The Recall Desk

Severity 3 of 5

High recalls

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

What “high” means here

Severity 3 (High) recalls have a known hazard but no confirmed illness, injury, or property damage in the source text. The risk is theoretical-but-real: a pathogen pre-emptively pulled from shelves before anyone got sick, an allergen mislabeling on an uncommon allergen, a precautionary correction on a device that hasn't yet malfunctioned in the field. Most allergen recalls land here, as do most preventive food recalls based on routine sampling. You should still stop using the product, but you don't need to panic.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

43751–43775 of 50511

  • HighCPSC·13171·2013-04-17

    Gerbings Recalls 12-Volt Heated Jacket Liners Due to Burn Hazard

    Gerbings is recalling about 9,900 12-volt heated jacket liners sold at Harley-Davidson dealerships and other stores because a defective wire connector can cause overheating and minor burns.

    Product
    12-volt heated jacket liners
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1064-2013·2013-04-17

    Arrow International Recalls FiberOptix Intra-Aortic Balloon Catheter Kits

    Arrow International is recalling 188 units of FiberOptix Intra-Aortic Balloon Catheter Kits due to a potential internal leak at the fill port.

    Product
    Arrow International FiberOptix Intra-Aortic Balloon Catheter Kit (IAB) 8 Fr 30 cc; Product Number: IAB-05830-LWS. The IAB is utilized for intra-aortic balloon counter-pulsation therapy.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Drugs)·D-244-2013·2013-04-17

    GSMS Recalls Lisinopril and Hydrochlorothiazide Tablets Due to Foreign Particulates

    GSMS Inc. is recalling specific lots of Lisinopril and Hydrochlorothiazide tablets because they contain minute stainless steel particulates.

    Product
    LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS, USP, 20 mg/25 mg, 100 (NDC 60429-046-01) and 1,000 (NDC 60429-046-10) count bottles, Rx only, GSMS Inc., Camarillo, CA
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1307-2013·2013-04-17

    Mikesell's Honey Barbecue Potato Chips Recalled for Gluten Free Mislabeling

    Mike-Sells Potato Chip Co is recalling Honey Barbecue flavored potato chips labeled as 'Gluten Free' due to mislabeling complaints.

    Product
    Mikesell's Honey Barbecue TOMATO AND SPICES WITH A HINT OF SWEET FLAVORED POTATO CHIPS Gluten Free 1 oz., 2 oz., 6 oz., 10 oz., 16 oz. MIKESELL'S SNACK FOOD CO. P.O. BOX 115 DAYTON, OH 45404.
    Category
    Food
    Distribution
    4 states
  • HighNHTSA·13V146000·2013-04-17

    Navistar Recalls International Trucks Due to Sun Shade Separation Risk

    Navistar is recalling certain 2011-2013 International commercial trucks because sun shades may separate from the roof, potentially distracting the driver and increasing crash risk.

    Product
    INTERNATIONAL — INTERNATIONAL LONESTAR, PROSTAR, DURASTAR, WORKSTAR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1072-2013·2013-04-17

    Elekta Precise Treatment Table Recalled for Column Rotation Defect

    Elekta, Inc. is recalling 443 Precise Treatment Tables because the column rotation can accidentally move from its locked position during radiation therapy.

    Product
    Precise Treatment Table. To be used as part of radiation therapy treatment process.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1083-2013·2013-04-17

    GE Healthcare Recalls VMX Mobile X-ray Units Due to Arm Base Casting Issue

    GE Healthcare is recalling VMX and VMX Plus mobile X-ray units because a defect in the arm base casting may impact operator or patient safety.

    Product
    VMX, VMX Plus Mobile Radiographic Unit with the following models: 45296139; 45296200; 45296350; 45296477; 45296964; 45297001; 45296966; 45297003; 2240169; 2240171; 2240172; 2240173. Product Usage: The VMX is a mobile radiography system incorporating stylish design for…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·13V144000·2013-04-16

    Dutchmen Recalls 2013 Travel Trailers for Incorrect Weight Rating Labels

    Dutchmen is recalling 2013 245RKS travel trailers because the Federal identification tag lists incorrect weight ratings, which could lead to vehicle overloading.

    Product
    DUTCHMEN — DUTCHMEN TRAVEL TRAILER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·13E018000·2013-04-15

    Schneider Electric Recalls EVlink Charging Stations for Overheating Risk

    Schneider Electric is recalling specific EVlink charging stations because the charger plug pin connectors may overheat, potentially melting the casing and causing burns or damage.

    Product
    ELECTRICAL SYSTEM:PROPULSION SYSTEM:CHARGING:CABLE/CORD:ACCESSORY recall
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·13167·2013-04-11

    Carter's Recalls Infant Clothing with Zippers Due to Choking Hazard

    Carter's is recalling about 218,000 one-piece footed infant garments because the zipper pull can detach, posing a choking hazard to young children.

    Product
    One-piece footed infant clothing with a zipper
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1054-2013·2013-04-10

    LeMaitre Stent Guide Recalled Due to Compromised Sterility

    LeMaitre Vascular, Inc. is recalling LeMaitre Stent Guide strips because they were not sealed correctly during manufacturing, compromising their sterility.

