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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32826–32850 of 40449

  • ModerateFDA (Devices)·Z-1930-2015·2015-07-08

    Roche Diagnostics Recalls Triglycerides/Glycerol Blanked In Vitro Test Kits

    Roche Diagnostics is recalling 6,255 units of Triglycerides/Glycerol Blanked in vitro test kits due to possible drug interference that may cause falsely decreased results.

    Product
    Triglycerides/Glycerol Blanked. In vitro test for the quantitative determination of triglycerides in human serum and plasma or Roche/Hitachi MODULAR systems, and cobas c systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1929-2015·2015-07-08

    Roche Triglycerides GPO Test Recalled for Potential Drug Interference

    Roche is recalling Triglycerides GPO tests because certain drugs may cause falsely decreased results on specific Cobas analyzers.

    Product
    Triglycerides GPO. In vitro test for the quantitative determination of triglycerides in human serum and plasma on the COBAS Integra 800 and 400 plus systems, cobas c111, Roche/Hitachi MODULAR systems, and cobas c systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1889-2015·2015-07-08

    Palindrome HSI Chronic Catheter Kit Recalled for Antimicrobial Specification Failure

    Covidien LLC is recalling Palindrome HSI Chronic Catheter Kits because they may not meet antimicrobial specifications. The recall affects 72,363 units in the US and 24,631 internationally.

    Product
    Palindrome HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 19cm Item Code: 8888145057C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1959-2015·2015-07-08

    Siemens ACUSON SC2000 Ultrasound Systems Recalled for Data Loss

    Siemens Medical Solutions USA is recalling 573 ACUSON SC2000 ultrasound systems because specific keystrokes during 2D Stress Echo studies may cause selected clips to not be saved.

    Product
    ACUSON SC2000 Ultrasound Systems between software versions VA16A and VA30A and with the Stress Echo Option. Model number 10433816: The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1933-2015·2015-07-08

    Siemens SOMATOM Emotion 16 CT Scanners Recalled for Broken Gantry Screws

    Siemens is recalling 40 SOMATOM Emotion 16 CT scanners due to broken or bowed screws in the gantry balance weight assembly.

    Product
    SOMATOM Emotion 16; produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angels or spiral planes taken at different angles.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1942-2015·2015-07-08

    Siemens EasyLink Data Management System Recalled for Software Limitations

    Siemens Healthcare Diagnostics is recalling 1,355 units of the EasyLink Data Management System due to software issues affecting reference ranges and sample actions.

    Product
    EasyLink Data Management System; a clinical data management system that assists medical laboratory professionals with preanalytic and post-analytic functions in conjunction with multiple instruments, the laboratory information system (LIS) and Siemens StreamLAB Automation…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1890-2015·2015-07-08

    Palindrome HSI Chronic Catheter Kit Recalled for Antimicrobial Specification Failure

    The FDA is recalling Palindrome HSI Chronic Catheter Kits because they may not meet antimicrobial specifications. The recall affects 72,363 units in the US and 24,631 internationally.

    Product
    Palindrome HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 19cm Item Code: 8888145048
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1968-2015·2015-07-08

    Tecan Infinite M1000 PRO Microplate Reader Recalled for Firmware Bug

    Tecan US, Inc. is recalling 868 Infinite M1000 PRO microplate readers because a firmware bug causes incorrect luminescence values to be displayed.

    Product
    Infinite M1000 PRO in vitro diagnostic. Product Usage: The Tecan Infinite M1000 PRO is a multifunctional monochromator based microplate reader that provides high performance for the vast majority of todays microplate applications and research. In addition to offering…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1910-2015·2015-07-08

    Palindrome Precision HSI Chronic Catheter Recalled for Antimicrobial Specification Failure

    Covidien LLC is recalling Palindrome Precision HSI Chronic Catheters because they may not meet antimicrobial specifications. The recall affects 72,363 units in the US and 24,631 internationally.

