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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29901–29925 of 40325

  • ModerateFDA (Devices)·Z-1938-2016·2016-06-15

    Teleflex Recalls Sterile Tracheal Tubes Due to Size Labeling Error

    Teleflex Medical is recalling 6,390 sterile tracheal tubes because some units labeled as 7mm may actually be 7.5mm.

    Product
    Sterile Sheridan/HVT Cuffed, Murphy Eye, Tracheal Tube, Ref: V5-10314, ID: 7.0 mm, Rx Only, Manufactured by: Teleflex Incorporated. A tracheal tube is inserted into a patients mouth or nose for airway management.
    Category
    Medical Device
    Distribution
    23 states
  • ModerateFDA (Devices)·Z-1932-2016·2016-06-15

    Beckman Coulter Uric Acid Reagent Recalled for False Low Results

    Beckman Coulter is recalling Uric Acid reagent (OSR6x98) because Dipyrone may cause erroneous, false low results in assays.

    Product
    Uric Acid, Catalog No. OSR6x98 Product Usage:Uric acid OSR6x98 is intended as a System reagent for the quantitative determination of Uric Acid in human serum, heparinized plasma and urine on Beckman Coulter AU analyzers.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1934-2016·2016-06-15

    Beckman Coulter Recalls Triglyceride Assay Due to Dipyrone Interference

    Beckman Coulter is recalling Triglyceride OSR6x118 assays because Dipyrone may cause false low results.

    Product
    Triglyceride, Catalog No. OSR6x118 Product Usage:Triglyceride OSR6x118 is intended as an Enzymatic colour test for the quantitative determination of triglyceride in human serum and plasma on Beckman Coulter AU analyzers.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1911-2016·2016-06-15

    Integrated Science Systems Recalls Sure Vue Staph Identification Kits

    Integrated Science Systems is recalling Sure Vue Staph kits due to customer complaints of weak reactions and false negative results.

    Product
    Sure Vue Color Staph 150T, Sure Vue Color Staph 300T, Sure Vue SELECT Staph, biokit SELECT Staph 75T The product is used as an aid in the identification of Staphylococcus aureus from Culture
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1921-2016·2016-06-15

    Remel Recalls Oxoid Nitrocefin In Vitro Diagnostic Reagents

    Remel Inc is recalling Oxoid Nitrocefin reagents because individual bottles may produce weak reactions, leading to delayed or false negative beta-lactamase test results.

    Product
    Oxoid Nitrocefin (+ Reconstitution Fluid Batch) REF: SR0112C, Oxoid Ltd. For the rapid chromogenic detection of beta-lactamase activity in bacterial cells. in vitro diagnostic
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1935-2016·2016-06-15

    Datascope Recalls Intra-Aortic Balloon Catheters Due to Incorrect Instruction Manual

    Datascope is recalling Mega and Sensation Plus Intra-Aortic Balloon Catheter kits because they were packaged with the wrong instruction manual for the STATLOCK device.

    Product
    MEGA¿ 7.5Fr. 30cc Intra-Aortic Balloon Catheter with Insertion Kit & STATLOCK¿ MEGA¿ 7.5Fr. 40cc Intra-Aortic Balloon Catheter with Insertion Kit & STATLOCK¿ MEGA¿ 8Fr. 50cc Intra-Aortic Balloon Catheter with Insertion Kit & STATLOCK¿ MEGA¿ 8Fr. 50cc Intra-Aortic…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1919-2016·2016-06-15

    Synthes Rapid Resorbable Orbital Floor Plate Recalled for Labeling Errors

    Synthes (USA) Products LLC is recalling 19 units of 1.5 mm Rapid Resorbable Orbital Floor Plates due to potential expiration date discrepancies on outer packaging labels.

