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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32851–32875 of 40449

  • ModerateFDA (Devices)·Z-1926-2015·2015-07-08

    Roche Lactate Reagent Recalled for Potential Drug Interference

    Roche Diagnostics is recalling Lactate reagent due to potential false results caused by drug interference with the Trinder reaction method.

    Product
    Lactate. Intended for use on COBAS INTEGRA 800 and 400 plus systems, cobas c111, Roche/Hitachi MODULAR systems, and cobas c systems for the quantitative determination of lactate concentration in plasm and cerebrospinal fluid.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1971-2015·2015-07-08

    Tecan Infinite 200 Microplate Reader Recalled for Firmware Bug

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

    Product
    Infinite 200 in vitro diagnostic. Product Usage: The Tecan Infinite 200 is a multifunctional microplate reader with injector option. The Infinite 200 provides high performance for the vast majority of todays microplate applications and research and is robotic compatible.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1913-2015·2015-07-08

    Vascutek Gelseal Vascular Grafts Recalled for Incorrect Length Labeling

    Vascutek 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 30cm. 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-1925-2015·2015-07-08

    Roche HDL-Cholesterol Reagent Recalled for Potential Drug Interference

    Roche Diagnostics is recalling HDL-Cholesterol plus gen.3. reagents due to potential false results when used with certain drugs.

    Product
    HDL-Cholesterol plus gen.3.; and Small Supersized Intended for use on COBAS Integra 800 and 400 plus systems, cobas c111, and cobas c systems for the quantitative determination of HDL-cholesterol concentration in serum and plasma.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1907-2015·2015-07-08

    Palindrome HSI Chronic Catheter Recall for Antimicrobial Specification Failure

    Covidien LLC is recalling Palindrome 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 HSI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 33cm Item Code: 8888133509
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1919-2015·2015-07-08

    LifeHealth IRMA TRUPoint 443914 Recalled for Barometric Pressure Drift

    LifeHealth is recalling seven IRMA TRUPoint 443914 devices because their barometric pressure measurements drift over time, potentially affecting critical care analyte results.

    Product
    LifeHealth, IRMA TRUPOINT model 443914, typically used in point-of-care settings. For the in vitro measurement of various critical care analytes in human whole blood. These analytes includes: pO2, pCO2, pH, iCa, Na, K and Cl.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1940-2015·2015-07-08

    Alcon Accurus Vitreous Probes Recalled for Packaging Seal Defect

    Alcon Research is recalling Accurus vitreous probes due to insufficient outer packaging seals that may compromise sterility.

    Product
    Accurus 2500 Standalone Vitreous Probe REF 8065741018; Accurus 23 GA Standalone Vitreous Probe REF 8065750821; Accurus 25+ 2500 CPM Standalone Vitreous Probe REF 8065751122; Anterior Accurus Probe with Infusion Needle REF 8065803650; Single Use Sterile Probes Rx only.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1931-2015·2015-07-08

    Roche Uric Acid Plus Test Recalled for Drug Interference

    Roche Diagnostics is recalling Uric Acid plus ver.2 tests because results may be falsely decreased when used with certain drugs.

    Product
    Uric Acid plus ver.2 In vitro test for the quantitative determination of uric acid in human serum, plasma and urine or Roche/Hitachi MODULAR systems, cobas c111, COBAS Integra 800 and 400 plus systems, and cobas c systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1941-2015·2015-07-08

    Boston Scientific Recalls Extractor Pro RX Retrieval Balloon Catheter Due to Labeling Error

    Boston Scientific is recalling one lot of Extractor Pro RX Retrieval Balloon Catheters because the device contains a syringe size larger than what is identified on the label.

    Product
    Extractor Pro RX Retrieval Balloon Catheter 9-12 mm Above Retrieval Balloon Catheter; Universal Product Number (UPN) M00547000 The Extractor Pro RX Retrieval Balloon Catheters are intended for use endoscopically to remove stones from the biliary system, or to facilitate…
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-1952-2015·2015-07-08

    Milestone Wand STA Handpiece Recalled Due to Mislabeled Packaging

    Milestone Scientific is recalling 165,850 Wand STA handpieces because they were mislabeled as STA handpieces, which cannot be installed in the STA instrument.