    Product
    Palindrome Precision HSI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 28cm Item Code: 8888128459P
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1949-2015·2015-07-08

    Intuitive Surgical Recalls da Vinci Xi Instrument Arm Drapes

    Intuitive Surgical is recalling da Vinci Xi Instrument Arm Drapes because a pinched drape may cause a 'Missing reload error' on the Vision Cart touchscreen.

    Product
    INSTRUMENT ARM DRAPE, IS4000, 20 PACK; used on the da Vinci Xi Surgical System. The Intuitive Surgical Endoscope Instrument Control System (da Vinci Surgical System, Model IS4000) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1928-2015·2015-07-08

    Roche LDL-Cholesterol Test Recalled for Potential Drug Interference

    Roche Diagnostics is recalling 6,255 units of the LDL-Cholesterol plus gen.2. test due to potential false results caused by drug interference.

    Product
    LDL-Cholesterol plus gen.2. The Boehringer Mannheim Direct LDL-Cholesterol test in intended for the quantitative determination of low-density lipoprotein Cholesterol (LDL-C) in serum and plasma.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1957-2015·2015-07-08

    Siemens CentraLink Data Management System Software Recall

    Siemens recalls CentraLink software because the sample query function may fail to return all samples from Dimension Vista systems under specific configurations.

    Product
    CentraLink" Data Management System; software is a network solution provider and multi-system data manager for the instruments and lab automation systems (LAS) within the lab. The CentraLink software consolidates data from all connected instruments so that an operator can review…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1869-2015·2015-07-08

    Covidien Recalls Palindrome Precision SI Chronic Catheter Kits

    Covidien LLC is recalling Palindrome Precision SI Chronic Catheter Kits because they may not meet antimicrobial specifications. The recall affects 72,363 units in the US and 24,631 internationally.

    Product
    Palindrome Precision SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 19cm Item Code: 8888145062CP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1927-2015·2015-07-08

    Roche LDL-Cholesterol Test Recalled for Potential Drug Interference

    Roche Diagnostics is recalling the LDL-Cholesterol gen.2 test because certain drugs may cause falsely decreased results when using the Trinder reaction method.

    Product
    LDL-Cholesterol gen.2. The Boehringer Mannheim Direct LDL-Cholesterol test in intended for the quantitative determination of low-density lipoprotein Cholesterol (LDL-C) in serum and plasma.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1915-2015·2015-07-08

    DePuy Synthes Titanium Recon Screws Recalled for Incorrect Insert

    Synthes, Inc. is recalling 276 DePuy Synthes 6.5 mm Titanium Recon Screws because certain lots contain the wrong insert.

    Product
    DePuy Synthes 6.5 mm Titanium Recon Screws w/T25 Stardrive (70mm, 75mm, 80mm, 85mm, 90mm, 95mm, 105mm); part of the Expert Lateral Femur Nail System and indicated to stabilize Subtrochanteric fractures, Ipsilateral neck/shaft fractures, Femoral shaft fractures, Impending…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1916-2015·2015-07-08

    RTI Surgical Recalls Mislabeled Bullet-Tip PEEK VBR Implants

    RTI Surgical is recalling 18 units of three lots of Bullet-Tip PEEK VBR implants distributed in Florida and New York due to incorrect color labeling.

    Product
    Bullet-Tip PEEK VBR/IBF System, 32mm(l) 13mm(H) Implant 32-13-32 UDI (01)008464680341 08(17)191218(10)200827; T-Plus PEEK VBR/IBF System, 10mm(W) x 27mm(l) x 13mm(H) Implant, 6degree lordotic 30-T-13-6 UDI (01) 00846468032920(17) 200116(10) 202726; and T-Plus PEEK VBR/IBF…
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1946-2015·2015-07-08

    Axis-Shield Homocysteine Reagent Recalled for Performance Deterioration

    Axis-Shield Diagnostics is recalling Liquid Stable 2-Part Homocysteine Reagents due to performance deterioration that causes under-recovery of test results.

