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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10376–10400 of 40095

  • HighFDA (Devices)·Z-1389-2023·2023-04-19

    Chromic Gut Absorbable Sutures recalled due to sterilization failure

    Covidien is recalling Chromic Gut Absorbable Sutures due to a sterilization process failure that may result in unsterile product. Use of affected sutures may cause infection or, in eye surgery, vision loss.

    Product
    Mild Chromic Gut Absorbable Sutures, CH GUT 5-0 12 UD SS-14 SS-14 (G-1766-K), CHROMIC GUT 6-0 45CM HE-1 X12 (G-1780K)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1366-2023·2023-04-19

    Inflatable penile prosthesis recalled due to pump wall thickness manufacturing defect

    Coloplast is recalling Titan NB inflatable penile prostheses with reduced pump wall thickness that may cause premature pump failure during normal use.

    Product
    Titan NB Scrotal Zero Ang 18cm, Catalog Number EN88182400; inflatable penile Prosthesis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1360-2023·2023-04-19

    Inflatable Prosthesis Pump Assembly Recalled for Premature Failure Risk

    Coloplast is recalling 9 Titan Pump Assemblies for inflatable penile prostheses due to decreased wall thickness that may cause premature pump failure during normal use.

    Product
    Titan Pump Assembly, Catalog Number 5177701400; inflatable penile Prosthesis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1351-2023·2023-04-19

    Outset Tablo Hemodialysis System Recall Due to Software Manufacturing Defect

    Outset Medical is recalling 374 Tablo hemodialysis systems due to a software malfunction introduced during manufacturing. The defect causes frequent high conductivity dialysate alarms in devices distributed nationwide.

    Product
    Outset Tablo Model Numbers (REF): PN-0006000 PN-0007001 Tablo is a next generation, self-contained hemodialysis system (Hemodialysis System or System), intended for acute, home and chronic dialysis therapy with or without ultrafiltration, in an acute or chronic care facil
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1370-2023·2023-04-19

    Inflatable Penile Prosthesis Recalled Due to Risk of Premature Pump Failure

    Coloplast is recalling Titan Touch Scro Zero Ang 20cm penile prostheses due to decreased wall thickness that could cause premature pump failure. Patients should contact their healthcare provider for guidance.

    Product
    Titan Touch Scro Zero Ang 20cm, Catalog Number ES29202400; inflatable penile Prosthesis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1372-2023·2023-04-19

    Titan Inflatable Penile Prosthesis Pump Failure Risk Recall

    Coloplast is recalling the Titan 0-Deg Infrapubic 20 Cm inflatable penile prosthesis due to reduced wall thickness in the pump that could cause premature failure. No injuries have been reported.

    Product
    Titan 0-Deg Infrapubic 20 Cm, Catalog Number ES88202400; inflatable penile Prosthesis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1377-2023·2023-04-19

    BioPlex 2200 Anti-CCP Reagent Pack Recalled for Reduced Diagnostic Specificity

    Bio-Rad is recalling BioPlex 2200 Anti-CCP Reagent Pack, Lot 301481, because the test's specificity is lower than claimed, which may increase false positive results. The diagnostic kit was distributed worldwide including the US, Canada, and several European countries.

    Product
    BioPlex 2200, Anti-CCP Reagent Pack, REF 665-3250, IVD
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1353-2023·2023-04-19

    PET/CT Imaging System Recall: Software Issue Prevents Image Reconstruction

    Shanghai United Imaging uMI 550 PET/CT imaging system is recalled due to a software defect that may prevent scatter correction during patient scanning, potentially blocking diagnostic PET image generation.

    Product
    Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography (PET) and Computed Tomography (CT), Model uMI 550 Part Number: 88000657 88000057
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1386-2023·2023-04-19

    Stryker MAKO RESTORIS tibial baseplate trial recalled for incorrect size marking

    Stryker is recalling 102 units of MAKO RESTORIS MultiCompartmental Knee tibial baseplate trials with incorrect size laser markings. Wrong markings could lead to selection of incorrect implant sizes during partial knee replacement surgery.

    Product
    stryker MAKO RESTORIS MCK BASEPLATE TRIAL (SIZE 6 RM/LL), REF 170616, intended for use in a Partial Knee Arthroplasty surgical procedure
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1359-2023·2023-04-19

    Titan Touch Pump Inflatable Prosthesis Recalled for Structural Defect Risk

    Coloplast Manufacturing is recalling Titan Touch Pump inflatable penile prostheses due to manufacturing defect causing decreased wall thickness that could lead to premature device failure.

    Product
    Titan Touch Pump, Catalog Numbers 5177502400; inflatable penile Prosthesis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1384-2023·2023-04-19

    Knee Patella Drills Recalled for Incorrect Diameter Markings

    Encore Medical is recalling EMPOWR Knee Patella drills due to reversed diameter markings that could cause incorrect drill selection during surgery, leading to implant loosening or bone fracture.

    Product
    EMPOWR Porous Knee Patella Over Drill, REF: 802-05-104; EMPOWR Knee Patella Drill, REF: 802-05-108
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-1378-2023·2023-04-19

    BioPlex 2200 Anti-CCP Reagent Kit recalled due to reduced test specificity

    Bio-Rad is recalling BioPlex 2200 Anti-CCP reagent kits due to reduced specificity that may cause false positive results. Four customer complaints documented discrepant results during validation testing.

    Product
    BioPlex 2200, Anti-CCP Calibrator Set, REF 663-3200, IVD
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1387-2023·2023-04-19

    Step Bladeless Trocars recalled for sterilization failure

    Covidien's Step Bladeless Trocars (Model S101010, Lot P2G0069) are being recalled due to a sterilization process failure that may have resulted in unsterile instruments. Use of affected units may lead to infection or vision loss in eye procedures.

