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

18251–18275 of 40124

  • HighFDA (Devices)·Z-1207-2020·2020-02-19

    Arrow International Recalls FlexTip Plus Epidural Catheterization Kits

    Arrow International is recalling FlexTip Plus Epidural Catheterization Kits due to potential syringe failures that could cause dural puncture.

    Product
    FlexTip Plus Epidural Catheterization Kit, Product Code MP-17019-TKP
    Category
    Medical Device
    Distribution
    37 states
  • HighFDA (Devices)·Z-1121-2020·2020-02-19

    Flowonix Prometra II Pump Recall for Firmware Alarm Anomaly

    Flowonix Medical Inc is recalling Prometra II 20mL implantable infusion pumps due to a firmware defect that may prevent the device from sending error codes or audible alarms for valve system issues.

    Product
    Prometra II 20mL Pump. Catalog No. 13827 The device is an implantable infusion pump. GTIN-14 00810335020228
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1110-2020·2020-02-19

    Terumo Advanced Perfusion Assembly Pump Guts Recalled for Potential Shaft Failure

    Terumo is recalling 16 Advanced Perfusion Assembly Pump Guts units because the pump shafts may fail, potentially causing the pump to stop during surgery.

    Product
    Terumo Advanced Perfusion Assembly Pump Guts, 6 Inch, Catalog Number 801798 - is indicated for use for up to 6 hours in the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1123-2020·2020-02-19

    Flowonix US Clinical 20mL Programmable Pump Recall for Firmware Alarm Defect

    Flowonix Medical Inc is recalling US Clinical 20mL Programmable Pumps because a firmware anomaly may prevent the device from sending error codes or audible alarms during valve system issues.

    Product
    US Clinical 20mL Programmable Pump. Catalog No. 01827 The device is an implantable infusion pump. GTIN-14 00810335020082
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1225-2020·2020-02-19

    Terumo AZUR CX Peripheral Coil System Recalled for Missing Implant Coil

    Microvention is recalling 1,187 units of Terumo AZUR CX Peripheral Coil Systems because the implant coil may be missing from the packaging.

    Product
    Terumo AZUR CX Peripheral Coil System, Detachable 35, CX Coil, REF numbers 45-751019, 45-751324, 45-751632, 45-752039, 45-750407, 45-750511, 45-750617, 45-750609, 45-750812, 45-750824, MV-AX50407CD, MV-AX50511CD, MV-AX50617CD, MV-AX50824CD, and MV-AX51019CD, Sterile, Rx. The…
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1125-2020·2020-02-19

    Flowonix Prometra II Pump Recall for Firmware Alarm Anomaly

    Flowonix Medical Inc is recalling Prometra II implantable infusion pumps because a firmware anomaly may prevent the device from sending error codes or audible alarms.

    Product
    Prometra II Programmable 20mL Pump. Catalog No. 93827 The device is an implantable infusion pump. GTIN-14 00810335020YYY (YYY= in-country language specific)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1146-2020·2020-02-19

    Revanesse Versa Recalled for Incorrect Expiration Date Labeling

    Prollenium Medical Technologies is recalling 48,457 kits of Revanesse Versa because the product is labeled with an 18-month expiration date, but it is only approved for 12 months.

    Product
    Revanesse Versa, PN40081
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1157-2020·2020-02-19

    Implant Direct Legacy 3 Implants Recalled for Incorrect Cover Screws

    Implant Direct is recalling 78 Legacy 3 dental implants because some packages contain incorrect cover screws and extenders, which may delay surgery or require new procedures.

    Product
    Implant Direct, CE 0086, REF: 855710, Legacy 3 Impant, Surface: SBM, Qty:1, Size:5.7mmD x 10mmL, 5.7mmD Platform, RxOnly, Sterile R,
    Category
    Medical Device
    Distribution
    23 states
  • ModerateFDA (Devices)·Z-1158-2020·2020-02-19

    Roche Recalls cobas infinity core Software Due to Display Error

    Roche Diagnostics is recalling cobas infinity core software modules because alarm flags with a '<' symbol are not displayed on the Validation screen.

