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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38976–39000 of 40449

  • HighFDA (Devices)·Z-0768-2013·2013-02-13

    Oxus Portable Oxygen Concentrator Li-Ion Battery Recall

    Oxus America is recalling 1,724 Li-Ion batteries for the RS-00400 Portable Oxygen Concentrator due to potential over-discharge damage to cells.

    Product
    Li-Ion battery used in the Oxus Portable Oxygen Concentrator (POC), RS-00400. Also branded as Reliability Plus byDrive. The Portable Oxygen Concentrator is intended to deliver concentrated oxygen for adult patients with chronic pulmonary diseases.
    Category
    Medical Device
    Distribution
    16 states
  • ModerateFDA (Devices)·Z-0765-2013·2013-02-13

    Sybron Endo Lightspeed LSX Files Recalled for Incorrect Length Markings

    Ormco/Sybronendo is recalling specific lots of Lightspeed LSX endodontic files because their length markings are incorrect.

    Product
    Sybron Endo Lightspeed: LSX Files, 25MM, Part Numbers: 835-2525; LSX Files, 25MM Assorted Kit, Part Numbers: 835-2455; LSX Files, 30MM, Part Numbers: 835-2031. An engine-driven rotary endodontic instrument used during endodontic procedures for cleaning and shaping the root…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0789-2013·2013-02-13

    ConMed Linvatec Recalls PopLok Bone Punch Due to Incorrect Shaft Diameter

    ConMed Linvatec recalled one lot of PopLok bone punches because the metal shaft diameter is 4.5mm instead of the specified 3.5mm.

    Product
    ConMed Linvatec Biomaterials, PopLok bone Punch PKL-35M, 3.5mm Orthopedic manual surgical instrument - Bone Punch
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0788-2013·2013-02-13

    Exactech Recalls Hip Replacement Liners Due to Labeling Error

    Exactech is recalling 26 hip replacement liners because the device labeling was inadvertently transposed. The units were distributed in five states.

    Product
    Exactech NOVATION CROWN CUP +5mm LATERALIZED LINER, Use with Crown Cup Only, GXL UHMWPE, SN 0123456, REF 136-32-53. Exactech Hip Systems are indicated for use in surgery for hip replacement.
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-0767-2013·2013-02-13

    Philips Easy Diagnost Eleva DRF Recalled for Image Marker Misinterpretation

    Philips Healthcare is recalling 14 Easy Diagnost Eleva DRF units because a mirror icon on images could be misinterpreted as a right lead marker in PACS systems.

    Product
    Phillips Easy Diagnost Eleva DRF. Model Number: 706034 Product Usage: Universal Fluoroscopic Applications
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0787-2013·2013-02-13

    Exactech Recalls Novation Crown Cup Hip Liners Due to Labeling Error

    Exactech is recalling 26 units of Novation Crown Cup hip replacement liners because device labeling was inadvertently transposed.

    Product
    Exactech NOVATION CROWN CUP, NEUTRAL LINER, Use with Crown Cup Only, GXL UHMWPE, SN 0123456, REF 130-32-53. Exactech Hip Systems are indicated for use in surgery for hip replacement.
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-0793-2013·2013-02-13

    OPTIGEN Food 30 Allergen Testing Kits Recalled for Potential False Negatives

    Hitachi Chemical Diagnostics is recalling 20 kits of OPTIGEN Food 30 allergen testing products due to a potential low fill volume that could cause false negative results.

    Product
    OPTIGEN Food 30; Catalog number: 85035. For allergen testing. Manufactured by Hitachi Chemical Diagnostics, Mountain View, CA. Distributed by Theridiag, Cedex, France
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0790-2013·2013-02-13

    Remel Recalls Oxoid Aztreonam Antimicrobial Susceptibility Test Discs

    Remel Inc is recalling Oxoid Aztreonam test discs because some may lack antibiotic impregnation, potentially affecting test accuracy.

    Product
    Oxoid Antimicrobial Susceptibility Test Discs, Aztreonam 30 ug, IVD, REF CT0264B, Oxoid Ltd., UK, [email protected] (Both Remel & Oxoid, Ltd are a part of Thermo Fisher Scientific) An antimicrobial susceptibility test disc is a device that consists…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0792-2013·2013-02-13

    Diagnostic Hybrids RhMK Culture Media Recalled for Fungal Contamination

    Diagnostic Hybrids is recalling RhMK culture media due to fungal contamination. The affected products are used to cultivate viruses from patient specimens.

