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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35976–36000 of 40449

  • HighFDA (Devices)·Z-1469-2014·2014-04-23

    Brainlab Spine & Trauma 3D 2.0 Navigation Software Recalled for Registration Defect

    Brainlab AG is recalling 133 units of Spine & Trauma 3D 2.0 Navigation Software due to a defect in the fluoro match registration function.

    Product
    Brainlab, Spine & Trauma 3D 2.0, Navigation Software. An intraoperative image-guided localization system to enable minimally invasive surgery. Catalog Number: 22264
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Devices)·Z-1466-2014·2014-04-23

    Edwards Lifesciences Recalls Fem-Flex II Arterial Cannulae Due to Tip Separation

    Edwards Lifesciences is recalling 13,115 Fem-Flex II Arterial and femoral Cannulae because the dilator tips may separate. The recall covers units distributed nationwide and to foreign, government, and military consignees.

    Product
    Edwards Lifesciences Fem-Flex II Arterial and femoral Cannulae, arterial cannula sizes 16, 18 and 20 French, models: FEMII016A, FEMII016AS, FEMII018A, FEMII018AS, FEMII020A, and FEMII020AS.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1464-2014·2014-04-23

    Philips Ingenuity Core 128 CT Systems Recalled for Software Reconstruction Failures

    Philips is recalling 116 Ingenuity Core 128 CT systems worldwide because a software upgrade caused intermittent reconstruction failures.

    Product
    Ingenuity Core 128, Computed Tomography X-ray systems, Philips Medical Systems (Cleveland), Inc.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1470-2014·2014-04-23

    Ortho-Clinical Diagnostics Recalls VITROS Carbamazepine Slides Due to Potential Bias

    Ortho-Clinical Diagnostics is recalling VITROS CRBM Slides, Lot 3920-0080-8403, because they may produce biased carbamazepine results.

    Product
    VITROS Chemistry Products CRBM Slides, REF 889 2382, IVD -- Ortho-Clinical Diagnostics, Inc. For in vitro diagnostic use only. VITROS Chemistry Products CRBM Slides quantitatively measure carbamazepine (CRBM) concentration in serum and plasma using VITROS 250/350/950/5,1 FS…
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-1456-2014·2014-04-23

    Synthes CMF Battery Powered Driver Recalled for Misleading Case Graphics

    Synthes is recalling CMF Battery Powered Drivers because the packaging graphics suggest off-label use with taps, which is not intended.

    Product
    Synthes CMF Battery Powered Driver, Part no. 305.840. Used to place screws in the cranialfacial bones, and to drill and/or tap holes to prepare cranialfacial bones for screw insertion.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1465-2014·2014-04-23

    Terumo Cardiovascular Procedure Kit Recalled for Incorrect Customer Notification Label

    Terumo is recalling 37 units of Cardiovascular Procedure Kits in California due to an incorrect customer notification label applied to the Tyvek lid.

    Product
    Terumo Cardiovascular Procedure Kit- X-Coated Pump and Table Pack with FX25RE Catalog Number: 73431
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1463-2014·2014-04-23

    Solta Medical Recalls Fraxel DUAL Laser Systems Due to Incorrect Labeling

    Solta Medical is recalling 1,077 Fraxel DUAL 1550/1927 Laser Systems because obsolete treatment cards may contain incorrect indications for treating Melasma.

    Product
    FRAXEL DUAL 1550/1927 Laser System, (FRAXEL SR 1500 DUAL Laser System), for dermatological procedures.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1468-2014·2014-04-23

    Codman Certas Programmable Valves Recalled for Missing Verification Tools

    Codman & Shurtleff is recalling 9,445 units of Certas Programmable Valves to ensure customers have tools to verify valve settings and location on x-ray images.

