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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Minimum severity

Any3+ (High and above)4+ (High and above)5+ (High and above)

Clear filters

8276–8300 of 13683

  • ModerateFDA (Devices)·Z-2648-2023·2023-10-11

    Siemens MAGNETOM headphones may create artifacts during MRI imaging

    Siemens Medical Solutions is recalling over-ear headphones used with MAGNETOM MRI systems. Lubricating grease in the headband may cause visible imaging artifacts during head examinations.

    Product
    (1) Over-ear headphones used with the MAGNETOM Amira MAGNETOM Free.Star MAGNETOM Sempra, MAGNETOM Free.Max, MAGNETOM Mica MAGNETOM Spectra Siemens Model Number:11060845 Used with the following MAGNETOM MRI Systems: MAGENTOM Amira 10836777 & 10838610; MAGENTOM Free.Max 1140
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2657-2023·2023-10-11

    Medtronic Restore Clinician Programmer software recalled for compatibility issue

    Medtronic is recalling Restore Clinician Programmer Application Software due to compatibility issues with legacy software that prevent communication with implanted neurostimulators. The recall affects 2,408 devices worldwide.

    Product
    Restore Clinician Programmer Application Software, model number A71100, used with the Restore Neurostimulators.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2631-2023·2023-10-04

    Philips Respironics V60 and V60 Plus Ventilators Power Management Failure Recall

    Philips Respironics V60 and V60 Plus ventilators are recalled because their power management components may fail, causing complete loss of ventilator function. The FDA classified this as a Class I recall.

    Product
    Philips Respironics V60/V60 Plus Ventilator, PCBA Part Number: 453561544461 V60 Device Part Numbers 1053617 (US) and 1137276 (Philippines)
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-2645-2023·2023-10-04

    Stryker Recalls Expired Cinchlock SS Knotless Anchor Inserter Units

    Stryker Corporation is recalling 96 units of the expired Cinchlock SS Knotless Anchor Inserter (Part Number CAT02462, Lot 19175AE2) distributed nationwide. Expired surgical devices may not perform reliably during use.

    Product
    Cinchlock SS Knotless Anchor Inserter, Part Number CAT02462
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2635-2023·2023-10-04

    Ivenix Infusion System Software Startup Delays in Certain Flow Rate Ranges

    Fresenius Kabi USA has recalled Ivenix Infusion System Large Volume Pump software versions 5.0.0 and 5.0.1 due to startup time delays that may exceed 6 minutes at flow rates between 50-200 ml/hr.

    Product
    Ivenix Infusion System (IIS), Large Volume Pump (LVP) Software: 5.0.0 and 5.0.1 Part Number: LVP-SW-0004. Indicated for use in a hospital and in outpatient care environments for the controlled administration of fluids through clinically accepted routes of administration.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2641-2023·2023-10-04

    MobileLink Acetabular Cup System Recalled for Incorrect Offset Labeling

    Waldemar Link is recalling 8 units of the MobileLink Acetabular Cup System due to labeling with an incorrect offset specification. The mislabeling could affect proper surgical placement of this orthopedic implant.

    Product
    MobileLink Acetabular Cup System, Shell/Insert Adapter for Shell 74-80mm, Insert Size F, +12mm Offset 20 degrees Inclination
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-2639-2023·2023-10-04

    3M Attest Sterilization Indicator Caps May Melt or Crack

    3M is recalling 172,464 units of Attest biological indicators used to validate steam sterilization because caps may melt, deform, or crack during sterilization at 132°C and 135°C.

    Product
    3M Attest Super Rapid 5 Steam-Plus Steam Challenge Pack, REF 41482V; designed to qualify and monitor dynamic-air removal steam sterilization processes
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2632-2023·2023-10-04

    Palindrome Chronic Catheter Kit recalls devices with incorrect length labeling

    Covidien LP is recalling Palindrome Chronic Catheter Kit devices where some catheters labeled as 23 cm implant length actually contain 28 cm devices. The mislabeling could affect proper catheter placement.

