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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9551–9575 of 13717

  • HighFDA (Devices)·Z-1431-2023·2023-05-03

    Surgical Convenience Kits Recalled for Separating Light Handle Covers

    ROi CPS LLC is recalling sterile surgical convenience kits because light handle covers may separate and fall off during use. The recall affects 278 kits distributed in Florida and Missouri.

    Product
    Sterile surgical convenience kits: 1. regard Item Number: 880405003, GS01011C - General Laparoscopy; 2. regard Item Number: 880424004, GS01031D - Thoracic.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1469-2023·2023-05-03

    Angiography system display malfunction affects diagnostic imaging capability

    Siemens recalls the ARTIS one angiography system due to a hybrid cable display issue that may prevent image function on examination room monitors. Four US units are affected.

    Product
    ARTIS one with a hybrid cable- An angiography system developed for diagnostic imaging and interventional procedures. Material Number: 10848600
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1429-2023·2023-05-03

    Hamilton HAMILTON-C6 Ventilator Software Error Disables Patient Input Monitoring

    The HAMILTON-C6 ventilator (103 units) has a software error that disables patient input monitoring when switching to adaptive ventilation modes with a connected controller or humidifier. The device will alarm but cannot respond to patient inputs.

    Product
    HAMILTON-C6, REF: 160021
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1438-2023·2023-05-03

    Surgical Kit Light Handle Covers May Separate During Use

    ROi CPS LLC is recalling 1,369 sterile surgical convenience kits because light handle covers may separate and fall off during use. The affected kits were distributed nationwide in Florida and Missouri.

    Product
    Sterile surgical convenience kits: 1. regard Item Number: 880473001, OR01105A - Total Shoulder/Hip; 2. regard Item Number: 880426004, OR01033D - Total Hip; 3. regard Item Number: 880427003, OR01034C - Total Knee; 4. regard Item Number: 880474001, OR01106A - Knee Arthro
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1426-2023·2023-05-03

    Lateral lumbar spine implant plate may disassemble during surgery

    SPINEART's JULIET Ti LL lateral lumbar implant plates may disassemble during preparation or implant removal, causing surgical delays. The FDA is recalling 544 affected units distributed across eight US states.

    Product
    JULIET Ti LL, LATERAL LUMBAR TI-LIFE PLATE SMALL, REF: JLT-PL 02 08-S, JLT-PL 02 10-S, JLT-PL 02 12-S, JLT-PL 02 14-S, JLT-PL 02 16-S; JULIET Ti LL, LATERAL LUMBAR TI-LIFE PLATE LARGE, REF: JLT-PL 04 08-S, JLT-PL 04 10-S, JLT-PL 04 12-S, JLT-PL 04 14-S, JLT-PL 04 16-S, JLT-PL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1432-2023·2023-05-03

    Sterile Surgical Kits Recalled Due to Light Handle Cover Separation Risk

    ROi CPS LLC is recalling 662 sterile surgical convenience kits because light handle covers may separate from the light handle and fall off during use. The kits were distributed in Florida and Missouri.

    Product
    Sterile surgical convenience kits: 1. regard Item Number: 880353009, GS00797I - Laparotomy Pk; 2. regard Item Number: 880429002, GS01036B - Universal Custom ; 3. regard Item Number: 800725004, GS00930D - OH Base Robot Pack ; 4. regard Item Number: 800725005, GS00930E - O
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1464-2023·2023-05-03

    VersaOne Positioning Cannula Recalled for Metal Burr Manufacturing Defect

    Covidien LP recalls VersaOne Reusable Positioning Cannula due to manufacturing defect that may leave a metal burr inside the device. No injuries reported.

    Product
    VersaOne Reusable Positioning Cannula 11mm Standard, Model Number RC11STS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1423-2023·2023-05-03

    Biopsy forceps may fail to open when endoscope is bent

    Biopsy forceps may become unable to open when the endoscope shaft is bent approximately 90 degrees. Additional bending of the forceps shaft can prevent opening entirely.

    Product
    FLEX. BIOPSY FORCEPS 5FR WL 550MM, Product Number 829.051
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1470-2023·2023-05-03

    Digital X-ray System Arm May Break, Posing Injury Risk

    FUJIFILM's FDR AQRO digital X-ray system arm may break during use. The tube head support is susceptible to failure, which could cause serious harm to patients or operators.

