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 the agency’s own highest classification or reported deaths or serious injuries, 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.

Filters

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All agenciesFDA (Food)FDA (Drugs)FDA (Devices)USDA FSISCPSCNHTSAEPA

Category

All categoriesFoodDrugMedical DeviceVehicleConsumer Product

Minimum severity

Any3+ (High and above)4+ (High and above)5+ (High and above)

Clear filters

20976–21000 of 27647

  • HighFDA (Devices)·Z-2805-2016·2016-09-21

    ICU Medical Recalls Transpac IV Monitoring Kits Due to Leak Risk

    ICU Medical is recalling 420 Transpac IV Monitoring Kits with SafeSet Reservoirs due to a potential leak. The affected units were distributed nationwide in the US.

    Product
    Transpac IV Monitoring Kit with SafeSet 84inch Arterial Pressure Tubing, Reservoir, Squeeze Flush and 2 Needleless Valves, Item No. 011-42646-66 Usage: The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2796-2016·2016-09-21

    Merge Healthcare Recalls RadSuite Software Due to Missing Studies

    Merge Healthcare is recalling RadSuite software versions where studies may be missing from archives before watermarking.

    Product
    RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2799-2016·2016-09-21

    Siemens RAPIDPoint 500 Blood Gas Analyzer Recalled for Data Mismatch

    Siemens Healthcare Diagnostics Inc is recalling 6,786 RAPIDPoint 500 Blood Gas Analyzers because patient names may be printed with data from a different patient.

    Product
    Siemens RAPIDPoint 500 Blood Gas Analyzer Siemens Material Number (SMN): 10492730, 10696855, 10696857, 10697306
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2813-2016·2016-09-21

    ICU Medical Recalls Transpac IV Monitoring Kits Due to Leak Risk

    ICU Medical is recalling 90 units of Transpac IV Trifurcated Monitoring Kits due to a potential for leaks in the SafeSet Reservoir and blood sampling components.

    Product
    Transpac IV Trifurcated Monitoring Kit with 84" SafeSet Reservoir, 03 ml Squeeze Flush and Needleless Valves, Item No. 42650-66 Product Usage: The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2802-2016·2016-09-21

    Siemens RAPIDLab 1260 Blood Gas Analyzer Recalled for Data Mismatch

    Siemens is recalling 114 RAPIDLab 1260 Blood Gas Analyzers because patient names may be printed with data from different patients.

    Product
    RAPIDLab 1260 Blood Gas Analyzer Siemens Material Number (SMN): 10321846, 10491394
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2806-2016·2016-09-21

    ICU Medical Recalls Transpac IV Trifurcated Kits Due to Leak Risk

    ICU Medical is recalling 250 units of Transpac IV Trifurcated Kits due to a potential leak in the SafeSet Reservoir and blood sampling components.

    Product
    Transpac IV Trifurcated Kit With Safeset Reservoir And 2 Blood Sampling Ports, 84 inch Tubing, 3 3 ml Intraflo Flushes, 3 Disposable Transducers, Macrodrip, Item No. 42500-04 Usage: The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2825-2016·2016-09-21

    ICU Medical Recalls Transpac IV Transducer Kits Due to Leak Risk

    ICU Medical is recalling 140 units of TP4 Kits with SafeSet Reservoirs due to a potential for leaks. The affected medical devices were distributed nationwide.

    Product
    TP4 Kit with 10cc SafeSet Reservoir, Needleless Valve, Filter Millex and Admin Set, Item No. 46104-65 Usage: The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2789-2016·2016-09-21

    Stryker Patella Assembly Instrument Recalled for Component Disassociation Risk

    Stryker Howmedica Osteonics is recalling 2,039 units of the Scorpio Patella Assembly Instrument because press-fit failures could cause clamping components and pins to disassociate.

