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 the agency’s own highest classification or reported deaths or serious injuries, 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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22001–22025 of 40299

  • HighFDA (Devices)·Z-0203-2019·2018-10-31

    Data Innovations Recalls Abbott Alinity ci-series Software Driver

    Data Innovations is recalling a software driver for Abbott Alinity ci-series instruments that fails to process quality control results, potentially delaying or causing incorrect patient treatment.

    Product
    IM Abbott Alinity ci-series (abdicqii) accessory driver v8.00.0001 software product that can receive information from a hospital computer system (also called a Laboratory Information System [LIS]).
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0200-2019·2018-10-31

    Smith+Nephew Legion AP Femoral Cutting Block Recalled for Oversized Spring

    Smith & Nephew is recalling one lot of Legion AP femoral cutting blocks, size 6, because they were manufactured with an oversized spring.

    Product
    Smith+Nephew Orthopaedic Division LEGION A/P FEMORAL CUTTING BLOCK, SIZE 6 REF 71434411, QTY: (1) The LEGION AP Femoral Cutting Block is a reusable surgical instrument used to make bone cuts on the distal femur to prepare the bone to receive a LEGION femoral implant.
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0265-2019·2018-10-31

    Custom Healthcare Systems Recalls Surgical Gowns Due to Sterility Compromise

    Custom Healthcare Systems is recalling 89 units of surgical gowns and convenience kits because incorrect sealing specifications compromised product sterility.

    Product
    CHS Custom Convenience Kit: 1231-110XL SURGICAL GOWN, NRF W. HAND TOWEL 1231-080XL GOWN, SURGICAL XXL 1231-150XL GOWN, SURGICAL XXL
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-0201-2019·2018-10-31

    GE Healthcare Recalls 3.0T MR750 MRI Scanners Due to Coil Overheating Risk

    GE Medical Systems is recalling 356 Discovery 3.0T MR750 MRI scanners because a specific coil can overheat in Mode 2, posing a risk of serious patient thermal injury.

    Product
    GE Healthcare, Discovery 3.0T MR750, 5148810-2, 5373011-2, 5499460-2.
    Category
    Medical Device
    Distribution
    26 states
  • HighFDA (Devices)·Z-0209-2019·2018-10-31

    Siemens APTIO Input/Output Modules Recalled for Missing Pacemaker Warning Label

    Siemens Healthcare Diagnostics is recalling 441 APTIO Input/Output Modules because they may have been shipped without a warning label regarding potential interference with pacemaker functionality.

    Product
    APTIO INPUT/OUTPUT MODULE
    Category
    Medical Device
    Distribution
    38 states
  • HighFDA (Devices)·Z-0255-2019·2018-10-31

    Custom Healthcare Systems Recalls Sterility-Compromised Connector Packs

    Custom Healthcare Systems is recalling 150 units of CHS Custom Convenience Kit-CONNECTOR PACK due to incorrect sealing specifications that compromised product sterility.

    Product
    CHS Custom Convenience Kit-CONNECTOR PACK Product Number:D36-7520
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-0280-2019·2018-10-31

    Medtronic Recalls O-arm 1000 2nd Edition Imaging Systems Due to Software Anomalies

    Medtronic is recalling 596 O-arm 1000 2nd Edition Imaging Systems worldwide due to reported software anomalies affecting startup, motion control, and image acquisition.

    Product
    O-arm 1000 2nd Edition Imaging System, OARM ASSY Bl70000027GERR SYS PRODUCT REFURB, Model Number Bl70000027GERR Product Usage: The O-arm Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging and is intended to be used where a physician benefits…
    Category
    Medical Device
    Distribution
    45 states
  • HighFDA (Devices)·Z-0263-2019·2018-10-31

    Custom Healthcare Systems Recalls Convenience Kits Due to Sterility Compromise

    Custom Healthcare Systems is recalling 60 units of CHS Custom Convenience Kits because incorrect sealing specifications compromised product sterility.

