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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31101–31125 of 40325

  • ModerateFDA (Devices)·Z-0737-2016·2016-02-10

    Bard Denali Intravascular Filters Recalled for Missing Contraindications

    Bard Peripheral Vascular Inc is recalling 1,183 Denali intravascular filters because the instructions for use are missing critical contraindications regarding sepsis and nickel-titanium allergies.

    Product
    Denali Filter-Jugular/Subclavian DL950J Denali Filter-Femoral Delivery DL950F. Intravascular filters.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0754-2016·2016-02-10

    Siemens ADVIA Centaur PSA Assay Recalled for High Dose Hook Effect Failure

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur PSA Assay kits because they do not meet the High Dose Hook Effect expectation in the Instructions for Use.

    Product
    ADVIA Centaur PSA Assay; Catalog Number: 06574155/SMN 10310292 (100 test kit) and Catalog Number: 02676506/SMN 10310293 (500 test kit) Product Usage: This in vitro diagnostic assay is intended to quantitatively measure prostate-specific Antigen (PSA) in human serum using the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0749-2016·2016-02-10

    bioMérieux Recalls BacT/ALERT SN Culture Bottles Due to Shipping Exposure

    bioMérieux is recalling 2,741 BacT/ALERT SN culture bottles because non-normal shipping conditions may have degraded the media, potentially impacting microbial growth performance.

    Product
    BacT/ALERT¿ SN, bioM¿rieux, Inc. Product Usage: BacT/ALERT¿ Culture Bottles are used with the BacT/ALERT¿ Microbial Detection System in qualitative procedures for enhanced recovery and detection of aerobic and facultative anaerobic microorganisms (bacteria and yeast).
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0742-2016·2016-02-10

    Horiba Instruments Recalls ABX PENTRA Triglycerides Assay Due to Interference

    Horiba Instruments Inc is recalling ABX PENTRA Triglycerides CP assays because N-acetylcysteine in patient blood can cause falsely low results.

    Product
    ABX PENTRA Triglycerides CP ref. A11A01640 is an in vitro diagnostic assay for the quantitative determination of triglycerides in human serum and plasma based on an enzymatic colorimetric test. It is composed of a 99 ml mono-reagent cassette. Reagent is a chemical solution with…
    Category
    Medical Device
    Distribution
    29 states
  • ModerateFDA (Devices)·Z-0740-2016·2016-02-10

    Horiba ABX PENTRA Glucose Reagent Recalled for NAC Interference

    Horiba Instruments Inc is recalling ABX PENTRA Glucose reagents because N-acetylcysteine in patient blood can cause falsely low glucose results.

    Product
    ABX PENTRA Glucose PAP CP ref. A11A01668 reagent is intended for the quantitative in vitro diagnostic determination of glucose in human serum, plasma and urine using glucose oxidase method by colorimetry.
    Category
    Medical Device
    Distribution
    29 states
  • ModerateFDA (Devices)·Z-0731-2016·2016-02-10

    Baxter RAPIDFILL Syringe Strips Recalled for Shelf Life Packaging Claim

    Baxter is recalling RAPIDFILL Syringe Strips because the packaging claims a 12-month shelf life without supporting evidence.

    Product
    Baxter, RAPIDFILL Syringe Strip, 10 ml. For use with RAPIDFILL Automated Syringe Filler (ASF)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0689-2016·2016-02-03

    Cook Medical Recalls Zilver 518RX Vascular Stent Delivery Systems

    Cook Medical is recalling 753 Zilver 518RX Vascular Stent delivery systems because a manufacturing defect may cause the catheter joint to separate during use.

    Product
    Zilver¿ 518RX Vascular Stent with Rapid Exchange Delivery System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0690-2016·2016-02-03

    Globalmed Logistix Recalls Lipogems SPA Aspiration Cannulae Due to Bending Risk

    Globalmed Logistix is recalling 118 units of Lipogems SPA Aspiration Cannulae because they may bend during procedures. The affected sterile cannulae were distributed to seven states.

