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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4926–4950 of 39968

  • HighFDA (Devices)·Z-0810-2025·2025-01-15

    Xhibit Telemetry Receiver software versions may cause unsolicited system shutdowns

    Telemetry receivers with affected software versions may unexpectedly shut down for 1-1.5 minutes, temporarily disabling patient monitoring. This could delay clinical response if a patient event occurs during the outage.

    Product
    Xhibit Telemetry Receiver with Software, Model 96280. Intended to provide monitoring system with patient data.
    Category
    Medical Device
    Distribution
    27 states
  • HighFDA (Devices)·Z-0816-2025·2025-01-15

    Tec 820 SEV Anesthesia Vaporizer Recalled for Inadequate Anesthetic Delivery

    GE Medical Systems is recalling approximately 928 Tec 820 SEV anesthesia vaporizers due to a manufacturing defect that can cause them to deliver less anesthetic agent than the dial setting indicates. The devices are distributed nationwide and globally.

    Product
    Tec 820 SEV Anesthesia Vaporizer, Reference Number 1177-9820-SEV
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0811-2025·2025-01-15

    Mobile Radiographic System Arm May Drop Due to Missing Safety Bolts

    GE Healthcare Optima XR200amx mobile radiographic systems may have missing bolts in the Column Safety mechanism, which could allow the X-ray arm to drop if an internal cable fails.

    Product
    GE Healthcare Optima XR200amx, Mobile Digital Radiographic System, Model Numbers: 1) 5555000-3; 2) 5555000-4: 3) A0659MB
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0808-2025·2025-01-15

    Aerin Medical VivAer Stylus Recall: Programming Error Causes Device Misidentification

    Aerin Medical is recalling 479 units of VivAer Stylus (Lot #10235) due to incorrect programming in units from a single lot. When connected to the Aerin Console, affected devices will be incorrectly identified as RhinAer Stylus.

    Product
    Aerin Medical VivAer Stylus, REF CAT1785 (individual stylus), and REF CAT500 (5-pack), sterile.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0806-2025·2025-01-15

    EnVisio Patient Pad Transition Cushion surgical bed frame detachment risk

    Elucent Medical is recalling the EnVisio Patient Pad Transition Cushion due to a potential safety risk of the surgical bed frame's back section detaching during use. Approximately 283 units are affected across 16 U.S. states.

    Product
    EnVisio Patient Pad Transition Cushion, Model/Catalog Number: ENVISIO-SYS Product Description: The EnVisio Patient Pad Transition Cushion is a component of the EnVisio Navigation System which is a medical device that detects the presence of the SmartClip Soft Tissue Marker(s) an
    Category
    Medical Device
    Distribution
    17 states
  • HighFDA (Devices)·Z-0809-2025·2025-01-15

    Xhibit Telemetry Receiver may shut down, causing temporary loss of patient monitoring

    Spacelabs Healthcare's Xhibit Telemetry Receiver (Model 96280) may experience a Windows proxy issue causing the system to restart and go offline for 1-1.5 minutes, creating a temporary gap in patient monitoring.

    Product
    Xhibit Telemetry Receiver, Model 96280, with Service Manual. Intended to provide monitoring system with patient data.
    Category
    Medical Device
    Distribution
    44 states
  • ModerateFDA (Devices)·Z-0805-2025·2025-01-15

    Diagnostic Immunoassay Kits Recalled for Incorrect Expiration Date Labeling

    Qualigen is recalling 426 units of FastPack SHBG diagnostic kits due to incorrect expiration date labels on three lots. The kits were distributed to 15 U.S. states.

    Product
    The FastPack IP Sex Hormone Binding Globulin Immunoassay, Part #25000081, is for the quantitative measurement of SHBG in human serum and plasma. For in vitro diagnostic Use and contains 30 FastPacks.
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Devices)·Z-0772-2025·2025-01-08

    SynchroMed II and III implantable pumps recalled for software issues

    Medtronic recalled SynchroMed II and III implantable pumps for software issues in the clinician tablet application. Fifty-nine systems are affected.

    Product
    SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900C CLINICIAN TABLET UK with the A810 CP app version 2.x, CFN CT900C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0778-2025·2025-01-08

    Medline Surgical Procedure Kits Recalled for Endotoxin Contamination Risk

    Medline Industries is recalling 2344 custom surgical kits with non-sterile components that may contain endotoxins. The kits were distributed in the US, UAE, and Canada.