    Product
    CODMAN CERTAS Programmable Valves, central nervous system shunt, models as follows: 82-8800 In Line Valve Only 82-8801 In Line Valve with Catheter and Accessories 82-8802 In Line Valve with Unitized Catheter and Accessories 82-8803 In line Valve with Unitized BACTISEAL…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1457-2014·2014-04-23

    Synthes Hohmann Retractor Recalled for Incorrect Part Number Etching

    Synthes, Inc. is recalling 20 Hohmann retractors because they were mis-etched with the wrong part number.

    Product
    The Synthes Hohmann Retractor, 43 mm Long Shank, Angled 235 mm Product Usage: Used to expose bone for procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1448-2014·2014-04-16

    Pega Medical Recalls Fassier-Duval Intramedullary Rods Due to Material Defect

    Pega Medical Inc. is recalling five units of the Fassier-Duval IM Telescopic System because the male components were made with material of lower strength than specifications.

    Product
    Pega Medical Inc., Fassier-Duval IM Telescopic System, male component (solid shaft), Part number: M040-SS-110; Used in Implant Catalogue number: FD-040(LS)-SS. orthopedic intramedullary rod.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1440-2014·2014-04-16

    Draeger Oxylog 3000 Plus Ventilators Recalled Due to Potentiometer Fault

    Draeger Medical Systems is recalling three Oxylog 3000 plus ventilators because the control knobs may interrupt contact, causing the device to stop ventilation.

    Product
    Draeger Oxylog 3000 plus ventilators, emergency and transport ventilator. Part number: 5704833
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1426-2014·2014-04-16

    Aspen Surgical Recalls Sterile Wound Drainage Kits Due to Sterility Concerns

    Aspen Surgical Products is recalling sterile wound drainage kits because the sterile barrier may be compromised, posing a risk of infection.

    Product
    19FR Drain Kit Full Fluted with Trocar and 100ml S-Vac Bulb, Sterile (10/case) Intended for closed wound suction drainage
    Category
    Medical Device
    Distribution
    35 states
  • HighFDA (Devices)·Z-1432-2014·2014-04-16

    Aspen Surgical Recalls Sterile Wound Drainage Kits Due to Sterility Concerns

    Aspen Surgical Products is recalling sterile wound drainage kits because the sterile barrier may be compromised, potentially exposing patients to contamination.

    Product
    15FR Drain Kit Round End Perforated with Trocar and 100ml S-Vac Bulb Evacuator, Sterile (10/case) Intended for closed wound suction drainage
    Category
    Medical Device
    Distribution
    35 states
  • HighFDA (Devices)·Z-1418-2014·2014-04-16

    Aspen Surgical 10mm Drain Kit Recalled for Sterile Barrier Compromise

    Aspen Surgical Products is recalling 10mm Drain Kits due to a potential compromise of the sterile barrier, posing a risk of infection.

    Product
    10mm Drain Kit, Flat Full Perforated, Saber 100ml Bulb and 3C System Sterile (10/case) Intended for closed wound suction drainage
    Category
    Medical Device
    Distribution
    35 states
  • HighFDA (Devices)·Z-1425-2014·2014-04-16

    Aspen Surgical Recalls Sterile Wound Drainage Kits Due to Sterility Concerns

    Aspen Surgical Products is recalling sterile wound drainage kits because the sterile barrier may be compromised, potentially exposing patients to infection.

    Product
    15FR Drain Kit Full Fluted with Trocar and 100ml S-Vac Bulb, Sterile (10/case) Intended for closed wound suction drainage
    Category
    Medical Device
    Distribution
    35 states
  • HighFDA (Devices)·Z-1419-2014·2014-04-16

    Aspen Surgical Wound Drainage Kits Recalled for Sterility Concerns

    Aspen Surgical Products is recalling specific wound drainage kits due to a potential compromise of the sterile barrier.

