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.

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

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18951–18975 of 27647

  • HighFDA (Devices)·Z-0247-2018·2017-12-20

    Navilyst Medical Recalls Xcela and BioFlo PICC Kits Due to Handle Detachment

    Navilyst Medical is recalling Xcela and BioFlo PICC kits because the included introducer sheath handles may detach during use.

    Product
    Bio-Stable 5F DL-55CM MST-70 KIT Non-Valved PG, UPN H965458710, Catalog No. 45-871 The Xcela with PASV, BioFlo PICC with ENDEXO Technology, and BioFlo PICC with ENDEXO and PASV Valve Technology are indicated for short or long-term peripheral access to the central venous…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0239-2018·2017-12-20

    FDA Recalls Piranha Cervical Spine Screws Due to Incorrect Length Marking

    The FDA is recalling 82 Piranha screws used in cervical spine surgery because some units marked as 12 mm actually measure 14 mm.

    Product
    Piranha Screw 4.0 x 12mm, used in Piranha Surgical Plate System The Piranha Surgical Plate System is intended to provide stabilization of the cervical vertebrae for various indications as part of the Omni Spine Anterior Cervical Plate System. The Omni Spine Anterior Cervical…
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-0230-2018·2017-12-20

    Terumo Recalls Glidesheath Introducer Sheaths Due to Incomplete Packaging Seal

    Terumo Medical Corp is recalling specific lots of Glidesheath Slender Introducer Sheaths because an incomplete seal may compromise sterility.

    Product
    Glidesheath Slender Hydrophilic Coated Introducer Sheath, 7FR - 16CM (0.021), REF/Product Code RM*RS7F16PA, STERILE, Rx ONLY
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0228-2018·2017-12-20

    Terumo Recalls Glidesheath Introducer Sheaths Due to Incomplete Packaging Seal

    Terumo Medical Corp is recalling specific lots of Glidesheath Introducer Sheaths because an incomplete seal may compromise sterility.

    Product
    Glidesheath Slender Hydrophilic Coated Introducer Sheath, 6FR - 10CM (0.025), REF/Product Code RM*RS6J10PA, STERILE, Rx ONLY
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0234-2018·2017-12-20

    Elekta ERGO++ Medical Device Recall for Incorrect DICOM Mapping

    Elekta Inc is recalling 182 ERGO++ devices due to incorrect DICOM mapping of collimator or couch angles, which may lead to incorrect rotation during planning.

    Product
    Elekta ERGO++ Product Usage: ERGO is often used for stereotactic treatments.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0249-2018·2017-12-20

    Navilyst Medical Recalls Xcela and BioFlo PICC Kits Due to Handle Detachment

    Navilyst Medical is recalling Xcela and BioFlo PICC kits because the introducer handles may detach from the sheath during use.

    Product
    Bio-Stable 5F DL-55CM IR-145 Kit Valved with Nit GW, UPN H965458890, Catalog No. 45-889 The Xcela with PASV, BioFlo PICC with ENDEXO Technology, and BioFlo PICC with ENDEXO and PASV Valve Technology are indicated for short or long-term peripheral access to the central venous…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0232-2018·2017-12-20

    Fujifilm FDR Visionary Suite X-ray Tube Recall for Cracking Risk

    Fujifilm is recalling three FDR Visionary Suite systems because cracks may develop in the X-ray tube holding shaft, posing a potential safety issue.

    Product
    FUJIFILM FDR Visionary Suite with CH-200. Model # CH-200, Catalog: Visionary Suite (FMSU Marketing Name) The FDR Visionary Suite is intended to generate digital or conventional radiographic images of the skull, spinal column, chest, abdomen, extremities, and other body parts…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0226-2018·2017-12-20

    Terumo Recalls Glidesheath Introducer Sheaths Due to Incomplete Packaging Seal

    Terumo Medical Corp is recalling specific lots of Glidesheath Introducer Sheaths because an incomplete seal may compromise sterility.

    Product
    Glidesheath Slender Hydrophilic Coated Introducer Sheath, 6FR - 10CM (0.021), REF/Product Code RM*RS6F10PA, STERILE, Rx ONLY
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0245-2018·2017-12-20

    Navilyst Medical Recalls Xcela and BioFlo PICC Kits

    Navilyst Medical is recalling Xcela and BioFlo PICC kits because the included introducer sheaths may have handles that detach during use.