    Product
    Medline custom medical procedure kits labeled as: 1) OPEN HEART CDS-LF, REFCDS840451M; 2) NEURO PACK, REFDYNJ41516M; 3) RFD- AAA PACK, REFDYNJ54242B; 4) OPEN HEART A&B, REFDYNJ901203C; 5) OPEN HEART A&B, REFDYNJ901203D; 6) ACDF-LF, REFDYNJ906681B; 7) ACDF-LF, REFDY
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0791-2025·2025-01-08

    Medline Deep Brain Stimulation Surgical Kits Recalled for Non-Sterile Contamination

    Medline has recalled 128 Deep Brain Stimulation surgical kits for containing non-sterile Surgical Patties and Strips with potential endotoxin contamination. Affected units were distributed worldwide including the US, UAE, and Canada.

    Product
    Medline custom medical procedure kits labeled as: DEEP BRAIN STIMULATION PACK-LF
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0773-2025·2025-01-08

    Medtronic Implantable Drug Pumps Recalled for Software Defects

    Medtronic has recalled 566 SynchroMed II and III implantable drug infusion pumps due to software issues in the controlling application. No injuries or illnesses have been reported.

    Product
    SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900D CLINICIAN TABLET GLOBAL with the A810 CP app version 2.x, CFN CT900D
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0799-2025·2025-01-08

    Surgical spears recalled for potential sterile barrier defect

    Carwild Corporation recalls 300 Ivalon cellulose surgical spears (Model Q604237) due to potential package seal defects that could compromise sterility during ophthalmic surgical procedures.

    Product
    Ivalon CELLULOSE SURGICAL SPEAR- Intended To Be Used During Ophthalmic Surgical Procedures For Fluid Management Model Number: Q604237
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-0792-2025·2025-01-08

    Medline Medical Procedure Kits Recalled for Non-Sterile Component Contamination

    Medline Industries is recalling 2,664 custom medical procedure kits containing non-sterile surgical components with potential endotoxin contamination. The affected kits were distributed in the US, UAE, and Canada.

    Product
    Medline custom medical procedure kits labeled as: 1) ENSEMBLE RACHIS-LF, REF DYNJ47568B; 2) UROLOGY ROBOTIC, REF DYNJ55555D; 3) KIT,SPINE LH, REF DYNJ906448A.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0794-2025·2025-01-08

    Medline surgical procedure kits recalled for non-sterile components and endotoxin contamination

    Medline is recalling 474,300 custom surgical procedure kits because they contain non-sterile Codman Surgical Patties and Strips with potential endotoxin contamination. These components could pose infection risks during surgical procedures.

    Product
    Medline custom medical procedure kits labeled as: 1) CRANI, REF CDS780089V; 2) CRANIOFACIAL CDS, REF CDS780102K; 3) CRANIOFACIAL CDS, REF CDS780102L; 4) CRANIOFACIAL CDS, REF CDS780102M; 5) CRANIOTOMY CDS-LF, REF CDS780105K; 6) CRANIOTOMY CDS-LF, REF CDS780105L; 7) CRANIO
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0798-2025·2025-01-08

    Ophthalmic Surgical Device Recalled for Potential Sterile Barrier Compromise

    Carwild Corporation is recalling Ivalon Eye Wick 20cm surgical devices due to package seals that are out of specification and cannot guarantee sterile barrier integrity for the life of the product.

    Product
    Ivalon Eye Wick 20cm- Intended to be used for the removal and collection of fluids from the Opthalmic surgical site. Model Number: Q604206
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-0783-2025·2025-01-08

    Medline Surgical Procedure Kits Recalled for Non-Sterile Components

    Medline is recalling 943 custom surgical kits containing non-sterile Codman Surgical Patties and Strips that may be contaminated with endotoxin.

    Product
    Medline custom medical procedure kits labeled as: 1) FREE FLAP BASIC SET-UP PK, REF DYNJ0991320J; 2) MVFF/FIBU #54-RF, REF DYNJ21927R; 3) FUNCTIONAL SINUS ENDOSCOPY, REF DYNJ40406A; 4) DR GOLDSTEIN ACCESSORY PACK, REF DYNJ51818F; 5) ENDOSCOPIC SKULL BASE, REF DYNJ58648
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0774-2025·2025-01-08

    SynchroMed II and III Implantable Pumps Recalled for Software Issues

    Medtronic has recalled 3,981 SynchroMed implantable pumps worldwide due to software issues in application version 2.x used to program the devices.

