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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35851–35875 of 40449

  • HighFDA (Devices)·Z-1608-2014·2014-05-21

    FDA Recalls Defective Ultrasound Needles That May Leak at Hub

    RM Temena GmbH is recalling 7,370 ultrasound needles that may leak at the needle hub. The defective needles were distributed in Maryland and Illinois.

    Product
    Ultrasound needles, 22G (0.7 mm) x 50mm, packaged individually, 10 needles/box, item number REF USC050-22. Needles for peripheral nerve blocking under ultrasound guidance.
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1606-2014·2014-05-21

    Zimmer Recalls Neoprene Tennis Elbow Supports Due to Latex Contamination

    Zimmer, Inc. is recalling 649 units of Neoprene Tennis Elbow Supports because raw material labeled as latex-free actually contained latex.

    Product
    Tennis Elbow Support, Neoprene***LATEX FREE" Product Usage: Provides compression and warmth for mild to moderate elbow strains and sprains.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1615-2014·2014-05-21

    Biomet ExploR Radial Stem Recalled for Missing Threads

    Biomet is recalling eight ExploR 7x26mm Modular Radial Stem implants because missing wedge ramp threads may cause set screw loosening, potentially requiring revision surgery.

    Product
    ExploR 7x26mm Modular Radial Stem, Catalog number 11-210062. Elbow prosthesis orthopedic implant.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1605-2014·2014-05-21

    Zimmer Hinged Knee Support Recalled Due to Latex Contamination

    Zimmer, Inc. is recalling 546 units of Hinged Knee Supports because raw material labeled as latex-free actually contained latex.

    Product
    Hinged Knee Support***LATEX FREE" Product Usage: Provide added lateral stability and allows the knee to tolerate more strenuous activity during recuperation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1604-2014·2014-05-21

    Zimmer Cartilage Knee Brace Recalled Due to Latex Contamination

    Zimmer, Inc. is recalling 2,222 units of Cartilage Knee Braces because raw material labeled as latex-free actually contained latex.

    Product
    Cartilage Knee Brace***LATEX FREE" Product Usage: Used in the treatment and support of many types of knee injuries or following surgical and nonsurgical correction.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1613-2014·2014-05-21

    Siemens Syngo Dynamics PACS Recalled for Patient Demographics Display Error

    Siemens Medical Solutions is recalling 50 Syngo Dynamics v9.5 systems due to a software error that may cause incorrect patient demographics to be displayed.

    Product
    Syngo Dynamics v9.5 system. A Picture Archiving and Communication System (PACS) intended for acceptance, transfer, display, storage, archive and manipulation of digital medical images, including quantification and report generation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1575-2014·2014-05-21

    Blue Belt Technologies Recalls Navio PFS Orthopedic Sterotaxic Instrument

    Blue Belt Technologies is voluntarily recalling 11 Navio PFS systems used in orthopedic knee surgery due to a potential electronic module defect that could cause latent failure.

    Product
    NavioPFSTM System, Orthopedic Sterotaxic Instrument, model #'s NPFS-02000, NPFS-02010, NPFS 02020.
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-1607-2014·2014-05-21

    HeartWare HVAD Pump Implant Kit Battery Recall for Support Issues

    HeartWare Inc is recalling HVAD Pump Implant Kit batteries that may not provide two hours of support or behave unusually.

    Product
    HeartWare HVAD Pump Implant Kit (Heartware Ventricular Assist Device) - HeartWare Battery For use as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage ventricular heart failure.The HeartWare VAS is designed for in-hospital and…
    Category
    Medical Device
    Distribution
    37 states
  • HighFDA (Devices)·Z-1620-2014·2014-05-21

    Baxter Recalls RAPIDFILL Syringe Strips Due to Sterile Barrier Breach

    Baxter Corporation is recalling RAPIDFILL Syringe Strips because of a possible breach in the sterile barrier of the inner and outer bags.

    Product
    RAPIDFILL Syringe Strip, For use with RAPIDFILL Automated Syringe Filler (ASF): H93890200 RAPIDFILL Syringe Strip, White. H93890221 RAPIDFILL Syringe Strip, Yellow. H93890222 RAPIDFILL Syringe Strip, Orange. H93890223 RAPIDFILL Syringe Strip, Red. H93890225 RAPIDFILL Syringe…
    Category
    Medical Device
    Distribution
    21 states
  • HighFDA (Devices)·Z-1618-2014·2014-05-21

    Fresenius Hemodialysis Machines Recalled for Potential UF Pump Detection Failure

    Fresenius Medical Care is recalling 79 hemodialysis machines and replacement parts because they may fail to detect a disconnected Ultrafiltration (UF) Pump.