    Product
    FujiFilm FDR AQRO (Model DR-XD1000)- A digital mobile X-ray system intended for use in general purpose radiography for generating radiographic images of human anatomy, including adult, pediatric, and neonatal exams
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1463-2023·2023-05-03

    VersaOne Reusable Positioning Cannula Recalled for Internal Metal Burr

    Covidien LP is recalling 145 units of the VersaOne Reusable Positioning Cannula due to a manufacturing defect that may create a metal burr inside the device at the weld joint.

    Product
    VersaOne Reusable Positioning Cannula 8 mm Standard, Model Number RC8STS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1462-2023·2023-05-03

    Cardiosave Hybrid Intra-Aortic Balloon Pump Power Cord Incompatible with Brazilian Outlet

    Datascope Corp. is recalling 54 units of the Cardiosave Hybrid Intra-Aortic Balloon Pump distributed to Brazil. The Type J power cord plug is incompatible with Brazilian Type N electrical receptacles.

    Product
    MAQUET CARDIOSAVE hybrid Intra-Aortic Balloon Pump, Model Number 0998-XX-0800-32
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1430-2023·2023-05-03

    Caspar Cervical Retractor Basket Lids Recalled for Incorrect GTIN Labeling

    Aesculap Implant Systems recalls Caspar Cervical Retractor (CCR) Basket lids with incorrect GTIN labeling. The product bears GTIN #04046955299592 instead of the correct #04046955299607.

    Product
    Caspar Cervical Retractor (CCR) Basket ME754 - Lid Only and ME764 Casper Cervical Retractor (CCR) Basket Full System - Lid Only. A lid to a container intended to provide a suitable platform for placing/containing many medical/surgical/dental instruments. Note: The CCR basket
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1357-2023·2023-04-26

    Shiley Adult Flexible Tracheostomy Tubes Recalled Due to Undersized Connectors

    Covidien is recalling Shiley Adult Flexible Tracheostomy Tubes due to undersized connectors that create loose connections with 15mm respiratory circuit components. Unsecure connections could cause respiratory failure, difficulty breathing, treatment delays, or serious injury.

    Product
    Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff, and Cuffless: Disposable Inner Cannula or Reusable Inner Cannula (REF, Product Description): 10CN10H, 10.0MM SHILEY CUFFED TRACH CAN; 10CN10R, 10.0MM ADT FLEX TRACH W TG CUFF; 10UN10A, 10.0MM UNCUFF TRACH TUBE X1;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1411-2023·2023-04-26

    Spinal Implant Screws Recalled for Defective Titanium Material

    Medtronic is recalling INFINITY spinal implant screws manufactured with incorrect titanium material. The defect reduces the screw's gripping strength, risking implant performance in critical spinal fusion surgery.

    Product
    INFINITY Occipitocervical Upper Thoracic System, PARTIALLY THREADED MULTI AXIAL SCREW, Size: 4.0mm x 22mm, REF 360PT4022; for immobilization and stabilization of spinal segment as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical unctio
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1403-2023·2023-04-26

    FDA Recalls MectaLIF ANTERIOR Interbody Fusion Device Due to Screw Breakage Risk

    Medacta Usa Inc is recalling the MectaLIF ANTERIOR interbody fusion device due to potential breakage of the small screw that affixes the anti-backout plate. The recall affects 34 units distributed in the United States.

    Product
    MectaLIF ANTERIOR - Lag Plate Flush H16, REF 03.30.303, interbody fusion device
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-1404-2023·2023-04-26

    Interbody Fusion Device Recalled for Potential Screw Breakage

    Medacta's MectaLIF ANTERIOR fusion device is being recalled due to potential breakage of a small screw used to affix the anti-backout plate. The recall affects 17 units distributed across the US.

    Product
    MectaLIF ANTERIOR - Lag Plate Flush H18, REF 03.30.304, interbody fusion device
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-1415-2023·2023-04-26

    Laboratory diagnostic device software issue may delay clinical diagnosis

    BD Kiestra InoqulA+ (software versions 5.1/5.1.1) fails to display plate information after processing in clinical laboratories, risking diagnostic delays or specimen recollection.