    Product
    CHS Custom Convenience Kit-TUBING W. CONNECTOR Product Number:UNC-10884
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-0277-2019·2018-10-31

    Medtronic Recalls O-arm 1000 2nd Edition Imaging Systems for Software Anomalies

    Medtronic Navigation is recalling 596 O-arm 1000 2nd Edition Imaging Systems worldwide due to reported software anomalies affecting startup, communication, and image acquisition.

    Product
    O-arm 1000 2nd Edition Imaging System, BASE OARM Bl70000027230 SYSTEM 230V, Model Number Bl7000002 7230 Product Usage: The O-arm Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging and is intended to be used where a physician benefits from 2D…
    Category
    Medical Device
    Distribution
    45 states
  • HighFDA (Devices)·Z-0266-2019·2018-10-31

    Custom Healthcare Systems Recalls Non-Sterile Convenience Gowns

    Custom Healthcare Systems is recalling 72,832 units of convenience gowns because they were sealed with incorrect specifications, compromising sterility.

    Product
    CHS Custom Convenience (1) 1231-150L GOWN, RAGLAN, LG, NONREINF (2) 1231-150XL GOWN, RAGLAN, XL, NONREINF (3) 1231-140XL GOWN, SPECIALTY XL, XLONG
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-0274-2019·2018-10-31

    Medtronic Recalls O-arm 1000 2nd Edition Imaging Systems Due to Software Anomalies

    Medtronic is recalling 596 O-arm 1000 2nd Edition Imaging Systems worldwide due to reported software anomalies affecting startup, communication, and imaging functions.

    Product
    O-arm 1000 2nd Edition Imaging System, BASE OARM Bl70000027100R SYSTEM lOOV RWK, Model Number Bl70000027100R Product Usage: The O-arm Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging and is intended to be used where a physician benefits…
    Category
    Medical Device
    Distribution
    45 states
  • ModerateFDA (Devices)·Z-0222-2019·2018-10-31

    Nakanishi Surgical Handpieces Recalled for Updated Reprocessing Instructions

    Nakanishi Inc. is recalling six SGA-E2G surgical handpieces because reprocessing instructions have been updated to include manual cleaning and specific autoclave parameters.

    Product
    Surgical Handpiece, Model: SGA-E2G Order Code: H184, Nakanishi Inc. The SGS/SGA Surgical Handpieces are intended for surgical use. Typical usage includes dental implant use: drilling and tapping the maxilla and mandible.
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-0239-2019·2018-10-31

    Philips DigitalDiagnost Software Recall for X-ray System Stitching Defects

    Philips is recalling DigitalDiagnost software for stationary X-ray systems due to intermittent stitching interruptions and incorrect baseline data on the system CD.

    Product
    Philips DigitalDiagnost software 4.1.x and 4.2.x, A Stationary X-ray System Models: 712027, 712028, 712029, 712031, 712032701032, 712033, 712224, 712225, 712226, 712227, 712228.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0233-2019·2018-10-31

    Ecolab Recalls Disposable Accessory Kits for Da Vinci Robotic System

    Ecolab Inc is recalling specific lots of Disposable Accessory Kits, 3-Arm, due to potential pouch seal defects that could compromise sterility.

    Product
    Disposable Accessory Kit, 3-Arm (Box of 5) individually sealed in poly-Tyvek pouches / Rx Sterile / to used exclusively on the Intuitive Surgical Da Vinci Si Robotic system / Distributed by Intuitive Surgical Product Usage: Microtek Medical Equipment Drapes are intended to…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0279-2019·2018-10-31

    Medtronic Recalls O-arm 1000 2nd Edition Imaging Systems Due to Software Anomalies

    Medtronic is recalling 596 O-arm 1000 2nd Edition Imaging Systems worldwide due to software anomalies affecting startup, motion control, and image acquisition.