    Product
    cobas infinity core, Material No. 7154003001. The device is a calculator/data processing module, for clinical use.
    Category
    Medical Device
    Distribution
    19 states
  • ModerateFDA (Devices)·Z-1219-2020·2020-02-19

    Bard Intra-abdominal Pressure Monitoring Device Recalled for Potential Leaks

    C.R. Bard Inc. is recalling 1,300 units of the Bard Intra-abdominal Pressure Monitoring Device due to leaks or disconnects that may cause inaccurate readings.

    Product
    The Bard Intra-abdominal Pressure Monitoring Device is composed of a tubing set used for infusing fluid into the urinary bladder through the Foley catheter sampling port. It utilizes a clamping device to occlude the urinary drainage tubing to form a fluid column through which…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1228-2020·2020-02-19

    CooperVision Vertex Toric Contact Lenses Recalled for Incorrect Power

    CooperVision is recalling specific lots of Vertex Toric contact lenses because they were manufactured with an incorrect power.

    Product
    Coopervision Vertex Toric /2 Clear Toric- Power +2.25 -0.75/120 Soft (hydrophilic) Contact Lens (extended wear)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1169-2020·2020-02-19

    DePuy Orthopaedics Recalls Specialist 2 Distal Femoral Cutting Blocks

    DePuy Orthopaedics is recalling 140 Specialist 2 Distal Femoral Cutting Blocks because they will not connect to the required outrigger, rendering them unusable in surgery.

    Product
    SPECIALIST 2 DISTAL FEMORAL CUTTING BLOCK. Part code 966115. The product is a femoral cutting block.
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1127-2020·2020-02-19

    Nextremity Solutions Recalls Stratum Lapidus Plate Due to Labeling Error

    Nextremity Solutions is recalling 40 Stratum Lapidus Plate units because the package labeling indicates a right plate, but the product contains a left plate.

    Product
    Stratum Lapidus Plate - Small Rt, Part No. STRM-LAP-SMR, UDI 00817701025467. The product is part of the Stratum Foot Plating System, a plate and screws construction indicated for bone fixation.
    Category
    Medical Device
    Distribution
    22 states
  • ModerateFDA (Devices)·Z-1118-2020·2020-02-19

    LivaNova Recalls Six VNS Therapy SENTIVA Generators for Sterilization Error

    LivaNova USA Inc is recalling six VNS Therapy SENTIVA Generator Model 1000 units because they were sterilized one additional cycle, failing to meet quality specifications.

    Product
    VNS Therapy SENTIVA Generator Model # 1000 Labeling 26-0009-6800 Model 1000 Generator Sample Labels 26-0009-9600 Patient s Manual for Depression 26-0009-9500 Patient s Manual for Epilepsy 76-0000-5000 VNS Therapy System Physician s Manual (refer to Attachment 1)
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1227-2020·2020-02-19

    CooperVision Vertex Toric Contact Lenses Recalled for Incorrect Power

    CooperVision is recalling 216 units of Vertex Toric contact lenses because they have an incorrect power than expected.

    Product
    Coopervision Vertex Toric /2 Clear Toric- Power -2.50 -0.75 /90 Soft (hydrophilic) Contact Lens (extended wear)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1119-2020·2020-02-19

    LivaNova Sorin Connect Datapad Recall for Incorrect Manufacturing Date Labels

    LivaNova USA Inc. is recalling five Sorin Connect Datapad devices because they have incorrect manufacturing date labels. The devices were distributed in New Jersey and California.

    Product
    LivaNova Sorin Connect DPIII KOMPL. S5 REF 96-415-130, 2017-08-15, IPX1, RXOnly, (01)04033817901594 Product Usage: The S5 System is used to perform, control and monitor extracorporeal blood circulation during an operation for up to six hours.
    Category
    Medical Device
    Distribution
    2 states
  • LowFDA (Devices)·Z-1229-2020·2020-02-19

    Taewoong Esophageal Stents Recalled Due to Misprinted Instructions for Use

    Taewoong Medical Co., Ltd. is recalling 178 esophageal stents because the Instructions for Use (IFUs) shipped with the devices were misprinted.