    Product
    Bio-Stable 5F DL-55CM IR-145 Kit Valved PG, UPN H965458330, Catalog No. 45-833 The Xcela with PASV, BioFlo PICC with ENDEXO Technology, and BioFlo PICC with ENDEXO and PASV Valve Technology are indicated for short or long-term peripheral access to the central venous system…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0246-2018·2017-12-20

    Navilyst Medical Recalls Xcela and BioFlo PICC Kits Due to Handle Detachment Risk

    Navilyst Medical is recalling specific Xcela and BioFlo PICC kits because the included introducer sheaths may have handles that detach during use.

    Product
    Bio-Stable 5F DL-55CM MST-70 KIT Non-Valved PG, UPN H965458710, Catalog No. 45-871 The Xcela with PASV, BioFlo PICC with ENDEXO Technology, and BioFlo PICC with ENDEXO and PASV Valve Technology are indicated for short or long-term peripheral access to the central venous…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0243-2018·2017-12-20

    Navilyst Medical Recalls Xcela and BioFlo PICC Kits Due to Sheath Defect

    Navilyst Medical is recalling Xcela and BioFlo PICC kits because the included introducer sheath handles may detach during use.

    Product
    XCELA PASV 5F DL 55CM IR-145 KIT PG, UPN H965457330, Catalog No. 45-733 The Xcela with PASV, BioFlo PICC with ENDEXO Technology, and BioFlo PICC with ENDEXO and PASV Valve Technology are indicated for short or long-term peripheral access to the central venous system for…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0231-2018·2017-12-20

    Radiometer ABL800 Analyzer Recalled for Barcode Misinterpretation

    Radiometer America Inc. is recalling 1,749 ABL800 analyzers because a barcode scanner error may display results from a different patient.

    Product
    ABL800 analyzer with FLEXQ module. Device intended for in vitro testing of samples of whole blood for the parameters pCO2, cK+, cNa+, cCa2+, cCl , cGlu, cLac, cCrea, ctBil, and co-oximetry parameters (ctHb, sO2, and the hemoglobin fractions FO2Hb, FCOHb, FMetHb, FHHb and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0235-2018·2017-12-20

    Beckman Coulter Remisol Advance Software Recalled for Potential Wrong Results

    Beckman Coulter is recalling Remisol Advance Software versions 1.6-1.9 because a software nonconformity may cause the system to display incorrect results.

    Product
    Remisol Advance Software (Driver Architect) Catalog Number B32129 The Remisol Advance Data Manager (Stand alone Data Management Systems) collects and manages data and manages workflows for connected systems. (i.e. Beckman Coulter Instruments, Automations, LIS &). It…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0250-2018·2017-12-20

    Navilyst Medical Recalls PICC Kits Due to Potential Handle Detachment

    Navilyst Medical is recalling specific PICC kits because the included introducer sheath handles may detach during use.

    Product
    Bio-Stable 5F DL-55CM MST-70 KIT Non-Valved w/ Nit GW, UPN H965458950, Catalog No. 45-895 The Xcela with PASV, BioFlo PICC with ENDEXO Technology, and BioFlo PICC with ENDEXO and PASV Valve Technology are indicated for short or long-term peripheral access to the central…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0251-2018·2017-12-20

    Navilyst Medical Recalls Xcela and BioFlo PICC Kits Due to Handle Detachment

    Navilyst Medical is recalling specific Xcela and BioFlo PICC kits because the introducer sheath handles may detach during use.

    Product
    Bio-Stable 5F DL-55CM MST-70 KIT Non-Valved w/ Nit GW, UPN H965458950, Catalog No. 45-895 The Xcela with PASV, BioFlo PICC with ENDEXO Technology, and BioFlo PICC with ENDEXO and PASV Valve Technology are indicated for short or long-term peripheral access to the central…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0205-2018·2017-12-13

    FDA Recalls Unapproved Compressible Limb Therapy Systems Due to Incorrect Air Compression

    Won Industry Co. is recalling three unapproved Compressible Limb Therapy Systems because they have incorrect air compression level setups. The devices were distributed in Maryland, Texas, and Mexico.

    Product
    Compressible Limb Therapy System (Leg Cuffs, Arm Sleeves, Waist pads and air injection hoses) Product Usage: Intended for limb massage utilizing air compression. It is specially designed to improve venous and lymphatic circulation by compressing and releasing air pressure…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0196-2018·2017-12-13

    Becton Dickinson Recalls Trypticase Soy Agar Plates Due to Listeria Contamination

    Becton Dickinson is recalling Trypticase Soy Agar with 5% Sheep Blood plates because they are contaminated with Listeria monocytogenes. The affected lots are distributed worldwide.

