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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31351–31375 of 40449

  • HighFDA (Devices)·Z-0470-2016·2015-12-30

    Hardy Diagnostics Recalls FB Broth Due to Potential Contamination

    Hardy Diagnostics is recalling FB Broth (Lot 15231) because of potential Burkholderia fungorum contamination. The product was distributed in California, Wisconsin, Maryland, and Utah.

    Product
    FB Broth, 10ml (Fastidious Bacteria Broth) Cat. no: K31 Lot: 15231 A fastidious bacteria broth for the enriched cultivation of Neisseria spp., Haemophilus spp., Streptococcus spp., Corynebacterium spp., and other fastidious bacteria from clinical specimens.
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-0460-2016·2015-12-30

    Siemens Reagent Management System Recalled for Electrical Hazard

    Siemens is recalling Reagent Management System (RMS) modules for the Dimension RxL Max clinical chemistry system because some units have missing safety covers on electrical termination blocks.

    Product
    Reagent Management System (RMS) Dimension RxL Max w/o HM Product Usage: The Reagent Management System (RMS) is a module for use with the Dimension¿ clinical chemistry system. The RMS doubles the available storage of refrigerated Flex¿ reagent cartridges on the Dimension¿…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0552-2016·2015-12-30

    Airways Development Recalls WaterPAP Positive Airway Pressure Devices

    Airways Development LLC is recalling 1,464 WaterPAP Positive Airway Pressure Devices due to a reported canister leak.

    Product
    Airways Development LLC WaterPAP Positive Airway Pressure Device Reference #WP-7700.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0461-2016·2015-12-30

    Siemens Reagent Management System Recalled for Electrical Safety Hazard

    Siemens is recalling 151 Reagent Management System units because missing safety covers expose electrical termination blocks, creating a shock hazard.

    Product
    Reagent Management System (RMS) Dimension RxL Max HM STM Product Usage: The Reagent Management System (RMS) is a module for use with the Dimension¿ clinical chemistry system. The RMS doubles the available storage of refrigerated Flex¿ reagent cartridges on the Dimension¿…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0471-2016·2015-12-30

    Biomet Black Mamba Suture Passer Recalled for Weld Defect

    Biomet is recalling 50 Black Mamba Suture Passers because a weld defect may cause the instrument's jaw to fail to actuate properly.

    Product
    Black Mamba Suture Passer
    Category
    Medical Device
    Distribution
    20 states
  • HighFDA (Devices)·Z-0423-2016·2015-12-30

    Aesculap Flexible Bone Awl Recalled for Potential Shaft Breakage

    Aesculap, Inc. is recalling 41 Flexible Bone Awls (SJ607R) because the flexible shaft may break during surgery, posing a risk of fragments remaining in patients.

    Product
    Flexible Bone Awl; SJ607R; NON STERILE; B Braun Aesculap; Aesculap AG: These instruments are intended for use during the implantations of the A-Space SIBD and Arcadius XP L systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0456-2016·2015-12-30

    BD Vacutainer K2 EDTA Blood Collection Tubes Recalled for Stopper Defect

    Becton Dickinson is recalling 4.8 million blood collection tubes because stoppers may not be fully inserted, posing a risk of blood exposure.

    Product
    BD Vacutainer K2 EDTA (K2E) 5.4mg Plus Blood Collection Tubes. Product Usage: BD Vacutainer¿ tubes are used to collect, transport and process blood in a closed system. These tubes are used for testing serum, plasma or whole blood in the clinical laboratory. The BD…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0458-2016·2015-12-30

    Siemens Reagent Management System Recalled for Electrical Hazard

    Siemens is recalling 106 Reagent Management System units because a missing safety cover exposes an electrical hazard on the compressor.

    Product
    Reagent Management System (RMS) Dimension EXL with LM Product Usage: The Reagent Management System (RMS) is a module for use with the Dimension¿ clinical chemistry system. The RMS doubles the available storage of refrigerated Flex¿ reagent cartridges on the Dimension¿…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0453-2016·2015-12-30

    Zimmer Universal Power System Handpieces Recalled for Malfunction

    Zimmer, Inc. is recalling 89 Universal Power System handpieces that may start by themselves when the power source is connected.

    Product
    Zimmer UNIVERSAL Power System Loaner and Modular Electric/Battery Single Trigger Handpiece. Rx only Made in Switzerland
    Category
    Medical Device
    Distribution
    32 states
  • HighFDA (Devices)·Z-0459-2016·2015-12-30

    Siemens Reagent Management System Recalled for Electrical Hazard

    Siemens is recalling four Reagent Management System units because a missing safety cover exposes an electrical termination block, creating a shock hazard.

