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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Minimum severity

Any3+ (High and above)4+ (High and above)5+ (High and above)

Clear filters

9701–9725 of 13717

  • ModerateFDA (Devices)·Z-1298-2023·2023-04-05

    Medical device lysis beads recalled for misleading label statements

    Entopsis recalls PCRopsis Lysis Beads (363 units) due to misleading label statements on the product packaging. The affected product was distributed nationwide and to Canada, UK, Portugal, Spain, Germany, Brazil, Denmark, South Korea, Colombia, and Lithuania.

    Product
    PCRopsis Lysis Beads, IVDD: a) 25 tubes , REF 597000; b) 25 tubes, REF 597825; c) 50 tubes, REF 597850; d) 25 grams, REF 5970025; e) 1000 kilogram, REF 5971000; coated beads that facilitate lysis of microorganisms; nucleic acid extraction from a variety of biological samples
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1267-2023·2023-03-29

    DePuy Attune Tibial Insert Recalled for Excessive Radiation Exposure

    DePuy Orthopaedics is recalling Attune Posterior tibial insert implants that received excessive gamma radiation during manufacturing, which may degrade the material properties of the knee replacement component.

    Product
    Attune Posterior (PS) Fixed Bearing (FB) Tibial Insert SZ5 7MM, Part Number 151640507
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1264-2023·2023-03-29

    Orthopedic Tibial Insert Recalled Due to Excessive Radiation Exposure

    DePuy Orthopaedics is recalling Attune Revision LPS Tibial Insert devices (Lot JP9016) because they received excessive gamma radiation during manufacturing, which may compromise material properties.

    Product
    Attune Revision Limb Preservation System (LPS) Tibial Insert XSM 12MM, Part Number 151760212
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1276-2023·2023-03-29

    Cardiosave Hybrid intra-aortic balloon pump safety disk defect may reduce therapy efficacy

    Datascope's Cardiosave Hybrid intra-aortic balloon pump may have a faulty Safety Disk that reduces balloon inflation and cardiac augmentation. No injuries reported.

    Product
    Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-35, 0998-00-0800-45, 0998-00-0800-52, 0998-00-0800-53, 0998-00-0800-55, and 0998-00-0800-65
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1278-2023·2023-03-29

    Cardiosave IABP Safety Disk Model 0202-00-0140 Recalled for Performance Defect

    Datascope Corp. is recalling 669 Cardiosave IABP Safety Disks due to a performance defect that may reduce balloon inflation during cardiac support therapy. The affected devices may not provide adequate augmentation to patients requiring mechanical circulatory support.

    Product
    Cardiosave Intra-Aortic Balloon Pump (IABP) Safety Disk, Model Number 0202-00-0140
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1284-2023·2023-03-29

    G7 Acetabular Liner Recalled for Size and Label Discrepancy

    Biomet recalled 12 units of its G7 Acetabular System 40mm Size D Liner because the actual implant is a 38mm Size C. The mismatch between outer labeling and the actual implant could result in wrong-size component placement during surgery.

    Product
    G7 Acetabular System, Dual Mobility Acetabular Liner, 40 mm, Size D, Model Number 110024462
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-1265-2023·2023-03-29

    Attune Revision Limb Preservation System Tibial Insert Recalled for Over-Irradiation

    DePuy Orthopaedics is recalling 7 units of the Attune Revision Limb Preservation System Tibial Insert (Lot JP9022) that received higher than specified gamma radiation doses. The over-irradiation may cause changes to implant material properties.

    Product
    Attune Revision Limb Preservation System (LPS) Tibial Insert XSM 26MM, Part Number 151760226
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1263-2023·2023-03-29

    Orthopedic Implant Recall: Excessive Radiation Exposure in Revision Tibial Insert

    DePuy Orthopaedics recalls 7 units of Attune Revision LPS Tibial Inserts (Part 151760118, Lot JP6452) distributed worldwide due to excessive gamma radiation during manufacturing. This overage may result in material property changes.

