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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27051–27075 of 40357

  • HighFDA (Devices)·Z-1834-2017·2017-04-26

    Signal Medical Soft Face Mallet Recalled for Tip Detachment Risk

    Signal Medical Corporation is recalling 1,640 Soft Face "No Bounce" Mallets because the poly tip may detach during use, posing a risk of foreign material in the surgical field.

    Product
    Soft Face "No Bounce" Mallet Model/Catalog: BIO-1-1090
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1868-2017·2017-04-26

    FDA Recalls 84 Zimmer CAS SmartTools Knee System Instruments

    Orthosoft, Inc. dba Zimmer CAS is recalling 84 SmartTools Knee System Orthopedic Stereotaxic Instruments due to complaints of bent or broken Drive Pins.

    Product
    SmartTools Knee System Orthopedic Stereotaxic Instrument
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1859-2017·2017-04-26

    Zimmer Biomet Recalls Polyethylene Implants Due to High Endotoxin Levels

    Zimmer Biomet is recalling 28,253 polyethylene implants for shoulder and elbow replacements because endotoxin levels exceeded process maximum limits.

    Product
    various polyethylene implants Extremities, Shoulders and Elbows BioModular Shoulder System; Comprehensive Shoulder System; Comprehensive Reverse Shoulder System Product Usage: Shoulder Replacement Elbow Replacement
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1860-2017·2017-04-26

    Zimmer Biomet Recalls Polyethylene Hip Implants Due to Endotoxin Levels

    Zimmer Biomet is recalling 28,253 polyethylene hip implant components worldwide because endotoxin levels exceeded process maximum limits.

    Product
    various polyethylene implants Hips Active Articulation ArComXL Bearings Active Articulation E1 Bearings Arcos Taper Cap BIOLOX delta Option Head E1 RingLoc Bi-Polar Freedom Constrained Liner +5mm Hi-Wall ArcomXL All Poly Rimloc E1 10 Degree Liner RingLoc +3mm Hi-Wall…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1867-2017·2017-04-26

    Mizuho Wilson Frame Pads Recalled for Potential Pressure Injury Risk

    Mizuho OSI is recalling 216 Wilson Frame Pads due to a design deficiency that may allow patients to contact the frame's carbon fiber structure, potentially causing pressure injuries.

    Product
    216 Wilson Frame Pads, Model # 5319-37; Used with Radiolucent Wilson Frames, model numbers 5319G and 5321G. General and Plastic Surgery: These pads are used as a component of the Wilson Frames, which support the torso of a prone patient during spine surgery. The pads are…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1862-2017·2017-04-26

    Zimmer Biomet Recalls Polyethylene Implants Due to High Endotoxin Levels

    Zimmer Biomet is recalling 28,253 custom polyethylene implants because endotoxin levels exceeded process maximum limits. The affected parts were distributed worldwide.

    Product
    various polyethylene implants Custom parts Product Usage: Custom
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1836-2017·2017-04-26

    Valleylab Laparoscopic Handset Recalled for Activation Button Failure

    COVIDIEN MEDTRONIC is recalling Valleylab Laparoscopic Handsets because customer reports indicate the device may continue operating after the activation button is released.

    Product
    Valleylab Laparoscopic Handset; Material # E2750; Laproscopic Handset Non-Sterile Bulk; Material # E2750NSB Product Usage: For use in 5mm cannulas or larger cannulas with 5mm adapters during laparoscopic and thorascopic procedures. For use with a minimum peak voltage of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1871-2017·2017-04-26

    C.R. Bard Recalls SURESTEP Drainage Bags Due to Latex Mislabeling

    C.R. Bard is recalling 5,030 SURESTEP Drainage Bags because they are labeled as latex-free but may contain natural rubber latex.

    Product
    SURESTEP Tray, Bardex I.C. Complete Care Drainage Bag, 2000 ml Drainage Bag, 16 Fr., Sterile.
    Category
    Medical Device
    Distribution
    24 states
  • HighFDA (Devices)·Z-1853-2017·2017-04-26

    NAMIC Fluid Delivery Set Recalled for Potential Non-Sterility

    Angiodynamics Inc. is recalling NAMIC Fluid Delivery Sets because they may not be sterile due to packaging errors.

    Product
    NAMIC Fluid Delivery Set - 72" (183cm) UPN H965913000051, Catalog 91300005
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-1863-2017·2017-04-26

    Zimmer Biomet Recalls Polyethylene Implants Due to High Endotoxin Levels

    Zimmer Biomet is recalling Repicci II Tibial Components for partial knee replacement because endotoxin levels exceeded process maximum limits.

    Product
    various polyethylene implants Sports Med Repicci II Tibial Components Product Usage: Partial knee replacement
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1830-2017·2017-04-26

    Ion Beam Applications Recalls Proteus 235 Proton Therapy Systems

    Ion Beam Applications is recalling two Proteus 235 Proton Therapy Systems because users may restart aborted irradiations without selecting correct data.

    Product
    Proteus 235, Proton Therapy System
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1872-2017·2017-04-26

    CP Medical Recalls PGCL Absorbable Sutures Due to Tensile Strength Failure

    CP Medical Inc is recalling PGCL absorbable sutures because they failed to meet USP tensile strength requirements over their shelf life.