    Product
    TrypticaseTM Soy Agar with 5% Sheep Blood (TSA IITM), Catalog Number 221261 Trypticase Soy Agar with 5% or 10% Sheep Blood is used for cultivating fastidious microorganisms and for the visualization of hemolytic reactions produced by many bacterial species.
    Category
    Medical Device
    Distribution
    47 states
  • HighFDA (Devices)·Z-0210-2018·2017-12-13

    Biosense Webster Recalls SMARTABLATE RF System Generator Units

    Biosense Webster is recalling 185 SMARTABLATE RF System Generators because they may inadvertently deliver RF energy if the foot pedal is placed near Stereotaxis magnets.

    Product
    SMARTABLATE RF System Generator
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Devices)·Z-0207-2018·2017-12-13

    BD Precision Glide Needles Recalled for Hub Damage and Leakage

    Becton Dickinson is recalling 2,598,000 BD Precision Glide Needles due to hub damage that can cause breakage or leakage during use.

    Product
    BD Precision Glide Needle 18G x 1 RB, Catalog 305195 Product Usage: These needles are intended for general purpose fluid injection/aspiration, infusion, venipuncture to obtain blood collection and insulin injection.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0193-2018·2017-12-13

    Pro-Med Instruments Recalls DORO Sterile Disposable Skull Pins Due to Breakage

    Pro-Med Instruments is recalling DORO Sterile Disposable Skull Pins because two instances of pin tip breakage were reported during surgery.

    Product
    pmi, pro med instruments, DORO(R) Sterile Disposable Skull Pins, 3 pieces (3 pieces per blister, 12 blisters per box), STERILE R, Rx ONLY The DORO(R) Skull Pins are inserted into the receptacles of the skull clamp and fixate the head during surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0197-2018·2017-12-13

    Roche Recalls Accu-Chek Connect App Due to Bolus Advisor Bug

    Roche Diabetes Care is recalling the Accu-Chek Connect app because a bug in the Bolus Advisor feature may prevent correction bolus advice from being available for recent glucose readings.

    Product
    Accu-Chek Connect diabetes management software app, Catalog number 07562462001 / GTIN number 00365702700000, Catalog number 07250452001 / GTIN number 00365702700017 The Accu-Chek Connect Diabetes Management App is indicated as an aid in the treatment of diabetes. The software…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0202-2018·2017-12-13

    GE CARESCAPE Patient Data Module Recalled for Missing Apnea Alarms

    GE Medical Systems is recalling CARESCAPE Patient Data Module software because it fails to generate visual or audible alarms for impedance respiration apnea events.

    Product
    CARESCAPE Patient Data Module (PDM) v2.6 software used with CARESCAPE Monitors B850, B650, and B450 v2.0.7 or earlier software The PDM is intended to provide uninterrupted acquisition of physiologic parameter data on adult, pediatric and neonatal patients during…
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0195-2018·2017-12-13

    ICU Medical Recalls MedNet Medication Management Suite Software

    ICU Medical Inc is recalling MedNet 6.1 and 6.21 software because it may alter piggyback medication settings without user notice.

    Product
    ICU Mednet(TM) Medication Management Suite 6.1 and 6.21, Product Code/List Numbers: (a) 16037-64-01; MedNet 6.1 b) 16037-64-02; MedNet 6.1 c) 16037-64-03; MedNet 6.1 d) 16037-64-04; MedNet 6.21 The ICU Medical MedNet Medication Management Suite (MMS) is intended to…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0208-2018·2017-12-13

    Intersurgical Solus Flexible Laryngeal Mask Airways Recalled for Occlusion Risk

    Intersurgical Inc is recalling Solus Flexible wire-reinforced laryngeal mask airways because a defect in the tubing may cause partial or total occlusion when the cuff is over-inflated.

    Product
    Solus Flexible wire-reinforced laryngeal mask airways under the following sizes: 1) small pediatric size 2 catalog #8002001, 2) large pediatric size 2.5 catalog #8025001, 3) small adult size 3 catalog #8003001, 4) medium adult size 4 catalog #8004001 and 5) large adult size 5…
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-0175-2018·2017-12-06

    Siemens Dimension Vista Protein 1 Control M Recalled for Inaccurate Ceruloplasmin Results

    Siemens Healthcare Diagnostics is recalling Dimension Vista Protein 1 Control M units because they may produce inaccurate ceruloplasmin results below the reference range.

    Product
    Dimension Vista Protein 1 Control M, PROT 1 CON M, Siemens Material Number (SMN) 10445920, Product Code KC716; IVD
    Category
    Medical Device
    Distribution
    Distributed nationwide