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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8201–8225 of 13652

  • HighFDA (Devices)·Z-0088-2024·2023-10-18

    Medical Procedure Packs Recalled Due to Defective Components

    Cardinal Health is recalling surgical procedure packs due to defective components. The recall affects 13,351 packs distributed across the US and Canada.

    Product
    Procedure packs: (1) Presource Portacath Pack, Cat. SANV1PIFSB, Medstar Franklin Square Med CE, Sterile; and (2) Presource Bone Marrow Harvest Pack, Cat. SAN12BHGT1, Medstar Georgtown University H, Sterile.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0097-2024·2023-10-18

    Surgical gloves recalled for incomplete sterile pouch sealing

    Ansell Healthcare Products LLC has recalled certain NOVAPLUS GAMMEX NON-LATEX PI GREEN surgical gloves because some sterile pouches were not completely sealed. Improper sealing could allow contamination before use.

    Product
    NOVAPLUS GAMMEX NON-LATEX PI GREEN Surgical gloves, REF: V20685255 through V20685290
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0096-2024·2023-10-18

    GAMMEX NON-LATEX PI GREEN Surgical Gloves with Unsealed Sterile Pouches

    Ansell is recalling GAMMEX NON-LATEX PI GREEN surgical gloves because some sterile pouches were not completely sealed. Approximately 1,511 units were distributed nationwide across multiple states.

    Product
    GAMMEX NON-LATEX PI GREEN Surgical gloves, REF: 20685255 through 20685290
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0107-2024·2023-10-18

    Immunoassay Analyzer Software Error May Cause Sample Result Mix-up

    The DxI 9000 Access Immunoassay Analyzer may mix up test results from different patient samples. A software defect causes the system to replace current sample barcodes with previously-used IDs, potentially associating wrong results with wrong patients.

    Product
    DxI 9000 Access Immunoassay Analyzer, REF C11137, Sofware Versions 1.15 and below; invitro diagnostic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0099-2024·2023-10-18

    Constellation Vision System surgical units recalled for pressure control defect

    Alcon Research recalls Constellation Vision System ophthalmic microsurgical units due to a printed circuit board design flaw that could disable pressure control, risking infection and tissue damage.

    Product
    Constellation Vision System, REF: 8065751150
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0109-2024·2023-10-18

    Surgical instrument button malfunction may extend operative time

    Olympus THUNDERBEAT surgical instruments may have a blue seal button that remains engaged after release, potentially extending surgery time. The company is recalling 271 affected units nationwide.

    Product
    THUNDERBEAT, 5MM, 45CM, Front-actuated Grip Type S Model: TB-0545FCS Indicated for open, laparoscopic (including single-site surgery) general surgery and gynecological surgery (including urologic, thoracic, plastic and reconstructive, bowel resections, cholecystectomies, Nissen
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0089-2024·2023-10-18

    Cardinal Health Recalls Surgical Procedure Packs Due to Defective Components

    Cardinal Health is recalling 13,351 surgical procedure packs distributed nationwide and in Canada. The packs contain recalled equipment drapes, table covers, and surgical room turnover kits.

    Product
    Procedure packs: (1) Presource PBDS Cat. PNVMNIB21, Kit, Neuro IMAS, Sterile; (2) Presource PBDS Cat. PN08LAG13, Kit, Spine, Sterile; (3) Presource PBDS Cat. PN08LAG17, Kit, Spine, Sterile; (4) Presource PBDS, Cat. PN11SFS40, Kit, Thoracolumbar Fusion, Sterile; (5) Presour
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0098-2024·2023-10-18

    Reverse Shoulder Prosthesis Screws May Have Incorrect Size

    Reverse shoulder prosthesis packages labeled as containing 5mm x 30mm screws may instead contain incorrect 3.5mm x 30mm screws. Using the wrong size screws could cause surgical delay and inadequate fixation.

    Product
    REVERSE PROSTHESIS SHOULDER SYSTEM, SCREW, LOCKING BONE, RSP, 5mmX30mm long, REF: 506-03-130
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0081-2024·2023-10-18

    Infusion pump component force sensor may malfunction or trigger false alarms

    Smiths Medical is recalling 118 units of Medfusion infusion pump plunger case components due to potential force sensor calibration drift. The sensor may malfunction, leading to delayed occlusion detection, false alarms, or system failure.

