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

Agency

Category

Minimum severity

Clear filters

12376–12400 of 13802

  • ModerateFDA (Devices)·Z-0498-2022·2022-01-26

    Medical Device Assay Kits Recalled for Potential Instrument Leakage

    Luminex Corporation is recalling ARIES HSV 1&2 Assay kits due to a potential leak that may occur inside the ARIES diagnostic instrument. No illnesses or injuries have been reported.

    Product
    ARIES HSV 1&2 Assay, Part Number/REF 50-10017
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0505-2022·2022-01-26

    Medical Device Mattress Recalled for Labeling Non-Compliance with FDA Requirements

    Philips is recalling 141,750 Infa-Therm Transport Mattresses because modified labeling does not comply with FDA clearance requirements. The devices cannot be distributed or sold without new FDA clearance.

    Product
    Infa-Therm Transport Mattress, Reference Number 989805616831 1015
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0506-2022·2022-01-26

    Infant Heel Warmers Recalled for Unauthorized Labeling Changes

    Philips North America is recalling 5,164,600 units of Infant Heel Warmers due to labeling changes made after FDA clearance without new approval. The devices cannot be distributed or sold without new FDA 510(k) clearance.

    Product
    Infant Heel Warmers w/strap, Reference # 989805603201 1223
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0468-2022·2022-01-19

    Maquet Sevoflurane vaporizer filling recalled due to potential hydrogen fluoride exposure

    Getinge Usa Sales Inc recalls Vaporizer Sevoflurane components in anesthesia systems due to potential chemical degradation that may cause hydrogen fluoride exposure via inhalation or skin contact.

    Product
    Vaporizer Sevoflurane Maquet Filling, Part No. 6886601 Component of the following systems: Product Code(s) UPN/UDI: Flow-c Anesthesia System 6887700 07325710009765 Flow-e Anesthesia System 6887900 07325710010457 Flow-i Anesthesia System C20 6888520 07325710010617 Flow-i
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0475-2022·2022-01-19

    CT Scanner Software Update Causes Head Image Quality Degradation

    Siemens SOMATOM Definition Edge CT scanners with software version VB20_SP5 may produce degraded head images, increasing the risk of patient misdiagnosis. Devices have been distributed nationwide.

    Product
    SOMATOM Definition Edge -Computed tomography system Model 10590000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0489-2022·2022-01-19

    Hip Stem Device Recalled Due to Undersized Bore Diameter Risk

    DePuy Orthopaedics recalls the GLOBAL UNITE STD STEM SZ 14 hip stem in 451 units worldwide due to undersized spigot bore diameter. The defect may prevent proper separation of the stem during surgery without surgical delay or bone damage.

    Product
    GLOBAL UNITE STD STEM SZ 14 Product Code: 110014100
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0490-2022·2022-01-19

    Hip prosthetic stem undersized bore complicates removal surgery

    DePuy Orthopaedics' GLOBAL UNITE STD STEM prosthetics may have undersized spigot bores, complicating removal during revision surgery. Affected patients may experience surgical delays or bone damage.

    Product
    GLOBAL UNITE STD STEM SZ 16 Product Code: 110016100
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0473-2022·2022-01-19

    CT Scanner Software Defect May Degrade Image Quality

    Software version VB20_SP5 in certain Siemens CT scanners may degrade head image quality, increasing misdiagnosis risk. The recall affects 794 units distributed nationwide.

    Product
    SOMATOM Definition AS-Computed tomography system Model 8098027
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0465-2022·2022-01-19

    Subdermal Needle Electrode Corkscrew Recall: Risk of Blue Hub Detachment

    Technomed Europe is recalling 117,672 disposable subdermal needle electrodes due to risk of the blue hub detaching, potentially leaving the needle in the patient's scalp.

    Product
    Disposable Subdermal Needle Electrode, Corkscrew, Single Use, Sterile; Model Numbers TE/S50715-001-C, TE/S50725-001C, and TE/S50715-001.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0488-2022·2022-01-19

    Orthopaedic Stem Implants Recalled for Undersized Bore Manufacturing Defect

    DePuy Orthopaedics is recalling approximately 870 GLOBAL UNITE STD STEM implants worldwide because an undersized spigot bore may prevent proper separation, causing potential surgical delay or bone damage.

    Product
    GLOBAL UNITE STD STEM SZ 12 Product Code: 110012100
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0495-2022·2022-01-19

    LigaSure Blunt Tip Laparoscopic Sealer Devices Recalled for Jaw Opening Defect

    Covidien is recalling LigaSure Blunt Tip Laparoscopic Sealer/Divider devices (lot 11320187X) due to an assembly defect that may prevent the device jaws from opening after tissue application, creating a risk of bleeding and tissue injury.

    Product
    LigaSure Blunt Tip Laparoscopic Sealer/Divider, Nano-Coated, Product Number LF1837
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0478-2022·2022-01-19

    OCT Camera Laser Safety Shut-Off Malfunction Affects Three Units

    Haag-Streit USA is recalling OCT-Camera 211 01 A3 units due to malfunction of the automatic laser beam shut-off. The device may not correctly recognize when the laser beam is safely switched off.

    Product
    OCT-Camera 211 01 A3; Running software iOCT-Control 3 v1.4
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0479-2022·2022-01-19

    Radiotherapy Planning Software BeamAdjust and VeriSoft Recalled for Measurement Errors

    PTW North America is recalling BeamAdjust 2.2 and VeriSoft 8.0 software due to measurement errors that can report incorrect radiation doses in patient treatment plans.

