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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12401–12425 of 13837

  • HighFDA (Devices)·Z-0497-2022·2022-01-26

    Senior Living Nurse Call Systems Failing to Alarm Due to Memory Issue

    Stanley Security Solutions is recalling 11 Senior Living Arial Emergency and Nurse Call Systems because they fail to alarm due to increased memory consumption, potentially preventing nursing staff from responding to resident emergencies.

    Product
    Senior Living Arial Emergency and Nurse Call Systems
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0504-2022·2022-01-26

    Gentueri Viral Transport Medium Recalled Due to Turbidity and Discoloration

    Gentueri Inc is recalling 4,150 units of Gentueri Viral Transport Medium (VTM) nationwide due to visual turbidity and discoloration that may compromise diagnostic samples in transit.

    Product
    Gentueri Viral Transport Medium (VTM), Sterile, IVD
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0512-2022·2022-01-26

    Dental Implant Mislabeling: Neodent Easypack Helix GM Acqua Dimension Error

    Straumann USA LLC recalls Neodent Easypack Helix GM Acqua dental implants due to mislabeling. Implants have incorrect dimensions compared to carton labels, which could affect surgical planning and placement.

    Product
    Neodent Easypack Helix GM Acqua 3.5X8/Smart 4.5X2.5 -intended for dental implant Item 138.089
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0511-2022·2022-01-26

    Microbiological Reference Products Recalled for Bacterial Contamination

    Microbiologics Inc is recalling KWIK-STIK and LYFO DISK microbiological reference products contaminated with Staphylococcus epidermidis. Fifty-nine kits were distributed to multiple U.S. states and countries.

    Product
    KWIK-STIK 2 Pack, Catalog #0894P; KWIK-STIK 6 Pack, Catalog #0894K; and LYFO DISK, Catalog #0894L; Microsporum canis derived from ATCC 36299.
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Devices)·Z-0510-2022·2022-01-26

    Voyager Rollator Walkers Recalled for Wheel Separation and Fall Risk

    Compass Health Brands is recalling 3,734 Voyager Rollator walkers due to cracking wheel spokes that may cause wheels to separate from the axle, potentially resulting in patient falls and injuries.

    Product
    Voyager Rollator-intended as a mechanical walker Model Number: RLEU10xx (RLEU10BL, RLEU10PK, RLEU10WT) RLEU10BL Voyager Rollator Cobalt Blue UPC: 815067078066; RLEU10PK Voyager Rollator Rose Gold UPC: 815067078073; RLEU10WT Voyager Rollator Ice Palace UPC: 815067078080
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0502-2022·2022-01-26

    Blood Collection Tubes Recalled Due to Lithium Heparin Variation

    Greiner Bio-One is recalling 889,200 blood collection tubes (Lot #B21053QG) due to variation in lithium heparin that may cause blood clotting. The tubes were distributed to ten U.S. states.

    Product
    greiner bio-one VACUETTE TUBE, 5 ml LH Lithium Heparin Sep, 13x100 green cap-yellow ring, non-ridged, 24 racks of 50 pcs., 1200 pcs. in total, REF 456087P
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Devices)·Z-0508-2022·2022-01-26

    Cardinal Infant Heel Warmer recalled due to unapproved labeling changes

    Philips North America recalls Cardinal Infant Heel Warmers because labeling was changed without FDA approval. The devices cannot be sold or distributed without new FDA clearance.

    Product
    Cardinal Infant Heel Warmer, Reference # 989805617251 11470-010T
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0507-2022·2022-01-26

    Heel Snuggler devices recalled for labeling changes without FDA approval

    Philips North America recalled approximately 2.5 million Heel Snuggler units because labeling was modified after FDA clearance without obtaining updated regulatory approval.

    Product
    Heel Snuggler, Reference # 989805603411 99047
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0509-2022·2022-01-26

    Medichoice Infant Heel Warmer recalled due to unapproved labeling changes

    Philips is recalling 2,925,800 Medichoice Infant Heel Warmer units because labeling was modified beyond the scope of FDA clearance. The devices cannot be sold without new 510(k) approval.

    Product
    Medichoice Infant Heel Warmer, Reference # 989805643721 1079906
    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
  • 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-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
  • 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-0484-2022·2022-01-19

    GLOBAL UNITE STD STEM orthopedic implant manufacturing defect recall

    DePuy Orthopaedics is recalling GLOBAL UNITE STD STEM orthopedic implants due to undersized spigot bore diameter that may prevent proper removal during revision surgery, risking surgical delay and bone damage.

    Product
    GLOBAL UNITE STD STEM SZ 8 Part Number: 110008100
    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-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-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-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-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-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-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-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-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-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