    Product
    Milestone Wand STA Handpiece for the delivery of local anesthesia to dental tissue. Model Number STA-5050-305. The Wand STA handpiece is a single use syringe used in conjunction with the CompuDent STA computer controlled dental injection system.
    Category
    Medical Device
    Distribution
    4 states
  • SevereFDA (Devices)·Z-1820-2015·2015-07-01

    Hill-Rom Steriseal-Cannula Ophthalmic Recall Due to Dislodgement Risk

    Hill-Rom is recalling Steriseal-Cannula Ophthalmic handpieces because the metal cannula can rotate and become dislodged from the plastic handpiece.

    Product
    Steriseal-Cannula Ophthalmic; Bi-Manual Irrigating/Aspirating Handpiece.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1835-2015·2015-07-01

    Stryker Recalls Optical Access Systems Due to Fracture Risk

    Stryker is recalling specific Optical Access Systems because they may fracture at the tip, leaving fragments at the surgical site.

    Product
    Optical Access System; 5mm x 100mm and 12mm x 100mm; Model #: CTR03 and CTR73. Indicated for use to establish a port of entry fro endoscopic instruments in patients requiring minimally invasive surgical procedures including thoracic, gynecologic laparoscopy and other…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1834-2015·2015-07-01

    Stryker Recalls Fios First Entry Trocars Due to Fracture Risk

    Stryker is recalling Fios First Entry trocars because some may fracture at the distal tip, leaving fragments at the surgical site.

    Product
    Fios First Entry; 5mm x 100mm and 12mm x 100mm; Model #:CTF03 and CTF73. Indicated for use to establish a port of entry fro endoscopic instruments in patients requiring minimally invasive surgical procedures including thoracic, gynecologic laparoscopy and other abdominal…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1831-2015·2015-07-01

    Stryker Recalls SERFAS 90 Degree Energy Probes Due to Fragmentation

    Stryker Endoscopy is recalling 22,063 SERFAS 90 degree Energy Probes because fragments of the probe have been reported to break off into patients during arthroscopic procedures.

    Product
    SERFAS 90 degree Energy Probe, Part Number 279-350-101; SERFAS Energy Probes are indicated for arthroscopic procedures of the knee, shoulder, ankle, hip, elbow and wrist. Specifically, the probes are used for resection, ablation and coagulation of soft tissue, as well as the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1809-2015·2015-07-01

    Teleflex Recalls Lifesaver Manual Resuscitators Due to Potential Intake Port Blockage

    Teleflex Medical is recalling 9,333 units of Lifesaver Single Patient Use Manual Resuscitators because the intake port may be blocked, causing the bag to fail to fill.

    Product
    Lifesaver Single Patient Use Manual Resuscitator Product Usage: The Hudson RCI Lifesaver Single Patient Use manual resuscitator with pressure monitoring port is a disposable medical device intended for use on patients requiring temporary augmentation of ventilation with or…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1836-2015·2015-07-01

    Stryker Recalls Trocars Due to Reported Fracture at Distal Tip

    Stryker is recalling specific cannula and seal models because they may fracture at the tip, leaving fragments at the surgical site.

    Product
    Cannula and Seal; 5mm x 100mm and 12mm x 100mm Model #: CTS02 and CTS22. Indicated for use to establish a port of entry fro endoscopic instruments in patients requiring minimally invasive surgical procedures including thoracic, gynecologic laparoscopy and other abdominal…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1827-2015·2015-07-01

    Fresenius NaturaLyte Liquid Bicarbonate Concentrate Recalled for Bacterial Contamination

    Fresenius Medical Care is recalling NaturaLyte Liquid Bicarbonate Concentrate due to bacterial contamination. The product is used in hemodialysis machines.

