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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19551–19575 of 40124

  • HighFDA (Devices)·Z-2756-2019·2019-10-02

    Medline Electric Surgical Clipper Recalled for Overheating Charger Base

    Medline Industries is recalling 500 electric surgical clippers because a defective circuit board component may cause the charger base to overheat and malfunction.

    Product
    MEDLINE ELECTRIC SURGICAL CLIPPER AND BASE, REF DYND70800 Product Usage: Medline Surgical Clipper is intended for the removal of body hair from the patient as required prior to surgery or other minor procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2560-2019·2019-10-02

    Elekta Monaco RTP System Recalled for Potential Dose Calculation Errors

    Elekta Inc is recalling 30 units of the Monaco RTP System 5.40 Unity because unintentional changes to electron density settings may result in incorrect dose calculations for radiation treatment plans.

    Product
    Monaco RTP System, 5.40 Unity, radiation treatment planning system Product Usage: The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The system calculates dose for photon, electron, and carbon treatment…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2556-2019·2019-10-02

    Arrow Central Venous Catheterization Kit Recalled for Incorrect Banner Card

    Arrow International Inc is recalling 231 units of 8.5 Fr. X 16 cm Quad-Lumen Central Venous Catheterization Kits because they may contain the incorrect banner card.

    Product
    Arrow 8.5 Fr. X 16 cm Quad-Lumen Central Venous Catheterization Kit Product Code:AK-42854-P1A - Product Usage: The Arrow Central Venous Catheters are intended to permit venous access to the central circulation by way of the femoral, jugular or subclavian veins.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2551-2019·2019-10-02

    Sentinel CH SpA Recalls MULTIGENT Lithium Reagent Kits

    Sentinel CH SpA is recalling 15,919 MULTIGENT Lithium reagent kits due to a potential carryover issue that may cause falsely elevated patient results.

    Product
    MULTIGENT Lithium-intended for the quantitation of lithium in serum or plasma using respectively the ARCHITECT c Systems and the Alinity c analyzer List Number: 8L25-30
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2559-2019·2019-10-02

    Getinge Recalls One Vascular Graft Due to Incorrect Packaging Label

    Getinge is recalling one HEMASHIELD GOLD vascular graft that was incorrectly packed in a carton labeled for a HEMASHIELD PLATINUM graft.

    Product
    The HEMASHIELD PLATINUM Woven Double Velour Vascular Graft is a woven double velour polyester graft impregnated with highly purified bovine collagen. The HEMASHIELD PLATINUM Woven Double Velour Vascular Graft is designed to reduce bleeding at implant and thereby eliminates the…
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2755-2019·2019-10-02

    Abbott APS Accelerator Modules Recalled for Missing Pacemaker Safety Label

    Abbott is recalling 159 APS Accelerator modular systems because the safety pacemaker label is missing. The Operations Manual has been updated to specify a 200 mm minimum safety distance for pacemaker wearers.

    Product
    APS Accelerator modular systems, 208-230 V-, 50/60 Hz, 1800 VA, IVD, RX, Class 2 Laser Product,
    Category
    Medical Device
    Distribution
    21 states
  • ModerateFDA (Devices)·Z-2553-2019·2019-10-02

    GN Otometrics Recalls Gold Cup and Snap Leadwires Due to Conductor Defect

    GN Otometrics is recalling Gold Cup and Snap Leadwires because the electrode lead connector has a protruding conductor beyond the insulation.

    Product
    Gold Cup Leadwire and Snap Leadwire with the following component descriptions: 1. 24" Snap Leadwire, Blue; 2. 40" Snap Leadwire, Blue; 3. 24" Snap Leadwire, Red; 4. 40" Snap Leadwire, Red; 5. 24" Snap Leadwire, Green; 6. 40" Snap Leadwire, Green…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2554-2019·2019-10-02

    Smiths Medical Medfusion 4000 Syringe Infusion Pump Recall for Wireless Connectivity Issues

    Smiths Medical is recalling Medfusion 4000 Syringe Infusion Pumps with PharmGuard Server Software due to potential wireless network connectivity issues caused by a Radio Module defect.

    Product
    Medfusion¿ Model 4000 Syringe Infusion Pump, with PharmGuard¿ Server Software (PGS). Sold under the following names: MEDFUSION¿ 4000 Pump V1.0; MEDFUSION¿ 4000 Pump V1.1, v1.1.1, v1.1.2; MEDFUSION¿ 4000 Pump V1.1, V1.1.1, V1.1.2; MEDFUSION¿ 4000 Pump V1.5, V1.5.1…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2558-2019·2019-10-02

    V-Twin Automated Chemistry Analyzer Recalled for Software Lockup

    Vital Scientific N.V. is recalling two V-Twin automated chemistry analyzers in New York because a software lockup prevents the instruments from producing patient results.

    Product
    V-Twin, Model # 6002-800, UDI: 03661540600180 Product Usage: An in-vitro diagnostic device, which is an automated chemistry analyzer, micro type, intended for clinical use in conjunction with certain materials to measure a variety of analytes, including applications in…
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2754-2019·2019-10-02

    Siemens Recalls Atellica IM Anti-CCP IgG Assay Due to Mitigation Failure

    Siemens Healthcare Diagnostics is recalling 169 kits of the Atellica IM anti-CCP IgG assay because a reagent carryover mitigation step fails to complete on the analyzer.

    Product
    Atellica IM anti-CCP IgG (aCCP) Assay Siemens Material Number: 10732998 (100 Test) Test Version1.0 - Product Usage: The ADVIA Centaur¿ Anti-CCP IgG (aCCP) assay is for in vitro diagnostic use in the semi-quantitative determination of the IgG class of autoantibodies specific to…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2753-2019·2019-10-02

    Accu-Chek Connect App Recall for Android Data Transfer Failure

    Roche Diabetes Care is recalling the Accu-Chek Connect App because users on Android OS 8.0 and above may be unable to transfer meter values to the app.

