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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21151–21175 of 40248

  • ModerateFDA (Devices)·Z-1014-2019·2019-03-27

    Siemens Dimension Vista 500 Analyzer Recall for Water Module Contamination

    Siemens is recalling 5,373 Dimension Vista 500 analyzers because specific Millipore water purification modules may cause falsely elevated triglyceride results.

    Product
    Dimension Vista 500, Analyzer, chemistry Model no. 10284473
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1029-2019·2019-03-27

    Smith & Nephew Recalls Mislabelled High Offset StikTite Coated Hip Stems

    Smith & Nephew is recalling 9 units of hip stems where the outer label incorrectly identified the product as size "1" instead of the actual size "-1".

    Product
    smith&nephew SMF(TM) HIGH OFFSET STIKTITE(TM) COATED STEM 12/14 TAPER -1H SIZE, STEM, REF 713552511
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-1038-2019·2019-03-27

    ConvaTec Recalls FilterFlow Suction Handles Due to Sterile Barrier Breach Risk

    ConvaTec is recalling 124,000 FilterFlow Suction Handles because an internal assessment found a potential breach in the sterile barrier.

    Product
    FilterFlow Suction Handle CH24, 20 eaches per sales unit. Product Usage: Filter Flow is designed for orthopedic surgery and combines suctioning function with filtering. The device is intended for orthopedic surgical procedures to remove and collect debris and bone fragments…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1035-2019·2019-03-27

    ConvaTec Recalls Forceps Blue Due to Potential Sterile Barrier Breach

    ConvaTec, Inc. is recalling Forceps Blue, disposable sterile forceps, because an internal assessment confirmed the potential for a breach in the sterile barrier.

    Product
    Forceps Blue, disposable, sterile, 100 eaches per sales unit. Product Usage: Forceps are sterile disposable devices intended for use during clinical procedures to grasp, manipulate, maneuver or assist with the removal of debris, particulates or wound tissue. Typically…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1032-2019·2019-03-27

    ACell Recalls Gentrix Surgical Matrix Thick Due to Tensile Strength Failure

    ACell, Inc. is recalling one lot of Gentrix Surgical Matrix Thick devices because a sample failed to meet tensile strength specifications.

    Product
    Gentrix Surgical Matrix Thick, 30 x 40cm, Catalog Number PSMT3040, Lot 013948 - Product Usage: Gentrix Surgical Matrix Thick is intended for implantation to reinforce soft tissue where weakness exists in patients requiring gastroenterological or plastic and reconstructive…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1028-2019·2019-03-27

    Smith & Nephew Recalls Mislabelled Hip Stem Implants Due to Size Error

    Smith & Nephew is recalling 58 hip stem implants because the outer label incorrectly identified the product as size "1" instead of "-1".

    Product
    smith&nephew SMF(TM) STANDARD OFFSET STIKTITE(TM) COATED STEM 12/14 TAPER -1 SIZE, STEM, REF 713552510
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-1018-2019·2019-03-27

    Randox Fructosamine Control 3 Calibrator Recall Due to Value Reassignment

    Randox Laboratories is recalling 133 kits of Fructosamine Control 3 because the assigned value was decreased by 25%. The product is used for in vitro calibration.

    Product
    Fructosamine Control 3, FR2996 This product is intended for in vitro use in the calibration of the Randox Liquid Fructosamine assay on clinical chemistry systems.
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-1017-2019·2019-03-27

    Randox Fructosamine Calibrator Recall Due to Value Reassignment

    Randox Laboratories is recalling 141 kits of Fructosamine Control 1 because the assigned value was decreased by 25%.

    Product
    Fructosamine Control 1, FR2994 This product is intended for in vitro use in the calibration of the Randox Liquid Fructosamine assay on clinical chemistry systems.
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-1016-2019·2019-03-27

    Randox Fructosamine Calibrator Recall Due to Value Reassignment

    Randox Laboratories is recalling 85 kits of Fructosamine Calibrator FR2993 because the assigned value was decreased by 25%.