    Product
    Step Bladeless Trocars, 10 mm cannula and dilator with radially expandable sleeve and 5 - 10 mm reducer, Product Number S101010
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1352-2023·2023-04-19

    Flex-Neck Catheter Repair Kit design test product inadvertently distributed to patients

    Merit Medical Systems inadvertently distributed 17 Flex-Neck Catheter External Repair Kits intended for design verification testing to customers in Maryland, Michigan, Ohio, and Texas.

    Product
    Flex-Neck Catheter External Repair Kit REF CE-1400 LOT CE-1400/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1361-2023·2023-04-19

    Inflatable Penile Prosthesis Recalled Due to Pump Failure Risk

    Coloplast is recalling the Titan Touch NB Infr Zero 16cm inflatable penile prosthesis due to decreased wall thickness in the pump, which may cause premature failure with repeated use.

    Product
    Titan Touch NB Infr Zero 16cm, Catalog Number EN28162400; inflatable penile Prosthesis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1363-2023·2023-04-19

    Inflatable Penile Prosthesis Risk of Premature Pump Failure

    Coloplast's Titan Touch NB Scrot Zero 16cm prosthesis has been recalled due to decreased wall thickness that could cause premature pump failure. The defect was identified in specific lot units distributed worldwide.

    Product
    Titan Touch NB Scrot Zero 16cm, Catalog Number EN29162400; inflatable penile Prosthesis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1385-2023·2023-04-19

    Knee implant trial components recalled for incorrect size laser markings

    Stryker MAKO RESTORIS MCK tibial baseplate trial components used in knee surgery contain incorrect laser markings indicating component size. This affects 52 units distributed internationally and could lead to implantation of wrong-sized components during surgery.

    Product
    stryker MAKO RESTORIS MCK BASEPLATE TRIAL (SIZE 5 RM/LL), REF 170615, intended for use in a Partial Knee Arthroplasty surgical procedure
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1365-2023·2023-04-19

    Inflatable Penile Prosthesis Recalled for Potential Pump Failure Risk

    Coloplast is recalling certain Titan NB Infra Zero Ang 16cm inflatable penile prostheses due to thinner-than-standard pump wall thickness that could lead to premature pump failure.

    Product
    Titan NB Infra Zero Ang 16cm, Catalog Number EN88162400; inflatable penile Prosthesis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1373-2023·2023-04-19

    Titan Penile Prosthesis Recalled Due to Premature Pump Failure Risk

    Coloplast Manufacturing is recalling the Titan 0-Deg Scrotal 18 Cm inflatable penile prosthesis (25 units) due to decreased wall thickness that may cause premature pump failure. Patients with affected lot numbers should contact their healthcare provider.

    Product
    Titan 0-Deg Scrotal 18 Cm, Catalog Number ES89182400; inflatable penile Prosthesis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1354-2023·2023-04-19

    Thermage CPT System unit improperly tested and calibrated during manufacturing

    Solta Medical is recalling one Thermage CPT System unit that was potentially improperly tested and calibrated during manufacturing. The company is contacting the affected customer regarding corrective action.

    Product
    thermage THERMAGE CPT SYSTEM REF TG-2B *** Solta Medical, Inc. thermage RF GENERATOR REF TG-2B *** Solta Medical, Inc. Dermatologic and general surgical procedures for electrocoagulation and hemostasis; " Non-invasive treatment of periorbital wrinkles and rhytids including u
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1374-2023·2023-04-19

    Inflatable Penile Prosthesis Titan Recalled Coloplast Manufacturing Class II

    Coloplast Manufacturing recalls 20 units of Titan 0-Deg Scrotal inflatable penile prosthesis (Lot Numbers 8849601, 8849600, 8849621) with worldwide distribution. The specific reason for the recall is not specified in FDA records.

    Product
    Titan 0-Deg Scrotal 20 Cm, Catalog Number ES89202400; inflatable penile Prosthesis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1381-2023·2023-04-19

    NanoKnife Surgical Probes Recalled Due to RFID Programming Error

    Angiodynamics recalls NanoKnife 5-Probe Procedure Packs due to a programming error affecting RFID function. The probes may not be recognized by the NanoKnife generator, potentially delaying surgical procedures.

    Product
    NanoKnife 5-Probe Procedure Pack 15 cm - Activation. Indicated for the surgical ablation of soft tissue. Catalog Number: 20400111 UPN: H787204001110
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1275-2023·2023-04-12

    FreeStyle Libre Reader batteries pose fire and swelling hazard

    FreeStyle Libre Reader batteries used in glucose monitoring systems may swell, overheat, or pose a fire hazard. Users should only charge with the included cable and discontinue use if devices show damage, excessive heat, or charging problems.

    Product
    FreeStyle Libre Reader, REF: 71951-01, 71952-01, 71953-01 a component of the FreeStyle Libre 2 Flash Glucose Monitoring System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1288-2023·2023-04-12

    Trilogy EV300 Portable Electric Ventilator may deliver insufficient oxygen

    The Trilogy EV300 Portable Electric Ventilator may deliver insufficient oxygen during high-concentration therapy due to accuracy deviations. The device's internal oxygen sensor may also display incorrect readings, creating a risk of oxygen under-delivery to patients.

    Product
    Trilogy EV300 Portable Electric Ventilator, Model Numbers DS2200X11B, IN2200X15B, FX2200X15B, CA2200X12B, CN2200X17B, BR2200X18B, KR2200X15B, IA2200X15B, FR2200X14B, ND2200X15B, IT2200X21B, ES2200X15B, DE2200X13B, BL2200X15B, GB2200X15B, EU2200X15B, EU2200X19, EE2200X15B, TR2200X
    Category
    Medical Device
    Distribution
    Distributed nationwide