    Product
    Fresenius 2008T Hemodialysis Machine with Revision K Actuator Test Boards and also sold as replacement parts for use with Fresenius 2008-Series Hemodialysis Machines (2008K, 2008K2, 2008K@home and 2008T). Part Number: 190234 Revision K
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1621-2014·2014-05-21

    InterValve V8 Balloon Aortic Valvuloplasty Catheter Recalled for Leak Issues

    InterValve Inc is recalling specific V8 Balloon Aortic Valvuloplasty Catheters due to leak issues discovered during accelerated age testing.

    Product
    InterValve V8 Balloon Aortic Valvuloplasty Catheter, model 172212C110, 192412C110, 212612C110, 232812C110. Used in Cardiovascular procedures for Balloon Aortic Valvuloplasty.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1603-2014·2014-05-21

    Zimmer Drop Lok Knee Brace Recalled Due to Latex Contamination

    Zimmer, Inc. is recalling Drop Lok Knee Braces because raw material labeled as latex-free was found to contain latex. The recall affects 131 units distributed in the US and internationally.

    Product
    DROP LOK" Knee Brace***LATEX FREE" Product Usage: Used in the treatment, support, and rehabilitation of many types of knee injuries or following surgical correction.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1571-2014·2014-05-21

    Codman MedStream Infusion Pump Recall for Low Battery Alarm Issue

    Codman & Shurtleff is recalling 90 MedStream Programmable Infusion Pumps because a small number may trigger a low battery alarm at the beginning of the implanted life.

    Product
    MedStream Programmable Infusion Pump, 20 mL, Product Code: 91-4200 The MedStream programmable pump is intended for the intrathecal delivery of Baclofen in the US market and for the intrathecal delivery of Morphine or Baclofen in the EMEA market.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1610-2014·2014-05-21

    Ortho Development Recalls PS-C Femoral Knee Implant Components

    Ortho Development Corporation is recalling five PS-C Femoral Nonporous Rt Sz 6 knee implant components because pegged versions were found in boxes labeled for the pegless version.

    Product
    PS-C Femoral Nonporous Rt Sz 6, Model Number 161-1604 Component of the Balanced Knee System and Balanced Knee Revision System, for total knee arthroplasty procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1572-2014·2014-05-21

    Codman MedStream Infusion Pump Recall for Low Battery Alarm Issue

    Codman & Shurtleff is recalling 34 MedStream Programmable Infusion Pumps because they may trigger a low battery alarm at the beginning of the implanted life.

    Product
    MedStream Programmable Infusion Pump, 40 mL, Product Code: 91-4201 The MedStream programmable pump is intended for the intrathecal delivery of Baclofen in the US market and for the intrathecal delivery of Morphine or Baclofen in the EMEA market.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1576-2014·2014-05-21

    FDA Recalls Unapproved Enaly 1000 BT-12 Ozone Generator for Medical Use

    William C. Domb, D.M.D., A Professional Corporation is recalling 16 units of the Enaly 1000 BT-12 Ozone Generator because the device is not approved or cleared by the FDA for medical use.

    Product
    Enaly 1000 BT-12 Ozone Generator, Model # 1000BT-12 The 1000BT-12 ozone generator is capable of delivering up to 1gram of ozone per hour from pure oxygen. The 1000BT-12 ozone generator is designed to continuously generate ozone by corona discharge. The conversion of oxygen to…
    Category
    Medical Device
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-1611-2014·2014-05-21

    Mindray DPM 6 Patient Monitor Recalled for Uncleared ST/Arrhythmia Feature

    Mindray DS USA is recalling four DPM 6 patient monitors in Ohio because the included Multi Parameter Module contains a cardiac ST/Arrhythmia analysis feature that is not cleared for marketing.

    Product
    DPM 6 Monitor in use with a Multi Parameter Module (MPM). Patient monitor used for monitoring, displaying, reviewing, storing, and alarming of multiple physiological parameters including ECG, arrhythmia detection, ST segment analysis, heart rate (HR), respiration rate (RESP)…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1614-2014·2014-05-21

    Greatbatch Recalls Coaxial Micro-Introducer Kits Due to Shelf Life Documentation Issues

    Greatbatch Medical is recalling Coaxial Micro-Introducer Kits because documentation does not support the claimed five-year shelf life.

