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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13326–13350 of 13802

  • HighFDA (Devices)·Z-2155-2021·2021-08-04

    Proteus 235-Proton Therapy System May Deliver Unintended Radiation

    The Proteus 235-Proton Therapy System may deliver proton therapy without prescribed beam gating if the user forgets to select the trigger input. This could cause radiation to be positioned incorrectly.

    Product
    Proteus 235-Proton Therapy System
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-2151-2021·2021-08-04

    CooperVision Contact Lenses Recalled for Misaligned Axis Mark

    CooperVision is recalling MEDIFLEX ELITE 1 DAY TORIC daily disposable contact lenses (lot W0106167) due to misaligned axis marks that can cause blurred vision.

    Product
    MEDIFLEX ELITE 1 DAY TORIC Power -07.00 -1.75/170 Daily Disposable Contact Lens with UV blocker
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2156-2021·2021-08-04

    Affinity Four Birthing Bed Latch Mechanism Defect Poses Fall Risk

    The latch mechanism on the Lift-Off foot section of certain Affinity Four Birthing Beds may be damaged, potentially causing improper engagement and creating a fall risk for patients. Hill-Rom is recalling approximately 1,096 affected beds.

    Product
    Affinity Four Birthing Bed-used as a birthing bed for women of child bearing age in an LDR (Labor, Delivery, Recovery) or LDRP (Labor, Delivery, Recovery, Postpartum) setting within the acute care Labor and Delivery market Model Numbers: P3700B, P3700C, P3700D, & P3700E
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2166-2021·2021-08-04

    Medical inflation device recalled due to handle separation risk

    Merit Medical Systems is recalling basixALPHA Inflation Devices due to a design flaw where the syringe handle can separate when withdrawn, affecting device functionality.

    Product
    basixALPHA Inflation Device 30 atm/bar 20 mL - Product Usage: Used to inflate and deflate an angioplasty balloon or other interventional device, and to measure the pressure within the balloon.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2160-2021·2021-08-04

    OEC 3D Imaging X-Ray Systems Recalled for Coin Cell Battery Depletion

    GE OEC Medical Systems is recalling certain OEC 3D Imaging fluoroscopic X-ray systems due to potential premature depletion of the coin cell battery used to monitor X-ray tube temperature, which could cause the system to become inoperable.

    Product
    OEC 3D Imaging, Image-Intensified Fluoroscopic X-Ray System, Mobile - Product Usage: designed to provide fluoroscopic and digital spot images of adult and pediatric populations during diagnostic, interventional, and surgical procedures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2150-2021·2021-08-04

    Contact lens recall: misaligned axis mark may cause blurred vision

    CooperVision is recalling CLARITI 1 DAY TORIC contact lenses (Lot W0106167) due to misaligned axis marks that may cause blurred vision. The recall affects 450 lenses distributed across select U.S. states and multiple countries.

    Product
    CLARITI 1 DAY TORIC Power -07.00 -1.75/170 Daily Disposable Contact Lens with UV blocker
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2164-2021·2021-08-04

    Semi-automatic Biopsy Needles Recalled Due to Sterilization Defect

    INNOVATIVE TOMOGRAPHY PRODUCT GMBH is recalling semi-automatic biopsy needles because labeled sterile units may not have been adequately sterilized. Affected devices distributed in California should not be used.

    Product
    Semi-automatic Biopsy-Needle, ITP innotom.com, CE 0297, STERILE EO for the following article numbers: Article no. BIM 18/10, Length 100 mm, Diameter 18 G (1.25 mm); Article no. BIM 18/15, Length 150 mm, Diameter 18 G (1.25 mm); Article no. BIM 18/20, Length 200 mm, Diameter
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2144-2021·2021-08-04

    Contact Lens Axis Mark Misalignment May Cause Blurred Vision

    CooperVision's AQUATECH PLUS 1 DAY TORIC contact lenses (lot R0121629) have misaligned axis marks that may cause blurred vision in patients.