    Product
    Diagnostic Hybrids, Inc., RhMK, Model #:49-0600, 49-0600A, 49-0102A, and 49-T075A. Culture media, used in the cultivation and amplification of viruses, such as respiratory viruses, enteroviruses, measles, and poliovirus from patient specimens.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0744-2013·2013-02-13

    Carestream Recalls Dental Film Due to Missing Label Symbols

    Carestream Health is recalling specific lots of Kodak Insight Dental Film because the clear carton labels are missing required symbols and manufacturer information.

    Product
    KODAK INSIGHT DENTAL FILM in SureSoft Packets, Size 2 Single Packet Film, Model Number IP21S, REF/Catalog Number 8118226 --- COMMON/USUAL NAME: Dental Intraoral Radiographic Film -- 20 cartons of 80 packets. Product Usage: Dental intraoral radiography
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0754-2013·2013-02-06

    GE AdvantageSim MD Software Recall for Incorrect Series Labeling

    GE Healthcare is recalling AdvantageSim MD versions 7.4 through 7.6 because incorrect series labeling may lead to under-treatment of tumors.

    Product
    AdvantageSim MD versions 7.4 through 7.6, Model 5160092-2 Version 7.4, 5160092-3 Version 7.5, 5160092-4 version 7.6.
    Category
    Medical Device
    Distribution
    13 states
  • SevereFDA (Devices)·Z-0741-2013·2013-02-06

    Hamilton T1 Ventilator Recall for Pediatric Software Calculation Error

    Hamilton Medical Inc is recalling 97 Hamilton T1 ventilators with software versions 1.1.2 or lower due to a calculation error affecting oxygen consumption estimates for small pediatric patients.

    Product
    HAMILTON-T1 Ventilator with software versions 1.1.2 or lower. The HAMILTON T-1 Ventilator is intended to provide positive pressure ventilatory support to adults and pediatrics
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0758-2013·2013-02-06

    Ethicon ENSEAL G2 Tissue Sealers Recalled for Potential Self-Activation

    Ethicon Endo-Surgery Inc. is recalling ENSEAL G2 Tissue Sealers because they may self-activate during use, causing unintended thermal damage.

    Product
    Ethicon Endo-Surgery Inc. The ENSEAL¿ G2 Tissue Sealers are indicated for bipolar coagulation and mechanical transection of tissue during laparoscopic and open procedures. Model Numbers: NSLG2C14 NSLG2C25 NSLG2C35 NSLG2C45 NSLG2514 NSLG2S25 NSLG2S35 NSLGS545
    Category
    Medical Device
    Distribution
    46 states
  • HighFDA (Devices)·Z-0760-2013·2013-02-06

    Varian Medical Systems Recalls Titanium Rectal Retractors for Brachytherapy

    Varian Medical Systems is recalling 152 titanium rectal retractors used in brachytherapy due to potential contamination risks that could cause infections, toxicity, or allergic reactions.

    Product
    Rectal Retractors, titanium, item # AL07368000, a component of Varian Medical Ring and Tandem Applicator Sets; Intended for use in Brachytherapy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0740-2013·2013-02-06

    Cordis ExoSeal Vascular Closure Device Recalled for Sterility Assurance Failure

    Cordis is recalling ExoSeal Vascular Closure Devices because the sterilization process did not meet required sterility assurance levels.

    Product
    Cordis, a Johnson and Johnson Company, ExoSeal(TM) 6F Vascular Closure Device, cat. No EX500, EX600, and EX700. Used for femoral artery puncture site closure, reducing times to hemostasis and ambulation in patients who have undergone diagnostic or interventional procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0759-2013·2013-02-06

    Varian Medical Rectal Retractors Recalled for Contamination Risk

    Varian Medical Systems is recalling stainless steel rectal retractors used in brachytherapy due to potential contamination that could cause infections, toxicity, or allergic reactions.

    Product
    Rectal Retractors, stainless steel, item # AL07289000, a component of Varian Medical Ring and Tandem Applicator Sets; Intended for use in Brachytherapy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0752-2013·2013-02-06

    Extremity Medical Recalls IO FiX System Screw Measuring Device

    Extremity Medical LLC is recalling 93 units of the IO FiX System Accessory screw measuring device because it may measure screw length approximately 5 mm short, potentially leading to the selection of an inappropriate implant size.