    Product
    Software BeamAdjust version 2.2, Catalog No: S070009 Software VeriSoft version 8.0, Catalog No: S080032
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0485-2022·2022-01-19

    DePuy Joint Stem May Have Undersized Bore, Complicating Surgical Removal

    DePuy Orthopaedics has recalled 3 units of GLOBAL UNITE REV STEM SZ 8 due to an undersized spigot bore. Separation of the implant components may not be possible without surgical delay and/or bone damage.

    Product
    GLOBAL UNITE REV STEM SZ 8 Part Number: 110008600
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0477-2022·2022-01-19

    OCT-Camera Laser Shut-Off Malfunction Poses Patient Safety Risk

    Haag-Streit OCT-Camera devices with automatic laser shut-off malfunction may fail to recognize when the laser is safely switched off, posing a potential safety risk.

    Product
    OCT-Camera 211 01 A1, Running software iOCT-Control 3 v1.4
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0471-2022·2022-01-19

    Philips Azurion X-ray System recalled for startup and emergency stop failures

    Philips recalls 10 Azurion interventional X-ray systems due to intermittent startup communication failures and emergency stop recovery issues that could prevent system restart and movement functionality.

    Product
    Philips Azurion Interventional Fluoroscopic X-ray System with Azurion R2.2 with LUC configuration start-up issue; Azurion R2.2 emergency stop recovery issue Model Numbers: 722221, 722228, 722225, 722068, 722226, 722078, 722224
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0474-2022·2022-01-19

    Computed Tomography System Software May Degrade Head Image Quality

    Siemens SOMATOM Edge Plus CT systems running software version VB20_SP5 may produce degraded head images, potentially leading to patient misdiagnosis.

    Product
    SOMATOM Edge Plus-Computed tomography system Model 1026700
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0470-2022·2022-01-19

    RefleXion Medical Radiotherapy System Recall Due to Dose Discrepancy

    Reflexion Medical is recalling three RefleXion X1 radiotherapy systems due to a potential dose discrepancy when delivering treatment in Feet First Supine patient orientation.

    Product
    RefleXion Medical Radiotherapy System - System Label: "*** refleXion REF RXM1000 ***" Physics Guide/Treatment Delivery User Manual/Treatment Planning User Manual: "RefleXion X1 Model: RXM1000"
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0483-2022·2022-01-19

    Hip Stem Component Recalled Due to Undersized Bore Diameter

    DePuy is recalling GLOBAL UNITE STD STEM SZ 6 orthopedic stems due to undersized spigot bore that may prevent safe removal during revision surgery, risking surgical delays and bone damage.

    Product
    GLOBAL UNITE STD STEM SZ 6 Part Number: 11000610
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0469-2022·2022-01-19

    Sterilized medical convenience kits recalled for missing latex warning label

    ROi CPS LLC is recalling 195 Regard T AND A - Rogers sterilized convenience kits due to missing rubber latex warning labels. Consumers with latex allergies face risk of allergic reaction if exposed to the unlabeled latex.

    Product
    Regard, T AND A - Rogers, sterilized convenience kits
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0472-2022·2022-01-19

    CT Scanner Software Defect May Degrade Image Quality Nationwide

    Siemens SOMATOM Confidence CT scanners with software version VB20_SP5 may experience degraded head image quality, creating a potential risk of misdiagnosis. The recall affects 108 units distributed nationwide.

    Product
    SOMATOM Confidence -Computed tomography systems Model 10590100
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0476-2022·2022-01-19

    Philips wireless footswitches for Allura Xper and Azurion X-ray systems recalled for connection issues

    Philips wireless footswitches used with Allura Xper and Azurion X-ray systems may experience connection issues that interrupt fluoroscopic imaging during patient procedures. The recall affects 1,971 systems distributed worldwide.

    Product
    Wireless Footswtich used with the following Philips Allura Xper and Azurion Interventional Fluoroscopic X-ray System . Model Number: 722001, 722002, 722003, 722005, 722006, 722008, 722010, 722011, 722012, 722013, 722014, 722015, 722019, 722020, 722022, 722023, 722024, 722025, 72
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0486-2022·2022-01-19

    Hip stem implants recalled due to undersized bore defect

    DePuy Orthopaedics is recalling 781 hip stem implants that may have an undersized spigot bore diameter, potentially preventing surgical removal without additional surgical delay or bone damage.

    Product
    GLOBAL UNITE STD STEM SZ 10 Part Number: 110010100
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0466-2022·2022-01-19

    Proton Therapy System software startup allows test processes to contaminate clinical environment

    The Proteus 235 proton therapy system can start clinical processes while test processes are still running, potentially using test components in clinical treatments without user notification. This could impact patient treatment if versions differ.

    Product
    Proteus 235; Version: PTS-8 versions before PTS-8.7.2
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-0491-2022·2022-01-19

    Medtronic Perfusion Kits Recalled: Missing Endotoxin Testing

    Medtronic is recalling approximately 6,653 Custom Perfusion kits used in cardiac procedures because they were labeled as non-pyrogenic without completing required endotoxin testing.

    Product
    Medtronic Custom Perfusion kits, with the following product descriptions and corresponding model numbers: 1. CUSTOM PACK BB10Q85R FILTER (Model BB10Q85R); 2. CUSTOM PACK BB11C01R MIDI DEEP (Model BB11C01R); 3. CUSTOM PACK BB7H95R22 HYP MAIN (Model B7H95R22); 4.
    Category
    Medical Device
    Distribution
    Distributed nationwide