    Product
    Medfusion ASSEMBLY PLUNGER CASE LEFT 1/EA, Component Number G6001587, used on infusion pump
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0078-2024·2023-10-18

    Syringe Pump Force Sensor Drift May Cause Detection Delays or False Alarms

    Smiths Medical Medfusion syringe pumps may have force sensors that drift out of calibration, causing delays in detecting line occlusions or triggering false alarms. Devices produced before April 2022 are at higher risk.

    Product
    Medfusion Syringe Pump, Model 3500-0600-XX: a) 0600-00; b) 0600-01; c) 0600-50; d) 0600-51; e) 0600-82; f) 0600-249; software versions: v3, v4, v5, and v6
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0108-2024·2023-10-18

    Olympus THUNDERBEAT surgical instrument blue seal button may fail to return to neutral

    Olympus is recalling 2,496 units of THUNDERBEAT Model TB-0535FCS surgical instruments because the blue seal button may fail to return to neutral position after release, potentially causing prolonged surgery. The recall affects units distributed nationwide.

    Product
    THUNDERBEAT, 5MM, 35CM, Front-actuated Grip Type S. Model: TB-0535FCS Indicated for open, laparoscopic (including single-site surgery) general surgery and gynecological surgery (including urologic, thoracic, plastic and reconstructive, bowel resections, cholecystectomies, Nisse
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0103-2024·2023-10-18

    EMPOWR hip acetabular implant packaging incorrectly contains knee implant component

    Encore Medical recalled 20 units of EMPOWR Acetabular System hip implant liners after knee implant components were mistakenly placed in hip surgery packages. Surgeons using the wrong implant could receive an anatomically incompatible component.

    Product
    EMPOWR Acetabular System, Liner, 10¿ Hooded, HXe+, 40H, REF: 942-01-40H
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0082-2024·2023-10-18

    RoyalVibe Unapproved Medical Devices Recalled Due to Lack of FDA Authorization

    RoyalVibe Health recalled multiple unapproved medical devices including ultrasound generators and therapy devices never FDA-authorized or cleared. Users could forgo legitimate medical treatment based on unproven marketing claims.

    Product
    CellQuicken Analyzer (Smart-Watch and Software), RoyalVibe Ultrasound Generator, Brainvibe, Envirovibe Water Restructuring Pad, RoyalVibe Therapy Balls
    Category
    Medical Device
    Distribution
    38 states
  • HighFDA (Devices)·Z-0074-2024·2023-10-18

    Flower Orthopedics Cannulated Reamer Recalled for Breaking During Surgical Use

    The FDA is recalling Flower Orthopedics Flex-Thread TM 3.2mm Cannulated Reamer because the device can break during use, potentially requiring revision surgery.

    Product
    Coventus Flower Orthopedics Flex-Thread TM 3.2mm Cannulated Reamer-used to ream and subsequently open the intramedullary canal to the appropriate depth for nail insertion; Flex-Thread TM 3.2mm is provided sterile, single use. Catalogue Number: 8528-1-S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0090-2024·2023-10-18

    Cardinal Health Recalls Surgical Procedure Packs With Recalled Components

    Cardinal Health is recalling 13,351 procedure packs used in surgical procedures because they contain recalled components. The affected packs were distributed nationwide and in Canada.

    Product
    Procedure pack: Presource PBDS Cat. PLMHCSBHF, Hermann Hospital MHHS, Kit, C Section B MHHS, Sterile.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0091-2024·2023-10-18

    Presource PBDS Surgical Procedure Packs Subject to Nationwide Recall

    Cardinal Health is recalling 13,351 Presource PBDS surgical procedure packs distributed nationwide in the US and Canada. The specific reason for the recall was not disclosed in the available FDA notice.

    Product
    Procedure packs: (1) Presource PBDS Cat. PN33BPCR2, Kit, Back, Sterile; (2) Presource PBDS Cat. POCGANA11, Kit, ARN Anterior Hip, Sterile; (3) Presource PBDS Cat. PODKHAKAB, Kit, Hip Arthroscopy, Sterile; (4) Presource PBDS, Cat. POMHKAESV, Kit, Knee Arthroscopy, SE, Sterile; (5
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0087-2024·2023-10-18

    Surgical Procedure Packs Recalled Due to Recalled Components

    Cardinal Health is recalling 13,351 surgical procedure packs containing previously recalled components including equipment drapes, table covers, and surgical room turnover kits distributed nationwide in the US and Canada.

