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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27401–27425 of 27722

  • HighFDA (Devices)·Z-2287-2012·2012-09-05

    Unimed Recalls Medline Electrosurgical Electrodes Due to Sterility Concerns

    Unimed Surgical Products is recalling Medline electrosurgical electrodes due to concerns regarding sterility. The affected products are intended for cutting and coagulation of soft tissue.

    Product
    Product is labeled in part: "***MEDLINE***Extended PTFE Coated Needle 4.0" (10.16cm) Length***Reorder: ES0016A***Contents: 1 Each***SINGLE USE ONLY**latexfree***RX Only***STERILE EO***www.medline.com Manufactured for Medline Industries, Inc. MEDLINE is a registered trademark…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2267-2012·2012-09-05

    Metrex Recalls CaviCide Disinfectant Due to Reported Health Reactions

    Metrex Research is recalling CaviCide disinfectant with Spring Fresh Fragrance because it caused health reactions like headaches and nausea in some users.

    Product
    CaviCide, Part Numbers: 13-1025, 13-1000, 13-1024, MC-1000. Alternate brands: EnviroCide, part number: 13-3325. Private labeled products of Cavicide: Backscratchers Cavicide, part number: 13-4800. MaxiSpray Plus, part numbers: 13-7400 and 13-7405. pdCARE Surface…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2290-2012·2012-09-05

    Unimed Recalls Medline Electrosurgical Needles Due to Sterility Concerns

    Unimed Surgical Products is recalling Medline electrosurgical needles due to concerns about sterility. The affected lot is distributed nationwide.

    Product
    Product is labeled in part: "***MEDLINE***Staight Microsurgical Needle 3cm (1.81) Length***Reorder: ESE1651***Contents: 1 Each***SINGLE USE ONLY**latexfree***RX Only***STERILE EO***www.medline.com Manufactured for Medline Industries, Inc. MEDLINE is a registered trademark of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2288-2012·2012-09-05

    Unimed Recalls Medline Electrosurgical Electrodes Due to Sterility Concerns

    Unimed Surgical Products is recalling specific lots of Medline electrosurgical electrodes due to concerns regarding sterility.

    Product
    Product is labeled in part: "***MEDLINE***Extended PTFE Coated Needle with Extended Insulation 4.0" (10.16cm) Length***Reorder: ES0016AM***Contents: 1 Each***SINGLE USE ONLY**latexfree***RX Only***STERILE EO***www.medline.com Manufactured for Medline Industries, Inc. MEDLINE…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2263-2012·2012-09-05

    Cisco HealthPresence Software Recall for Vital Signs Display Errors

    Cisco Systems is recalling HealthPresence software version 2.1 because subsequent vital signs readings may not update correctly in the OnePlace tab, potentially leading to incorrect interpretations.

    Product
    Cisco brand HealthPresence, version 2.1; Model/Catalog Number: CHP-ENTPRSYR2.I-K9; Product is manufactured and distributed by Cisco Systems, Inc. San Jose, CA Cisco HealthPresence, version 2 is intended for remote consultation of patients with a healthcare provider. Cisco…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2286-2012·2012-09-05

    Medline Extended PTFE Needle Recall for Sterility Concerns

    Unimed Surgical Products is recalling Medline Extended PTFE Needles due to sterility concerns. The recall affects 1,440 units distributed nationwide.

    Product
    Product is labeled in part: "***MEDLINE***Extended PTFE Needle 6.5" (16.51cm) Length***Reorder: ES0016***Contents: 1 Each***SINGLE USE ONLY**latexfree***RX Only***STERILE EO***www.medline.com Manufactured for Medline Industries, Inc. MEDLINE is a registered trademark of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2265-2012·2012-09-05

    Canon Solid State X-ray Imager Recall Due to Loose Screws

    Canon is recalling 468 Solid State X-ray Imagers because screws holding the 55REF circuit board are loosening and roaming inside the sealed sensor.

    Product
    Canon Solid State X-ray Imager (Flat Panel/Digital Imager), Digital Radiography, Models CXDI-55C, CXDI-55G and CXDI-70C. These devices are intended to replace radiographic film/screen systems in all general purpose diagnostic procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2292-2012·2012-09-05

    Unimed Recalls Medline Electrosurgical Electrodes Due to Sterility Concerns

    Unimed Surgical Products is recalling Medline electrosurgical electrodes due to concerns about sterility. The recall affects 1,920 units distributed nationwide.