    Product
    Accu-Chek Connect Diabetes Management App
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2555-2019·2019-10-02

    Arrow International Recalls Central Venous Access Kits Due to Incorrect Banner Card

    Arrow International Inc is recalling 520 units of ARROW+gard Blue PSI Kit Cath-Gard central venous access devices because they may contain the incorrect banner card.

    Product
    8.5 Fr. X 10 cm ARROW+gard Blue PSI Kit Cath-Gard for use with 7.5 - 8 Fr.Catheters Product Code: CDC-29803-1A - Product Usage: The MACTM Two-Lumen Central Venous Access Device with ARROWg+ard Blue¿ permits venous access and catheter introduction to the central circulation. It…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2557-2019·2019-10-02

    Randox Urinalysis Control Level 2 Recalled for Incorrect Leukocyte Range

    Randox Laboratories is recalling Randox Urinalysis Control Level 2 kits because the leukocyte range for the Siemens Multistix method was incorrect.

    Product
    Randox Urinalysis Control Level 2 (IVD) Ref: UC5034 - Product Usage: Product is intended for in vitro diagnostic use in the quality control of urine test strips.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2498-2019·2019-10-02

    Philips Recalls Two DigitalDiagnost C50 X-ray Systems for Missing Labels

    Philips Healthcare is recalling two DigitalDiagnost C50 stationary X-ray systems in Puerto Rico due to a missing label identified during recent evaluations.

    Product
    DigitalDiagnost C50, Stationary X-ray System
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2541-2019·2019-09-25

    Wilson-Cook Recalls Hemospray Endoscopic Hemostat Due to Misassembly

    Wilson-Cook Medical Inc. is recalling 160 units of Hemospray Endoscopic Hemostat because misassembly may prevent the device from spraying powder.

    Product
    Hemospray Endoscopic Hemostat
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2149-2019·2019-09-25

    Maquet Cardiopulmonary Sets Recalled Due to Incorrect Quick Connector Assembly

    Maquet is recalling 54 cardiopulmonary sets because quick connectors were assembled in reverse, preventing proper priming and function.

    Product
    Maquet Cardiopulmonary (MCP)/Getinge HLS Set Advanced 7.0. Model Number BEQ-HLS-7050 USA, Part Number 701052794
    Category
    Medical Device
    Distribution
    17 states
  • HighFDA (Devices)·Z-2544-2019·2019-09-25

    Ad-Tech Drill Sleeve Guides Recalled for Potential Drill Bit Seizure

    Ad-Tech Medical Instrument Corporation is recalling specific Drill Sleeve Guides because the inner diameter was under tolerance, which could cause the drill bit to seize during surgery.

    Product
    AD-TECH Drill Sleeve Guides, used with Ad-Tech Placement Kits: (a) REF DSG-90-2.3N (b) REF DSG-6.3-090-2.4N
    Category
    Medical Device
    Distribution
    18 states
  • HighFDA (Devices)·Z-2543-2019·2019-09-25

    Boston Scientific Recalls S-ICD Devices Due to Battery Depletion

    Boston Scientific is recalling 404 EMBLEM MRI S-ICD devices because a compromised electrical component causes accelerated battery depletion, potentially requiring earlier replacement.

    Product
    Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEM MRI S-ICD Pulse Generator
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2542-2019·2019-09-25

    Boston Scientific Recalls 28 Subcutaneous Implantable Cardioverter Defibrillators

    Boston Scientific is recalling 28 EMBLEM S-ICD devices due to accelerated battery depletion. Patients should contact their healthcare provider for evaluation.

    Product
    Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEMTM S-ICD Pulse Generator
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2547-2019·2019-09-25

    Philips IntelliVue Remote Antenna Cable Recalled for Incorrect Rating

    Philips is recalling IntelliVue 1.4 GHz Remote Antenna cables used with MX40 monitors because they lack the required rating for some installations.

    Product
    IntelliVue 1.4 GHz Remote Antenna Used with Philips MX4O Monitors-The affected product is a 74 foot (22.6m) combined coax and unshielded twisted pair data cable bundle and is a component of the Philips Remote Antenna (PN 867151). The Remote Antenna is used with IntelliVue…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2545-2019·2019-09-25

    CooperSurgical Recalls LEEP Return Patient Pads Due to Expiration Date Errors

    CooperSurgical is recalling LEEP Return Patient Pads because the expiration dates on the outer boxes have the month and day reversed compared to the individual pouches.

    Product
    LEEP Return Patient Pads (10/ box) Model # 6050Pl used in electrosurgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2314-2019·2019-09-18

    Teleflex Medical Recalls Sheridan Preformed Tracheal Tubes Due to Disconnection Risk

    Teleflex Medical is recalling specific lots of Hudson RCI Sheridan Preformed tracheal tubes because the 15 mm connector may disconnect from the tube, potentially causing insufficient oxygenation.

    Product
    Hudson RCI Sheridan Preformed: a) 3.0 mm, REF 5-22006, REF 5-22106 b) 3.5 mm, REF 5-22007, REF 5-22107 c) 4.0 mm, REF 5-22008, REF 5-22108, REF 5-22208 d) 4.5 mm, REF 5-22009, REF 5-22109, REF 5-22209 e) 5.0 mm, REF 5-22010, REF 5-22110, REF 5-22210 f) 5.5 mm, REF 5-22011…
    Category
    Medical Device
    Distribution
    Distributed nationwide