpectedly due to component failure, risking patient injury including fractures and lacerations.

    Product
    BrightView X, gamma camera for SPECT; Model Nos.: 6-digit format 882478; 12-digit format 453560824741 453560829261;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0929-2024·2024-02-14

    BrightView Gamma Camera Detector May Fall and Injure Patients

    Philips BrightView gamma camera detectors may fall due to component failure, potentially causing patient injury including lacerations and fractures. The FDA is recalling all affected units.

    Product
    BrightView, gamma camera system; Model Nos.: 6-digit format 882480; 12-digit format 453560279781 453560279791 453560279811 453560279801; 4x4 digit format 2170-3000A 2170-3001A 2170-3002A 2170-3003A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0853-2024·2024-02-14

    Cardinal Health Monoject Syringes Recalled Due to Manufacturing Changes

    Cardinal Health is removing all sizes of Monoject sterile syringes and enteral syringes from the market due to manufacturing and rebranding changes. Products were distributed in the US and Canada.

    Product
    Cardinal Health Monoject, 6 mL Syringe Luer-Lock Tip Soft Pack, REF 1180600777
    Category
    Medical Device
    Distribution
    Distributed nationwide