    Product
    Palindrome Chronic Catheter Kit Symmetrical Tip14.5 Fr/Ch(4.8mm)x23cm
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2637-2023·2023-10-04

    3M Attest Biological Indicator caps may fail during steam sterilization

    3M is recalling 79,500 Attest Super Rapid Readout Biological Indicators because the cap may melt, deform, or crack during steam sterilization cycles, potentially compromising sterilization validation.

    Product
    3M Attest Super Rapid Readout Biological Indicator, REF 1492V; used to qualify or monitor dynamic-air-removal steam sterilization cycles
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2638-2023·2023-10-04

    3M Attest Biological Indicators Recalled for Defective Caps

    3M is recalling specific lots of Attest biological indicators used in steam sterilization monitoring. Certain lots have caps that may melt, deform, or crack at sterilization temperatures of 132°C and 135°C, potentially compromising sterilization process verification.

    Product
    3M Attest Super Rapid Readout Steam Challenge Pack, REF 1496V; designed to qualify and monitor dynamic-air removal steam sterilization processes
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2636-2023·2023-10-04

    ProSun Luxura Vegaz Model 52X UV Tanning Device Safety Circuit Defect Recall

    J&T Health and Wellness LLC recalls the ProSun Luxura Vegaz Model 52X ultraviolet tanning device due to a potential safety circuit defect. A communication isolator may cause a disturbance that compromises the safety circuit.

    Product
    ProSun International Luxura Vegaz, Model 52X; Ultraviolet Tanning Device
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2642-2023·2023-10-04

    Henke-Ject-2 Sterile Syringes Recalled for Potential Sterile Barrier Damage

    Wolf, Henke Sass is recalling Henke-Ject-2 single-use sterile syringes due to potential damage to the sterile barrier that could compromise product sterility. Approximately 216,000 units are affected across the US and Canada.

    Product
    Henke-Ject-2 part luer sterile single use syringes - used for intravenous, intramuscular, subcutaneous, intracutaneous and intraarterial injection of liquids or diluted drugs in combination with an adequate medical device or for withdrawal of fluids from the body. Ref: 4100.00
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2629-2023·2023-10-04

    Aquilex Fluid Control System May Cause Fluid Overload During Hysteroscopy

    The Aquilex Fluid Control System (Models AQL-100PBS, AQL-100P) display may freeze at maximum volume (30,000 ml) during long procedures, causing inaccurate fluid monitoring and potential fluid overload.

    Product
    Aquilex Fluid Control System-Intended to provide fluid distension of the uterus during diagnostic and operative hysteroscopies and to monitor the volume differential between the irrigation fluid flowing into and out of the uterus. Models AQL-100PBS and AQL-100P
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2644-2023·2023-10-04

    B.Braun NORM-JECT Luer Lock Solo 10ml Syringe Sterility Recall

    B.Braun NORM-JECT Luer Lock Solo 10ml sterile syringes are being recalled because the sterile blister packaging may be damaged, potentially compromising sterility. The recall affects 604,800 units distributed nationwide.

    Product
    B.Braun NORM-JECT Luer Lock Solo, 10 ml, Sterile-Intended to be used to deliver (inject) or withdraw an accurate metered dose of a fluid to/from the body. Distributed by: Air-Tite Products Co., Inc, 565 Central Drive, Virginia Beach, VA 23454. REF: NJ-4606728-02
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2640-2023·2023-10-04

    3M Attest Biological Indicators Cap May Melt During Sterilization

    3M is recalling 77,280 Attest biological indicators due to caps that may melt, deform, or crack during steam sterilization cycles, potentially compromising process validation.

    Product
    3M Attest Super Rapid 5 Steam-Plus Steam Challenge Pack, REF 41482VF; designed to qualify and monitor dynamic-air removal steam sterilization processes
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2646-2023·2023-10-04

    Medical Device Software May Display Duplicate Medication Doses

    BD Pyxis MedBank MedPass Software may continue displaying dispensed medication doses as available, risking duplicate medication administration to patients.