    Product
    Product is labeled in part: "***MEDLINE***Extended PTFE Coated Blade 6.5 (16.51cm) Length***Reorder: ES0014***Contents: 1 Each***SINGLE USE ONLY**latexfree***RX Only***STERILE EO***www.medline.com Manufactured for Medline Industries, Inc. MEDLINE is a registered trademark of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2291-2012·2012-09-05

    Unimed Recalls Medline Electrosurgical Electrodes Due to Sterility Concerns

    Unimed Surgical Products is recalling specific lots of Medline electrosurgical electrodes due to concerns regarding sterility.

    Product
    Product is labeled in part: "***MEDLINE***Standard PTFE Coated Needle with Extended Insulation 2.75 (6.99cm) Length***Reorder: ES0013M***Contents: 1 Each***SINGLE USE ONLY**latexfree***RX Only***STERILE EO***www.medline.com Manufactured for Medline Industries, Inc. MEDLINE is…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2279-2012·2012-09-05

    Mindray Recalls V Series Patient Monitors Due to Software Anomalies

    Mindray is recalling 979 V Series Patient Monitors worldwide due to two identified software anomalies. No injuries have been reported.

    Product
    V Series Patient Monitors; Mindray DS USA, Inc. Product Usage: The V Series Monitor is intended for intra hospital use under the direct supervision of a licensed healthcare practitioner. The indications for Use for the V Series include the monitoring of the following human…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2294-2012·2012-09-05

    Unimed Recalls Medline Electrosurgical Electrodes Due to Sterility Concerns

    Unimed Surgical Products is recalling Medline electrosurgical electrodes due to sterility concerns. The affected lot is 052709-01.

    Product
    Product is labeled in part: "***MEDLINE***Extended 5mm PTFE Coated Ball 5.0 (12.70cm) Length***Reorder: ES0009***Contents: 1 Each***SINGLE USE ONLY**latexfree***RX Only***STERILE EO***www.medline.com Manufactured for Medline Industries, Inc. MEDLINE is a registered trademark…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1649-2012·2012-08-29

    Custom Medical Specialties Recalls Sterile Access Trays Due to Sterility Concerns

    Custom Medical Specialties is recalling 35 sterile access trays because they contain sodium chloride bags subject to a separate recall for leaking.

    Product
    Custom Access Tray, Sterile, contains Sodium Chloride 0.9% 50 mL, Re-order #: CMS-1667-R2(94-2478), Manufactured for KM Medical, Inc., 124 Jewett Street, Georgetown, MA 01833, the tray also contains other components not listed in this product description.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-2205-2012·2012-08-29

    CareFusion Recalls Alaris Pump Module 8100 Due to Keypad Overlay Separation

    CareFusion 303, Inc. is recalling Alaris Pump Module 8100 units because the keypad overlay may separate from the assembly, posing a potential risk.

    Product
    Alaris Pump Module Model 8100 (formerly Medley Pump Module) Subsequent Product Code: FPA. The Pump module is intended for facilities that utilize infusion for the delivery of fluids, medications, blood, and blood products using continuous or intermittent delivery through…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2230-2012·2012-08-29

    Terumo Serial Interface Module Recalled for Data Loss and Smoke Odor

    Terumo is recalling 579 Serial Interface Modules for the Advanced Perfusion System 1 due to reported malfunctions involving data loss and smoke odor.

    Product
    Serial interface module RS-232 Product Usage: The System 1 provides perfusion case data transfer through the use of the data transfer module. This module is a general purpose serial interface and is the interface between the TLink Data Management ystem or Sarns CCPro Data…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2239-2012·2012-08-29

    Philips PET/CT Systems Recalled Due to UPS Battery Thermal Runaway

    Philips is recalling seven PET/CT systems because a UPS battery cabinet experienced thermal runaway, causing a battery to overheat and burn through the casing.

    Product
    Positron Emission Tomography (PET) and X-ray Computed Tomography, GEMINI TF 16 PET/CT, GEMINI GXL 16 PET/CT, GEMINI TF Big Bore PET/CT, Philips Medical Systems, Cleveland, OH. The device is a diagnostic imaging system for fixed or mobile installations that combines Positron…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2223-2012·2012-08-29

    Philips CT Scanner Recall for Dose Limit Software Defect

    Philips is recalling eight Brilliance 64 and Ingenuity CT scanners because a software update allows users to disable dose alerts, potentially permitting scans that exceed safety limits.

