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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21601–21625 of 40175

  • HighFDA (Devices)·Z-0525-2019·2018-12-12

    ASO Recalls Family Wellness Sterile Gauze Pads Due to Sterilization Concerns

    ASO, LLC is recalling Family Wellness First Aid Sterile Gauze Pads because they may not be fully sterilized. The affected units were distributed nationwide to ten states.

    Product
    Family Wellness First Aid Sterile Gauze Pad 3 in x 3 in, 10 CT. White, bleached, non-woven, rayon/polyester sterile Gauze Pad 3 inch x 3 inch, 12-ply 10 count cardboard box
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0550-2019·2018-12-12

    Capintec Recalls Captus 3000 Thyroid Uptake Systems Due to Spring Arm Failure

    Capintec Inc is recalling 385 Captus 3000 Thyroid Uptake Systems because a broken tension rod can cause the spring arm to fail and the collimator to fall.

    Product
    Captus 3000 Thyroid Uptake System, Model # 5430-0076 and 5430-0077
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0531-2019·2018-12-12

    Zimmer Biomet Recalls Humeral Guide Wires Due to Sterility Compromise

    Zimmer Biomet is recalling specific lots of M/DN Intramedullary Fixation Humeral Guide Wires because creases in the packaging may compromise sterility.

    Product
    Zimmer M/DN¿ Intramedullary Fixation Humeral Guide Wire - Smooth, 2.4 mm Diameter, 70 cm Length Item Number: 00-2255-025-00 Product Usage: A single use surgical instrument used during orthopaedic surgery for implantation of a prosthesis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0535-2019·2018-12-12

    Zimmer Biomet Recalls Guide Wires Due to Sterility Compromise

    Zimmer Biomet is recalling ZMS Intramedullary Fixation Smooth Guide Wires because creases in the sealing area may compromise product sterility.

    Product
    Zimmer ZMS¿ Intramedullary Fixation Smooth Guide Wire - Bullet Tip, 3.0 mm Diameter, 100 cm Length Item Number: 47-2237-038-00 Product Usage: A single use surgical instrument used during orthopaedic surgery for implantation of a prosthesis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0530-2019·2018-12-12

    Zimmer Biomet Recalls Pressure Sentinel Guide Wires Due to Sterility Compromise

    Zimmer Biomet is recalling Pressure Sentinel Guide Wires because creases in the sealing area compromise product sterility. The recall affects 48,320 units distributed worldwide.

    Product
    Zimmer Pressure Sentinel¿ Intramedullary Reaming System, Guide Wire, Bullet Tip, 2.4 mm Diameter Item Number: 00-2228-024-00 Product Usage: A single use surgical instrument used during orthopaedic surgery for implantation of a prosthesis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0537-2019·2018-12-12

    Zimmer Biomet Recalls Smooth Guide Wires Due to Sterility Compromise

    Zimmer Biomet is recalling Smooth Guide Wires because creases in the sealing area may compromise product sterility. The recall affects 48,320 units distributed worldwide.

    Product
    Zimmer Smooth Guide Wire - Bullet Tip, 3.0 mm Diameter, 100 cm Length Item Number: 47-2255-008-01 Product Usage: A single use surgical instrument used during orthopaedic surgery for implantation of a prosthesis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0547-2019·2018-12-12

    Philips Brilliance 10 Slice CT Scanner Recalled for Gantry Cover Failure Risk

    Philips is recalling Brilliance 10 Slice CT scanners because fiberglass resin may separate, causing the gantry front cover and metal support to fail or fall.

    Product
    Brilliance 10 Slice (Air), Model 728251 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0540-2019·2018-12-12

    Zimmer Biomet Recalls Natural Nail System Guide Wires Due to Sterility Concerns

    Zimmer Biomet is recalling 12,724 units of Natural Nail System Tear Drop Guide Wires because creases in the packaging may compromise sterility.

    Product
    Zimmer Natural Nail¿ System - Tear Drop Guide Wire, 3.0 mm Diameter, 70 cm Length Item Number: 47-2490-098-00 Product Usage: A single use surgical instrument used during orthopaedic surgery for implantation of a prosthesis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0548-2019·2018-12-12

    Philips Brilliance 6 Slice CT Scanner Recalled for Gantry Cover Separation Risk

    Philips Medical Systems is recalling Brilliance 6 Slice CT scanners because fiberglass resin may separate, causing the gantry front cover to fail or fall.