    Product
    Stryker Orthopaedics Patella Assembly Instrument, REF 3182-1000, Non-Sterile, NDC (01) 07613327215854 (10) The Scorpio Patella Assembly Instrument is used during total knee replacement surgery for the implantation of Scorpio Patella implant components. The device functions to…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2788-2016·2016-09-21

    Howmedica Recalls AccuLIF PL Cages Due to Height Reduction

    Howmedica Osteonics Corp. is recalling AccuLIF PL Cages because some implants have shown a reduction in height greater than 1 mm.

    Product
    AccuLIF PL 10-16mm x 11mm x 27mm x 8 Cage, Rx only, Sterile R, Legal The AccuLIF PL Cages are indicated for intervertebral body fusion with autograft and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft when the subject device is used as an…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2798-2016·2016-09-21

    Siemens RAPIDPoint 405 Blood Gas Analyzer Recalled for Data Mismatch

    Siemens is recalling RAPIDPoint 405 Blood Gas Analyzers because patient names may be printed with results from a different patient.

    Product
    Siemens RAPIDPoint 405 Blood Gas Analyzer nBili Siemens Material Number (SMN): 10282093, 10310464, 10314817, 1031 7193, 10318999, 10320055, 10321238, 10322347, 10328278, 10328302, 10336784
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2827-2016·2016-09-21

    ICU Medical Recalls Transpac IV Trifurcated Monitoring Kits Due to Leak Risk

    ICU Medical is recalling 150 units of Transpac IV Trifurcated Monitoring Kits due to a potential leak in the SafeSet Reservoir and blood sampling components.

    Product
    Transpac IV Trifurcated Monitoring Kit with SafeSet Reservoir, Port and 03 ml Squeeze Flush Devices, Item No. 46110-84 Usage: The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2801-2016·2016-09-21

    Siemens RAPIDLab 1245 Blood Gas Analyzer Recalled for Data Mismatch

    Siemens is recalling 197 RAPIDLab 1245 Blood Gas Analyzers because patient names may be printed with data from a different patient.

    Product
    RAPIDLab 1245 Blood Gas Analyzer Siemens Material Number (SMN): 10321844, 10337179, 10491393
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2824-2016·2016-09-21

    ICU Medical Recalls Transpac IV Monitoring Kits Due to Leak Risk

    ICU Medical is recalling 100 units of Transpac IV Monitoring Kits with SafeSet Reservoirs due to a potential leak hazard.

    Product
    Transpac IV Monitoring Kit with SafeSet 84" Arterial Pressure Tubing, Reservoir, Squeeze Flush and Needleless Valve, Item No. 46104-53 Usage: The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2795-2016·2016-09-21

    T2 Biosystems Recalls T2Candida Cartridges Due to Invalid Results

    T2 Biosystems is recalling T2Candida Cartridges because they produced elevated levels of invalid results. The recall affects 6,864 units distributed to 17 states.

    Product
    T2Candida¿Cartridges; Part Number: 90-01794 (box of 12) and Part Number: 91-01534 (individual cartridge base). A qualitative T2 Magnetic Resonance (T2MR¿) assay for the direct detection of Candida species in EDTA human whole blood specimens.
    Category
    Medical Device
    Distribution
    17 states
  • HighFDA (Devices)·Z-2821-2016·2016-09-21

    ICU Medical Recalls Pediatric Pressure Transducer Kits Due to Leak Risk

    ICU Medical is recalling 20 Pediatric Kits with 30mL Flush Devices due to a potential leak in the SafeSet Reservoir and blood sampling components.

    Product
    Pediatric Kit with 30mL Flush Device, Item No. 46099-10 Product Usage: The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2828-2016·2016-09-21

    ICU Medical Recalls SafeSet Reservoir Kits Due to Leak Potential

    ICU Medical is recalling 20 units of SafeSet Reservoir and blood sampling kits containing Transpac IV transducers due to a potential for leak.

