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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13351–13375 of 13837

  • ModerateFDA (Devices)·Z-2168-2021·2021-08-11

    Infant Heel Warmer Instructions Updated for Activation Safety Warning

    ROi CPS LLC is updating instructions for the Regard NEWBORN KIT infant heel warmer (688 units in Missouri) to include a warning: activate away from the face, infant, and others.

    Product
    Regard NEWBORN KIT, LD00201K, Item Number: 830016011. Medical convenience kit which includes an infant heel warmer.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2202-2021·2021-08-11

    Beta-Hydroxybutyrate diagnostic reagent recalled due to stability degradation

    Stanbio Laboratory is recalling Cardinal Health Beta-Hydroxybutyrate in vitro diagnostic reagents due to reagent instability causing out-of-range quality control values that may affect diagnostic accuracy.

    Product
    Cardinal Health Beta-Hydroxybutyrate . in vitro diagnostic reagent.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2200-2021·2021-08-11

    Beta-Hydroxybutyrate Diagnostic Reagent Recalled for Stability Degradation

    Stanbio Laboratory recalled Beta-Hydroxybutyrate Reagent A due to deterioration in reagent stability. The degradation resulted in out-of-range Quality Control values that could affect diagnostic accuracy.

    Product
    Beta-Hydroxybutyrate Reagent A - Enzyme (unlabeled). in vitro diagnostic reagent.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2203-2021·2021-08-11

    In Vitro Diagnostic Reagent Recalled Due to Stability Deterioration

    Cardinal Health Beta-Hydroxybutyrate diagnostic reagent has been recalled due to stability deterioration causing out-of-range quality control values. No illnesses have been reported.

    Product
    Cardinal Health Beta-Hydroxybutyrate LiquiColor for Synchron CX/LX/DX. in vitro diagnostic reagent.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2005-2021·2021-08-04

    Recirculator 8.0s Disposable Lavage Kit recalled for potential aluminum ion release

    Eight Medical International BV is recalling the Recirculator 8.0s Disposable Lavage Kit due to potential aluminum ion release during warming therapy that may expose patients under certain use conditions.

    Product
    Recirculator 8.0s Disposable Lavage Kit (product code number 8100) , GTIN: 08719992086016. Hyperthermic Perfusion System intended to raise the temperature of the thoracic or peritoneal cavity to a target temperature.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2157-2021·2021-08-04

    Zippie Voyage Early Intervention Stroller Seating System May Detach

    Sunrise Medical recalls Zippie Voyage early intervention strollers because the seating system may unexpectedly detach and fall, causing injury. Approximately 9,865 devices are affected.

    Product
    Zippie Voyage, early intervention stroller - Product Usage: is manually operated by a caregiver for purposes of assisting a disabled person while providing supportive elements for assisted transportation and seating for a child or small adult not to exceed 75 pounds.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2158-2021·2021-08-04

    Zippie Voyage Early Intervention Stroller Seating System Detachment

    Sunrise Medical is recalling the Zippie Voyage early intervention stroller due to unexpected seating system detachment that can cause falls and injury. Approximately 4,741 devices are affected worldwide.

    Product
    Zippie Voyage, early intervention stroller - Product Usage: is manually operated by a caregiver for purposes of assisting a disabled person while providing supportive elements for assisted transportation and seating for a child or small adult not to exceed 75 pounds.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-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-2154-2021·2021-08-04

    Daily Toric Contact Lenses Recalled for Misaligned Axis Mark

    CooperVision is recalling SOFMED BREATHABLES 1 DAY TORIC contact lenses (Lot W0106167) due to misaligned axis marks that can cause blurred vision. Affected lenses were distributed in the US and internationally.

    Product
    SOFMED BREATHABLES 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-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-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-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-2162-2021·2021-08-04

    Coaxial Interventional Needles Recalled for Potential Sterilization Defects

    INNOVATIVE TOMOGRAPHY PRODUCT GMBH is recalling Coaxial Interventional Needles distributed in California due to potential sterilization defects. Needles labeled as sterile may not have been adequately sterilized, creating infection risks.

    Product
    Coaxial Interventional Needle, ITP innotom.com, CE 0297, STERILE EO for the following article numbers: Article no. KIM 22/05, Length 50 mm, diameter 22G/0,7 mm; Article no. KIM 22/07,Length 75 mm, diameter 22 G (0.7 mm); Article no. KIM 22/10, Length 100 mm, diameter 22 G
    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-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-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-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-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-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-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-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-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-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