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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12776–12800 of 13802

  • HighFDA (Devices)·Z-0103-2022·2021-10-20

    Smiths Medical Blood Sampling System Recalled for Pressure Malfunction and Incorrect Readings

    Smiths Medical LogiCal MEDEX closed blood sampling system sets are recalled due to reported pressure shifts and incorrect pressure readings. Approximately 3,620 units were distributed to Austria, France, Germany, Great Britain, and Saudi Arabia.

    Product
    smiths medical medex CBSS-5ML, Double set, (172+15cm), Model Number DPSHC0094
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0085-2022·2021-10-20

    Spinal Implant Engraving May Not Match Pouch Labels

    Medtronic Sofamor Danek is recalling the Endoskeleton TAS Interbody System because the engraving on the implants may not match the information on the pouch labels.

    Product
    Endoskeleton" TAS Interbody System with Titan nanoLOCK" Surface Technology, Nanolock 12 Dg Interbody, Large, 12mm
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0101-2022·2021-10-20

    Blood sampling system sets recalled for pressure reading and measurement errors

    Smiths Medical is recalling its medex blood sampling system sets due to pressure shifts and incorrect readings that may affect sample collection accuracy.

    Product
    smiths medical medex CBSS-5ML, Triple set, (172/15cm), Model Number DPSHC0092
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0078-2022·2021-10-20

    Philips HeartStart Defibrillator Recall: Previous Recall Notifications Not Sent

    Philips HeartStart FR2+ Defibrillators (models M3860A and M3861A) were not accompanied by notifications about previous recalls. Affected customers should contact Philips for information about prior safety issues.

    Product
    Philips, HeartStart FR2 + Defibrillator, Model # M3860A and M3861A
    Category
    Medical Device
    Distribution
    12 states
  • HighFDA (Devices)·Z-0106-2022·2021-10-20

    Ion Flexison Biopsy Needle recalled for potential sheath tip separation

    Intuitive Surgical recalled 1,625 Ion Flexison Biopsy Needles due to potential sheath tip separation from the shaft. Affected units are distributed across 29 US states and China; no injuries have been reported.

    Product
    Ion Flexison Biopsy Needle, 19G, Extension Range : 0-3 cm, Ref: 490104-09 and 49004-10, 5-pack, Sterile EO, Rx only, UDI:00886874115978
    Category
    Medical Device
    Distribution
    26 states
  • HighFDA (Devices)·Z-0086-2022·2021-10-20

    Endoskeleton TCS Interbody System implant engraving may not match pouch labels

    Medtronic is recalling 9 Endoskeleton TCS Interbody System surgical implants because engraving on the devices may not match the labels on the pouches. The mismatch could result in wrong devices being implanted.

    Product
    Endoskeleton" TCS Interbody System with Titan nanoLOCK" Surface Technology, NanoLock, 6 Deg, Interbody, Medium, 10mm
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0082-2022·2021-10-20

    Bio-Rad BioPlex 2200 ANA Screen Control lot incompatible with reagents

    Bio-Rad Laboratories has recalled certain lots of BioPlex 2200 ANA Screen Control Sets due to incompatibility with older lots of ANA Screen Reagent Packs and Calibrator Sets, which may affect test accuracy.

    Product
    BioPlex 2200 ANA Screen Control Set, REF: 663-1131 incompatible with ANA Screen Reagent Packs/ANA Kits, REF: 665-1150; and ANA Screen Calibrator Sets, REF: 663-1101
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0109-2022·2021-10-20

    Babylog VN500 Ventilator Firmware Defect May Cause Brief Ventilation Interruption

    A software defect in the Babylog VN500 Ventilator may cause it to restart, interrupting ventilation and losing PEEP for about 8 seconds. The issue affects 2,169 units distributed nationwide.

    Product
    Babylog VN500 Ventilator with Installed CO2 Measurement Option-intended for the ventilation of neonatal patients from 0.4 kg (0.88 lbs) up to 10 kg (22 lbs) and pediatric patients from 5 kg (11 lbs) up to 20 kg (44 lbs) bodyweight. Catalog Number: 8417400
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0117-2022·2021-10-20

    Beckman Coulter Power Processor 3K Recalled for Missing Splash Guard

    Beckman Coulter is recalling Power Processor 3K laboratory equipment due to a missing splash guard that may expose users to hazardous materials. Approximately 271 units were distributed in the U.S. and internationally.