    Product
    The Brilliance 64 and Ingenuity CT are whole body 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. This device may include signal analysis and…
    Category
    Medical Device
    Distribution
    2 states
  • SevereFDA (Drugs)·D-1651-2012·2012-08-29

    Custom US Breast Core Biopsy Tray Recalled for Sterility Concerns

    Custom Medical Specialties is recalling 25 breast biopsy trays because they contain saline bags subject to a separate recall for leaking.

    Product
    CMS-2374-R4 Custom US Breast Core Biopsy Tray, Sterile, contains Sodium Chloride 0.9% 50 mL, Manufactured by: CMS Custom Medical Specialties, Inc., 330 East Main St, PO Box 177, Pine Level, NC 27568, the tray also contains other components not listed in this product…
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Drugs)·D-1650-2012·2012-08-29

    CMS-8934 Custom Phlebectomy Tray Recalled Due to Sterility Assurance Concerns

    Custom Medical Specialties is recalling 20 sterile phlebectomy trays because they contain sodium chloride bags subject to a separate recall for leaking.

    Product
    CMS-8934 Custom Phlebectomy Tray, Sterile, contains Sodium chloride 0.9% 50 mL, Manufactured by: CMS, Custom Medical Specialties, Inc., 330 East Main St, PO Box 177, Pine level, NC 27568, the tray also contains other components not listed in this product description.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-2233-2012·2012-08-29

    Terumo Interface Module for CDl System 500 Recalled for Malfunctions

    Terumo is recalling Interface Modules for the CDl System 500 due to reported malfunctions involving loss of data transfer and smoke odor.

    Product
    Interface module for CDl System 500 Product Usage: The Interface Module for CDl 500 is the interface between the CDl 500 monitor and the system. The module performs the following functions: Communicates primary pump flow data to the CDl 500 Receives blood parameter data from…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2237-2012·2012-08-29

    Abbott i-STAT cTnI Cartridges Recalled for Incorrectly Elevated Troponin Results

    Abbott Point of Care is recalling i-STAT cTnI cartridges because they may produce incorrectly elevated cardiac troponin I results.

    Product
    i-STAT cTnI cartridges Product Usage: The i-STAT cTnl test is an in vitro diagnostic test for the quantitative measurement of cardiac troponin I in heparinized whole blood or plasma samples. Cardiac I troponin measurement cane be used as an aid in the diagnosis and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2234-2012·2012-08-29

    Exactech Recalls Optetrak Proximal Tibial Spacers Due to Dimensional Incompatibility

    Exactech, Inc. is recalling 70 Optetrak Proximal Tibial Spacers because they are dimensionally incompatible with the Logic Tibial Tray.

    Product
    OPTETRAK LOGIC Proximal Tibial Spacer & Screws (2) 2.5 LT BLUE Size 2.5, 8mm***STERILE***Match insert/spacer/tray color. Use with LOGIC Tibial Components. REF 02--012-42-2508. The Optetrak Comprehensive Knee Systems are indicated for use in skeletally mature individuals…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2254-2012·2012-08-29

    Hitachi MRI Software Recall for Image Orientation Error

    Hitachi is recalling MRI software due to a defect that may reverse the orientation of the first image in a dataset.

    Product
    Hitachi Echelon MRI System/Oasis MRI, Software. These are software controlled MRI devices. Product Usage: The Echelon and Oasis MR systems are imaging devices, intended to provide the physician with physiological and clinical information that can be useful in diagnosis…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2259-2012·2012-08-29

    Beckman Coulter Recalls UniCel DxC Immunoassay Systems Due to Software Anomaly

    Beckman Coulter is recalling UniCel DxC 660i, 680i, 860i, and 880i systems because a software anomaly may cause erroneous test results.

    Product
    UniCel DxC 660i, 680i, 860i, 880i SYNCHRON Access Clinical Systems, Part Numbers: DxC 660i: A64871; DxC 680i: A64903; DxC 860i: A64935; DxC 880i: A59102. The DxI Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2220-2012·2012-08-29

    DePuy Altralinked Polyethylene Liners Recalled for Incorrect Size Labeling

    DePuy Orthopaedics is recalling 20 Altralinked polyethylene liners because a size 52 liner was incorrectly labeled as size 54.

    Product
    Altrx" Altralinked" Polyethylene liners Description: An acetabular liner is one of the implants used during total hip arthroplasty to replace the damaged hip joint to help increase patient mobility and to reduce pain. Packaging: Product is placed into a PETG tray, sealed with…
    Category
    Medical Device
    Distribution
    1 state