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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25451–25475 of 40357

  • ModerateFDA (Devices)·Z-0236-2018·2017-12-20

    Beckman Coulter UniCel DxH800 Automated Hematology Analyzer Recall

    Beckman Coulter is recalling 15 UniCel DxH800 automated hematology analyzers because the Single-Tube Station shield may interfere with sample aspiration.

    Product
    UniCel DxH800, Part Numbers: 629029 and B24802, automated hematology analyzer
    Category
    Medical Device
    Distribution
    6 states
  • 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
  • ModerateFDA (Devices)·Z-0211-2018·2017-12-13

    Biosense Webster Recalls PENTARAY NAV High-Density Mapping Catheters

    Biosense Webster is recalling PENTARAY NAV High-Density Mapping Catheters because the instructions for use were updated to indicate they should not be used in patients with prosthetic valves.

    Product
    PENTARAY NAV High-Density Mapping Catheter.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0199-2018·2017-12-13

    DeRoyal Surgical Kits Recalled for Incorrect Expiration Date on Prep Pads

    DeRoyal is recalling sterile custom surgical kits containing Medline Aplicare Povidone Iodine Prep Pads due to incorrect expiration dates.

    Product
    DeRoyal Sterile Custom kits containing Medline Aplicare Povidone Iodine Prep Pads: a) Incision and Drainage Tray, REF 47-763.04 b) Incision and Drainage Tray, REF 47-763.06 c) Incision and Drainage Tray, REF 47-763.07 d) Cricothyreotomy Ambulance Kit, REF 89-6752.01 e)…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0206-2018·2017-12-13

    Novo Nordisk Recalls Dial-A-Dose Insulin Pen Cartridge Holders

    Novo Nordisk is recalling specific batches of Dial-A-Dose insulin pen cartridge holders because they may crack or break when exposed to certain cleaning agents.

    Product
    Dial-A-Dose Insulin Delivery Device (Pen-Injector) cartridge holders Product Usage: The NovoPen Echo¿ is a re-usable pen injector for single patient use by diabetics for the self injection of a desired dose of insulin. The pen injector uses Penfill 3 mL cartridge of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0209-2018·2017-12-13

    Remel Mueller-Hinton Broth Recalled for Incorrect Cation Labeling

    Remel Inc is recalling 7 units of Mueller-Hinton Broth IVD because the product label may contain incorrect cation information.

    Product
    CM0405 Mueller-Hinton Broth IVD, 500g makes 23.8 litres.
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-0201-2018·2017-12-13

    Exactech Recalls Vantage Total Ankle Tibial Inserts Due to Labeling Mismatch

    Exactech, Inc. is recalling nine Vantage Total Ankle Tibial Inserts because the inner labeling and packaged device may not match the outer box label.

    Product
    Vantage Total Ankle Tibial Insert, Fixed Bearing, 10 mm, Left, Size 3. Exactech Inc. Intended for patients with ankle joints damage by severe rheumatoid, post-traumatic, or degenerative arthritis. It is also indicated for revision of failed previous reconstructions where…
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0204-2018·2017-12-13

    FDA Recalls Two Unapproved Morning Life Air Compression Devices

    Won Industry Co. is recalling two Morning Life air compression devices because they were distributed without FDA approval and have incorrect air compression settings.

    Product
    Morning Life, Model WIC2008S & WIC2008, UDI 8809293 870336 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 programmed on the device. It helps to…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0200-2018·2017-12-13

    Exactech Vantage Total Ankle Tibial Insert Recalled for Labeling Mismatch

    Exactech is recalling nine Vantage Total Ankle Tibial Inserts due to possible mismatches between inner and outer packaging labels.

    Product
    Vantage Total Ankle Tibial Insert, Fixed Bearing, 7 mm, Left, Size 3. Exactech Inc., Intended for patients with ankle joints damage by severe rheumatoid, post-traumatic, or degenerative arthritis. It is also indicated for revision of failed previous reconstructions where…
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0203-2018·2017-12-13

    Fukuda Denshi Patient Monitor Recall for Damaged Lithium-Ion Capacitor

    Fukuda Denshi is recalling DS-8100M and DS-8100N patient monitors because a damaged lithium-ion capacitor may cause a short-term battery error message.

    Product
    Fukuda Denshi patient monitor model DS-8100M and DS-8100N Product Usage: Use of the Fukuda Denshi DynaScope Model DS-8100N/8100M Patient Monitor is indicated in those situations where observation of one or more of the following parameters on an individual patient may be…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0212-2018·2017-12-13

    Biosense Webster Recalls PENTARAY NAV Mapping Catheters Due to Labeling Update

    Biosense Webster is recalling 73,796 PENTARAY NAV High-Density Mapping Catheters to update contraindication language in the Instructions For Use regarding prosthetic valves.

    Product
    PENTARAY NAV High-Density Mapping Catheter.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0198-2018·2017-12-13

    BD Phoenix AP Instrument Recalled for Potential Robot Arm Movement

    Becton Dickinson & Co. is recalling seven BD Phoenix AP instruments due to a potential for unexpected robot arm movement.

    Product
    BD PhoenixTM AP, Catalog Number 448010 The BD Phoenix" AP instrument is designed for use with the BD Phoenix" system is intended to standardize ID broth tube inoculum, add AST indicator to the AST broth tube and transfer an aliquot of ID broth to AST broth tubes, as required…
    Category
    Medical Device
    Distribution
    3 states
  • LowFDA (Devices)·Z-0590-2018·2017-12-13

    C.R. Bard Recalls Arctic Sun ArcticGel Pads Due to Labeling Error

    C.R. Bard is recalling 128 units of Arctic Sun ArcticGel Pads - Medium because the product box displays an incorrect reference number.

    Product
    Arctic Sun ArcticGel Pads - Medium, Product Code 317-07
    Category
    Medical Device
    Distribution
    0 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
  • HighFDA (Devices)·Z-0171-2018·2017-12-06

    BD Phoenix PMIC-107 Panels Recalled Due to Quality Control Failures

    Becton Dickinson is recalling specific lots of BD Phoenix PMIC-107 panels due to manufacturing issues that may affect antibiotic susceptibility testing results.

    Product
    BD Phoenix PMIC-107, Catalog Number 448417, UDI #s (01)30382904484171, (10)7031818(17)180228(30)0025, IVD. PMIC-107 is a Gram positive AST Only panel used to test antibiotic susceptibility. The inducible macrolide-linosamide-steptogramin B (iMLSb) resistance D-test screen for…
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-0178-2018·2017-12-06

    Zimmer Biomet Recalls ROSA Surgical Device 2.5.8 Units

    Zimmer Biomet is recalling 22 ROSA Surgical Device 2.5.8 units due to an issue with the optional neuro-endoscopy module detected during internal testing.

    Product
    ROSA Surgical Device 2.5.8
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-0192-2018·2017-12-06

    Hill-Rom Recalls Monarch Airway Clearance Systems Due to EMI Risk

    Hill-Rom is recalling 60 Monarch Airway Clearance Systems because electromagnetic interference may disrupt implanted pacemakers or defibrillators.

    Product
    Monarch Airway Clearance System, Model 1000, Product Numbers: PMACS1NA (has blue tooth capability only) and PMACS1WI (has WIFI capability). The firm name on the label is Hill-Rom Services Pte. Ltd., Singapore. The Monarch Airway Clearance System, Model 1000, is intended to…
    Category
    Medical Device
    Distribution
    Distributed nationwide