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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5076–5100 of 39987

  • HighFDA (Devices)·Z-0581-2025·2024-12-11

    BIORAPTOR Suture Anchors Recalled for Sterile Barrier Packaging Breach

    Smith & Nephew is recalling BIORAPTOR Suture Anchors due to inadequate packaging design that fails to maintain sterile barriers, potentially contaminating the implant. No injuries or illnesses have been reported.

    Product
    BIORAPTOR Suture Anchors. Tendon/ligament, non-bioabsorbable bone anchor.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0644-2025·2024-12-11

    MEDLINE circumcision kits recalled due to defective smoke evacuation component

    MEDLINE is recalling circumcision kits manufactured with SafeAir Smoke Evacuation Pencils that were previously recalled by Stryker. No injuries have been reported.

    Product
    MEDLINE convenience kits labeled as: 1) CIRCUMCISION PACK, REF DYNJ16826O; 2) D-CIRCUMCISION PACK, REF DYNJ64432; 3) PACK,CIRCUMCISION ASC, REF DYNJ906909A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0590-2025·2024-12-11

    Medical Device: BD MAX System Service Credential Breach Poses Unauthorized Access Risk

    An unauthorized actor accessed service credentials for Becton Dickinson's BD MAX diagnostic systems. Until credentials are updated, there is risk of unauthorized access that may impact data confidentiality, system integrity, and availability.

    Product
    BD MAX System, BD MAX Instrument Version or Model: 441916 Catalog Number: 441916
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0647-2025·2024-12-11

    MEDLINE Surgical Convenience Kits Recalled Due to Defective Smoke Evacuation Equipment

    Medline is recalling surgical convenience kits that contain defective smoke evacuation pencils previously recalled by Stryker. The 478 affected units were distributed nationwide; healthcare facilities should discontinue use immediately and contact Medline for instructions.

    Product
    MEDLINE convenience kits labeled as: 1) TOT/ GYN LITHOTOMY CDS, REF CDS985431J; 2) TOT/ GYN LITHOTOMY CDS, REF CDS985431K; 3) TOT/ GYN LITHOTOMY CDS, REF CDS985431L; 4) GENERAL LITHOTOMY PACK, REF DYNJ44153G; 5) CHRISTUS AH GYN LAPAROSCOPY, REF DYNJ60924C; 6) D&C PAC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0599-2025·2024-12-11

    Atellica CH β2-Microglobulin Reagent Produces Falsely Depressed Results

    Siemens Atellica CH β2-Microglobulin reagent may produce falsely depressed test results for samples between 18-30 mg/L, potentially leading to missed or delayed kidney disease diagnoses. No illnesses have been reported.

    Product
    Atellica¿ CH ¿2-Microglobulin (B2M) - In vitro diagnostic use in the quantitative determination of ¿2-microglobulin in human serum and plasma. Siemens Material Number (SMN): 11097635
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0582-2025·2024-12-11

    Cook Medical HEMO-7-EU Hemospray Devices Recalled for Activation Knob Defect

    Cook Medical HEMO-7-EU Hemospray devices are being recalled because the activation knob may crack or break during use due to manufacturing defects. The affected devices were distributed to Argentina, Brazil, and Israel.

    Product
    Cook Medical HEMO-7-EU Hemospray Endoscopic Hemostat, REF G24663, 2.8 cm, sterile.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0606-2025·2024-12-11

    CT imaging system issue causes progressive image rotation during scans

    GE Healthcare CT systems have a technical issue causing progressive image rotation during helical and cardiac scans. No injuries reported, but unnoticed rotation could affect diagnosis or require rescans.

    Product
    GE Healthcare Revolution Ascend Elite, Model Number 6967000-100; X-ray/computed tomography system
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0578-2025·2024-12-11

    Ziehm Vision RFD X-ray System Hand Switch May Cause Unintended Radiation

    Orthoscan's Ziehm Vision RFD fluoroscopic x-ray systems may have wired hand switches that fail under mechanical stress, potentially causing unintended radiation. The manufacturer is recalling affected units in the U.S. and Puerto Rico.