    Product
    Power Processor 3K, 3K High Speed Stockyards Module Nameplate: PP 3K Stockyard (Refrig) 9707 REF A88116
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0108-2022·2021-10-20

    Evita V500 Ventilator Software Defect May Cause Temporary Ventilation Loss

    Draeger's Evita V500 ventilator software version 2.51 and lower may restart unexpectedly, briefly stopping ventilation and breathing support. 6,797 units are affected nationwide.

    Product
    Evita V500 Ventilator with Installed CO2 Measurement Option-Intended for the ventilation of adult,pediatric and neonatal patients. Catalog Number: 8416400
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0097-2022·2021-10-20

    Smiths Medical CBSS blood sampling sets recalled for pressure measurement errors

    Smiths Medical is recalling CBSS 5 ml blood sampling sets (Model DPSHC0083) due to reported pressure shifts and incorrect pressure readings. Approximately 7,080 units were distributed in Austria, France, Germany, Great Britain, and Saudi Arabia.

    Product
    smiths medical medex CBSS 5 ml, einfach proximaler Entnahmeport 60 cm, Model Number DPSHC0083
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0093-2022·2021-10-20

    Smiths Medical HemoDraw Plus Blood Sampling Sets Recalled for Pressure Monitoring Errors

    Smiths Medical ASD Inc. is recalling 140 HemoDraw Plus Closed Blood Sampling Sets with LogiCal Pressure Monitoring System for pressure shifts and incorrect pressure readings. Affected units were distributed to Austria, France, Germany, Great Britain, and Saudi Arabia.

    Product
    smiths medical medex HemoDraw Plus Closed Blood Sampling Set with LogiCal Pressure Monitoring System, Model Numbers: a) MX961H182P1 b) MX961H212P1 c) MX962H182P1 d) MX962H212P1
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0098-2022·2021-10-20

    Medical Device Recall: Blood Sampling System Pressure and Reading Errors

    Smiths Medical is recalling LogiCal Closed Blood Sampling System sets due to reported pressure shifts and incorrect pressure readings that could affect blood collection accuracy.

    Product
    smiths medical medex CBSS 5 ml, zweifach proximaler Entnahmeport 60 cm, Model Number DPSHC0084
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0084-2022·2021-10-20

    MYLA Diagnostic System Software Versions Recalled for Risk of False Negatives

    BioMerieux MYLA diagnostic system software versions 4.7–4.8.2 may produce false negative results under certain conditions, potentially missing diagnoses. Affected units are being recalled worldwide.

    Product
    MYLA Versions: 4.7, 4.7.1, 4.8, 4.8.1 and 4.8.2, part of the VIRTUO System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0102-2022·2021-10-20

    Smiths Medical blood sampling system recalled for pressure reading errors

    Smiths Medical has recalled its Medex closed blood sampling system due to pressure shifts and incorrect pressure readings. Approximately 13,620 units were distributed internationally.

    Product
    smiths medical medex CBSS-5ML, Single Set, (172/15cm), Model Number DPSHC0093
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0077-2022·2021-10-20

    Gore VIABAHN VBX endoprosthesis recalled for incorrect device dimension labeling

    W L Gore & Associates is recalling GORE VIABAHN VBX balloon expandable endoprosthesis units due to labeling showing incorrect device dimensions. Two units with specification mismatches were distributed to Italy and Lebanon.

    Product
    Heparin, GORE VIABAHN VBX, BALLOON EXPANDABLE ENDOPROTHESIS, REF BXAL085902E, 8 MM X 59 MM 8 Fr, LARGE BALLOON EXPANDLBE, Nominal Stent Diameter 8 mm, Max Post-Dilated Stent Diameter 16 mm, UDI:
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0092-2022·2021-10-20

    Medex LogiCal Closed Blood Sampling System Recalled for Pressure Reading Errors

    Smiths Medical ASD Inc. is recalling medex LogiCal 5mL Closed Blood Sampling System sets due to reported pressure shifts and incorrect pressure readings that could affect patient safety.

