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

Agency

Category

Minimum severity

Clear filters

19751–19775 of 40248

  • ModerateFDA (Devices)·Z-2437-2019·2019-09-11

    Heidelberg SPECTRALIS Ophthalmic Imaging Device Recalled for Data Display Error

    Heidelberg Engineering is recalling 29 SPECTRALIS ophthalmic imaging devices because a software configuration error may cause incorrect display of patient master data.

    Product
    SPECTRALIS with HEYEX2 image management system. a non-contact ophthalmic diagnostic imaging device.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2441-2019·2019-09-11

    Fujifilm FDR Go Plus X-ray System Recalled for Software Glitch

    Fujifilm is recalling 174 FDR Go Plus mobile X-ray systems because a graphics driver issue may cause the device to display a Blue Screen of Death.

    Product
    Fujifilm FDR Go Plus mobile X-ray system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2442-2019·2019-09-11

    Boston Scientific Recalls Mislabeled AMS 800 Artificial Urinary Sphincter Cuffs

    Boston Scientific is recalling AMS 800 Artificial Urinary Sphincter belt cuffs labeled as 4.5 cm but measuring 4.0 cm due to mislabeling.

    Product
    AMS 800 Artificial Urinary Sphincter AMS 800 Belt Cuff, 4.5 cm Part Number: 72400161
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2445-2019·2019-09-11

    Roche Tina-Quant Myoglobin Gen. 2 Assay Recalled for QC Imprecision

    Roche is recalling Tina-Quant Myoglobin Gen. 2 assays due to signal drops causing calibration failures and QC imprecision on specific analyzers.

    Product
    The Tina-Quant Myoglobin Gen. 2 Tests system is an immuno-turbidimetric assay for the quantitative in vitro determination of myoglobin in human serum and plasma on Roche automated clinical chemistry analyzers
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2434-2019·2019-09-11

    Helena Laboratories Recalls Titan Gel Serum Protein Control Kits

    Helena Laboratories is recalling 65 kits of Titan Gel Serum Protein Control due to customer complaints about a narrow assay range.

    Product
    Titan Gel Serum Protein Control: SPE Control Cat. No 5136 1 x 2.0 mL
    Category
    Medical Device
    Distribution
    10 states
  • ModerateFDA (Devices)·Z-2436-2019·2019-09-11

    Coltene Recalls Diatech Diamond Dental Burs Due to Length Variations

    Coltene is recalling a specific lot of Diatech diamond dental burs because the instruments in the batch vary in length despite having the same shape and grit.

    Product
    DIATECH, swiss dental instruments, ROUND END TAPER, 856-016-7-F
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2443-2019·2019-09-11

    CareFusion Alaris EtCO2 Capnographs Recalled for Calibration Error

    CareFusion 303, Inc. is recalling 76 Alaris EtCO2 capnographs because they may have been calibrated with a lower-than-specified CO2 concentration.

    Product
    Alaris EtCO2, Model 8300, UDI: 10885403830013, CareFusion for models 11634567 and 8300ADXeN933
    Category
    Medical Device
    Distribution
    10 states
  • ModerateFDA (Devices)·Z-2450-2019·2019-09-11

    SonarMed AirWave Monitor Recalled Due to Potential Error Codes

    SonarMed Inc is recalling 16 AirWave Monitor units because two error codes may render the devices inoperable.

    Product
    SonarMed AirWave Monitor, Model Number M0001
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-2447-2019·2019-09-11

    Karl Storz Flexible Intubation Fiberscopes Recalled for Manufacturing Defect

    Karl Storz Endoscopy is recalling 14 Flexible Intubation Fiberscopes because they were improperly manufactured with a double port luer instead of a single port luer.

    Product
    Flexible Intubation Fiberscope, Model # 11301AB1
    Category
    Medical Device
    Distribution
    9 states
  • ModerateFDA (Devices)·Z-2484-2019·2019-09-11

    Haag-Streit Recalls HS Hi-R NEO 900A Operating Microscopes Due to Software Error

    Haag-Streit USA Inc is recalling HS Hi-R NEO 900A operating microscopes and specific floor stands due to a software error in the central control unit.

    Product
    HS Hi-R NEO 900A NIR Reference # 657 822 Serial # from 101 Product Usage: A wide range of surgical interventions are made possible through the modular construction and the diversity of the equipment and accessories. The operating microscope HS Hi-R NEO 900/HS Hi-R NEO…
    Category
    Medical Device
    Distribution
    1 state
  • LowFDA (Devices)·Z-2444-2019·2019-09-11

    AngioDynamics VenaCure EVLT NeverTouch Procedure Kit Recalled for RFID Error

    AngioDynamics is recalling VenaCure EVLT NeverTouch Procedure Kits because an RFID programming error prevents the product from being used with the laser source.

    Product
    AngioDynamics VenaCure EVLT NeverTouch Procedure Kit, 45CM NEVERTOUCH FRS .018 PROCEDURE KIT PG, Catalog Number 11403012
    Category
    Medical Device
    Distribution
    8 states
  • LowFDA (Devices)·Z-2475-2019·2019-09-11

    Alere Cholestech LDX Analyzer Recalled for Reversed Power Supply Polarity

    Alere San Diego, Inc. is recalling 186 Alere Cholestech LDX Analyzer kits because the power supplies have reversed polarity, rendering the devices inoperable.

