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.

Filters

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All agenciesFDA (Food)FDA (Drugs)FDA (Devices)USDA FSISCPSCNHTSAEPA

Category

All categoriesFoodDrugMedical DeviceVehicleConsumer Product

Minimum severity

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

Clear filters

12501–12525 of 13837

  • HighFDA (Devices)·Z-0416-2022·2021-12-29

    Philips Allura Xper FD Ceiling Monitors Risk Falling Due to Loose Screws

    Set screws on ceiling-mounted extra monitors can loosen, causing monitors to fall and potentially injure patients, staff, or service technicians.

    Product
    Philips Allura Xper FD series with Software Version Number: 2.1.x- intended for Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures. Model Number: 722005, 722006, 722008, 722010, 722012, 722013
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0412-2022·2021-12-29

    Leica M220 F12 Surgical Microscope Optics Carrier May Drop Into Surgical Field

    Leica Microsystems is recalling 2,800 M220 F12 surgical microscopes because the optics carrier may unintentionally drop into the surgical field, risking patient contact. No injuries have been reported.

    Product
    Leica Microsystems M220 F12 Microscope Systems
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0401-2022·2021-12-29

    Wright Medical CHARLOTTE MTP Hex Screw Recall: Incorrect Product in Packaging

    Wright Medical recalled 22 units of CHARLOTTE MTP Hex Screws with incorrect product in packaging. Affected lots 02010697711582590 and 02010697711582591 were distributed to surgical facilities in the US, Canada, Australia, Spain, UK, and Chile.

    Product
    Wright Medical Technology Inc. CHARLOTTE MTP Hex Screw, Model #41122718, 2.7mm x 18mm, a component of the CHARLOTTE Lisfranc Reconstruction System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0397-2022·2021-12-29

    VirtuTRAX Instrument Navigator Sensor May Fail to Tighten Properly

    Civco Medical Instruments is recalling VirtuTRAX Instrument Navigator sensors because they may fail to tighten properly onto surgical instruments. This functional defect could affect safe use during medical procedures.

    Product
    VirtuTRAX Instrument Navigator, Sensor with 10 17 GA VirtutTRAX
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0403-2022·2021-12-29

    Hemashield Gold Knitted Bifurcated Vascular Graft Mislabeling Recall

    Maquet Cardiovascular is recalling Hemashield Gold vascular grafts due to probable mislabeling. A different graft product may have been packaged in the carton.

    Product
    Hemashield Gold Knitted Bifurcated, 18 mm x 9 mm; reference number M002020851890
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0399-2022·2021-12-29

    Cholesterol Reagent Recalled for Calibration Failures and Erroneous Results

    Beckman Coulter is recalling 1,433 units of a cholesterol reagent that may fail calibration and produce erroneous low test results. Affected units were distributed nationwide and internationally.

    Product
    SYNCHRON Systems Cholesterol (CHOL) Reagent, REF: 467825
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0402-2022·2021-12-29

    Nurse Call Communication System Components May Fail to Reboot

    Hill-Rom's NaviCare and Voalte nurse call communication systems may experience an unrecoverable software error causing components to fail reboot cycles and become non-functional, requiring replacement.

    Product
    These are communication systems, labeled as: a. NaviCare Nurse Call, Part Numbers: 3.6, 3.7, 3.9 b. Voalte Nurse Call, Part Number 4.0 *Product was rebranded from NaviCare to Voalte in 2020
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0408-2022·2021-12-29

    Malosa Core Phaco Pack 2 Surgical Kit Recalled for Packaging Sterility Risk

    Beaver Visitec International is recalling the Malosa Core Phaco Pack 2 medical refractive kit due to small holes in the kit packaging that may compromise product sterility.

    Product
    Malosa Core Phaco Pack 2- Medical Refractive Kit intended to be used to aid in cataract, corneal, or refractive surgery. Part Number: MMK834/1
    Category
    Medical Device
    Distribution
    9 states
  • ModerateFDA (Devices)·Z-0396-2022·2021-12-29

    VirtuTRAX Instrument Navigator recalled for potential tightening failure

    Civco Medical Instruments is recalling VirtuTRAX Instrument Navigator devices due to a potential defect that may prevent proper tightening onto medical instruments. The device was distributed worldwide.

    Product
    VirtuTRAX Instrument Navigator, 14 Ga VirtuTRAX
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0413-2022·2021-12-29

    Testicular Prosthesis Recalled Due to Incorrect Size Labeling

    Coloplast Manufacturing is recalling Torosa Saline-Filled Testicular Prosthesis (Size Small) due to incorrect size labeling. Nineteen units were distributed in the US and Canada.

    Product
    Torosa Saline-Filled Testicular Prosthesis (Size Small)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0404-2022·2021-12-29

    Stanbio TDM/B-Hydroxybutyrate Controls Recalled Due to Improper Storage Temperature

    Medline Industries is recalling Stanbio TDM/B-Hydroxybutyrate Tri-Level Controls due to improper storage conditions. The product was shipped at room temperature instead of the required refrigerated environment.

    Product
    Stanbio TDM/B-Hydroxybutyrate Tri-Level Controls, Ref. No. 2460-605
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0336-2022·2021-12-22

    Cardiosave Hybrid IntraAortic Balloon Pump Recall Due to Fluid Ingress Risk

    Datascope Corp. is recalling Cardiosave Hybrid IntraAortic Balloon Pumps due to the risk of fluid entering the device, which could cause system failure and hemodynamic instability.