    Product
    Niti-S Esophageal Stent, REF ES1806F, ES1808F, ES1810F, ES1815F, ES2006B, ES2010B, ES1612B, ES1615B, ES1810B, ES1812B, ES1815B, ES1610F, ES1612F, ES1615F, ES2006F, ES2008F, ES2010F; Esophageal TTS Stent, REF: EST1806F, EST2012F, EST2012B, EST2015F, EST2008F, EST1808F…
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-0980-2020·2020-02-12

    Pacific Medical Fetal Transducers Recalled for Lack of Regulatory Clearance

    Pacific Medical Group Inc. is recalling 628 fetal transducers distributed without 510(k) clearance. The devices may fail to monitor vital signs, posing risks of burns or delayed detection of distress.

    Product
    Pacific Medical GE Corometrics Nautilus Toco Transducer w/wing (2264LAX), FFCM3260
    Category
    Medical Device
    Distribution
    45 states
  • SevereFDA (Devices)·Z-1002-2020·2020-02-12

    Cardinal Health Recalls AAMI 3 Fabric Reinforced Gowns Due to Contamination

    Cardinal Health is recalling AAMI 3 Fabric Reinforced Gowns due to unknown levels of bioburden, microbiological flora, and particulate contamination.

    Product
    AAMI 3 FABRIC REINFORCEDGown 2XL NS, Item Code 9571NA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1014-2020·2020-02-12

    Cardinal Health Recalls RoyalSilk Gowns Due to Unknown Contamination

    Cardinal Health is recalling RoyalSilk gowns because they contain unknown levels of bioburden, microbiological flora, and particulate contamination.

    Product
    ROYALSILK 3XLARGE/XLONG NS, Gown Item Code 95998N
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0927-2020·2020-02-12

    Intuitive Surgical Recalls da Vinci SP Systems Due to Defective Capacitors

    Intuitive Surgical is recalling four da Vinci SP Surgical Systems because defective capacitors on circuit boards may cause vision loss or non-recoverable system errors.

    Product
    da Vinci SP Surgical System, SP1098, 00886874114605 Product Usage: used with an endoscope, surgical instruments, and accessories to perform minimally invasive surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1013-2020·2020-02-12

    Cardinal Health Recalls AAMI 3 Royalsilk Surgical Gowns Due to Contamination

    Cardinal Health is recalling AAMI 3 Royalsilk Surgical Gowns because they contain unknown levels of bioburden, microbiological flora, and particulate contamination.

    Product
    AAMI 3 ROYALSILK SURGGOWN BNS 2XL, Item Code 9578NB
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0915-2020·2020-02-12

    ResMed Stellar Ventilators Recalled for Potential Alarm Failure

    ResMed is recalling 69 Stellar ventilators because a software and component failure may prevent audible alarms from operating properly.

    Product
    ResMed Stellar, Non-invasive/invasive ventilators, Model: 100, 150
    Category
    Medical Device
    Distribution
    9 states
  • SevereFDA (Devices)·Z-1030-2020·2020-02-12

    Cardinal Health Recalls Surgical Gowns Due to Unknown Contamination

    Cardinal Health is recalling AAMI 3 Nonreinforced Surgical Gowns (4XL) because they contain unknown levels of bioburden, microbiological flora, and particulate contamination.

    Product
    AAMI 3 NONREINF SURGICAL GOWN 4XL, Item Code 9599
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1004-2020·2020-02-12

    Cardinal Health Recalls Surgical Gowns Due to Unknown Contamination

    Cardinal Health is recalling AAMI 3 surgical gowns because they contain unknown levels of bioburden, microbiological flora, and particulate contamination.

    Product
    AAMI 3 FABREINF SURG GOWN L NS, Item Code 9511NB
    Category
    Medical Device
    Distribution
    Distributed nationwide