    Product
    Brilliance 6 Slice (Air), Model 728256 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0557-2019·2018-12-12

    Stephanix D2RS Digital Dynamic Remote System Recalled for Table Movement Risk

    Stephanix is recalling 17 D2RS Digital Dynamic Remote Systems because the table may continue moving after a command is released.

    Product
    STEPHANIX D2RS Digital Dynamic Remote Systemhttp://cts.fda.gov/division-tracking/images/trash.png Product The D2RS Digital Dynamic Remote System is indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0541-2019·2018-12-12

    Zimmer Biomet Recalls Natural Nail System Tear Drop Guide Wires

    Zimmer Biomet is recalling Natural Nail System Tear Drop Guide Wires due to creases in the sealing area that compromise sterility.

    Product
    Zimmer Natural Nail¿ System - Tear Drop Guide Wire, 2.4 mm Diameter, 70 cm Length Item Number: 47-2490-098-01 Product Usage: A single use surgical instrument used during orthopaedic surgery for implantation of a prosthesis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0546-2019·2018-12-12

    Philips Brilliance 16 Slice CT Scanner Recall for Cover Separation

    Philips is recalling Brilliance 16 Slice CT scanners because fiberglass resin may separate, causing the gantry front cover to fail or fall.

    Product
    Brilliance 16 Slice (Air), Model 728246 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0543-2019·2018-12-12

    Philips Brilliance 64 CT Scanner Recall for Gantry Cover Separation Risk

    Philips Medical Systems is recalling Brilliance 64 CT scanners due to a potential fiberglass resin separation that could cause the gantry front cover to fail and fall.

    Product
    Brilliance 64, Model 728231 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0553-2019·2018-12-12

    Zimmer Biomet Recalls 20mm Compress Device Short Anchor Plug

    Zimmer Biomet is recalling 6 units of the 20mm Compress Device Short Anchor Plug due to potential metal burrs that may prevent proper insertion of drill and transverse pins.

    Product
    Biomet 20mm Compress Device Short Anchor Plug With Drill Set / With Pin Inserter Ion Implant Item number: 178562 Product Usage: 1. Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. 2. Tumor resections. 3. Revision of previously…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0556-2019·2018-12-12

    Pfizer Recalls Thermacare Heatwraps Due to Material Leakage

    Pfizer is recalling specific lots of Thermacare Heatwraps because the wraps may come apart and leak granular material.

    Product
    Thermacare HEATWRAPS JOINT PAIN THERAPY, 8 HEATWRAPS; MUSCLE PAIN THERAPY, 3 HEATWRAPS a) UPC 0573301311 b) UPC 0573301311 Product Usage: Provides heat therapy for temporary relief of minor muscular and joint aches and pains associated with overexertion, sprains, and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0555-2019·2018-12-12

    Pfizer Recalls Thermacare HeatWraps Menstrual Due to Material Leakage

    Pfizer is recalling Thermacare HeatWraps Menstrual because the wraps may come apart and leak granular material.

    Product
    Thermacare HeatWraps Menstrual a) UPC 0573302002 b) UPC 0573302044 Product Usage: Provides heat therapy for temporary relief of minor menstrual cramp pain and associated back aches.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0559-2019·2018-12-12

    Tosoh AIA-360 Analyzer Recalled for Labeling Clarifications on Maintenance Requirements

    Tosoh Bioscience is recalling 1,228 AIA-360 Analyzers to update labeling and training materials regarding maintenance and reagent requirements.

    Product
    AIA-360 Analyzer, product code 019945/019945R The Tosoh AIA-360 Automated Immunoassay Analyzer is for use in vitro diagnostic to provide testing for a broad menu of assays in a unique patented dry reagent format.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0528-2019·2018-12-12

    Becton Dickinson Recalls Trypticase Soy Agar Plates Due to Growth Inhibition

    Becton Dickinson is recalling 54,300 plates of Trypticase Soy Agar with 5% Sheep Blood because a manufacturing error inhibited the growth of Gram-negative organisms.

