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.

Filters

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All agenciesFDA (Food)FDA (Drugs)FDA (Devices)USDA FSISCPSCNHTSAEPA

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All categoriesFoodDrugMedical DeviceVehicleConsumer Product

Minimum severity

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

Clear filters

31201–31225 of 40449

  • 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
  • HighFDA (Devices)·Z-0645-2016·2016-01-27

    Cyberonics VNS Therapy AspireSR Generator Recall for Sensing Delays

    Cyberonics is recalling 29 Model 106 VNS Therapy AspireSR Generators due to delays in heartbeat sensing and potential decreased battery longevity.

    Product
    Cyberonics Vagus Nerve Stimulator VNS Therapy AspireSR Generator, Model 106
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-0684-2016·2016-01-27

    Abeon Medical Recalls TLC Self Retaining Retractor System Due to Sterility Compromise

    Abeon Medical Corporation is recalling 2,570 units of the TLC Self Retaining Retractor System because some sealed pouches contain tears that compromise the product's sterility.

    Product
    TLC¿ Self Retaining Retractor System Contents 1-RETRACTOR FRAME 6-ELASTIC STAYS STERILE EO Rx ONLY. Indicated for use in the retraction of soft tissue away from the operative surface.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0669-2016·2016-01-27

    MWT Materials Recalls Accusorb MRI Leg Wraps Due to Overheating Risk

    MWT Materials, Inc. is recalling 18 Accusorb MRI Leg Wraps because they may overheat when not used correctly, posing a risk of patient injury.

    Product
    Accusorb MRI MAC7005 Part Number: MRI-05 Leg Wrap Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0676-2016·2016-01-27

    Rymed InVision-Plus IV Connector Recall Due to Cracking Risk

    Rymed Technologies is recalling 46,600 InVision-Plus CS Needleless IV Connectors because the female luer component may crack during use.

    Product
    InVision-Plus CS Needleless IV Connector, Catalog Number RYM-7001. Disposable, Single Use. Products are intended for single patient use in intravenous and blood administration sets without the need for needles, thus eliminating the potential for needle-stick injuries during…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0659-2016·2016-01-27

    Cyberonics Recalls VNS Therapy AspireSR Generators Due to Stimulation Failure

    Cyberonics is recalling 4,935 VNS Therapy AspireSR Generators worldwide after three reports of device resets that disabled stimulation output.

    Product
    VNS Therapy AspireSR Generator Model 106. Indicated for use as an adjunctive therapy in reducing the frequency of seizures.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0666-2016·2016-01-27

    MWT Materials Recalls Accusorb MRI Breast Shields Due to Overheating Risk

    MWT Materials, Inc. is recalling six Accusorb MRI Breast Shields because they may overheat when not used correctly, posing a risk of patient injury.

    Product
    Accusorb MRI MAC7007 Part Number: MRI-07 MRI-Breast Shield Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0686-2016·2016-01-27

    Abeon Wilson Penile Implantation System Retractor Frame Recalled for Sterility Compromise

    Abeon Medical Corporation is recalling Wilson Penile Implantation System Retractor Frames because some sealed pouches contain tears that compromise the product's sterility.

    Product
    Wilson Penile Implantation System Retractor Frame, Retractor Stays & Penile Elevation Strap, SINGLE USE ONLY Rx ONLY. Indicated to aid in tissue retraction during a surgical procedure.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0683-2016·2016-01-27

    IBA Dosimetry Lift Table Recalled for Uncontrolled Movement Risk

    IBA Dosimetry GmbH is recalling Lift Table Type 4320 units because they may move up in an uncontrolled manner when connected to power.

    Product
    IBA Dosimetry GmbH Lift Table Type 4320, Catalog HA03-010#2 and HA03-000#2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0682-2016·2016-01-27

    GE Medical Systems Recalls Anesthesia Device Service Kits Due to Valve Defect

    GE Medical Systems is recalling 240 anesthesia device service kits because a drive gas check valve could become stuck open, potentially causing excessive pressure in the patient breathing circuit.

    Product
    Anesthesia device service kits. ASSY-MSN, VENT ENGINE ASSY, 1503-8101-000 ASSY-MSN, VENT ENGINE ASSY 7900, 1009-8216-000 ASSY-MSN, VENT ENGINE ASSY AESPIRE 7900 1009-8423-000 ASSY-MSN, VENT ENGINE ASSY, AESTIVA 7900 MRI 1503-8102-000 ASSY-MSN, VLV ASSY DR GAS CHK…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0664-2016·2016-01-27

    MWT Materials Recalls Accusorb MRI Arm Sleeves Due to Overheating Risk

    MWT Materials, Inc. is recalling 31 Accusorb MRI arm sleeves distributed in New York and Massachusetts because they may overheat and injure patients when not used correctly.

    Product
    Accusorb MRI MAC7002 Part Number: MRI-02 MRI-Arm Sleeve Various Sizes Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0675-2016·2016-01-27

    Rymed InVision-Plus IV Connectors Recalled for Cracking Risk

    Rymed Technologies is recalling InVision-Plus IV connectors because the female luer component may crack during use.

    Product
    InVision-Plus and InVision-Plus Junior Needleless IV Connector, Disposable, Single Use Products are intended for single patient use in intravenous and blood administration sets without the need for needles, thus eliminating the potential for needle-stick injuries during use.
    Category
    Medical Device
    Distribution
    Distributed nationwide