    Product
    Ziehm Vision RFD. Interventional fluoroscopic x-ray system
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0615-2025·2024-12-11

    GE Healthcare CT Operator Console Update: Images May Rotate Progressively

    GE Healthcare operator console upgrades for certain CT systems can cause progressive image rotation during scans. Images may rotate up to 56 degrees per exam, potentially affecting diagnostic accuracy.

    Product
    GE Healthcare Operator Console Upgrade Types, FRU Spare Parts Number B80522DA: China Only: Revolution Discovery CT
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0608-2025·2024-12-11

    GE Healthcare CT Systems Recalled Due to Progressive Image Rotation

    GE Healthcare CT systems may display progressively rotated images, particularly in helical, cine, and cardiac scans. Rotations up to 56 degrees may affect image interpretation and could necessitate additional patient scanning.

    Product
    GE Healthcare Revolution EVO, Model Number 5454001-260; X-ray/computed tomography system
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0575-2025·2024-12-11

    X-ray system hand switch may fail, risking unintended radiation exposure

    Three Ziehm Vision x-ray systems have hand switches that may fail under mechanical stress, potentially causing unintended radiation. Owners should verify their serial numbers and contact the manufacturer.

    Product
    Ziehm Vision system, x-ray, tomography, computed.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0595-2025·2024-12-11

    BACTEC 9120 System Recalled Due to Compromised Service Credentials

    BD recalled BACTEC 9120 Systems because technical support credentials were compromised by an unauthorized actor. Until credentials are updated, there is a risk of unauthorized access to the devices and associated data.

    Product
    BACTEC 9120 System Version or Model: 445570 Catalog Number: 445570
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0649-2025·2024-12-11

    Medline recalls surgical kits containing Stryker smoke evacuation pencil component

    Medline is recalling medical convenience kits containing SafeAir Smoke Evacuation Pencils that were previously recalled by Stryker.

    Product
    MEDLINE convenience kits labeled as: 1) ORTHO LAMINECTOMY-LF, REF CDS780112J; 2) NEURO CRANIOTOMY CDS #36-RF, REF CDS780119V; 3) BASIC BACK CDS, REF CDS780147N; 4) INSTRUMENTED BACK CDS, REF CDS780148Q; 5) INSTRUMENTED BACK CDS, REF CDS780148R; 6) TOTAL HIP, REF CDS920027W
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0601-2025·2024-12-11

    GE Healthcare Optima 520 CT systems recalled for image rotation

    GE Healthcare recalled 11 Optima 520 CT systems that produce progressively rotated scan images in helical, cine, and cardiac modes, potentially affecting diagnostic accuracy.

    Product
    GE Healthcare Optima 520, Catalog number 5439126; X-ray/computed tomography systems
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0593-2025·2024-12-11

    BD BACTEC FX Instrument Top credential compromise enables unauthorized access risk

    BD service credentials for BACTEC FX instruments were accessed by an unauthorized actor, creating risk of unauthorized system access until credentials are updated.

    Product
    BD BACTEC FX, Instrument Top, Packaged Version or Model: 441385 Catalog Number: 441385
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0598-2025·2024-12-11

    Cartiva Synthetic Cartilage Implants Recalled Due to Higher Complication Rates

    Cartiva Synthetic Cartilage Implants are being recalled due to higher-than-expected rates of complications including implant displacement, subsidence, nerve damage, and fragmentation. Patients with these implants should consult their surgeon.

    Product
    Cartiva Synthetic Cartilage Implant (SCI) Catalog: CAR-06-US (6mm), CAR-08-US (8mm), CAR-10-US (10mm), CAR-12-US (12mm)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0620-2025·2024-12-11

    Olympus Removes Acecide-C Disinfection from GIF-1TH190 Endoscope Reprocessing

    Olympus has removed high-level disinfection with Acecide-C as an approved reprocessing method for the GIF-1TH190 gastrointestinal videoscope. Approximately 1,770 units nationwide are affected.