    Product
    Lipogems SPA Aspiration Cannulae, intended for aspiration of adipose tissue. LGC 13G (13G x 185mm), Sterile.
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-0651-2016·2016-02-03

    Midmark Vantage Panoramic X-Ray System Recalled for Collimator Failure

    Midmark Corp dba Progeny Inc is recalling 832 Vantage Panoramic X-Ray Systems because a primary collimator failure may cause unintentional movement without an error message.

    Product
    Vantage Panoramic X-Ray System used to perform dental and orthodontic radiological imaging The Vantage Panoramic X-Ray System is a class II extra oral X-Ray system used to provide dental radiographic examination and diagnosis of diseases of the teeth, jaw and oral structures.…
    Category
    Medical Device
    Distribution
    34 states
  • HighFDA (Devices)·Z-0693-2016·2016-02-03

    Fresenius Liberty Cycler Peritoneal Dialysis Machines Recalled for Door Latch Defect

    Fresenius Medical Care is recalling 14,094 Liberty Cycler peritoneal dialysis machines because the door latch may not fully close, posing a risk of injury or treatment delay.

    Product
    Fresenius Liberty Cycler-Peritoneal Dialysis Cycler Model: 180111 and RTLR180111
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0695-2016·2016-02-03

    Bio-Rad D-10 Rack Loader Recalled for Potential Sample ID Error

    Bio-Rad is recalling D-10 Rack Loaders because a rare configuration issue could assign patient results to incorrect sample IDs.

    Product
    D-10 Rack Loader; Model Number 220-0600; Hematology: The D-10 is a fully integrated system for sample dilution, processing and analysis of hemoglobin, designed for use with specific Bio-Rad reagent kits. The D-10 incorporates the use of a dedicated software system for…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0697-2016·2016-02-03

    Phadia Recalls EliA SmDP Wells Due to Invalid Test Results

    Phadia Ab is recalling 76 units of EliA SmDP Well lot 0018 because nonspecific signals may cause incorrect positive or equivocal test results for systemic lupus erythematosus.

    Product
    EliA SmDP Well, Article Number 14-5624-01 Product Usage: EliA SmDP is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to Sm in human serum and plasma (EDTA, citrate) as an aid in the clinical diagnosis of systemic lupus erythematosus (SLE)…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0660-2016·2016-01-27

    St. Jude Medical Recalls Optisure Dual Coil Defibrillation Leads

    St. Jude Medical is recalling Optisure Dual Coil Defibrillation Leads due to potential insulation cuts in the SVC shock coil.

    Product
    Optisure Dual Coil Defibrillation Leads, Model No. LDA220, LDA220Q, LDA230Q, LDP220Q. St. Jude Medical. Designed for long term attachment to an Implantable Cardioverter Defibrillator (ICD).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0631-2016·2016-01-27

    Arkray SPOTCHEM II Reagent Test Strips Recalled for Glucose Error

    Arkray Factory USA is recalling specific lots of SPOTCHEM II test strips because they may display inaccurate glucose results for high values.

    Product
    arkray SPOTCHEM II Basic Panel - 1 Reagent test strips, Product # 11726, MEDTEST DX Catalog # 77484. Calcium, Blood Urea Nitrogen, Glucose, Albumin, Creatinine. For the in vitro quantitative determination of calcium, blood urea nitrogen (BUN), glucose, albumin, and…
    Category
    Medical Device
    Distribution
    8 states
  • SevereFDA (Devices)·Z-0665-2016·2016-01-27

    MWT Materials Recalls Accusorb MRI Radio Frequency Shielding Products

    MWT Materials, Inc. is recalling Accusorb MRI radio frequency shielding blankets and body-part covers because they may overheat and lead to patient injury when not used correctly.

    Product
    Accusorb MRI MAC7004 Part Number: MRI-04 MRI-Poncho Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0680-2016·2016-01-27

    GE Aisys Anesthesia System Recalled for Potential Barotrauma Risk

    GE Medical Systems is recalling 13 Aisys Anesthesia Systems because a stuck valve could cause excessive pressure in the patient breathing circuit, potentially resulting in barotrauma.