    Product
    Reagent Management System (RMS) Dimension EXL with LM STM Product Usage: The Reagent Management System (RMS) is a module for use with the Dimension¿ clinical chemistry system. The RMS doubles the available storage of refrigerated Flex¿ reagent cartridges on the Dimension¿…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0455-2016·2015-12-30

    CareFusion Recalls Alaris EtCO2 Module 8300 Due to Calibration Error

    CareFusion is recalling 157 Alaris EtCO2 Module 8300 units because they may have been tested with high CO2 concentrations, potentially causing incorrect measurements.

    Product
    Alaris EtCO2 Module, Model 8300. A capnograph that continuously monitors end tidal carbon dioxide (EtCO2), fractional inspired carbon dioxide (FiCO2), and respiratory rate (RR).
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0467-2016·2015-12-30

    Siemens MAGNETOM MRI Systems Recalled for Quench Line Installation Errors

    Siemens is recalling MAGNETOM MRI systems due to potential quench line installation errors that could cause oxygen displacement or cold burns.

    Product
    MAGNETOM systems, magnetic resonance diagnostic devices (MRDD).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0474-2016·2015-12-30

    Becton Dickinson Recalls Enterococcus Screen Agar QUAD Plates

    Becton Dickinson is recalling 770 units of Enterococcus Screen Agar QUAD Plates due to potential breakthrough growth of Enterococcus faecalis near the end of shelf life.

    Product
    Enterococcus Screen Agar QUAD Plate
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0551-2016·2015-12-30

    Terumo Recalls Winged Infusion Sets Due to Improper Bonding

    Terumo Medical Corp is recalling 80,500 units of Surflo Winged Infusion Sets distributed in California due to potential improper bonding between the tube and luer.

    Product
    Terumo Surflo Winged Infusion Set with Filter and Needle Protection (Surshield), Product Code: SV-S25FL35.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0445-2016·2015-12-30

    CareFusion Recalls Alaris Pump SmartSite Infusion Sets Due to Leakage Risk

    CareFusion is recalling Alaris Pump SmartSite Infusion Sets because disconnection and leakage may occur during infusion.

    Product
    Alaris Pump SmartSite Infusion Set, Model No. 2420-0500. Used to administer fluid and medications through a needle or catheter inserted into the patient's artery or vein.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0452-2016·2015-12-30

    Zimmer Universal Power System Handpieces Recalled for Malfunction

    Zimmer, Inc. is recalling 87 Universal Power System handpieces because a malfunction could cause them to start unexpectedly when connected to a power source.

    Product
    Zimmer UNIVERSAL Power System Loaner and Modular Electric/Battery Double Trigger Handpiece. Rx only Made in Switzerland
    Category
    Medical Device
    Distribution
    32 states
  • HighFDA (Devices)·Z-0450-2016·2015-12-30

    Biomet Recalls A.L.P.S. 4.0mm Cancellous Locking Screws Due to Thread Defect

    Biomet is recalling A.L.P.S. 4.0mm Cancellous Locking Screws because a single-lead thread design may cause screws to sit proud or back out, potentially requiring revision surgery.

    Product
    A.L.P.S. 4.0mm Cancellous Locking Screws intended for use in stabilization and fixation of fractures, revision procedures, fusions, reconstructions (osteotomy) and non-unions of the bones.
    Category
    Medical Device
    Distribution
    51 states
  • ModerateFDA (Devices)·Z-0545-2016·2015-12-30

    Philips Brilliance iCT CT System Recalled for Perfusion Software Issue

    Philips is recalling 51 Brilliance iCT CT systems because the perfusion scan feature may be unavailable on specific software versions.

    Product
    Brilliance iCT Computed Tomography X-ray system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0550-2016·2015-12-30

    Siemens Syngo Imaging XS PACS Recall for Incorrect Print Sizes

    Siemens is recalling 42 units of Syngo Imaging XS software because printouts may be in incorrect anatomical size when using unsupported printers.

    Product
    Syngo Imaging XS is a Picture Archiving and Communication System (PACS)
    Category
    Medical Device
    Distribution
    23 states
  • ModerateFDA (Devices)·Z-0508-2016·2015-12-30

    Ameditech Immutest 11 Pnl Drug Screen Cup Recall for Reduced Reactivity

    Ameditech is recalling Immutest 11 Pnl Drug Screen Cups because they may show reduced reactivity for two specific benzodiazepine compounds.

    Product
    Immutest 11 Pnl Drug Screen Cup w/ Adult, Item No. IMCA-11OP
    Category
    Medical Device
    Distribution
    Distributed nationwide