    Product
    Alere Cholestech LDX Analyzer, model # 14-874 containing power supplies with the identifying codes of 1837d and 1843d - Product Usage: The Alere Cholestech LDX System is a small, portable analyzer and test cassette system. The System is for in vitro diagnostic use only. The…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2433-2019·2019-09-11

    Getinge CO2 Absorber Recalled for Reversed Expiration and Manufacturing Dates

    Getinge is recalling 1,444 boxes of disposable CO2 absorbers because the expiration and manufacturing dates on the labels are reversed.

    Product
    Getinge MCC Flow i Disposable CO2 absorber, used in anesthesia systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2386-2019·2019-09-04

    Bard GlidePath Hemodialysis Catheter Recalled for Tip Damage

    Bard Peripheral Vascular Inc. is recalling GlidePath Long-Term Hemodialysis Catheters because the molded tip may break or be damaged during placement.

    Product
    GlidePath Long-Term Hemodialysis Catheter with Preloaded Stylet, REF/Product code:5393420, 14.5F, Straight, 42cm length, BARD, UDI: 00801741012228
    Category
    Medical Device
    Distribution
    53 states
  • SevereFDA (Devices)·Z-2378-2019·2019-09-04

    Bard Equistream XK Hemodialysis Catheter Recalled for Tip Damage

    Bard Peripheral Vascular Inc is recalling Equistream XK Long-Term Hemodialysis Catheters because the molded tip may break or be damaged during placement.

    Product
    EQUISTREAM XK Long-Term Hemodialysis Catheter with Preloaded Stylet, REF/Product code:5913230, 16F, Straight, 23cm length, BARD, UDI: 00801741013843
    Category
    Medical Device
    Distribution
    53 states
  • SevereFDA (Devices)·Z-2367-2019·2019-09-04

    Siemens Artis X-Ray Systems Recalled for Patient Table Cracks

    Siemens is recalling 17 Artis zee and Artis Q interventional X-ray systems because cracks in the patient table mainframe could cause the upper bed to detach, posing a hazard to patients and staff.

    Product
    Artis zee and Artis Q/ Q.zen Interventional Fluoroscopic X-Ray System with patient tables as follows: Systems Material Number Artis zee biplane 10094141; Artis Q floor 10848280; Artis Q biplane 10848282; Artis Q.zen floor…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2379-2019·2019-09-04

    Bard Equistream XK Hemodialysis Catheter Recall for Tip Defects

    Bard Peripheral Vascular Inc is recalling Equistream XK Long-Term Hemodialysis Catheters because the molded tip may break or be damaged during placement.

    Product
    EQUISTREAM XK Long-Term Hemodialysis Catheter with Preloaded Stylet, REF/Product code:5913270, 16F, Straight, 27cm length, BARD, UDI: 00801741013850
    Category
    Medical Device
    Distribution
    53 states
  • HighFDA (Devices)·Z-2405-2019·2019-09-04

    Siemens SOMATOM go.Top CT Scanner Recall for Falling Injector Holder

    Siemens is recalling SOMATOM go.Top CT scanners because the injector holder could fall off with the injector and storage box.

    Product
    SOMATOM go.Top; Models #11061648 Product Usage: This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2377-2019·2019-09-04

    Bard Equistream XK Hemodialysis Catheter Recalled for Tip Defect

    Bard Peripheral Vascular Inc is recalling Equistream XK Long-Term Hemodialysis Catheters because the molded tip may break or be damaged during placement.

    Product
    EQUISTREAM XK Long-Term Hemodialysis Catheter with Preloaded Stylet, REF/Product code:5913190, 16F, Straight, 19cm length, BARD, UDI: 00801741013836
    Category
    Medical Device
    Distribution
    53 states
  • HighFDA (Devices)·Z-2380-2019·2019-09-04

    Bard Equistream XK Hemodialysis Catheter Recalled for Tip Breakage

    Bard Peripheral Vascular Inc is recalling 46 units of Equistream XK Long-Term Hemodialysis Catheters because the molded tip may break or become damaged during placement.

    Product
    EQUISTREAM XK Long-Term Hemodialysis Catheter with Preloaded Stylet, REF/Product code:5913350, 16F, Straight, 35cm length, BARD, UDI: 00801741013874
    Category
    Medical Device
    Distribution
    53 states
  • HighFDA (Devices)·Z-2411-2019·2019-09-04

    Becton Dickinson Recalls Jamshidi Bone Marrow Biopsy Needles Due to Sterility Concerns

    Becton Dickinson is recalling 700 units of Jamshidi Crown Bone Marrow biopsy needles because product pouches may not be sealed properly, potentially compromising sterility.

    Product
    8 G x 10 CM Jamshidi Crown Bone Marrow biopsy/Aspiration Needle with MAC Catalog Number: TMJ4008
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2401-2019·2019-09-04

    Siemens SOMATOM go.Up CT Systems Recalled for Falling Injector Holder

    Siemens is recalling three SOMATOM go.Up CT systems because the injector holder could fall off with the injector and storage box.

    Product
    SOMATOM go.Up; Models ##11061628 Product Usage: This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2419-2019·2019-09-04

    Stryker Endintrak 2 Hook Blade Recall Due to Compromised Sterile Seal

    Stryker GmbH is recalling 76 units of the Endintrak 2 Hook Blade because the sterile bag seal may be compromised, potentially affecting sterility.

    Product
    Endintrak 2 Hook Blade, Catalog Number 4058-1 The EPF system is designed for the treatment of plantar fasciosis. The EPF system is a minimally invasive surgical technique for chronic plantar fasciitis (fasciosis). The EGR system is designed for the treatment of gastrocnemius…
    Category
    Medical Device
    Distribution
    Distributed nationwide