    Product
    Fructosamine Calibrator, FR2993 This product is intended for in vitro use in the calibration of the Randox Liquid Fructosamine assay on clinical chemistry systems.
    Category
    Medical Device
    Distribution
    4 states
  • LowFDA (Devices)·Z-1024-2019·2019-03-27

    Cook Medical Recalls Celect Platinum Vena Cava Filters for Labeling Updates

    Cook Medical is recalling Celect Platinum Vena Cava Filter Sets to update the Instructions for Use. The recall affects 9,173 units distributed nationwide.

    Product
    Cook Celect Platinum Vena Cava Filter Set for Femoral Vein Approach, Catalog Number IGTCFS-65-1-FEM-CELECT-PT Product Usage: The Cook Celect Platinum Filter implant is intended for the prevention of recurrent pulmonary embolism (PE) via placement in the vena cava in the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1034-2019·2019-03-27

    Agfa Radiographic Film Recalled for Visible Pinholes in Images

    Agfa N.V. is recalling specific lots of PET Plates Coated Film-MONOMEDBV2S2 radiographic film because inhomogeneous coating solutions cause visible pinholes in images.

    Product
    PET Plates Coated Film-MONOMEDBV2S2- Radiographic Film REF: XJUB8, XJM73, XJUDD, XJM85, EKLYZ. Product Usage: Due to an inhomogeneous coating solution, pinholes can become visible in even dark images. Visibility of the pinholes varies as material from this coating run…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1026-2019·2019-03-27

    Cook Medical Recalls Celect Platinum Vena Cava Filters for Labeling Updates

    Cook Medical is recalling Celect Platinum Vena Cava Filter Sets to update the Instructions for Use. The recall affects 9,173 units distributed nationwide.

    Product
    Cook Celect Platinum Vena Cava Filter Set for Femoral and Jugular Vein Approach, Catalog Number IGTCFS-65-1-UNl-C ELECT-PT Product Usage: The Cook Celect Platinum Filter implant is intended for the prevention of recurrent pulmonary embolism (PE) via placement in the vena…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1023-2019·2019-03-27

    Cook Medical Recalls Gunther Tulip Vena Cava Filters for Labeling Updates

    Cook Medical is recalling 9,173 Gunther Tulip Vena Cava Filter Sets to update the Instructions for Use. The products were distributed nationwide.

    Product
    Gunther Tulip Vena Cava Filter Set for Femoral and Jugular Vein Approach, Catalog Number IGTCFS-65-1-UNl-TULIP Product Usage: The Gunther Tulip Filter is intended for the prevention of recurrent pulmonary embolism (PE) via placement in the vena cava in the following…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1025-2019·2019-03-27

    Cook Medical Recalls Celect Platinum Vena Cava Filters for Labeling Updates

    Cook Medical is recalling Celect Platinum Vena Cava Filters to update the Instructions for Use. The recall affects 9,173 units distributed nationwide.

    Product
    Cook Celect Platinum Vena Cava Filter Set for Jugular Vein Approach, Catalog Number GTCFS-65-1-JUG-CELECT-PT Product Usage: The Cook Celect Platinum Filter implant is intended for the prevention of recurrent pulmonary embolism (PE) via placement in the vena cava in the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1022-2019·2019-03-27

    Cook Medical Recalls Gunther Tulip Vena Cava Filters for Labeling Updates

    Cook Medical is recalling 9,173 Gunther Tulip Vena Cava Filter Sets to update the Instructions for Use. The products were distributed nationwide.

    Product
    Gunther Tulip Vena Cava Filter Set for Jugular Vein Approach, Catalog Number IGTCFS-65-1-JUG-TULIP Product Usage: The Gunther Tulip Filter implant is intended for the prevention of recurrent pulmonary embolism (PE) via placement in the vena cava in the following situations…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1021-2019·2019-03-27

    Cook Medical Recalls Gunther Tulip Vena Cava Filters for Labeling Updates

    Cook Medical is recalling 9,173 Gunther Tulip Vena Cava Filter Sets to update the Instructions for Use.

    Product
    Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach, Catalog Number IGTCFS-65-1-FEM-TU LIP Product Usage: The Gunther Tulip Filter implant is intended for the prevention of recurrent pulmonary embolism (PE) via placement in the vena cava in the following…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0992-2019·2019-03-20

    Ortho-Clinical Diagnostics Recalls VITROS Chemistry Products Na+ Slides

    Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products Na+ Slides because imprecision in the affected lot may produce biased patient sample and quality control fluid results.