    Product
    EVIS EXERA III Gastrointestinal Videoscope GIF-1TH190. Model Number: GIF-1TH190
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0589-2025·2024-12-11

    BD COR GX Instrument recalled due to compromised service credentials

    Becton Dickinson recalls the BD COR GX Instrument due to unauthorized access to product service credentials. Until credentials are updated, there is a risk of unauthorized device access and potential impact to data security.

    Product
    BD COR GX Instrument Version or Model: 443990 Catalog Number: 443990
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0592-2025·2024-12-11

    BD Phoenix M50 Automated Microbiology System Service Credentials Exposed

    BD confirmed that service credentials used by technical support teams were accessed by an unauthorized actor, creating a risk of unauthorized access to BD microbiology systems and associated data.

    Product
    BD Phoenix M50 Automated Microbiology System Version or Model: 443624 Catalog Number: 443624
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0524-2025·2024-12-11

    Fusion Pro 24 Laser Safety Interlock Fails, Allowing Dangerous Radiation Exposure

    Epilog Laser Corp. is recalling Fusion Pro 24 Model 17000 laser systems because an incorrectly placed interlock device allows the front-loading door to open during operation, potentially exposing users to Class 4 laser radiation.

    Product
    Fusion Pro 24, Model 17000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0579-2025·2024-12-11

    Ziehm Vision RFD 3D Hand Switch Defect May Cause Unintended Radiation

    The Ziehm Vision RFD 3D hand switch can fail when exposed to mechanical stress like dropping, potentially initiating unintended radiation from the x-ray system.

    Product
    Ziehm Vision RFD 3D. Interventinoal fluoroscopic x-ray system
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0604-2025·2024-12-11

    CT imaging systems may display progressively rotated images in certain scan modes

    Certain GE Healthcare CT systems may display progressively rotated images, particularly during helical, cine, or cardiac scans. The rotation increases with each image, potentially reaching 56 degrees maximum.

    Product
    GE Healthcare Revolution Advance, Model number 5849504; X-ray/computed tomography systems
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0584-2025·2024-12-11

    BD EpiCenter Medical Device Software Service Credentials Accessed by Unauthorized Party

    BD EpiCenter software service credentials were accessed by an unauthorized actor. Until credentials are updated, there is risk of unauthorized access to the software and associated data.

    Product
    BD EpiCenter Single User Software Version or Model: 441007 Catalog Number: 441007
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0634-2025·2024-12-11

    Medline Convenience Kits Recalled Due to Defective Smoke Evacuation Component

    Medline is recalling 14,388 surgical convenience kits nationwide manufactured with certain lots of SafeAir Smoke Evacuation Pencils previously recalled by Stryker. Affected kits should not be used.

    Product
    MEDLINE convenience kits labeled as: 1) LAKELAND SINGLE BASIN PACK-LF, REF DYNJ0619907I; 2) LAKELAND SINGLE BASIN PACK-LF, REF DYNJ0619907K; 3) LKLND SNGL BASIN PK RFID-LF, REF DYNJ0619907L; 4) BASIN SET W/ RING BASIN, REF DYNJ06966M; 5) OPEN HEART C--BASIN PACK-LF, RE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0637-2025·2024-12-11

    MEDLINE Burn Convenience Kits Recalled Due to Defective Component

    MEDLINE is recalling 486 burn convenience kits because they were manufactured using SafeAir Smoke Evacuation Pencil components that were previously recalled by Stryker.

    Product
    MEDLINE convenience kits labeled as: 1) BURN, REF CDS983465M; 2) BURN, REF CDS983465N; 3) BURN PACK, REF DYNJ63331D
    Category
    Medical Device
    Distribution
    Distributed nationwide