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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10051–10075 of 27470

  • HighFDA (Devices)·Z-0972-2022·2022-04-27

    X-ray Imaging System May Fail to Cool Tube Properly

    Siemens Artis zee biplane MN X-ray systems may have inadequate cooling in the X-ray tube circuit, causing automatic system shutdown during operation. Seven affected systems are distributed nationwide.

    Product
    Artis zee biplane MN, Model Number 10094143
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0958-2022·2022-04-27

    Acumed Cannulated Screws May Lack Sufficient Strength for Bone Fixation

    Acumed 4.0mm x 10mm Cannulated Screws may not have sufficient strength to hold bone fragments in place. This could result in improper bone healing, fracture, or soft tissue damage.

    Product
    4.0mm x 10mm Cannulated Screw, Short Thread; Part number 3005-40010
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0975-2022·2022-04-27

    X-ray Imaging System Coolant Deficiency May Disable Equipment Operation

    The Artis Q X-ray system may fail to adequately cool the X-ray tube if coolant levels drop, causing the system to disable imaging and display error messages. 418 systems are affected nationwide.

    Product
    Artis Q ceiling, Model Number 10848281
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0985-2022·2022-04-27

    Medical imaging system software errors may delay treatment procedures

    Siemens Artis icono biplane diagnostic imaging systems may experience software errors affecting block movements and detector rotation, potentially delaying treatment until the system is restarted.

    Product
    Artis icono biplane- in combination with a Siemens Healthineers table or Trumpf/MAQUET table (OEM). Intended use single and biplane diagnostic imaging and interventional procedures. Model: 11327600
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0963-2022·2022-04-27

    Sight OLO Blood Analysis Device: Incorrect Reference Ranges May Display

    The Sight OLO blood analysis device may display and print incorrect reference ranges in software versions 2.59.3 and earlier. This could occur when custom reference ranges were configured after device installation.

    Product
    The Sight OLO device is a computer vision based platform for blood analysis. The platform combines computer-vision algorithms for image processing to identify and quantify blood components (e.g., red blood cells) and their characteristics (e.g., cell volume) in an automated fa
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0979-2022·2022-04-27

    Siemens Artis Q.zen ceiling system recall: inadequate X-ray tube cooling risk

    Siemens recalls 81 Artis Q.zen ceiling imaging systems distributed nationwide due to risk of inadequate X-ray tube cooling if coolant levels fall below a critical threshold, potentially triggering system shutdown.

    Product
    Artis Q.zen ceiling, Model Number 10848354
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0977-2022·2022-04-27

    Artis Q zeego X-ray system recalled for inadequate cooling risk

    Siemens is recalling 38 Artis Q zeego X-ray systems nationwide due to a cooling circuit malfunction that may prevent adequate cooling of the X-ray tube, triggering automatic system shutdown.

    Product
    Artis Q zeego, Model Number 10848283
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0973-2022·2022-04-27

    Artis zeego X-ray imaging system recalled for insufficient cooling

    Siemens is recalling 183 Artis zeego X-ray imaging systems due to a cooling system defect that may prevent adequate X-ray tube cooling, triggering automatic system shutdown.

    Product
    Artis zeego, Model Number 10280959
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0918-2022·2022-04-20

    Cub 2 Enclosed Bed Canopy System Recalled Due to Potential Misuse

    Sensory Medical Inc recalled 225 units of the Cub 2 Enclosed Bed Canopy System for potential misuse risk. The firm is updating product warnings and precautions for devices distributed before December 16, 2021.

    Product
    Cub 2 Enclosed Bed Canopy System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0916-2022·2022-04-20

    ROTAWIRE guidewires recalled due to potentially compromised sterile pouch seals

    Boston Scientific is recalling ROTAWIRE Drive guidewires due to potentially open pouch seals that could compromise product sterility. Affected units were distributed in the US, territories, Japan, and Canada.

    Product
    ROTAWIRE Drive and wireClip Torquer, ROTAWIRE Drive Extra Support
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0913-2022·2022-04-20

    Hammertoe Correction Surgical System Recalled for Driver Connection Defect

    Nextremity Solutions recalls the Nextra Hammertoe Correction System because the driver's proximal end is oversized, making it difficult to connect and remove from the implant, potentially delaying surgery.

    Product
    Nextra Hammertoe Correction System 3.5 Middle and 3.2 Proximal Saw Cut SKU: NX-3532K-SC Orthopedic surgical instrument
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0920-2022·2022-04-20

    Verigene Processor SP Recalled for No Call Results

    Luminex Corporation is recalling 4 Verigene Processor SP diagnostic devices that repeatedly failed to produce results, returning No Call outputs instead. Two of three customer complaints involved this malfunction.

    Product
    Verigene Processor SP, Model Numbers: 10-0000-07 and 10-0000-07-R
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0924-2022·2022-04-20

    Abbott INDEFLATOR Plus 30 Device Recalled for Leaks and Connection Faults

    Abbott Vascular is recalling INDEFLATOR Plus 30 balloon inflators due to increasing complaints of leaks and intermittent loose connections that could affect device function during medical procedures.

    Product
    INDEFLATOR Plus 30 - REF 1000183 WPL2122277-01 (2019-03-01)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0937-2022·2022-04-20

    CLARAVUE Pre-wired Electrode fails to meet electrical safety specification

    Graphic Controls' CLARAVUE Pre-wired Electrode units fail to meet electrical safety specifications required for defibrillation. The device delivers an inefficient electrical charge and may result in ineffective defibrillation.