    Product
    Coaxial Micro-Introducer Kit. Greatbatch Part Number/Bard Access Systems Order Number/Part Description 10636-001 8004011 Kit Coax 10 Pack 4FR Bard 10636-002 8005011 Kit Coax 10 Pack 5FR Bard 10636-007 8004012 Kit Coax 10 Pack 4FR Bard 10636-008 8005012 Kit…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1574-2014·2014-05-21

    Anspach Cutting Bur Recall Due to Incorrect Product Code Labeling

    The Anspach Effort, Inc. is recalling 30 Anspach Cutting Burs (REF L-3SD) because the product code S-3SD was included, which is shorter than the labeled product.

    Product
    ANSPACH Cutting bur, 3 mm Diamond Ball, Standard Length. REF L-3SD Use with LONG Attachments. Used for cutting and shaping bone, including the spine and cranium.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1617-2014·2014-05-21

    McKesson Radiology-PACS software recall for missing high-priority alert icon

    McKesson Medical Imaging is recalling 45 units of McKesson Radiology-PACS software because the high-priority alert icon was not displayed when no Stat studies were present.

    Product
    McKesson Radiology-PACS. McKesson Radiology is a medical image and information application that is intended to receive, transmit, store, retrieve, display, print and process digital medical images, digital medical video, and associated medical information from various medical…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1541-2014·2014-05-14

    Med-Mizer Retractabed Recall for Insufficient Welding on Foot Cross Tube

    Med-Mizer is recalling 191 Retractabed Clinical Contour adjustable beds manufactured before June 7, 2008, due to insufficient welding that could cause bed collapse.

    Product
    RetractaBed , Clinical Contour, Med - Mizer Inc..... Model SS 762 ( 76 " bed w/ 2 motors); 763 (3 motors); 763 A ( 3 motors, autocontour) 120 V, ...Max Safe Working Load 450 LBS. Acute/Longterm Care AC Powered Adjustable Bed for geriatric care.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1561-2014·2014-05-14

    Teleflex Medical Recalls Silk Sutures Due to Needle Detachment Risk

    Teleflex Medical is recalling specific lots of Deknatel Silk Sutures because the needle may detach from the suture during use.

    Product
    Deknatel Teleflex Medical Silk Black Braided Silk Suture Nonabsorbable Surgical Suture U.S.P. Indicated for use in soft tissue approximation.
    Category
    Medical Device
    Distribution
    28 states
  • SevereFDA (Devices)·Z-1542-2014·2014-05-14

    Med-Mizer RetractaBed Recall for Insufficient Welding on Foot Cross Tube

    Med-Mizer is recalling RetractaBed Clinical Contour adjustable beds due to insufficient welding on the foot cross tube, which may cause bed collapse or rollers to detach.

    Product
    RetractaBed , Clinical Contour, Med - Mizer Inc..... Model SS 799, 120 V, ...Max Safe Working Load 450 LBS. Acute/Longterm Care AC Powered Adjustable Bed for geriatric care.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1546-2014·2014-05-14

    Alere INRatio2 Test Strips Recalled for Inaccurate INR Results

    Alere San Diego, Inc. is recalling INRatio2 PT/INR Professional Test Strips because they may report inaccurately low INR results, potentially affecting warfarin therapy monitoring.

    Product
    Alere INRatio2 PT/INR Professional Test Strips, Model Number: 99008G2. The Alere INRatio2 PT/INR Monitoring System (Professional Use), consisting of the Monitor and test strip, is used for quantitative determination of international normalized ratio (INR) in fresh, capillary…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1570-2014·2014-05-14

    Medtronic SynchroMed II Implantable Pumps Recalled for Overinfusion Risk

    Medtronic is recalling SynchroMed II implantable drug infusion pumps because they may overinfuse medication, potentially causing life-threatening overdose or drug withdrawal.

    Product
    Medtronic SynchroMed¿ II Implantable Drug Infusion Pump, Model 8637-20, 8637-40. The implantable Medtronic SynchroMed II programmable pumps are part of an infusion system that stores and delivers a prescribed drug to a specific site. The implanted infusion system consists of…
    Category
    Medical Device
    Distribution
    0 states