    Product
    10FR Drain Kit, Flat Full Perforated with Trocar, Saber 100ml Bulb and 3C System, Sterile (10/case) Intended for closed wound suction drainage
    Category
    Medical Device
    Distribution
    35 states
  • HighFDA (Devices)·Z-1445-2014·2014-04-16

    Alcon LenSx Ophthalmic Laser Recalled for Gantry Motion Defect

    Alcon LenSx is recalling 75 ophthalmic lasers used in cataract surgery due to reports of unexpected downward motion of the gantry.

    Product
    Alcon LenSx Ophthalmic Laser, for use in cataract surgery for the creation of corneal cuts/incisions, anterior capsulotomy and laser phacofragmentation.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1424-2014·2014-04-16

    Aspen Surgical Recalls Sterile Wound Drainage Kits Due to Sterility Concerns

    Aspen Surgical Products is recalling sterile wound drainage kits because the sterile barrier may be compromised, potentially exposing patients to infection.

    Product
    10FR Drain Kit Full Fluted with Trocar and 100ml S-Vac Bulb, Sterile (10/case) Intended for closed wound suction drainage
    Category
    Medical Device
    Distribution
    35 states
  • HighFDA (Devices)·Z-1433-2014·2014-04-16

    Aspen Surgical Products Recalls Sterile Wound Drainage Kits Due to Sterility Concerns

    Aspen Surgical Products is recalling sterile wound drainage kits because the sterile barrier may be compromised, potentially increasing the risk of infection.

    Product
    19FR Drain Kit Flat Full Perforated with Trocar, Saber 100ml Bulb and 3CSystem, Sterile (10/case) Intended for closed wound suction drainage
    Category
    Medical Device
    Distribution
    35 states
  • HighFDA (Devices)·Z-1421-2014·2014-04-16

    Aspen Surgical Recalls Sterile Wound Drainage Devices Due to Sterility Concerns

    Aspen Surgical Products is recalling sterile wound drainage devices due to a potential compromise of the sterile barrier.

    Product
    Saber 100ml Infection Control PVC Bulb with 150ml 3C System, Sterile (10/case) Intended to provide manual suction and collection of fluids for closed wound drainage systems
    Category
    Medical Device
    Distribution
    35 states
  • HighFDA (Devices)·Z-1438-2014·2014-04-16

    Philips HeartStart XL+ Defibrillator Recall for Software Communication Failure

    Philips is recalling HeartStart XL+ Defibrillators because a software failure may lock users out of clinical mode, potentially delaying therapy.

    Product
    Philips HeartStart XL+ Defibrillator/Monitor with system software version B.00.00 or B.00.01 installed Model: 861290, automatic external defibrillator.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1417-2014·2014-04-16

    Aspen Surgical Recalls Sterile Wound Drainage Kits Due to Sterility Concerns

    Aspen Surgical Products is recalling 7mm Drain Kits because the sterile barrier may be compromised, potentially exposing patients to infection.

    Product
    7mm Drain Kit, Flat Full Perforated, Saber 100ml Bulb and 3C System Sterile (10/case) Intended for closed wound suction drainage
    Category
    Medical Device
    Distribution
    35 states
  • HighFDA (Devices)·Z-1446-2014·2014-04-16

    Breg Recalls Knee Sleeves for Missing Latex Warning Labels

    Breg Inc is recalling specific knee sleeves because they contain latex but lack the required caution labels.

    Product
    Economy Elastic Knee Sleeve Open, Model No. 121414 and 121415. Product Usage: The product is intended to provide flexible knee support.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1428-2014·2014-04-16

    Aspen Surgical Recalls Sterile Wound Drainage Kits Due to Sterility Concerns

    Aspen Surgical Products is recalling sterile wound drainage kits because the sterile barrier may be compromised, potentially increasing the risk of infection.

    Product
    10mm Drain Kit Flat Full Perforated with Trocar and 100ml S-Vac Bulb Evacuator, Sterile (10/case) Intended for closed wound suction drainage
    Category
    Medical Device
    Distribution
    35 states