    Product
    CLARAVUE Pre-wired Electrode - IP SET M5 RT ADULT-US Model: 32028778 50601-US
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0943-2022·2022-04-20

    Ventilator trolley mounting brackets can detach and cause device to fall

    The mounting brackets on Breas Ventilator Trolleys can become detached, allowing ventilators to fall. This poses an injury risk to people near the equipment.

    Product
    Breas Ventilator Trolley with the Vivo 50/60/65 and Vivo 45LS ventilator models Article no 007384
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0919-2022·2022-04-20

    MUSE Cardiology System edits and diagnosis data lost after test signed

    GE Healthcare's MUSE Cardiology Information System may lose test measurement edits and diagnosis statements after signing. The Class II recall affects 147 units in the US and internationally.

    Product
    MUSE Cardiology Information System, Model Numbers: a) 3101011-040, b) 3101010-401, c) 3101010-009, d) 3101010-008
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0922-2022·2022-04-20

    FDA Recalls Abbott Vascular Priority Pack Accessory Kits for Leak and Connection Issues

    Abbott Vascular is recalling 23 lots of Priority Pack accessory kits and packs due to reports of leaks and loose connections in the devices.

    Product
    20/30 Priority Pack Accessory Kit/.096 RHV - REF 1000186 WPL2122270-01 (2019-03-01) 20/30 Priority Pack w/.115 RHV - REF 1000186-115 WPL2122270-02 (2019-03-01)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0915-2022·2022-04-20

    Boston Scientific ROTAWIRE Drive guide wire devices recalled for open pouch seals

    Boston Scientific is recalling ROTAWIRE Drive and ROTAWIRE Drive Floppy guide wire devices because pouch seals may be open, compromising sterility. The recall affects 433 5-packs distributed in the US, territories, Japan, and Canada.

    Product
    ROTAWIRE Drive and wireClip Torquer, ROTAWIRE Drive Floppy
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0873-2022·2022-04-20

    Hemodialysis Conductivity Sensors recalled for potential cracks and dialysate leaks

    B Braun Medical Inc is recalling conductivity sensors used in Dialog hemodialysis systems due to potential cracking during use, which could cause leaks in the dialysate circuit and improper ultrafiltration. Affected patients should contact their healthcare provider.

    Product
    Conductivity Sensors utilized on Dialog and Dialog+ Hemodialysis Systems. Conductivity Sensor (END) - VERSION 2, Article Code Number 3456103A. These conductivity sensors may be used as spare parts for the following dialysis machines: 710200L (UDI 04046963686345), 710200S (UDI 0
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0910-2022·2022-04-20

    Orthopedic Surgical Instrument Kit Recalled for Improper Driver Fit

    The Nextra Hammertoe Correction System surgical kit is being recalled due to an oversized driver that cannot properly connect to and remove from the implant. This defect can delay surgery.

    Product
    Nextra Hammertoe Correction System 4.5 Middle 3.2 Proximal Kit SKU: NX-4532K Orthopedic surgical instrument
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0929-2022·2022-04-20

    Siemens Atellica CH Hemoglobin A1c Reagent Kits Recalled for Quality Control Issues

    Siemens Healthcare is recalling Atellica CH Hemoglobin A1c reagent kits due to potential reagent carryover affecting quality control and patient test results. The issue may cause inaccurate diabetes monitoring measurements.

    Product
    Atellica CH Enzymatic Hemoglobin A1c (A1c_E/A1c_H), Siemens Material Number 11097536
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0900-2022·2022-04-20

    FDA Updates Labeling for LIPOSORBER LDL Adsorption Column Due to Anaphylactoid Shock Risk

    LIPOSORBER LA-15 LDL Adsorption Column labeling has been updated to address a risk of severe anaphylactoid reactions and shock in patients receiving treatment while taking ACE inhibitors.

    Product
    LIPOSORBER System, Model: LA-15, consisting of: Apheresis machine, product# 101445 model: MA-03, and disposables (product#, model) [#101447, KP-05 Sulflux Plasma Separator], [#101473, HDE KP-05 Sulflux Plasma Separator], [#101785, LA-15 (AU) LDL Adsorption Column (L
    Category
    Medical Device
    Distribution
    34 states
  • HighFDA (Devices)·Z-0935-2022·2022-04-20

    ECG Electrode Set Fails Electrical Safety, May Prevent Effective Defibrillation

    Graphic Controls' CLARAVUE pediatric electrode set fails electrical safety standards. The device may not deliver adequate charge during defibrillation, potentially rendering emergency treatment ineffective.

    Product
    CLARAVUE Pre-wired Electrode IP-SET N3 - PEDIATRIC-US Model: 32028776 50401-US
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0931-2022·2022-04-20

    Siemens Atellica CH Lithium reagent recalled for potential reagent carryover

    Siemens Healthcare Diagnostics recalls approximately 2,158 units of Atellica CH Lithium_2 reagent (Lot Numbers 110108, 110185, 110238, 110302) due to potential for reagent carryover affecting quality control results, patient samples, and calibrator results.

    Product
    Atellica CH Lithium_2 (LITH_2), Siemens Material Number 11097637
    Category
    Medical Device
    Distribution
    Distributed nationwide