    Product
    BD BBL Trypticase Soy Agar with 5% Sheep Blood, Catalog No. 221261, (non-selective, non-differential)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0561-2019·2018-12-12

    Helena Laboratories Recalls Cascade Abrazo c-ACT-LR Test Cards

    Helena Laboratories is recalling 27 kits of Cascade Abrazo c-ACT-LR Test Cards due to reported variations in test results.

    Product
    Cascade Abrazo c-ACT-LR Test Card IVD FOR IN VITRO DIAGNOSTIC USE Store at 2 to 8 C HELENA LABORATORIES 003366 12/13(2) FOR EXPORT ONLY
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0554-2019·2018-12-12

    Pfizer Recalls Thermacare HeatWraps Due to Leaking Granular Material

    Pfizer is recalling Thermacare Muscle Pain Therapy HeatWraps because the wraps may come apart and leak granular material.

    Product
    Thermacare Muscle Pain Therapy HeatWraps: a) UPC 0573301314 b) UPC 0573301303 Product Usage: Provides heat therapy for temporary relief of minor muscular and joint aches and pains associated with overexertion, sprains, and arthritis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0529-2019·2018-12-12

    Helena Laboratories Recalls Gel Alkaline Phosphatase Isoenzyme Control Kits

    Helena Laboratories is recalling 43 Gel Alkaline Phosphatase Isoenzyme Control Kits due to customer complaints of lower enzyme activity.

    Product
    Gel Alkaline Phosphatase Isoenzyme Control Kit: Gel Alkaline Phosphatase Isoenzyme Control Cat. No. 5104 1 x 2.0 mL FOR IN-VITRO DIAGNOSTIC USE Gel Alkaline Phosphatase Isoenzyme Control 20mL 001831 Alkaline Phosphatase Isoenzyme Control is to be used as a…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0526-2019·2018-12-12

    Neomed NeoConnect Enteral Extension Sets Recalled for Incorrect Expiration Date

    Neomed Inc is recalling NeoConnect Enteral Extension Sets because the sterile pouch labels display an incorrect expiration date of 2016-11-19 instead of 2019-11-09.

    Product
    NEOCONNECT, Enteral Extension with ENFit connector, REF EXT-60NC The NeoMed NeoConnect Enteral Only Extension Set is intended for use as an extension set for nasogastric/oralgastric or gastric tube enteral feeding tubes, incorporating safety connectors which help mitigate…
    Category
    Medical Device
    Distribution
    8 states
  • SevereFDA (Devices)·Z-0507-2019·2018-12-05

    NxStage PureFlow B Solution Recalled for Potential Bag Bursting Hazard

    NxStage Medical is recalling PureFlow B Solution because the smaller chamber of the bag can burst, releasing electrolyte fluid that may cause injury if it contacts eyes or skin.

    Product
    NxStage PureFlow B Solution-RFP-RFP-456, Premixed Dialysate for Hemodialysis NxStage PureFlow B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate during hemodialysis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0514-2019·2018-12-05

    Eurotrol HemoTrol Level 2 Recalled Due to Microbial Contamination

    Eurotrol Inc. is recalling HemoTrol Level 2 hematology quality control mixtures because microbial contamination causes incorrect measurement results.

    Product
    HemoTrol Level 2- In Vitro Diagnostic Hematology quality control mixture Catalogue number: 171.002.002 Eurotrol HemoLin is an assayed hemoglobin control intended for professional use in the verification of the linearity of the HemoCue¿ Hb 201 systems
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0506-2019·2018-12-05

    NxStage PureFlow B Solution Recalled Due to Bag Bursting Risk

    NxStage Medical is recalling 7,275 units of PureFlow B Solution because the bag's smaller chamber may burst, releasing electrolyte fluid that can injure eyes or skin.

    Product
    NxStage PureFlow B Solution-RFP-RFP-454, Premixed Dialysate for Hemodialysis NxStage PureFlow B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate during hemodialysis.
    Category
    Medical Device
    Distribution
    Distributed nationwide