    Product
    Monitoring Kit with TP4, 30 ml Squeeze Flush Device, 10 cc Contamination Syringe and Needleless Valve, Item No. 46112-65 Product Usage: The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2807-2016·2016-09-21

    ICU Medical Recalls Transpac IV Bifurcated Kits Due to Leak Risk

    ICU Medical is recalling 10 units of Transpac IV Bifurcated Kits with SafeSet Reservoirs due to a potential for leaks.

    Product
    Transpac IV Bifurcated Kit with SafeSet Reservoir, 03 ml Squeeze Flush and Needleless Valve, Item No. 42500-66 Usage: The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2814-2016·2016-09-21

    ICU Medical Recalls SafeSet Reservoir Kits Due to Leak Potential

    ICU Medical is recalling 20 units of Single Monitoring Kits with 30mL Flush Devices due to a potential for leak in the SafeSet Reservoir and blood sampling components.

    Product
    Single Monitoring Kit with 30mL Flush Device, Item No. 46073-38 Product Usage: The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2818-2016·2016-09-21

    ICU Medical Recalls SafeSet Reservoir and Blood Sampling Kits

    ICU Medical is recalling 70 units of SafeSet Reservoir and blood sampling kits due to a potential leak.

    Product
    Monitoring Kit with 03mL Flush Device, Item No. 46080-57 Product Usage: The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2816-2016·2016-09-21

    ICU Medical Recalls SafeSet Reservoir Kits Due to Potential Leak

    ICU Medical is recalling 150 units of SafeSet Reservoir kits with Transpac IV transducers due to a potential for leak.

    Product
    Triple Line SafeSet Kit with 03mL Flush Device, Item No. 46076-27 Product Usage: The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2832-2016·2016-09-21

    Circulatory Technology Recalls Bigger-Better-Bladder 2 Devices Due to Seal Leak

    Circulatory Technology Inc is recalling 20 units of the Bigger-Better-Bladder, TM 2 device because the seal between the balloon and housing may leak.

    Product
    The Bigger-Better-Bladder, TM 2 With 3/8"ID tubing, 72" long tubing, ITEM BBB38-72 A device that isolates pressure tranducers from blood contact when measurements of blood pressure in extracorporeal circuits are made during short and long term procedures. The pressure signal…
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-2831-2016·2016-09-21

    C.R. Bard Recalls Option-vm Urinary Catheters Due to Sterility Concerns

    C.R. Bard is recalling 274 units of Option-vm Urinary Catheters because an FDA inspection found them potentially nonsterile. The devices were distributed to 15 states.

    Product
    Option-vm Urinary Catheter. Male use only. Latex Free. Sterile, Rx only.
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Devices)·Z-2810-2016·2016-09-21

    ICU Medical Recalls Transpac IV Monitoring Kits Due to Leak Risk

    ICU Medical is recalling 1,420 Transpac IV Monitoring Kits because of a potential leak in the SafeSet Reservoir and blood sampling components.

    Product
    Transpac IV Monitoring Kit with 2 SafeSet 84" Arterial Pressure Tubing, Reservoir, 03 mL Squeeze Flush and 2 Needleless Valves, Item No. 42646-66 Usage: The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2811-2016·2016-09-21

    ICU Medical Recalls Transpac IV Monitoring Kits Due to Leak Risk

    ICU Medical is recalling specific Transpac IV Monitoring Kits because the SafeSet Reservoir and blood sampling components may leak.

    Product
    Transpac IV Monitoring Kit with SafeSet Reservoir and Blood Sampling Port, 24" Tubing, Disposable Transducer, 03 mL Squeeze Flush, Macrodrip (Patient Mount), Item No. 42648-06 Product Usage: The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2803-2016·2016-09-21

    Siemens RAPIDLab 1265 Blood Gas Analyzer Recalled for Data Mismatch

    Siemens is recalling RAPIDLab 1265 Blood Gas Analyzers because patient names may be printed with data from a different patient.

    Product
    RAPIDLab 1265 Blood Gas Analyzer Siemens Material Number (SMN): 10321852, 10470366, 10491395
    Category
    Medical Device
    Distribution
    Distributed nationwide