    Product
    1.5 mm Rapid Resorb Orbt1 F1 P1 w/Bending Template / 30 mm - Sterile, Rapid Resorbable Fixation System. 1.5 mm Rapid Resorbable Orbital Floor Plate with Bending Template. Intended for use in fracture repair and reconstructive procedures of the craniofacial skeleton in…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1942-2016·2016-06-15

    DePuy Synthes Recalls Norian Drillable Inject Due to Labeling Error

    DePuy Synthes is voluntarily recalling Norian Drillable Inject 3 CC-Sterile because the internal pouch may be labeled with the incorrect powder volume, though the actual contents are correct.

    Product
    Norian Drillable Inject 3 CC-Sterile; catalog # 07.704.003S Intended for bony voids or defects of the extremities and pelvis that are not intrinsic to the stability of the bony structure.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1944-2016·2016-06-15

    Synthes Recalls Norian Drillable Inject Due to Labeling Error

    Synthes (USA) Products LLC is recalling Norian Drillable Inject 10 CC-Sterile units because the internal rotary pouch may be labeled with the incorrect powder volume, though the actual contents are correct.

    Product
    Norian Drillable Inject 10 CC-Sterile; catalog # 07.704.010S Intended for bony voids or defects of the extremities and pelvis that are not instrinsic to the stability of the bony structure.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1910-2016·2016-06-15

    Stryker FlowPort II Adapter Recalled Due to Incorrect Orientation

    Stryker is recalling 21 FlowPort II Adapters because the arthroscope sits in the adapter 180 degrees in the wrong direction.

    Product
    Stryker FlowPort II Adapter: Model number: 00CAT00778 The FlowPort II Adapter is intended to connect the FlowPort II Cannulas to commercially available, 4mm arthroscopes in surgical procedures.
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1940-2016·2016-06-15

    Alcon Recalls CENTURION FMS Packs Due to Molding Irregularity

    Alcon is voluntarily removing specific lots of CENTURION FMS packs due to a molding irregularity that may reduce vacuum in the aspiration line.

    Product
    CENTURION FMS (Fluidics Management System) Pack for the CENTURION Vision System and identified Custom Paks
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1698-2016·2016-06-15

    Ellipse ND: YAG Laser Applicator Recalled for Missing Calibration Instructions

    Ellipse A/S is recalling 25 Ellipse ND: YAG Laser applicators because they lack required instructions for calibration procedures and schedules.

    Product
    Ellipse ND: YAG Laser applicator for Ellipse Nordlys system Medical Laser Products.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1933-2016·2016-06-15

    Beckman Coulter Cholesterol Reagent Recalled for False Low Results

    Beckman Coulter is recalling Cholesterol OSR6x16 reagent because Dipyrone may cause erroneous, false low results in cholesterol assays.

    Product
    Cholesterol, Catalog No. OSR6x16 Product Usage:Cholesterol OSR6x16 is intended as a System reagent for the quantitative determination of Cholesterol concentrations in human serum on Beckman Coulter AU analyzers.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1920-2016·2016-06-15

    Synthes Recalls 1.5 mm Rapid Resorbable Orbital Floor Plates Due to Labeling Errors

    Synthes (USA) Products LLC is recalling 14 units of 1.5 mm Rapid Resorbable Orbital Floor Plates because outer package expiration dates may exceed subcomponent dates.

    Product
    1.5 mm Rapid Resorb Orbt1 F1 P1 w/Bending Template / 35 mm - Sterile, Rapid Resorbable Fixation System. 1.5 mm Rapid Resorbable Orbital Floor Plate with Bending Template. Intended for use in fracture repair and reconstructive procedures of the craniofacial skeleton in…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1930-2016·2016-06-15

    Beckman Coulter Lipase Reagent Recalled for Potential False Low Results

    Beckman Coulter is recalling Lipase OSR6x30 reagent because Dipyrone may cause erroneous false low results in lipase assays.