    Product
    Attune Revision Limb Preservation System (LPS) Tibial Insert XXSM 18MM, Part Number 151760118
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1266-2023·2023-03-29

    Attune Revision Tibial Insert Recalled for Excessive Gamma Radiation Exposure

    DePuy Orthopaedics is recalling 7 units of the Attune Revision Tibial Insert that received excess gamma radiation during manufacturing, which may degrade implant material properties.

    Product
    Attune Revision Limb Preservation System (LPS) Tibial Insert SM 12MM, Part Number 151760312
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1281-2023·2023-03-29

    Raystation Treatment Planning System Collimator Angle Export Defect

    Raystation radiation therapy planning software may not correctly export collimator angle settings when using the DICOM export function. In exported files, the collimator angle may be replaced with zero regardless of the user's selection.

    Product
    Raystation treatment planning system for radiation therapy, Model Numbers 9.0.0, 9.0.1, 9.1.0, 9.2.0, 10.0.0, 10.0.1, 10.0.2, 10.1.0, 10.1.1, 11.0.0, 11.0.1, 11.0.3, 11.0.4, 12.0.0, 12.1.0, 12.1.1, 12.0.3, 12.1.2, 12.0.4, 12.1.3, 13.0.0, 13.1.0. Software Version Numbers 9A, 9B,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1207-2023·2023-03-29

    BD Pyxis Automated Medication Dispensing Systems Firmware Downgrade Recall

    CareFusion recalls 7,914 units of BD Pyxis automated medication dispensing systems after firmware was inadvertently downgraded during installation, potentially causing drawer failures and medication delivery delays.

    Product
    BD Pyxis Anesthesia ES System (PAS ES), REF: 327; BP Pyxis MedStation ES (Med ES Main), REF: 323; BD Pyxis MedStation ES Tower (Med ES Tower), REF: 352; all with BD Pyxis ES version 1.6.1 drawer firmware (version 1.10.2.5). Pyxis MedStation Enterprise Server (ES) System is an a
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1277-2023·2023-03-29

    Cardiosave Hybrid Intra-Aortic Balloon Pump Performance Issue Recall

    Datascope Corp. is recalling specific Cardiosave Hybrid intra-aortic balloon pumps due to a Safety Disk performance issue that may reduce balloon inflation and therapeutic benefit.

    Product
    Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Numbers Model Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1272-2023·2023-03-29

    Disposable Patient Circuit with Precision Flow System recalled for excessive condensation

    Vapotherm has recalled 5,869 Low Flow Disposable Patient Circuits for the Precision Flow System due to reports of excessive condensation that may lead to rainout.

    Product
    Low Flow Disposable Patient Circuit for the Precision Flow System, Product Code PF-DPC-LOW
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1279-2023·2023-03-29

    Cardiosave IABP Pneumatic Interface Module Recalled for Performance Issue

    Datascope Corp. recalls the Cardiosave IABP Pneumatic Interface Module due to a Safety Disk performance issue that may reduce balloon inflation. Ten specific units with identified serial numbers are affected.

    Product
    Cardiosave Intra-Aortic Balloon Pump (IABP) Pneumatic Interface Module (PIM) , Model Number 0997-00-1178
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1280-2023·2023-03-29

    Wearable ECG smartwatch software bug eliminates physician review

    Withings Scan Monitor/ScanWatch (model hwa09) has a software defect preventing physicians from reviewing ECG recordings, which is critical to the device's FDA clearance requirement for physician-supervised use. Users should discontinue use until the defect is corrected.

    Product
    Scan Monitor/ScanWatch, model number hwa09 Wearable, Bluetooth-connected wrist watch that records heart activity (ECG) and oxygen saturation (SpO2)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1283-2023·2023-03-29

    DeRoyal Suction Canister Recalled Due to Lid Shrinkage Seal Defect

    DeRoyal SafeLiner Suction Canister model PHESL-1000B is being recalled due to lid shrinkage that prevents proper vacuum seal formation and maintenance. The recall affects 27,200 devices distributed across multiple US states.