    Product
    BD Kiestra InoqulA+ with BD Kiestra" InoqulA+" and BeA Software version 5.1 and 5.1.1 as part of the Icefall A platform. An in vitro diagnostic medical device intended to automate specimen processing according to user-defined procedures and protocols. Catalog (Ref) No. : 447213
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1419-2023·2023-04-26

    Beckman Coulter Free T3 Reagent Test Kit Recalled for Falsely Elevated Results

    Beckman Coulter is recalling Access Free T3 reagent test kits (Catalog #A13422, Lot #233968) because approximately 15-20% of samples produce falsely elevated results that could lead to misdiagnosis and inappropriate thyroid treatment.

    Product
    Beckman Coulter Access Free T3, Triiodothyronine, Free, Catalog #A13422, each box contains 2 reagent packs.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1393-2023·2023-04-26

    Smith & Nephew Knee Implant Component Mispack: Wrong Size Distributed

    Smith & Nephew is recalling 12 JOURNEY II UNI Tibia Insert components due to a manufacturing mispack. Some boxes incorrectly contain a different size component.

    Product
    JOURNEY II UNI XLPE TIBIA INSERT MEDIAL SZ 7-8 8MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1402-2023·2023-04-26

    Medacta MectaLIF ANTERIOR spine implant recalled due to screw breakage risk

    Medacta USA is recalling MectaLIF ANTERIOR interbody fusion devices due to a potential for breakage of a small screw that secures the anti-backout plate. The defect affects 44 units distributed across five US states.

    Product
    MectaLIF ANTERIOR - Lag Plate Flush H14, REF 03.30.302, interbody fusion device
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-1413-2023·2023-04-26

    INFINITY Multi-Axial Spinal Screws Recalled for Titanium Material Defect

    Medtronic is recalling INFINITY Multi-Axial Spinal Screws due to incorrect titanium material used in manufacturing, which reduces the gripping strength of the screw head. The affected screws are used for spinal fusion and stabilization.

    Product
    INFINITY Occipitocervical Upper Thoracic System, MULTI AXIAL SCREW, Size: 4.0mm x 34mm, REF 3604034; for immobilization and stabilization of spinal segment as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical unction, the cervical spine
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1392-2023·2023-04-26

    BioFire FilmArray GI Panel Recalled for Potential False Negative Results

    BioFire Diagnostics is recalling FilmArray Gastrointestinal Panel test kits due to a manufacturing issue that may produce false negative results. Affected units may fail to detect gastrointestinal infections.

    Product
    FilmArray Gastrointestinal (GI) Panel for FILMARRAY Systems, REF: RFIT-ASY-0116, (30 pouches/kit)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1405-2023·2023-04-26

    Spinal fusion device antibackout screw may break, FDA recalls

    Medacta Usa Inc is recalling MectaLIF ANTERIOR antibackout lag covers due to potential breakage of the small screw that affixes the anti-backout plate. The defect affects spinal fusion procedures in select US states.

    Product
    MectaLIF ANTERIOR - Antibackout Lag Cover, REF 03.30.305, interbody fusion device
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-1409-2023·2023-04-26

    Spinal implant screws recalled due to defective titanium material

    Medtronic is recalling 45 units of INFINITY Multi-Axial Screws (lot H5802983) worldwide because incorrect titanium was used, reducing the screw head's gripping strength. No illnesses or injuries have been reported.

    Product
    INFINITY Occipitocervical Upper Thoracic System, MULTI AXIAL SCREW, Size: 4.0mm x 24mm, REF 3604024; for immobilization and stabilization of spinal segment as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical unction, the cervical spine
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1399-2023·2023-04-26

    Tobii Dynavox TD I-110 Speech Device Recalled Over Loose Battery Risk

    The FDA is recalling the Tobii Dynavox TD I-110, a speech-generating device, because the battery may become loose from its housing and potentially be damaged. This affects users worldwide who depend on this device for communication.

    Product
    Tobii Dynavox TD I-110 Speech Device-tablet style speech generating device used for ambulatory people with disabilities. Catalog #: 750567
    Category
    Medical Device
    Distribution
    Distributed nationwide