    Product
    Lipase, Catalog No. OSR6x30 Product Usage: Lipase OSR6x30 is intended as a System reagent for the quantitative determination of Lipase activity in human serum on Beckman Coulter AU analyzers.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1918-2016·2016-06-15

    Synthes Recalls 22 Rapid Resorbable Orbital Floor Plates Due to Labeling Errors

    Synthes (USA) Products LLC is recalling 22 units of 1.5 mm Rapid Resorbable Orbital Floor Plates because outer package expiration dates may exceed subcomponent dates.

    Product
    1.5 mm Rapid Resorb Orbt1 F1 P1 w/Bending Template / 24 mm - Sterile, Rapid Resorbable Fixation System. 1.5 mm Rapid Resorbable Orbital Floor Plate with Bending Template. Intended for use in fracture repair and reconstructive procedures of the craniofacial skeleton in…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1923-2016·2016-06-15

    Greiner Bio-One Recalls 4 ml FX Sodium Fluoride Tubes

    Greiner Bio-One is recalling 4 ml FX Sodium Fluoride/Potassium Oxalate tubes because they may contain low or no additives, potentially affecting glucose and lactate test results.

    Product
    4 ml FX Sodium Fluoride/Potassium Oxalate tube, Ref 454297 VACUETTE Glycolytic Inhibitor Tubes contain an antiglycolytic agent, sodium fluoride, and an anticoagulant, potassium oxalate. The product is suitable for the analysis of blood glucose and lactate
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1931-2016·2016-06-15

    Beckman Coulter Lactate Reagent Recalled for Potential False Low Results

    Beckman Coulter is recalling Lactate OSR6x93 reagent because Dipyrone may cause erroneous false low results.

    Product
    Lactate, Catalog No. OSR6x93 Product Usage: Lactate OSR6x93 is intended as a System reagent for the quantitative determination of L-Lactate in human plasma and cerebrospinal fluid (CSF) on Beckman Coulter AU analyzers.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1696-2016·2016-06-15

    Philips DuraDiagnost X-ray System Recalled for Image Acquisition Failure

    Philips Healthcare is recalling five DuraDiagnost stationary X-ray systems because the detector may incorrectly signal readiness, causing failed image acquisitions.

    Product
    Philips Healthcare DuraDiagnost stationary X-ray system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1719-2016·2016-06-15

    Philips CT System Recalled for Software Defects Affecting Scan Accuracy

    Philips Healthcare is recalling Ingenuity Elite CT systems due to software defects that cause incorrect scan lengths and dose calculations.

    Product
    Philips Healthcare Ingenuity Elite Computed Tomography X-Ray System
    Category
    Medical Device
    Distribution
    29 states
  • LowFDA (Devices)·Z-1924-2016·2016-06-15

    MedComp Recalls Tearaway Introducers Due to Incorrect Expiration Date Labeling

    Medical Components, Inc dba MedComp is recalling specific lots of Tearaway Introducers because they are labeled with incorrect expiration dates.

    Product
    Tearaway Introducer, Model # VS203, VS303, 510 K # 130687, packaged individually in a pouch, 5 pouches per carton, lot # MBZ140, MBZL450, MBZV930 MBZZ490 Product Usage: The 2F and 3F Vascu-Sheath Tearaway Introducer is intended for percutaneous venous access by modified…
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-1849-2016·2016-06-08

    Curity All Purpose Sponges Recalled Due to Compromised Sterility

    FDA is recalling Curity All Purpose Sponges due to compromised sterility from a barrier breach. The recall affects units distributed in the US and 20 other countries.

    Product
    Curity All Purpose Sponges, Non-woven, 4 Ply, Soft Pouch, 4" x 4" (10.2 cm x 10.2 cm) Item Number: 8047
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1859-2016·2016-06-08

    Recall of Vistec X-Ray Detectable Sponges Due to Sterility Breach

    Covidien LLC is recalling Vistec X-Ray Detectable Sponges because a breach of the barrier packaging may have compromised sterility.

    Product
    Vistec X-Ray Detectable Sponges, 26 Ply, 8" x 4" (20.3 cm x 10.2 cm) Item Number: 7321
    Category
    Medical Device
    Distribution
    Distributed nationwide