    Product
    PGCL [poly (glycolide-co-caprolactone)] Absorbable Suture, Manufacturer CP Medical, Portland OR, Sterile, Product Codes L923, L459, L493, L762, L463, L922, L495, L463, L497, L494, L493
    Category
    Medical Device
    Distribution
    22 states
  • HighFDA (Devices)·Z-1849-2017·2017-04-26

    Smith & Nephew ACUFEX TRUNAV Retrograde Drill Recall for Blade Detachment Risk

    Smith & Nephew is recalling ACUFEX TRUNAV Retrograde Drills because the cutting blade may detach or the drill head may fracture during use.

    Product
    Smith & Nephew ACUFEX TRUNAV Retrograde Drill 11MM Product Number: 72204048 The ACUFEX TRUNAV Retrograde Drill is intended for use in creating a back bore socket in bone
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1866-2017·2017-04-26

    BD Viper LT Software Recall Due to Inaccurate Test Results

    BD Diagnostic is recalling BD Viper LT software version 3.00H because it generates lower-than-expected RFU values, which may impact test results.

    Product
    BD Viper LT software, version 3.00H
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1865-2017·2017-04-26

    Avid Medical Recalls Vacutainer Tubes Due to Mixed Component Lots

    Avid Medical is recalling 25,308 Vacutainer tubes because an expired component was found in a kit with a later expiration date, leading to incorrect lot and expiration labeling.

    Product
    Vacutainer Tubes Vacutainer tubes are intended for clinical laboratory hematology studies including but not limited to lead level testing, FEP level testing, and CBC testing.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1837-2017·2017-04-26

    Alcon Recalls Patient Care Kits Due to Sterile Packaging Concerns

    Alcon is voluntarily removing 561,702 Patient Care Kits from the US market because the supplier reported potential sterile packaging compromise.

    Product
    Alcon Patient Care Kits Product Usage: A Patient Care Kit is an assemblage of single-use medical devices and accessories designed by medical professionals for specific procedures. The Patient Care kits are configured with customer-specific components
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1856-2017·2017-04-26

    Smith & Nephew Recalls D-RAD Orthopedic Screws Due to Incorrect Expiration Dates

    Smith & Nephew is recalling 100 units of D-RAD orthopedic screws because the expiration dates on the labels are incorrect and later than the actual expiration dates.

    Product
    D-RAD, 2.4MMX 20MM, S.T. CORTEX SCREW, QTY: (1), STERILE R, RES 74682420 Orthopedic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1852-2017·2017-04-26

    Verathon Recalls GVL 2 Stat Blades Packaged with Incorrect Size

    Verathon is recalling GVL 2 Stat blades (lot GC32825) because they were physically packaged with the incorrect size device, GVL 1 Stat blades.

    Product
    It is recommended for patients with weight/size between 4-22 lbs (1.8-10 kg). Part Number 0270-0429: GVL 2 Stat (box of 10 Stats). Part Number 0574-0027: GVL 2 Stat (single pouched Stat). Part Number 0270-0662: GlideScope AVL Video Baton 1-2 Kit (where one box of 10, part…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1828-2017·2017-04-26

    Merge Healthcare Recalls Eye Station and Eye Care PACS Software

    Merge Healthcare is recalling Eye Station and Eye Care PACS software because antivirus programs may permanently delete newly captured medical images.

    Product
    Merge Eye Station and Merge Eye Care PACS.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1857-2017·2017-04-26

    Smith & Nephew Recalls D-RAD Locking Screws Due to Incorrect Expiration Dates

    Smith & Nephew is recalling 197 units of D-RAD locking screws because the expiration dates on the labels are incorrect and later than the actual expiration dates.

    Product
    D-RAD, S.T. LOCKING SCREWS, T7, QTY: (1), STERILE R, in the following sizes: (a) 2.4MM X 10MM, RES 74692410 (b) 2.4MM X 12MM, RES 74692412 (c) 2.4MM X 16MM, RES 74692416 (d) 2.4MM X 22MM, RES 74692422 (e) 2.4MM X 24MM, RES 74692424
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1827-2017·2017-04-26

    Ferno Chair Cot Recalled Due to Incorrect Manufacturing Nut

    Ferno-Washington Inc is recalling 34 units of the PROFlexx Model 28Z Chair Cot because an incorrect nut was used during manufacturing.

    Product
    Ferno PROFlexx¿ Model 28Z Chair Cot
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-1824-2017·2017-04-26

    Siemens Artis zee Angiographic X-ray System Software Recall

    Siemens is recalling three Artis zee angiographic x-ray systems due to a software fault that prevents the system from initializing after a tube assembly failure.

    Product
    Artis zee, Angiographic x-ray system
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-1831-2017·2017-04-26

    Neodent CM Intraoral Scanbody Recalled for Incompatibility with CM Implants

    Instradent USA is recalling 170 Neodent CM Intraoral Scanbodies because the body diameter is incompatible with CM Implants when positioned subcrestally.

    Product
    NEODENT CM Intraoral Scanbody, Article Number: 108.139
    Category
    Medical Device
    Distribution
    7 states