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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10276–10300 of 39932

  • HighFDA (Devices)·Z-1435-2023·2023-05-03

    Sterile Surgical Kit Light Handle Covers May Separate During Use

    ROi CPS LLC is recalling 386 sterile surgical convenience kits (WPH GYN Laparoscopy Pack) because light handle covers may separate and fall off during use.

    Product
    Sterile surgical convenience kit: regard Item Number: 800753005, GY00958E - WPH GYN Laparoscopy Pack.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1437-2023·2023-05-03

    Surgical Convenience Kits Recalled Due to 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 affected kits were distributed in Florida and Missouri.

    Product
    Sterile surgical convenience kits: 1. regard Item Number: 800756005, NU00961E - OH Laminectomy Cust Pack; 2. regard Item Number: 880411008, NU01018H - Lumbar Universal ; 3. regard Item Number: 880396007, NU01001G - Craniotomy ; 4. regard Item: 880387005, NU00991E…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1422-2023·2023-05-03

    Surgical forceps may fail to open when endoscope shaft is bent

    Richard Wolf surgical forceps may fail to open when used during endoscopic procedures if the endoscope shaft becomes bent. Approximately 838 units are affected worldwide.

    Product
    FLEX. GRASP. FORCEPS 5FR WL 550MM, Product Number 828.051
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1424-2023·2023-05-03

    Endoscopic Forceps May Fail to Open When Shaft Bent

    Surgical grasping forceps may fail to open when the endoscope shaft is bent, potentially affecting their use during endoscopic procedures.

    Product
    FLEX. GRASP. FORCEPS 5FR WL 550MM, Product Number 8735.685
    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-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-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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1465-2023·2023-05-03

    VersaOne Reusable Positioning Cannula Recalled Due to Internal Metal Burrs

    Covidien LP is recalling VersaOne Reusable Positioning Cannulas (Model RC12STS) due to manufacturing defects that may produce metal burrs on the inside of the device, potentially causing internal tissue damage during use.

    Product
    VersaOne Reusable Positioning Cannula 12mm Standard, Model Number RC12STS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1433-2023·2023-05-03

    Sterile surgical kit recalled due to light handle cover separation risk

    ROi CPS LLC is recalling sterile surgical convenience kits because light handle covers may separate and fall off during use. Approximately 70 kits were distributed in Florida and Missouri.

    Product
    Sterile surgical convenience kit: regard Item Number: 800718003, GY00923C - WPH Major Vaginal Pack.
    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…
    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-1434-2023·2023-05-03

    Sterile surgical cardiac catheterization kit recalled for light handle cover separation

    A sterile surgical convenience kit for cardiac catheterization is being recalled because light handle covers may separate and fall off during use. The affected lot includes 322 kits distributed to Florida and Missouri.

    Product
    Sterile surgical convenience kit: regard Item Number: 880393003, HT00997C - Cardiac Cath.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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…
    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
  • 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-1412-2023·2023-04-26

    Spinal fixation screws recalled for reduced titanium gripping strength

    Medtronic is recalling 90 INFINITY Multi-Axial Screws (Lot H5806345) due to incorrect titanium material that reduces screw head gripping strength. The defect affects 5 batches distributed in the US and Canada.

    Product
    INFINITY Occipitocervical Upper Thoracic System, MULTI AXIAL SCREW, Size: 4.0mm x 26mm, REF 3604026; 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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1395-2023·2023-04-26

    Instrument Kit Drill Guides Have Incorrect Depth Range

    GEO Instrument Kits for EPS Plates contain drill guides marked with an incorrect depth range (30mm-60mm instead of 10mm-40mm), which could affect surgical implant placement.

    Product
    GEO Instrument Kit for EPS Plate, REF: 70120001, part of the GEO FirstFUSE 1st MTP Joint Arthrodesis Plating System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1401-2023·2023-04-26

    Medacta interbody fusion plate device recalled for screw breakage

    Medacta Usa Inc is recalling the MectaLIF ANTERIOR interbody fusion device because the small screw affixing the anti-backout plate may break, potentially compromising device integrity.

    Product
    MectaLIF ANTERIOR - Lag Plate Flush H12, REF 03.30.301, interbody fusion device
    Category
    Medical Device
    Distribution
    5 states
  • 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-1400-2023·2023-04-26

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

    Medacta Usa Inc is recalling the MectaLIF ANTERIOR Lag Plate Flush H10 interbody fusion device due to a potential risk of screw breakage in the anti-backout plate. No injuries have been reported.

    Product
    MectaLIF ANTERIOR - Lag Plate Flush H10, REF 03.30.300, interbody fusion device
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-1397-2023·2023-04-26

    Habib EndoHPB Bipolar RF Catheter Recalled Due to Thermal Injury Risk

    Boston Scientific recalls the Habib EndoHPB Bipolar RF Catheter used in pancreatic and biliary procedures due to inaccurate instructions that could result in excessive energy delivery and thermal injury.

    Product
    Habib EndoHPB Bipolar Radiofrequency (RF) Catheter 8F (2.7mm). A radiofrequency (RF) catheter which provides bipolar energy to perform partial or complete ablation of tissue in the pancreatic and biliary tracts. UPN: M00500070
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1417-2023·2023-04-26

    Philips 2D Perfusion Medical Imaging Software Recalled for Signal Processing Errors

    Philips is recalling 2D Perfusion diagnostic imaging software due to signal processing errors that can produce inaccurate presentations, potentially affecting clinical decisions.

    Product
    2D Perfusion, release R1.0.x, R1.1.x, R1.2, and R1.2.1
    Category
    Medical Device
    Distribution
    Distributed nationwide