    Product
    AQUATECH PLUS 1 DAY TORIC Power: -07.50 -0.75/060 Daily Disposable Contact Lens with UV blocker
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2134-2021·2021-08-04

    Diagnostic Genetic Probe Recalled for Unexpected Chromosome Signals

    Cytocell Ltd. is recalling CytoCell DiGeorge/VCFS genetic probes that may display unexpected chromosome signals, potentially causing misdiagnosis. Affected reagents were distributed to laboratories in multiple US states and Canada.

    Product
    CytoCell DiGeorge/VCFS TUPLE1 Region and 22q13.3 Region Probe, Model Number LPU004-A. analyte specific reagent for in vitro diagnostics
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-2137-2021·2021-08-04

    Infusomat Space Pump Administration Set Recalled for Inverted Anti-Free Flow Clip

    B. Braun Medical is recalling the Infusomat Space Volumetric Pump Administration Set due to a defect where the anti-free flow clip may be inverted, potentially causing unintended medication flow. No injuries have been reported.

    Product
    Infusomat Space Volumetric Pump Administration Set, Product Code 490100
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-2149-2021·2021-08-04

    CLARITI 1 DAY TORIC Contact Lenses Recalled Due to Axis Mark Misalignment

    CooperVision is recalling CLARITI 1 DAY TORIC contact lenses (Lot W0106167) due to misaligned axis marks that can cause blurred vision. Affected patients should discontinue use and contact their eye care provider.

    Product
    CLARITI 1 DAY TORIC -DIAGNOSTIC Power-07.00 -1.75/170 Daily Disposable Contact Lens with UV blocker
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2161-2021·2021-08-04

    OEC Elite Mobile C-Arm Recalled for Battery Depletion

    GE OEC Medical Systems is recalling 3,570 OEC Elite mobile C-arm imaging systems worldwide due to potential early depletion of the battery that monitors X-ray tube temperature, which could render the system inoperable.

    Product
    OEC Elite mobile C-arm - Product Usage: intended to provide fluoroscopic and digital spot images of the patient anatomy, interventional tools/devices, and contrast agents during diagnostic, interventional, and surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2147-2021·2021-08-04

    CooperVision CLARITI Contact Lenses Recalled for Misaligned Axis Marks

    CooperVision is recalling CLARITI 1 DAY TORIC contact lenses (Lot U0108940) because misaligned axis marks can cause blurred vision in patients.

    Product
    CLARITI 1 DAY TORIC Power -07.00 -1.25/180 Daily Disposable Contact Lens with UV blocker
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2143-2021·2021-08-04

    Contact Lens Recall: Misaligned Axis Mark May Cause Blurred Vision

    CooperVision is recalling CLARITI 1 DAY TORIC contact lenses with misaligned axis marks that may cause blurred vision. The defective lenses were distributed worldwide including multiple U.S. states.

    Product
    CLARITI 1 DAY TORIC Power: -07.50 -0.75/060 Daily Disposable Contact Lens with UV blocker
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2139-2021·2021-08-04

    GE CARESCAPE PDM monitor SpO2 display freezes during extended use

    GE Healthcare's CARESCAPE PDM-Masimo SpO2 physiological monitor displays can freeze after extended use without power down, preventing real-time oxygen saturation monitoring.

    Product
    CARESCAPE PDM-Masimo SpO2. Physiological data monitor.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2141-2021·2021-08-04

    OxyMask O2 Adult oxygen tubing disconnect hazard recalled

    Southmedic recalled OxyMask O2 Adult oxygen masks (Model OM-1125-14, Lot W73887) due to potential oxygen tubing disconnection that could interrupt oxygen delivery.

    Product
    OxyMask O2 Adult REF OM-1125-14
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2135-2021·2021-08-04

    Medtronic Endurant II Stent Graft Marker Detachment During Deployment

    Medtronic recalls Endurant II stent graft systems: the radiopaque marker bond may detach during deployment. The recall affects 18 devices in U.S. and international distribution. No illnesses or injuries reported.

    Product
    Endurant II/Endurant IIs Stent Graft System: Medtronic Endurant II Stent Graft System REF ETUF3214C102EE, ETCF3636C49EE, ETBF3216C166EE, and ETUF3614C102E. Used to treat infrarenal abdominal aortic or aortoiliac aneurysms using an endovascular approach.
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-2145-2021·2021-08-04

    Contact lens recall due to misaligned axis marking

    CooperVision Inc. is recalling FRESH DAY 1 DAY TORIC contact lenses (Lot R0121629) due to misaligned axis marks that may cause blurred vision in wearers.