    Product
    VITROS Chemistry Products Na+ Slides, Catalog Number 8379034 For in vitro diagnostic use only. VITROS Na+ Slides quantitatively measure sodium (Na+) concentration in serum, plasma, and urine using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600…
    Category
    Medical Device
    Distribution
    20 states
  • SevereFDA (Devices)·Z-0979-2019·2019-03-20

    Cook Transseptal Needle Recalled for Missing Back Bevel

    Cook Inc. is recalling 100 units of Transseptal Needles manufactured without a back bevel on the needle tip, which could damage the introducer during insertion.

    Product
    Cook Transseptal Needle, Reference Number TSNC-18-71.0, Order Number G02364. For transseptal left heart access in both diagnostic and interventional procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1006-2019·2019-03-20

    FDA Recalls NexGen Trabecular Metal Tibial Augments Due to Labeling Mismatch

    Zimmer Trabecular Metal Technology is recalling 26 units of NexGen Trabecular Metal Tibial Half Block Augments because the product in the box may not match the label.

    Product
    NexGenTrabecular Metal Tibial Half Block Augment, Left Lateral/Right Medial, Size 4 5MM Thickness W/Screws Item Number: 00544800436 Product Usage: The Trabecular Metal Tibial Cone Augments are intended for use where severe degeneration, trauma, or other pathology of the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0994-2019·2019-03-20

    Durex Pleasure Pack Condoms Recalled for Burst Pressure Failure

    Reckitt Benckiser is recalling Durex Pleasure Pack condoms because five batches failed burst pressure specifications.

    Product
    Durex Pleasure Pack (60 ct), synthetic polisoprene male condom, SKU 02340-98729-00 02340-98729-00 02340-98729-00 02340-98729-00 02340-98729-00 02340-98729-00
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0993-2019·2019-03-20

    Durex Real Feel Condoms Recalled for Burst Pressure Failure

    Reckitt Benckiser LLC is recalling Durex Real Feel condoms because five batches failed burst pressure specifications.

    Product
    Durex Real Feel, synthetic polisoprene male condom, SKU 02340-89456-14 02340-89455-00 02340-89456-14 02340-89456-14 02340-89455-00 02340-95767-00 02340-89456-14 02340-89457-00 02340-89456-14 02340-89456-14 02340-89455-00 02340-89455-00 02340-95767-00 02340-95767-00
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0996-2019·2019-03-20

    Steris Recalls AMSCO 5000 Series Washer/Disinfector Units Due to Software Defect

    Steris Corporation is recalling 68 AMSCO 5000 Series Washer/Disinfector units because a software defect may prevent the intended cleaning cycle from processing, potentially leading to inadequate disinfection.

    Product
    AMSCO 5000 Series Washer/Disinfector Model # 5052
    Category
    Medical Device
    Distribution
    27 states
  • HighFDA (Devices)·Z-1011-2019·2019-03-20

    US Endoscopy Padlock Clip Recalled for Potential Esophageal Laceration Risk

    US Endoscopy Group Inc is recalling Padlock Clip defect closure systems due to a risk of esophageal laceration during patient procedures.

    Product
    US Endoscopy Padlock Clip defect closure system Ref: C910001 The Padlock Clip is indicated for use in flexible endoscopy and for the compression of tissue in the gastrointestinal tract, for hemostasis or for treating lesions of the wall of the gastrointestinal organs.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0995-2019·2019-03-20

    Steris Recalls AMSCO 3000 Series Washer/Disinfector Units Due to Software Defect

    Steris Corporation is recalling 11 AMSCO 3000 Series Washer/Disinfector units because a software defect may prevent intended processing cycles, risking inadequate cleaning or damage to medical instruments.

    Product
    AMSCO 3000 Series Washer/Disinfector Model # 3052
    Category
    Medical Device
    Distribution
    27 states
  • HighFDA (Devices)·Z-0991-2019·2019-03-20

    Linet AVE 2 Birthing Bed Recalled for Power Cable Safety Issue

    Linet Spol. S.r.o. is recalling 253 AVE 2 Birthing Beds because the power cable may break or fail, posing a risk of sparks or exposure to live conductors.

    Product
    AVE 2 Birthing Bed
    Category
    Medical Device
    Distribution
    21 states