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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30001–30025 of 40449

  • 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
  • SevereFDA (Devices)·Z-1855-2016·2016-06-08

    Curity X-Ray Detectable Laparotomy Sponges Recalled for Sterility Breach

    The FDA is recalling Curity X-Ray Detectable Laparotomy Sponges because a breach of the barrier packaging may have compromised their sterility.

    Product
    Curity X-Ray Detectable Laparotomy Sponges, Soft Pouch Pack, 12" x 12" (30.5 cm x 30.5 cm) Item Number:6534
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1847-2016·2016-06-08

    Curity Gauze Sponges Recalled for Compromised Sterility

    Covidien LLC is recalling Curity Gauze Sponges because a breach of the barrier packaging may have compromised their sterility.

    Product
    Curity Gauze Sponges, 16 ply 4" x 4" (10.2 cm x 10.2 cm), Sterile 10's in Soft Pouch; Item Number: 397310; Open mesh fabric intended to be used to inside the body or a surgical incision to control bleeding, absorb fluid, or protect organs.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1852-2016·2016-06-08

    Curity X-Ray Detectable Laparotomy Sponges Recalled for Sterility Breach

    The FDA is recalling Curity X-Ray Detectable Laparotomy Sponges because a breach of the barrier packaging may have compromised their sterility.

    Product
    Curity X-Ray Detectable Laparotomy Sponges, Tray Pack, 18" x 18" (45.7 cm x 45.7 cm) Item Number: 6022
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1853-2016·2016-06-08

    Curity X-Ray Detectable Laparotomy Sponges Recalled for Sterility Breach

    FDA is recalling Curity X-Ray Detectable Laparotomy Sponges due to compromised sterility from a barrier breach.

    Product
    Curity X-Ray Detectable Laparotomy Sponges, Tray Pack, 8" x 36" (20.3 cm x 91.4 cm Item Number: 6056
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1856-2016·2016-06-08

    Curity X-Ray Detectable Laparotomy Sponges Recalled for Sterility Breach

    The FDA is recalling Curity X-Ray Detectable Laparotomy Sponges because a breach of the barrier packaging may have compromised their sterility.

    Product
    Curity X-Ray Detectable Laparotomy Sponges, Soft Pouch Pack, 4" x 18" (10.2 cm x 45.7 cm) Item Number: 6545
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1857-2016·2016-06-08

    Curity X-Ray Detectable Laparotomy Sponges Recalled for Sterility Breach

    The FDA is recalling Curity X-Ray Detectable Laparotomy Sponges due to compromised sterility caused by a breach of the barrier.

    Product
    Curity" X-Ray Detectable Laparotomy Sponges, Soft Pouch Pack, 8" x 36" (20.3 cm x 91.4 cm) Item Number: 6556
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1835-2016·2016-06-08

    Pentax Medical Recalls Video Duodenoscopes Due to CRE Infection Reports

    Pentax Medical is recalling 423 Video Duodenoscopes nationwide after reports of carbapenem-resistant Enterobacteriaceae (CRE) infection at a medical facility.

    Product
    Video Duodenoscope
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1851-2016·2016-06-08

    Kerlix X-Ray Detectable Laparotomy Sponges Recalled for Sterility Breach

    FDA is recalling Kerlix X-Ray Detectable Laparotomy Sponges due to compromised sterility from a barrier breach.

    Product
    Kerlix" X-Ray Detectable Laparotomy Sponges, Tray Pack, 8" x 32" (20.3 cm x 81.3 cm) Item Number: 4037
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1848-2016·2016-06-08

    Kerlix X-Ray Detectable Laparotomy Sponges Recalled for Sterility Breach

    The FDA is recalling Kerlix X-Ray Detectable Laparotomy Sponges due to compromised sterility from a barrier breach.

    Product
    Kerlix" X-Ray Detectable Laparotomy Sponges, Tray Pack, 16" x 17" (40.6 cm x 43.2 cm) Item Number: 4034
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1854-2016·2016-06-08

    Curity X-Ray Detectable Laparotomy Sponges Recalled for Sterility Breach

    The FDA is recalling Curity X-Ray Detectable Laparotomy Sponges due to compromised sterility caused by a barrier breach.

    Product
    Curity X-Ray Detectable Laparotomy Sponges, Soft Pouch Pack, 18" x 18" (45.7 cm x 45.7 cm) Item Number:6522
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1858-2016·2016-06-08

    FDA Recalls Vistec X-Ray Detectable Sponges Due to Sterility Breach

    The FDA is recalling Vistec X-Ray Detectable Sponges because a breach in the packaging barrier may have compromised their sterility.

    Product
    Vistec X-Ray Detectable Sponges, 16 Ply, 8" x 4" (20.3 cm x 10.2 cm) Item Number: 7319
    Category
    Medical Device
    Distribution
    Distributed nationwide