    Product
    O-arm 1000 2nd Edition Imaging System, OARM ASSY Bl70000027GER SYS PRODUCT GER, Model Number Bl70000027GER Product Usage: The O-arm Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging and is intended to be used where a physician benefits from…
    Category
    Medical Device
    Distribution
    45 states
  • ModerateFDA (Devices)·Z-0220-2019·2018-10-31

    Nakanishi Surgical Handpiece Recall for Updated Reprocessing Instructions

    Nakanishi Inc. is recalling SGS-E2G surgical handpieces to replace operation manuals with updated reprocessing instructions for manual cleaning and autoclave sterilization.

    Product
    Surgical Handpiece, Model: SGS-E2G Order Code: H185, Nakanishi Inc. The SGS/SGA Surgical Handpieces are intended for surgical use. Typical usage includes dental implant use: drilling and tapping the maxilla and mandible.
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-0223-2019·2018-10-31

    Nakanishi SGS-ES Micro Surgery Handpiece Recall for Updated Instructions

    Nakanishi Inc. is recalling 2,419 SGS-ES Micro Surgery Handpieces to replace operation manuals with updated reprocessing and sterilization instructions.

    Product
    Micro Surgery Handpiece SGS, Model: SGS-ES, Order Code: H264, Manufactured by: Nakanishi Inc. The SGS/SGA Surgical Handpieces are intended for surgical use. Typical usage includes dental implant use: drilling and tapping the maxilla and mandible.
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-0226-2019·2018-10-31

    Nakanishi Micro Surgery Handpiece Recall for Updated Reprocessing Instructions

    Nakanishi Inc. is recalling 1,878 Micro Surgery Handpiece SGA units to replace operation manuals with updated reprocessing and sterilization instructions.

    Product
    Micro Surgery Handpiece SGA, Model SGA-E2S Order Code: H265, Manufactured by: Nakanishi Inc. The SGS/SGA Surgical Handpieces are intended for surgical use. Typical usage includes dental implant use: drilling and tapping the maxilla and mandible.
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-0225-2019·2018-10-31

    Nakanishi Micro Surgery Handpiece Recall for Updated Reprocessing Instructions

    Nakanishi Inc. is recalling 440 Micro Surgery Handpiece SGA units because reprocessing instructions have been updated. Previous operation manuals must be replaced.

    Product
    Micro Surgery Handpiece SGA, Model SGA-ES, Order Code:H263, Manufactured by: Nakanishi Inc. The SGS/SGA Surgical Handpieces are intended for surgical use. Typical usage includes dental implant use: drilling and tapping the maxilla and mandible.
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-0230-2019·2018-10-31

    bioMerieux Recalls BACT/ALERT VIRTUO Systems Due to Firmware Calibration Issue

    bioMerieux is recalling 8 BACT/ALERT VIRTUO systems because firmware version R2.0 allows calibration standards to be moved, potentially causing anomalies if not returned to designated locations.

    Product
    BACT/ALERT VIRTUO system, A Unit China, with Version R2.0 Firmware Product Usage: The BacT/ALERT VIRTU Microbial Detection System is an automated microbial test system capable of incubating, agitating, and continuously monitoring for the detection of aerobic, facultative…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0237-2019·2018-10-31

    Micro-Tech Recalls Single-Use Biopsy Forceps Due to Incorrect Product Contents

    Micro-Tech (Nanjing) Co., Ltd. is recalling 1,360 units of Single-Use Biopsy Forceps because the boxes contained Grasping Forceps instead of the labeled product.

    Product
    Single-Use Biopsy Forceps, JUMBO ALLIGATOR,3.2mm, REF Catalog No. NBF13-01130230, UPN BF40180 (Pouch level) - BF40181(Case box level) BF40182 (Carton box level) - BF40183(Over shipper level), STERILE
    Category
    Medical Device
    Distribution
    Distributed nationwide