    Product
    BD Pyxis MedBank MedPass Software, REF: 139088-01
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-2634-2023·2023-10-04

    Medical devices recalled due to potential rodent exposure and temperature excursion

    Inmar Supply Chain Solutions recalled various medical devices nationwide due to potential rodent exposure and temperature excursions. Affected products include bandages, tampons, condoms, blood glucose monitors, adult diapers, COVID-19 test kits, and pregnancy tests.

    Product
    Various Medical Products stored on pallets, including but not limited to bandages, tampons, condoms, blood glucose monitors, adult diapers, COVID-19 test kits, and pregnancy tests.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2628-2023·2023-10-04

    Ambu aView 2 Advance Monitor Recalled Due to Battery Combustion Risk

    Ambu Inc. is recalling the aView 2 Advance Monitor because multiple impacts can cause the device to short-circuit and potentially combust the lithium-ion battery, resulting in smoke and flames.

    Product
    Ambu aView 2 A Monitor-The Ambu aView 2 Advance is intended to display live imaging data from compatible Ambu visualization devices, portable endoscopy system. Catalog No: 405011000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2633-2023·2023-10-04

    exoplan 3.1 Dental Software Filtering Error Affects Surgical Guide Planning

    Dental planning software exoplan 3.1 contains a filtering error that may display all surgical guide options instead of only supported ones, potentially causing patient injury.

    Product
    exoplan version 3.1 Rijeka Software -A medical software, intended to support the pre-operative planning of dental implants using the visualization of the implant placement within images of the patents anatomy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2643-2023·2023-10-04

    B. Braun NORM-JECT Sterile Syringes Recalled Due to Packaging Damage

    B. Braun NORM-JECT Luer Solo 10 ml sterile syringes are recalled because blister packaging may be damaged, potentially compromising sterility. Approximately 534,000 units are affected; lot numbers 22M28C8 and 23A09C8 are included.

    Product
    B. Braun NORM-JECT Luer Solo, 10 ml, Sterile-Intended to be used to deliver (inject) or withdraw an accurate metered dose of a fluid to/from the body. Distributed by: Air-Tite Products Co., Inc, 565 Central Drive, Virginia Beach, VA 23454. REF: NJ-4606108-02
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2647-2023·2023-10-04

    Baxter Epiphany Cardio Server E3 Caliper Tool Non-Responsive in ECG System

    Baxter Healthcare issued an urgent correction for the Epiphany Cardio Server E3 ECG Management System because the caliper tool may become non-responsive, temporarily preventing its use. Affects 89 units distributed across the US, Canada, and Bermuda.

    Product
    Baxter Epiphany Cardio Server E3 ECG Management System Servers with software versions: a) v6.1.x, b) v6.2.x, c) v7.0.x.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2528-2023·2023-09-27

    Intensive Care Ventilators Recalled Due to Capacitor Degradation Risk

    Hamilton Medical is recalling 12 intensive care ventilators (model Hamilton-MR1) due to degrading capacitors that may leak electrolyte, potentially causing ventilation interruption. The recall affects specific serial numbers across the US and Puerto Rico.

    Product
    Hamilton-MR1, REF: 161010, Intensive Care Ventilator
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2530-2023·2023-09-27

    Ventilator Spare Parts Recalled for Degrading Capacitor Risk

    Hamilton Medical is recalling ventilator spare parts (ESM Shielding Set) due to potentially degrading capacitors on the control board. These capacitors may leak electrolyte and cause a short circuit, interrupting ventilation.

    Product
    Hamilton-T1, REF: MSP161339/02, ESM Shielding Set, Spare Part for ventilator
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2527-2023·2023-09-27

    Hamilton-T1 Ventilator Recall: Degrading Capacitors May Interrupt Ventilation

    Hamilton Medical recalls 1,216 Hamilton-T1 ventilators due to degrading capacitors on the control board that may leak electrolyte and interrupt ventilation. The recall affects units distributed nationwide in the US and Puerto Rico.

    Product
    Hamilton-T1, REF: 161009, Intensive Care and Transport Ventilator
    Category
    Medical Device
    Distribution
    Distributed nationwide