    Product
    medex LogiCal 5mL Closed Blood Sampling System, Model Numbers: a) MX961E181P1 b) MX961E211P1 c) MX962E211P1 d) MX96AE181P1 e) MX96AE211P1
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0094-2022·2021-10-20

    Smiths Medical blood sampling system recalled for pressure measurement errors

    Smiths Medical is recalling 3,100 units of its CBSS blood sampling system due to pressure measurement failures. The devices may show incorrect pressure readings or experience pressure shifts during use.

    Product
    smiths medical medex CBSS 2-fach Druckmesset mit Option, Model Number DPSHC0076
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0105-2022·2021-10-20

    Thoraguard Chest Tube Kit 20 Fr Recalled for Adhesive Joint Failure

    Centese Inc. is recalling Thoraguard Chest Tube Kits (20 Fr) because an adhesive joint in the SmartValve component can fail, causing fluid to leak. The affected kits were distributed to a single facility in California.

    Product
    Thoraguard Chest Tube Kit, 20 Fr
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0100-2022·2021-10-20

    Smiths Medical Antishunt Sets Recalled Due to Pressure and Reading Errors

    Smiths Medical ASD Inc. is recalling approximately 20,800 Antishunt blood sampling sets due to reported pressure shifts and incorrect pressure readings. The affected model was distributed in Austria, France, Germany, Great Britain, and Saudi Arabia.

    Product
    smiths medical medex CBSS-5ML Antishunt set, (172/15cm), Model Number DPSHC0091
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0113-2022·2021-10-20

    Flower Drill Bit Kit Missing AO Connect Feature, May Delay Procedures

    Flower Orthopedics Corporation is recalling Flower Drill Bit Kit 2.7mm (DBK 027) due to missing AO connect feature that may delay surgical procedures. Affected kits were distributed across multiple U.S. states.

    Product
    Flower Drill Bit Kit 2.7mm- The Drill Bit Kit, 2.7mm (DBK 027) is intended to be used with solid 2.7mm screws and can be used with any the Flower Small and Medium Implant Set Flower Ankle Plating Set , Flower Rear Foot/Calcaneus Plating Set or Flower Upper Extremity Plating Set
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0081-2022·2021-10-20

    Philips HeartStart HS1 OnSite Defibrillator Recall: Notification of Previous Recalls

    Philips North America LLC is recalling 15 units of the HeartStart HS1 OnSite Defibrillator (Models M5066A and M5067A) due to failure to notify customers of previous recalls associated with these devices.

    Product
    Philips, HeartStart HS1 OnSite Defibrillator, Model #'s: M5066A and M5067A
    Category
    Medical Device
    Distribution
    12 states
  • ModerateFDA (Devices)·Z-0114-2022·2021-10-20

    Flower Lag Screw Kit drill bits missing AO connect feature recalled

    Flower Orthopedics is recalling Flower Lag Screw Kit 2.7 mm because drill bits lack the AO connect feature, which may delay surgical procedures.

    Product
    Flower Lag Screw Kit 2.7 mm-intended to be used with 2.7mm lag screws and can be used with any plate that as part of the Flower Small and Medium Implant Set, Flower Ankle Plating Set , Flower Rear Foot/Calcaneus Plating Set , or Flower Upper Extremity Plating Set and uses the med
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0111-2022·2021-10-20

    Flower Drill Bit Kit missing AO connect feature may delay procedures

    Flower Orthopedics is recalling Flower Drill Bit Kit 2.0 mm kits because drill bits are missing the AO connect feature, which may result in procedural delays. Affected units were distributed across multiple states.

    Product
    Flower Drill Bit Kit 2.0 mm - intended to be used with solid 2.0mm screws and can be used with any plate that has been cleared as part of the Flower Small and Medium Implant Set and uses the small locking mechanism. mechanism. Catalog Number: DBK 020 2013002721
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0080-2022·2021-10-20

    Philips HeartStart HS1 Home Defibrillator: Customers Not Notified of Previous Recalls

    Philips is recalling nine units of the HeartStart HS1 Home Defibrillator (Model M5068A) because customers were not notified of previous recalls associated with various defibrillator models.

    Product
    Philips, HeartStart HS1 Home Defibrillator, Model # Model number: M5068A
    Category
    Medical Device
    Distribution
    12 states