    Product
    FRESH DAY 1 DAY TORIC Power -07.50 -0.75/060 Daily Disposable Contact Lens with UV blocker
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2148-2021·2021-08-04

    Contact Lens Recall: Misaligned Axis Mark May Cause Blurred Vision

    CooperVision is recalling SPECSAVERS UMERE TORIC daily disposable contact lenses with UV blocker due to a manufacturing defect in which misaligned axis marks may cause blurred vision.

    Product
    SPECSAVERS UMERE TORIC Power -07.00 -1.25/180 Daily Disposable Contact Lens with UV blocker
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2136-2021·2021-08-04

    Medtronic Endurant IIs stent graft system marker detachment recall

    Medtronic is recalling 21 Endurant IIs stent graft systems due to radiopaque marker bond detachment during device deployment. The defect could affect surgical visualization and device positioning.

    Product
    Medtronic Endurant IIs Stent Graft System Medtronic Endurant IIs Stent Graft System REF ESBF3614C103EE and ESBF3214C103E. Used to treat infrarenal abdominal aortic or aortoiliac aneurysms using an endovascular approach.
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-2159-2021·2021-08-04

    Medtronic Vectris SureScan MRI lead kits recalled for incorrect labeling

    Medtronic Neuromodulation is recalling 1131 units of Vectris SureScan MRI lead kits with incorrect electrode spacing information on packaging labels. This could affect proper device installation.

    Product
    Medtronic Vectris SureScan MRI, Catalog Numbers: a) 977A260 b) 977A275 c) 977A290
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2140-2021·2021-08-04

    Heater Cooler Unit Recall Due to Potential Bacterial Contamination Risk

    Maquet Medical Systems USA is recalling 33 Heater Cooler Unit (HCU 30) devices due to potential water contamination in device circuits that could introduce Mycobacteria or other bacteria. The devices were distributed to nine U.S. states.

    Product
    Heater Cooler Unit (HCU 30) The device supplies temperature-controlled water for cardioplegia heat exchangers and for blood heat exchangers in extracorporeal circulation and for blankets with which patients can be warmed or cooled.
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Devices)·Z-2138-2021·2021-08-04

    RayStation radiation treatment planning system positioning error recall

    RayStation versions 9A through 11A may set initial delivery positions incorrectly during setup beam localization. Five units are affected; no patient injuries reported.

    Product
    RayStation (Radiation Treatment Planning System) : RayStation 9A, 9B, 9B SP1, 10A, 10A SP1, 10B and 11A, in combination with RayCare Model Numbers/ UDI: RayStation 9.0 (9.0.0.113) 07350002010174; RayStation 9.1 (9.1.0.933) 07350002010266; RayStation 9.1 Service Pack 1 (
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2163-2021·2021-08-04

    Coaxial Interventional Needles recalled for potential sterilization failure

    Coaxial Interventional Needles from INNOVATIVE TOMOGRAPHY PRODUCT GMBH may not be properly sterilized. Multiple lot numbers are affected and should not be used.

    Product
    Coaxial Interventional Needle, ITP innotom.com, CE 0297, STERILE EO for the following article numbers: Article no. KIR 23/05, Length 50 mm, Diameter 23 G (0.6 mm); Article no. KIR 23/05N, Length 50 mm, Diameter 23 G (0.6 mm); Article no. KIR 23/07, Length 75 mm, Diameter 2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2146-2021·2021-08-04

    CooperVision CLARITI 1 DAY TORIC contact lenses recalled for axis mark misalignment

    CooperVision is recalling CLARITI 1 DAY TORIC daily disposable contact lenses due to misaligned axis marks that can cause blurred vision. Affected lenses in lot U0108833 were distributed in seven US states and internationally.

    Product
    CLARITI 1 DAY TORIC Power -07.00 -1.75/170 Daily Disposable Contact Lens with UV blocker
    Category
    Medical Device
    Distribution
    Distributed nationwide