    Product
    SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900E CLINICIAN TABLET GLBL SMSNG and PROG CT900E CLINICIAN TABLET PAPER EN with the A810 CP app version 2.x, CFN CT900E
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0786-2025·2025-01-08

    Medline Custom Surgical Kits Recalled for Non-Sterile Components with Endotoxin Risk

    Medline Industries is recalling 3,903 custom medical procedure kits due to non-sterile Codman Surgical Patties and Strips with potential for endotoxin contamination. The recall affects products distributed in the US, UAE, and Canada.

    Product
    Medline custom medical procedure kits labeled as: 1) MEM MAXILLOFACIAL PACK-LF, REF DYNJ0660040R; 2) FREE FLAP PACK-LF, REF DYNJ42833A; 3) FREE FLAP PACK-LF, REF DYNJ42833B; 4) TYMPANOPLASTY PACK, REF DYNJ50692C; 5) MAJOR CRANIOTOMY SAFETY, REF DYNJ54736B; 6) FREE FLAP CU
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0800-2025·2025-01-08

    Surgical Nasal Packing Devices Recalled for Sterile Barrier Defect

    Carwild is recalling Ivalon Anatomical Nasal Packing devices because the package seal may be defective, leaving the sterile barrier unable to be guaranteed. Lot 24F1638 with approximately 140 units was distributed across multiple U.S. states and internationally.

    Product
    Ivalon Anatomical Nasal Packing with Airway Tube and String, 8.0 cm x 1.5cmx 3.0 cm- Intended To Be Used During Ophthalmic Surgical Procedures For Fluid Management Model Number: Q770410
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-0784-2025·2025-01-08

    Medline Custom Surgical Procedure Kits Recalled for Potential Endotoxin Contamination

    Medline Industries is recalling custom medical procedure kits due to non-sterile Codman Surgical Patties and Strips with potential endotoxin contamination. Approximately 1,072 units were distributed in the US, Canada, and UAE.

    Product
    Medline custom medical procedure kits labeled as: 1) ENDOSCOPIC SKULL BASE, REF DYNJ58648B; 2) ENDOSCOPIC SKULL BASE, REF DYNJ58648C; 3) ENT ENDO SINUS WILMINGTON PACK, REF DYNJ66447; 4) ENDOSCOPIC SKULL BASE, REF DYNJ58648D; 5) ENDOSCOPIC SKULL BASE, REF DYNJ58648J.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0796-2025·2025-01-08

    Rigid Intracardiac Sucker Units Recalled for Potential Sterility Breach

    Med Michigan Holding recalls SUC-4300S Rigid Intracardiac Suckers due to incomplete or partial pouch seals that may compromise sterility during cardiac surgery.

    Product
    SUC-4300S, Rigid Intracardiac Sucker Fluted Tip; 1/4" (6.4mm) connector 13" (33cm) length. Indicated for handheld use only to remove excess fluid from the surgical field.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0785-2025·2025-01-08

    Medline surgical procedure kits recalled for potential endotoxin contamination

    Medline is recalling three custom surgical procedure kits due to non-sterile Codman Surgical Patties and Strips that pose a potential endotoxin contamination risk. The affected kits were distributed in the US, Canada, and the UAE.

    Product
    Medline custom medical procedure kits labeled as: 1) PANENDOSCOPY-LF, REF DYNJ36728C; 2) ENDOSCOPIC SINUS PACK, REF DYNJ40644A; 3) ENDO SINUS PACK, REF DYNJ66449.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0789-2025·2025-01-08

    Medline MICRODISECTOMY PACK recalled for endotoxin contamination

    Medline custom MICRODISECTOMY PACK kits containing non-sterile Codman Surgical Patties and Strips with potential endotoxin contamination are being recalled. Approximately 1,494 units were distributed in the US, UAE, and Canada.

    Product
    Medline custom medical procedure kits labeled as: 1) MICRODISECTOMY PACK, REF DYNJ80585A; 2) MICRODISECTOMY PACK, REF DYNJ80585B.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0780-2025·2025-01-08

    Medline custom surgical procedure kits recalled for non-sterile components and endotoxin contamination

    Medline custom procedure kits containing non-sterile Codman Surgical Patties & Strips are being recalled due to potential endotoxin contamination. The recall affects 74 units distributed in the US, UAE, and Canada.

    Product
    Medline custom medical procedure kits labeled as: 1) UMC DR. BAKER SUPPLEMENT, REF DYNJ69476; 2) DIEP FLAP, REF DYNJ910120
    Category
    Medical Device
    Distribution
    Distributed nationwide