    Product
    NaturaLyte Liquid Bicarbonate Concentrate (Dialysate Concentrate for Hemodialysis (liquid), 6.4 Liter Bottle Catalog Number: 08-4000-LB This concentrate is formulated to be used with a three steam hemodialysis machine which is calibrated for acid and bicarbonate concentrates.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1841-2015·2015-07-01

    Remel VersaTREK Instrument Series 240 Recalled for False Positive Reports

    Remel Inc. is recalling 143 VersaTREK Instrument Series 240 devices because their use may result in false positive reports. The devices are used to cultivate microorganisms from blood and other sterile bodily fluids.

    Product
    VersaTREK Instrument Series 240 REF 6240, Manufactured for Remel Inc. The VersaTREK System is for cultivating and recovering microorganisms, especially bacteria and yeasts, from blood and other normally sterile bodily fluids.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1819-2015·2015-07-01

    Orthofix Centurion POCT System Drill Guide Recall for Depth Setting Risk

    Orthofix is recalling 36 Centurion POCT System Drill Guides because the thumb button may remain unlocked, allowing the drill stop to rotate unintentionally and change the depth setting.

    Product
    ORTHOFIX Centurion POCT System Drill Guide PN 69-1010 and PN 69-1012. Drill Guides are used to interface with various drill tips during the drilling procedure of bone preparation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1821-2015·2015-07-01

    Unomedical Infusion Set Needles Recalled for Potential Breakage During Use

    Unomedical is recalling specific infusion sets because the steel needle can break during use, interrupting medication delivery.

    Product
    Sure T, contact, contact detach, neria, neria detach, neria multi and thalaset Used in combination with infusion pumps for continuous subcutaneous infusion of medication.
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-1837-2015·2015-07-01

    DeRoyal Recalls Custom Surgical Kits with Defective Medtronic Gloves

    DeRoyal Industries is recalling custom surgical kits containing Medtronic Devon Light Gloves due to splits or holes.

    Product
    Custom Surgical Kits containing Medtronic Covidien Devon(TM) Light Gloves: ANGIO TRAY, REF 50-12127; NEURO SPINE TRAY, LAP CHOLE TRACECART(R), REF 53-1931; MINOR PROCEDURE TRACECART (R), REF 53-1932; MAJOR PROCEDURE TRACECART (R), 53-1933; Cover Light Handle Flexible, REF…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1822-2015·2015-07-01

    Smith & Nephew Recalls Ultra-Fast Fix Knot Pusher Suture Cutters

    Smith & Nephew is recalling Ultra-Fast Fix Knot Pusher Suture Cutters because the device's sterility may be compromised.

    Product
    ULTRA-FAST FIX Knot Pusher Suture Cutters Product Number: 72201537 Intended for Meniscal Repair.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1829-2015·2015-07-01

    Varian Leipzig-style Brachytherapy Applicator Set Recalled for Dose Rate Discrepancy

    Varian Medical Systems is recalling 46 Leipzig-style Surface Applicator Sets because the actual dose rate is approximately 14% higher than the rate published in the Instructions for Use.

    Product
    Surface Applicator Set with Leipzig-style Cone. Brachytherapy applicator set.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1825-2015·2015-07-01

    GE Healthcare T2100 Treadmill Recalled for Uncontrolled Walking Belt Motion

    GE Healthcare is recalling 11,423 T2100 Treadmills due to a potential safety issue involving uncontrolled motion of the walking belt.

    Product
    GE Healthcare, Treadmill T2100. For Exercise Testing, facilitating accurate blood pressure measurements and exercise testing within speed range of 0-13.5 miles per hour.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1846-2015·2015-07-01

    Siemens Artis zee/zeego Systems Recalled for Position Sensor Fault

    Siemens is recalling 475 Artis zee/zeego angiography systems because a position sensor fault could cause the system to exceed its usual speed and collide.

    Product
    Artis zee/ zeego systems; Product Usage: Usage: Artis zee/ zeego systems are dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be…
    Category
    Medical Device
    Distribution
    Distributed nationwide