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

7051–7075 of 27364

  • 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-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-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-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-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
  • 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-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-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
  • 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-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-2529-2023·2023-09-27

    Ventilator Control Board Spare Parts Recalled Due to Electrical Short-Circuit Risk

    Hamilton Medical is recalling 6 control board spare parts for ventilators due to degrading capacitors that may leak electrolyte and cause electrical short circuits, potentially interrupting ventilation.

    Product
    Hamilton C1/T1/MR1, REF: MSP161502/12, Control Board Spare part for ventilator
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2525-2023·2023-09-27

    Portable Intensive Care Ventilator Recalled for Degrading Capacitor Issue

    Hamilton Medical is recalling 164 Hamilton-C1 portable ventilators due to degrading capacitors that may leak electrolyte, causing electrical short circuits that could interrupt ventilation.

    Product
    Hamilton-C1, REF: 161001, Portable Intensive Care 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
  • HighFDA (Devices)·Z-2618-2023·2023-09-27

    Omnipod 5 App Software Error Prevented Control on Android Phones

    Omnipod 5 app users on certain Android phones encountered an error that prevented remote control of the insulin delivery system. The issue delayed therapy access but did not interrupt automatic insulin delivery, and was resolved by Insulet restoring cloud security settings.

    Product
    Omnipod 5 Automated Insulin Delivery System
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2605-2023·2023-09-27

    Orthopedic hip stem implant recalled due to sterilization failure

    Encore Medical has recalled a hip stem orthopedic implant that was not sterilized before shipment. Non-sterile implants may cause infection if implanted, requiring treatment and potentially revision surgery.

    Product
    DJO Surgical: CLP Hip, Stem, Polished Neck, Lateral Offset Implant, Size#3, REF: 426-11-030
    Category
    Medical Device
    Distribution
    26 states
  • HighFDA (Devices)·Z-2621-2023·2023-09-27

    Smith & Nephew knee implant recall: wrong size in packaging

    Smith & Nephew recalled 8 knee implants from a specific lot after finding packages labeled as SIZE 5N contained SIZE 4N implants instead. Patients who received these implants should contact their surgeon immediately.

    Product
    smith&nephew LEGION OXINUM POSTERIOR STABILIZED NONPOROUS FERMOAL COMPONENT, SIZE 5N, LEFT, NARROW, REF 71421265; knee joint
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-2616-2023·2023-09-27

    PDS Plus Antibacterial Sutures Recalled for Tensile Strength Defect

    Ethicon is recalling PDS Plus Antibacterial sutures from specific lots that failed internal tensile strength testing. The defective sutures could fail during or after surgery, creating a risk of serious patient harm.

    Product
    PDS Plus Antibacterial (polydioxanone) Suture, Product Numbers PDP072H40, PDP259H50, PDP416H50, PDP441H50, PDP442H50, PDP489G50, PDP489H40, PDP497G51, PDP497H16, PDP497H40, PDP498H40, PDP502V05, PDP507V05, PDP510V05, PDP515V05, PDP662H50, PDP663H50, PDP684H40, PDP9615H40, PDP9625
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2598-2023·2023-09-27

    Stryker ACM Advanced Cement Mixing System Nozzle May Disassemble

    Stryker is recalling the ACM bone cement mixing system because the break-away femoral nozzle may disassemble or break off during surgery, potentially causing loss of device function and components to fall into the surgical site.

    Product
    Stryker ACM (Advanced Cement Mixing) System: ACM Kit w/ Femoral Breakaway Nozzle-Allows the user to mix bone cement witha constant high vacuum through the process Catalog Number: 0306-563-000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2607-2023·2023-09-27

    Orthopedic implant components recalled due to sterilization failure

    Encore Medical is recalling 15 orthopedic implants (DJO Surgical Altivate Reverse) due to sterilization failure. If implanted, unsterilized components may cause infection requiring treatment, monitoring, or revision surgery.

    Product
    DJO Surgical: Altivate Reverse, Humeral Stem, Small Shell, Size 6 x 108mm, REF: 533-06-108
    Category
    Medical Device
    Distribution
    26 states
  • HighFDA (Devices)·Z-2606-2023·2023-09-27

    DJO Surgical Reverse Shoulder System Components Recalled Due to Missing Sterilization

    Reverse shoulder implant components were shipped without final sterilization, potentially leading to infection and possible revision surgery if implanted. Encore Medical is recalling 64 units distributed across the US and internationally.

    Product
    DJO Surgical: Reverse Shoulder System (RSP) Semi Humeral Socket Insert, 32mm, REF: 508-01-032; Baseplate, Glenoid HA-Coat, RSP, 6.5mm X 30mm, REF: 508-32-104; Reverse Shoulder System (RSP) Glenoid, Neutral Head W/ Retaining Screw, 36mm, REF: 508-36-101
    Category
    Medical Device
    Distribution
    26 states
  • HighFDA (Devices)·Z-2617-2023·2023-09-27

    PDS II Surgical Sutures Recalled for Tensile Strength Defect

    ETHICON is recalling specific lots of PDS II surgical sutures after internal testing confirmed some units did not meet tensile strength requirements. Approximately 868,363 units were distributed in the United States and globally.

    Product
    PDS II (polydioxanone) Suture, Product Numbers Z844G-50, D10065-05, D10085-05, D6776-05, D6776-05, D9297-05, D9297-05, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z416H-50, Z
    Category
    Medical Device
    Distribution
    Distributed nationwide