    Product
    GE Healthcare, Aisys, 1011-9000-000. The GE Datex-Ohmeda Aisys Anesthesia System is intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients (neonatal, pediatric, adult). The device is intended for volume or pressure control…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0630-2016·2016-01-27

    Arkray SPOTCHEM II Glucose Reagent Test Strips Recalled for Inaccurate Results

    Arkray Factory USA, Inc. is recalling SPOTCHEM II Glucose Reagent Test Strips because a lowered reaction rate causes inaccurate high glucose readings.

    Product
    arkray SPOTCHEM II Glucose Reagent test strips, Item No. 77101, MEDTEST DX Catalog # 77424. For the in vitro quantitative determination of glucose in human plasma from whole blood samples.
    Category
    Medical Device
    Distribution
    8 states
  • SevereFDA (Devices)·Z-0672-2016·2016-01-27

    MWT Materials Recalls Accusorb MRI Shielding Blankets Due to Overheating Risk

    MWT Materials, Inc. is recalling Accusorb MRI MAC7010 radio frequency shielding blankets and body-part covers because they may overheat when not used correctly, posing a risk of patient injury.

    Product
    Accusorb MRI MAC7010 Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0677-2016·2016-01-27

    GE Aespire Anesthesia Systems Recalled for Potential Barotrauma Risk

    GE Medical Systems is recalling Aespire 7900 and Aespire View anesthesia systems because a stuck valve could cause excessive pressure and barotrauma.

    Product
    GE Healthcare, Aespire 7900, 1009-9012-000 & Aespire View, 1009-9212-000. The family of GE Datex-Ohmeda Aespire anesthesia systems with 7900 ventilator (Aespire 7900 and Aespire View) is intended to provide general inhalation anesthesia and ventilatory support to a wide range…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0663-2016·2016-01-27

    MWT Materials Recalls Accusorb MRI Blankets Due to Overheating Risk

    MWT Materials, Inc. is recalling 49 Accusorb MRI blankets because they may overheat and lead to patient injury when not used correctly.

    Product
    Accusorb MRI MAC7001 Part Number: MRI-01 MRI-Large Blanket Various Sizes Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0671-2016·2016-01-27

    MWT Materials Recalls Accusorb MRI Leg Wrap Blankets Due to Overheating Risk

    MWT Materials, Inc. is recalling 47 units of Accusorb MRI Leg Wrap Blankets because they may overheat when not used correctly, posing a risk of patient injury.

    Product
    Accusorb MRI MAC7009 Part Number: MRI-09 MRI- Leg Wrap Blanket Various Sizes Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0598-2016·2016-01-27

    Brainlab Cranial Navigation System Recalled for Potential Software Inaccuracy

    Brainlab AG is recalling its Cranial Navigation System software due to a potential error that may cause inaccurate instrument display during surgery.

    Product
    Brainlab Cranial Navigation System: An Image Guided Surgery System / Stereotactic. Radiology Departments. The BrainLAB Cranial IGS System is intended to be an intra-operative image guided localization system to enable minimally invasive surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0685-2016·2016-01-27

    Abeon Medical Recalls Self-Retaining Retractor Frames Due to Sterility Compromise

    Abeon Medical Corporation is recalling 1,035 units of TLC Self-Retaining Retractor Frames because some sealed pouches contain tears that compromise the product's sterility.

    Product
    TLC¿ Self-Retaining Retractor Frames SINGLE USE ONLY Rx ONLY (USA) Indicated to aid in tissue retraction during a surgical procedure.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0667-2016·2016-01-27

    MWT Materials Recalls Accusorb MRI Radio Frequency Shielding Products

    MWT Materials, Inc. is recalling 15 Accusorb MRI radio frequency shielding blankets and body-part covers. The products may overheat when not used correctly, posing a risk of patient injury.

    Product
    Accusorb MRI MAC7008 Part Number: MRI-08 MRI-Boot Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment.
    Category
    Medical Device
    Distribution
    Distributed nationwide