    Product
    DeRoyal SafeLiner Suction Canister, 1000cc, REF PHESL-1000B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1282-2023·2023-03-29

    Contact Lens Recall: CooperVision Clariti 1-day Toric With Incorrect Power

    CooperVision is recalling Clariti 1-day toric contact lenses from lot W0124677 because they were made with a misaligned axis that results in incorrect lens power.

    Product
    Clariti 1-day toric soft contact lenses, Power -1.00 -1.25/90
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1190-2023·2023-03-22

    Closed Suction System Manifold Cracking Poses Respiratory Circuit Leak Risk

    Avanos Medical recalls BALLARD ACCESS Closed Suction System units due to manifold cracking, which can cause respiratory circuit leaks and inadequate ventilation in neonatal and pediatric patients.

    Product
    BALLARD* ACCESS Closed Suction System for Neonates/Pediatrics, Elbow Manifold.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1189-2023·2023-03-22

    BALLARD ACCESS Closed Suction System Manifold May Crack and Leak

    Avanos Medical is recalling 780 units of the BALLARD ACCESS Closed Suction System due to manifold cracking that can leak the respiratory circuit, potentially causing inadequate ventilation in neonatal and pediatric patients.

    Product
    BALLARD ACCESS Closed Suction System for Neonates/Pediatrics, Y-Manifold.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1246-2023·2023-03-22

    Synthes TFN-Advanced Femoral Nail Recalled for Dimensional Labeling Mismatch

    Synthes (USA) Products LLC is recalling TFN-Advanced Femoral Nails because labeled measurements do not match actual dimensions. Nails labeled 200mm may be 170mm and vice versa.

    Product
    TFN-Advanced Femoral Nail 12MM/125 DEG TI CANN TFNA 200MM STERILE. Intended for temporary fixation and stabilization of proximal femur fractures. Part Number: 04.037.213S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1250-2023·2023-03-22

    Arial mobile application recalled for Android loading failures

    Securitas Healthcare is recalling the Arial mobile application for Android devices because the app does not load or function properly. Users should stop using the app immediately.

    Product
    Arial mobile application, model #54630 and #54640 for Android devices downloaded from the Google Play Store as part of the Arial Emergency and Nurse Call system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1238-2023·2023-03-22

    BD Insulin Syringes Recalled Due to Nonsterile Condition

    BD Insulin Syringes (Catalog 329420) are being recalled due to nonsterile conditions that could expose patients to pathogenic microorganisms and increase infection risk. The recall affects 961,000 units distributed worldwide.

    Product
    BD Insulin Syringes with the BD Micro-Fine TM IV Needle 1ml, 12.7mm, 28G Single Unit Scale. Insulin Syringes are designed for administering insulin in the treatment of diabetes mellitus. Catalog Number: 329420
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1248-2023·2023-03-22

    TFN Femoral Nails dimensions mislabeled, may measure 170mm or 200mm

    Synthes recalled TFN-Advanced Femoral Nails because some units have incorrect dimensions: nails labeled 200mm may measure 170mm, while those labeled 170mm may measure 200mm. This dimensional mismatch could compromise surgical fixation.

    Product
    TFN-Advanced Femoral Nail 12MM/130 DEG TI CANN TFNA 170MM STERILE. Intended for temporary fixation and stabilization of proximal femur fractures Part Number: 04.037.242S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1249-2023·2023-03-22

    Plato 17 Microcatheter Recalled Due to Loose Particle Risk

    Scientia Vascular is recalling Plato 17 Microcatheters due to manufacturing defects that may introduce loose particles into the catheter lumen, potentially causing blood vessel blockage or inflammatory reactions.

    Product
    Plato 17 Microcatheter: Straight Tip, PL17-160-000 ; 45 degree Tip, PL17-160-045; 90 degree Tip, PL17-160-090
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1222-2023·2023-03-22

    Hair Growth Laser Comb Recalled for Missing Safety Warnings and Labels

    OMM Imports' Recreo Hair Growth Laser Comb is being recalled because 1,620 units lack required safety labels, warnings, and certification documentation. Missing labels create risk for users of the Class 3R laser device.

    Product
    Recreo Hair Growth Laser Comb
    Category
    Medical Device
    Distribution
    Distributed nationwide