    Product
    LeMaitre Stent Guide: 1102-00 (100 strips); 1102-50 (50 strips); 1102-20 (20 strips). Intended to be placed on the skin to assist during imaging procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1050-2013·2013-04-10

    Horiba Medical Recalls ABX Micros IM2 Data Management System

    Horiba Medical is recalling 180 units of the ABX Micros IM2 Data Management System because it may display incorrect patient test results under unanticipated operating conditions.

    Product
    ABX Micros IM2, Part# M60CSB110EN04 and D00A00202 The IM2 Data Management System consists of the IM2 Data Manager Software, Desktop Computer, keyboard, mouse, and a unidirectional serial cable. The IM2 software is used to store, retrieve, and process laboratory data received…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1036-2013·2013-04-10

    Siemens Medical Solutions Recalls COHERENCE RT Therapist Software for Safety Issues

    Siemens Medical Solutions is recalling COHERENCE RT Therapist software versions for Primus and Oncor linear accelerators to address performance defects and safety issues.

    Product
    SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B; Software release for COHERENCE Therapist 2.3 for Primus and Oncor Linear Accelerators; Model: COHERENCE AG TH, Part No. 5863506, Current R630; Product Usage: The intended use of…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1033-2013·2013-04-10

    Beckman Coulter Access 2 Immunoassay System Recall for Defective Pulley

    Beckman Coulter is recalling Access 2 Immunoassay Systems because a defective aluminum incubator belt pulley may create debris that falls into reaction vessels, risking erroneous test results.

    Product
    Access 2 Immunoassay System; P/N 107405S 2/12 The Access Immunoassay Systems are in vitro diagnostic devices used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·13166·2013-04-10

    Trumpette Recalls Baby Socks Due to Choking Hazard

    Trumpette is recalling Aubree's and Hearts baby socks because flowers and bows can detach, posing a choking hazard to young children.

    Product
    Aubree's and "Hearts" baby socks
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1029-2013·2013-04-10

    Philips Ingenuity TF PET/CT Software Update Addresses Potential Safety Risks

    Philips is updating software on one Ingenuity TF PET/CT system in Ohio to fix issues that could cause inaccurate readings or pose risks to patients and staff.

    Product
    Ingenuity TF PET/CT. Diagnostic imaging system that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Food)·F-1287-2013·2013-04-10

    Beehive Botanicals Recalls Propolis Chunks Due to Fluvalinate Contamination

    Beehive Botanicals, Inc. is recalling specific lots of Propolis Chunks due to the presence of Fluvalinate, a pesticide residue.

    Product
    Propolis Chunks-Coarse Ground, Standardized Bee Propolis Lot #: SDM-10081155/60, EXP: 10/14, 1# BAG.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1043-2013·2013-04-10

    Siemens Medical Solutions Recalls COHERENCE RT Therapist Software for Safety Issues

    Siemens Medical Solutions is recalling COHERENCE RT Therapist software versions for linear accelerators to address multiple performance defects and safety issues.

    Product
    SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B; Software release for COHERENCE Therapist 2.3 for Primus and Oncor Linear Accelerators; Model: Primeview 3i 2.1, Part No. 8147675, Current R640; Product Usage: The intended…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1030-2013·2013-04-10

    Integra Ojemann Cortical Stimulator Recalled for Potential Electrical Injury Risk

    Integra Burlington MA, Inc. is recalling 371 Ojemann Cortical Stimulators because a non-intended voltage could be transmitted to patients during surgery.

    Product
    Integra Ojemann Cortical Stimulator; Product / Catalogue No: OCS2. Intended for intraoperative cortical stimulation mapping procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1055-2013·2013-04-10

    LeMaitre Vascular Recalls Glow 'N Tell Tape Due to Sterility Compromise

    LeMaitre Vascular is recalling Glow 'N Tell 20 cm Tape because manufacturing defects compromised the sterility of the devices.

    Product
    Glow 'N Tell 20 cm Tape: 1100-00 (100 strips); 1100-50 (50 strips); 1100-20 (20 strips). Intended to be placed on the skin to assist during imaging procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1060-2013·2013-04-10

    Polymedco Recalls OC-Light iFOBT Test Strips Due to Stability Issues

    Polymedco is recalling OC-Light iFOBT test strips because they may not be stable through their labeled shelf-life, potentially causing false negative results.

    Product
    Test Strips packaged in the OC-Light Manual iFOBT Kit, Catalog No. FOBSTR. For the rapid, qualitative detection of human hemoglobin in feces.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1059-2013·2013-04-10

    Polymedco OC-Light iFOBT Test Strips Recalled for Potential False Negatives

    Polymedco is recalling OC-Light iFOBT test strips because they may not be stable through their labeled shelf-life, potentially causing false negative results.

    Product
    Test Strips packaged in the OC-Light Manual iFOBT Kit, Catalog No. FOB50. For the rapid, qualitative detection of human hemoglobin in feces.
    Category
    Medical Device
    Distribution
    Distributed nationwide