    Product
    Cardiosave Hybrid IntraAortic Balloon Pump. Model Numbers: 0998-00-0800-31, 0998-UC-0800-31, 0998-00-0800-32, 0998-UC-0800-32, 0998-00-0800-33, 0998-UC-0800-33, 0998-00-0800-34, 0998-UC-0800-34, 0998-00-0800-35, 0998-UC-0800-35, 0998-00-0800-36, 0998-UC-0800-36, 0998-00-0800-45,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0337-2022·2021-12-22

    FDA Class I Recall: Cardiosave Rescue Intra-Aortic Balloon Pump Fluid Ingress

    Datascope is recalling Cardiosave Rescue Intra-Aortic Balloon Pump devices due to possibility of fluid ingress, which could short electronic components and cause unsafe system shutdown.

    Product
    Cardiosave Rescue IntraAortic Balloon Pump. Model Numbers: 0998-00-0800-75, 0998-UC-0800-75, 0998-00-0800-83, 0998-UC-0800-83, 0998-00-0800-85, 0998-UC-0800-85.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0369-2022·2021-12-22

    Cardinal Health Surgical Gowns Recalled for Potential Packaging Seal Defects

    Cardinal Health is recalling 169,262 SmartSleeve surgical gowns due to potential package seal defects that could compromise sterility. Multiple affected lot numbers span 2020-2021 production with worldwide distribution.

    Product
    SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns-Large SKU: 9011
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0370-2022·2021-12-22

    Surgical Gowns Recalled Due to Potential Packaging Seal Defects

    Cardinal Health is recalling SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns (X-Large, SKU 9041) due to potential open packaging seals that could compromise sterility. The recall affects 231,219 units distributed worldwide.

    Product
    SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns-X-Large SKU: 9041
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0376-2022·2021-12-22

    RoyalSilk Surgical Gowns Recalled for Potential Sterility Compromise

    Cardinal Health is recalling 270,839 units of RoyalSilk Non-Reinforced Surgical Gowns (X-large, SKU 9548) due to potential packaging seal failures that could compromise sterility.

    Product
    RoyalSilk Non-Reinforced Surgical Gowns X-large SKU: 9548
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0374-2022·2021-12-22

    Cardinal Health Surgical Gowns Recalled Due to Compromised Packaging Seals

    Cardinal Health Poly-Reinforced Surgical Gowns (XX-large, SKU 9070) are recalled due to potential open packaging seals that could compromise sterility. Approximately 29,893 units distributed worldwide may be affected.

    Product
    Cardinal Health Poly-Reinforced Surgical Gowns XX-large SKU: 9070
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0377-2022·2021-12-22

    Cardinal Health RoyalSilk Surgical Gowns Recalled for Potential Sterility Compromise

    Cardinal Health has recalled RoyalSilk Non-Reinforced Surgical Gowns XX-large due to the potential for packaging seals to open, which could compromise product sterility. The recall affects approximately 9,990 units distributed worldwide.

    Product
    RoyalSilk Non-Reinforced Surgical Gowns XX-large SKU: 9578
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0389-2022·2021-12-22

    X-ray therapy applicator base plates may detach from device body

    Xstrahl Limited is recalling treatment applicators for Gulmay Medical 150 and Xstrahl 150 X-ray therapy systems. The base plate may detach from the applicator body, potentially affecting treatment positioning and delivery.

    Product
    Treatment applicator for Gulmay Medical 150 or Xstrahl 150 superficial X-ray therapy system
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0364-2022·2021-12-22

    EVOS Medial Distal Femur Plate IFU contains erroneous MRI scanning conditions

    Smith & Nephew recalled EVOS Medial Distal Femur Plates because the Instructions for Use contain erroneous MRI scanning data that was incorrectly incorporated from a vendor report.

    Product
    smith&nephew EVOS MEDIAL DISTAL FEMUR PLATE, R, 5H, 90MM, REF 72573201
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0361-2022·2021-12-22

    Medline Venous Access Pack-LF Recalled for Expired Saline Component

    Medline is recalling Venous Access Pack-LF Convenience Kits because the included saline solution component expired before the kit's labeled expiration date, creating a quality and safety issue.

    Product
    Venous Access Pack-LF Convenience Kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0371-2022·2021-12-22

    Surgical gowns recalled due to potential compromised sterility from packaging seals

    Cardinal Health is recalling 363,480 units of SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns due to potential open packaging seals that could compromise product sterility.

    Product
    SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns X-large, X-long SKU: 9041EL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0381-2022·2021-12-22

    Boston Scientific ROTAPRO System Console Recalled for Manufacturing Instruction Deficiency

    Boston Scientific recalled 7 ROTAPRO rotational atherectomy system consoles due to incomplete manufacturing instructions regarding proper handling of the pneumatic kit component upon failure. Affected devices were distributed in six US states and Germany.

    Product
    Boston Scientific ROTAPRO, Rotational Atherectomy System Console, Model numbers H74939309010 (US) and H74939309030 (EU).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0380-2022·2021-12-22

    FDA Updates Instructions for Miami J Select Collar Device

    Ossur Americas is updating instructions for the Miami J Select Collar (MJS-101) and Miami J Select Collar Set (MJSR-101) to provide additional guidance on device selection and proper use nationwide.

    Product
    Miami J Select Collar, Item: MJS-101, and Miami J Select Collar Set, Item: MJSR-101 Instructions for Use
    Category
    Medical Device
    Distribution
    Distributed nationwide