    Product
    Procedure packs: (1) Presource PBDS, Cat. PGMHSUESR, Southeast Hospital MHHS, Kit, Set Up No Drape, SE, Sterile; (2) Presource PBDS Cat. PGVGLBP20, Parkview Medical Center, Kit, Lap Chole, Sterile; (3) Presource PBDS Cat. PG63CCC31, USPI Christ Hosp Spine Srgry C, Kit, Basic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0101-2024·2023-10-18

    Medical Device Software Update Recall for 324 MAZOR X Surgical Robots

    Mazor Robotics has initiated a voluntary recall of 324 MAZOR X robotic guidance systems (Model TPL0059) due to a software issue requiring update. Affected devices were distributed nationwide in the US.

    Product
    MAZOR X robotic guidance system, Model TPL0059, with software versions 4.2.2 or 5.0.1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0110-2024·2023-10-18

    BD BACTEC Plus Aerobic/F Culture Vials Recalled for Duplicate Barcode Labels

    BD is recalling certain lots of BACTEC Plus Aerobic/F Culture Vials because some vials have duplicate barcode sequence numbers on their labels. The recall affects 781,600 vials distributed nationwide.

    Product
    BD BACTEC Plus Aerobic/F Culture Vials, Catalog Number 442023
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0084-2024·2023-10-18

    Cardinal Health surgical procedure packs recalled for defective components

    Cardinal Health is recalling 13,351 surgical procedure packs containing recalled components including equipment drapes, table covers, and surgical room turnover kits.

    Product
    Procedure packs: (1) Presource PBDS, Cat. PC71EXOU7, Ohio State Univ Wexner Med Ctr, Kit, Extraction Ross, Sterile; (2) Presource PBDS, Cat. PVOCMVBLC, Bellevue Hospital Center, Kit, Endovascular. (3) Presource PBDS, Cat. PVRMMVAOH7, Regional Medical Center of, Kit, Dr. Ross
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0085-2024·2023-10-18

    Cardinal Health recalls procedure packs containing defective components

    Cardinal Health is recalling 13,351 Presource PBDS surgical procedure packs (Lot #967679) containing defective equipment drapes, table covers, and surgical room turnover kits distributed nationwide and in Canada.

    Product
    Procedure pack: Presource PBDS, Cat. PEMHEEESR, Southeast Hospital MHHS, Kit, ENT, SE, Sterile.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0002-2024·2023-10-11

    Arrow ErgoPack central venous catheter recalled for incorrect labeling

    ARROW INTERNATIONAL is recalling 180 units of the Arrow ErgoPack Complete CVC catheter (Lot 33F23B0723) distributed in the US because the product code and product name were incorrectly listed on the kit's label.

    Product
    Arrow ErgoPack Complete, Pressure Injectable Arrowg+ard Blue Plus¿ Four-Lumen CVC, REF CDC-42854- PCN1A; catheter, intravascular, therapeutic, long-term greater than 30 days
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0003-2024·2023-10-11

    Arrow Central Venous Catheter Recalled for Incorrect Lidstock Labeling

    Arrow International is recalling 380 units of its Arrowg+ard Blue Plus Four-Lumen central venous catheter (model CDC-45854-P1A, lot 13F22L0806) due to incorrect product code and name listed on the package lidstock.

    Product
    Arrow Pressure Injectable Arrowg+ard Blue Plus¿ Four-Lumen CVC, REF CDC-45854-P1A; catheter, intravascular, therapeutic, long-term greater than 30 days
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0004-2024·2023-10-11

    FDA Recalls Arrow PICC Catheters with Incorrect Product Code Labels

    Arrow INTERNATIONAL recalled 172 units of ErgoPack PICC catheters due to incorrect product code and product name labels. The error affected lot 13F22G0508 distributed in the US.

    Product
    Arrow ErgoPack Pressure Injectable Arrowg+ard Blue Advance Three-Lumen PICC pre-loaded with Arrow VPS TipTracker Stylet, REF CDC-45563-TTS; catheter, intravascular, therapeutic, long-term greater than 30 days
    Category
    Medical Device
    Distribution
    0 states