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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19751–19775 of 27682

  • 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
  • SevereFDA (Devices)·Z-1776-2017·2017-04-19

    Volcano Recalls Refinity Short Tip Rotational IVUS Catheters Due to Kinking

    Volcano Corporation is recalling 718 Refinity Short Tip Rotational IVUS Catheters due to high complaint rates of kinking near the proximal shaft junction, which may disrupt clinical workflow or cause loss of imaging.

    Product
    Refinity Short Tip Rotational Intravascular Ultrasound (IVUS) Catheter; Product number: 400-0200.273; Catalog number 89900. Cardiovascular: The REFINITY (or REFINITY ST) Rotational IVUS Catheter (REFINITY or REFINITY ST) is intended for the intravascular ultrasound…
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1777-2017·2017-04-19

    Welch Allyn ProBP 2400 Digital Blood Pressure Device Recall

    Welch Allyn is recalling 981 ProBP 2400 digital blood pressure devices due to a defective electrical component that may cause over-voltage battery charging and melting of plastic parts.

    Product
    Welch Allyn ProBP 2400 Digital Blood Pressure Device #2400, REF 901096, Rx ONLY, Made in China --- Distributed by Welch Allyn Inc., 4341 State Street Road, Skaneateles Falls, NY 13153 --- Microlife Corporation 9F, 431, RuiGuang Road, NeiHu, Taipei, 11492, Taiwan, R.O.C.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1761-2017·2017-04-19

    PerkinElmer Recalls Specimen Gate Laboratory Software Due to Data Errors

    PerkinElmer is recalling 29 units of Specimen Gate Laboratory software due to a potential for errors in patient results. The software is used for processing laboratory data.

    Product
    Specimen Gate Laboratory; Product Number: 5002-0180 Specimen Gate Laboratory is intended for use as a data processing software used in the storage, retrieving, and processing of laboratory data.
    Category
    Medical Device
    Distribution
    23 states
  • SevereFDA (Devices)·Z-1773-2017·2017-04-19

    Draegar Delta XL Patient Monitors Recalled for Low Oxygen Alarm Failure

    Draegar Medical Systems is recalling Delta XL patient monitors because the low oxygen alarm may fail to sound when oxygen levels drop below the limit.

    Product
    Delta XL, Catalog Number: MS18596 in combination with Scio, Scio Four, Scio Four Oxi plus, Scio Four Oxi, Scio Four plus. Product Usage: The devices are intended to be used in the environment where patient care is provided by Healthcare Professionals, i.e. Physicians…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1702-2017·2017-04-19

    Medtronic StrataMR Valves Recalled for Incorrect Rotor Orientation

    Medtronic is recalling StrataMR valves and shunts because incorrect rotor orientation can cause underdrainage of cerebrospinal fluid, potentially leading to serious health consequences.

    Product
    The Medtronic StrataMR adjustable valves and shunts are designed to provide continuous cerebrospinal fluid (CSF) flow from the ventricles of the brain into the right atrium of the heart or the peritoneal cavity. The design enables the physician to non-invasive adjust valve…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1757-2017·2017-04-19

    ConMed Recalls Hyfrecator 2000 ESU Cartons with Non-Sterile Handpiece Sheaths

    ConMed is recalling Hyfrecator 2000 ESU cartons because they were packaged with non-sterile handpiece sheaths labeled as sterile, posing a risk of infection.

    Product
    Sterile Handpiece Sheaths, P/N 7-796-19, included in the Accessory Packages contained in the HYFRECATOR 2000 Electrosurgical Unit (ESU) cartons, 115 VOLTS AC, REF/Catalog Number 7-900-115, Rx Only . There is no problem with the Hyfrecator 2000 Electrosurgical Units.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1780-2017·2017-04-19

    GE Healthcare Recalls Vivid Ultrasound Systems Due to Patient Selection Error

    GE Healthcare is recalling Vivid Ultrasound systems because slow search times can cause operators to select the wrong patient, potentially leading to misdiagnosis.

    Product
    Vivid S60/S70/S60N/S70N, H45041SU, H45041SW, H45581MS, H45581PD.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1769-2017·2017-04-19

    Datascope Recalls Custom Tubing Packs Due to Assembly Error

    Datascope Corporation is recalling 21 custom tubing packs with Bioline coating due to a reported assembly error on the oxygenator line.

    Product
    Custom Tubing Pack with Bioline Coating UDI code: 00607567208230 Part Number: 709000058 The HLM Tubing Sets with Bioline Coating are for single use only. They may be sold sterile, non-sterile, and bulk packed. Custom tubing sets that are sold sterile are not to be…
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1785-2017·2017-04-19

    Windstone Medical Recalls Cataract Packs Due to Sterile Packaging Concerns

    Windstone Medical Packaging is recalling 7,508 cataract packs because the sterile packaging of the included eye pads may be compromised.

    Product
    Cataract Pack, part numbers 008886-1, AMS2806, PSS3442, PSS3442(A, WAL1155, and WAL1155(A. Product packaged in a convenient manner for use in a general clinical procedure
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1760-2017·2017-04-19

    ConMed Recalls Hyfrecator 2000 Handpiece Sheaths Due to Sterility Labeling Error

    ConMed is recalling Hyfrecator 2000 handpiece sheaths because non-sterile units were packaged in pouches labeled as sterile, posing a risk of infection.

    Product
    HYFRECATOR 2000 HANDPIECE SHEATH, REF/Part Number 7-796-19, Rx ONLY, STERILE, Single Patient Use -- CONMED CORPORATION, 525 FRENCH ROAD UTICA, NY 13502. --- There is no problem with the Hyfrecator 2000 Electrosurgical Units or with cases of P/N 7-796-19 sold in cases as P/N…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1817-2017·2017-04-19

    Micromedics FibriJet Endoscopic Catheter Introducer Recalled for Packaging Seal Defects

    Micromedics, Inc. is recalling 273 units of FibriJet Endoscopic Catheter Introducers because small channels in the sterile packaging seal may compromise package integrity and sterility assurance.

    Product
    Nordson Micromedics FibriJet Endoscopic Catheter Introducer, Catalog Number SA-3445. Sterilized using Ethylene Oxide
    Category
    Medical Device
    Distribution
    9 states