    Product
    Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT; 100 test format, 1000 test format, and 200 test format; and Private Label: (Distributed by BECKMAN COULTER, for professional use only, on the BECKMAN COULTER AU platforms (AU400, AU480, AU680 and AU5800)) Product…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1882-2015·2015-07-08

    Palindrome SI Chronic Catheters Recalled for Antimicrobial Specification Failure

    Covidien LLC is recalling Palindrome SI Chronic Catheters because they may not meet antimicrobial specifications. The recall affects units with expiry dates of February 2018 and earlier.

    Product
    Palindrome SI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 28cm Item Code: 8888128458
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1920-2015·2015-07-08

    Roche Cholesterol Reagent Recalled for Potential Drug Interference

    Roche Diagnostics is recalling Cholesterol CHOD-PAP reagents because drug interference may cause falsely decreased test results.

    Product
    Cholesterol CHOD-PAP. In vitro diagnostic reagent system intended for use on the Hitachi systems for The quantitative determination of total cholesterol in serum and plasma.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1912-2015·2015-07-08

    Vascutek Gelseal Vascular Grafts Recalled for Incorrect Length Labeling

    Vascutek, Ltd. is recalling 12 Gelseal vascular grafts labeled as 30cm but actually 15cm. The devices were distributed in Michigan and four other countries.

    Product
    Gelseal Straight Diameter 8mm Length 15cm. Vascular graft prosthesis is an implanted device intended to repair, replace, or bypass sections of native or artificial vessels, excluding coronary or cerebral vasculature, and to provide vascular access.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1960-2015·2015-07-08

    Spine Wave Access Kit Recalled for Mislabeled Probe Dimensions

    Spine Wave, Inc. is recalling 121 Spine Wave Access Kits because the outer carton mislabels the monopolar probe dimensions. The probe is listed as 200 x 1.5mm instead of the correct 280 x 1.5mm.

    Product
    Spine Wave Access Kit, Catalog Number 10-1530 Package contents: RLSP494-Rhythmlink Monopolar Stimulating Probe and 10-1525 Disposable Dilator Set. Product Usage: The Spine Wave Access Kit is comprised of a sterile monopolar stimulating probe (individually packaged by…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1921-2015·2015-07-08

    Roche Cholesterol Gen.2 Cassette Recalled for Potential Drug Interference

    Roche Diagnostics is recalling Cholesterol Gen.2 cassettes because Trinder reaction tests may yield falsely decreased results when specific drugs are present.

    Product
    Cholesterol Gen.2. The cassette COBAS Integra Cholesterol Gen.2 (CHOL2) contains an in vitro diagnostic reagent system intended for use on COBAS Integra 800 and 400 plus systems, cobas c111, and cobas c systems for the quantitative determination of total cholesterol in serum…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1967-2015·2015-07-08

    Tecan Infinite F500 Microplate Reader Recalled for Firmware Bug

    Tecan US, Inc. is recalling 868 Infinite F500 microplate readers because a firmware bug causes incorrect luminescence values to be displayed.

    Product
    Infinite F500, in vitro diagnostic. Product Usage: The Tecan Infinite F500 is a multifunctional microplate reader with injector option. The Infinite F500 provides high performance for the vast majority of todays microplate applications and research and is robotic…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1924-2015·2015-07-08

    Roche HDL-Cholesterol gen.3. Recalled for Potential Drug Interference

    Roche Diagnostics is recalling HDL-Cholesterol gen.3. reagents due to potential false results caused by drug interference on Cobas Analyzers.

    Product
    HDL-Cholesterol gen.3. For the quantitative determination of high-density lipoprotein Cholesterol (HDL-C) in serum and plasma.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1970-2015·2015-07-08

    Tecan Infinite 200 PRO Microplate Reader Recalled for Firmware Bug

    Tecan US, Inc. is recalling 868 Infinite 200 PRO microplate readers because a firmware bug causes incorrect luminescence values to be displayed.

    Product
    Infinite 200 PRO in vitro diagnostic. Product Usage: The Tecan Infinite 200 PRO is a multifunctional microplate reader with injector option. The Infinite 200 PRO provides high performance for the vast majority of todays microplate applications and research and is robotic…
    Category
    Medical Device
    Distribution
    Distributed nationwide