    Product
    Extremity Medical, IO FiX System Accessory. Catalog Number 101-00010. This screw measuring device is an accessory to the IO FiX Screw and Washer System that is used to measure the length of the screw by placing the depth gauge over the guidewire and down to the bone.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0756-2013·2013-02-06

    BD Vacutainer Citrate Blood Collection Tubes Recalled for Test Errors

    Becton Dickinson is recalling specific blood collection tubes due to reports of extended Partial Thromboplastin Time (aPTT) test results.

    Product
    BD Vacutainer Buffered Sodium Citrate (9NC) Plus Blood Collection Tubes; Sterile; IVD; REF 363083; 13 X 75 mm, 2.7 mL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0742-2013·2013-02-06

    Mindray Recalls DPM5 Monitors Due to Missing ST and Arrhythmia Features

    Mindray is recalling 13 DPM5 vital signs monitors because ST and Arrhythmia features may not be available.

    Product
    Mindray DPM5 Monitor, a vital signs monitor used on human patients in healthcare facilities.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0516-2013·2013-02-06

    Motorola Laser Utility Products Recalled for Incorrect Laser Power Settings

    Motorola Inc is recalling PCS3000/CS3070 laser utility products because they were manufactured with Class 2 laser power settings instead of the specified Class 1 levels.

    Product
    Motorola Solutions PCS3000/CS3070 Laser Utility/Peripheral Laser Products
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0762-2013·2013-02-06

    Roche COBAS TaqMan MTB Test Definition Files Recalled for False Negative Risk

    Roche is recalling COBAS TaqMan MTB Test Definition Files due to an incorrect cutoff value that may cause false negative results for tuberculosis tests.

    Product
    COBAS TaqMan Mycobacteria tuberculosis (MTB) Test FOR IN VITRO DIAGNOSTIC USE.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0757-2013·2013-02-06

    Abbott Vascular Recalls RX Accunet Embolic Protection System Lots

    Abbott Vascular is recalling specific lots of the RX Accunet Embolic Protection System because the peel-away sheath may be difficult to remove due to higher than normal wall thickness.

    Product
    Brand Name: RX Accunet Embolic Protection System Common Name: RX Accunet EPS. Part Numbers: 101649-45, 1011649-55, 1011649-65, 1011649-75, 1011650-55, 1011650-65, 1011651-45, 1011651-55. The RX Accunet EPS is indicated for use as a guide wire and embolic protection…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0738-2013·2013-02-06

    bioMerieux Recalls BacT/ALERT SA Blood Culture Bottles with Uncured Sensors

    bioMerieux, Inc. is recalling BacT/ALERT SA Blood Culture Bottles because some units may contain uncured sensors, potentially affecting the detection of microorganisms.

    Product
    BacT/ALERT SA Blood Culture Bottle. The BacT/ALERT SA reagent bottle is intended to be recover and detect aerobic microorganisms (bacteria and fungi) from blood and other normally sterile body fluids.
    Category
    Medical Device
    Distribution
    29 states
  • ModerateFDA (Devices)·Z-0750-2013·2013-02-06

    Envoy Medical Recalls Esteem Programmers for Noise Interference

    Envoy Medical is voluntarily correcting 44 Esteem Programmers to reduce susceptibility to noise interference.

    Product
    Esteem Programmer Model 6001, US and ISA, Model 3001 Dell E54XX, part of the Esteem Totally Implantable Hearing System. The ISA and Commander are software packages that run on a laptop personal computer.
    Category
    Medical Device
    Distribution
    14 states
  • ModerateFDA (Devices)·Z-0753-2013·2013-02-06

    Biomet TUNNELOC Round Head Interference Screw Recalled for Undersized Tip Hole

    Biomet is recalling 44 TUNNELOC Round Head Interference Screws because the hole at the tip is undersized. The defect may affect the device's performance during orthopedic procedures.

    Product
    TUNNELOC ROUND HEAD INTERFERENCE SCREW 8MMX25MM Biomet Sports Medicine manufactures a variety of internal fixation devices intended to aid in arthroscopic and orthopedic reconstructive procedures requiring soft tissue fixation, due to injury or degenerative disease. Implants…
    Category
    Medical Device
    Distribution
    7 states