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.

42126–42150 of 50511

  • HighFDA (Devices)·Z-0677-2014·2014-01-15

    ICU Medical Recalls NanoClave Needleless Connectors Due to Potential Leaking

    ICU Medical is recalling specific lots of NanoClave Needleless Connectors because a small percentage of devices may leak.

    Product
    14" (36 cm ) Appx 0.50 ml, Smallbore Ext Set w/MicroClave¿ Clear, NanoClave¿, 2 Clamps, Rotating Luer, Part No. A1000, Item No. A1081 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration…
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0699-2014·2014-01-15

    ICU Medical Recalls NanoClave Needlefree Connectors Due to Leakage Risk

    ICU Medical is recalling specific lots of NanoClave Needlefree Connectors because a small percentage of the devices may leak.

    Product
    120" 10 Drop Primary Set w/2 BCV-CLAVE¿, Remv 2 Gang CLAVE¿ Stopcock, Remv CLAVE¿ Stopcock, NanoClave¿ T-Connector, Rotating Luer, 2 Ext, Part No. A1000, Item No. SC125 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an…
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0674-2014·2014-01-15

    ICU Medical Recalls NanoClave Needlefree Connectors Due to Potential Leaking

    ICU Medical is recalling specific lots of NanoClave Needlefree Connectors because a small percentage of the devices may leak.

    Product
    10" Smallbore Pentafuse Ext Set w/5 NanoClave", 5 Clamps, Rotating Luer, Part No. A1000, Item No. A1071 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of…
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0655-2014·2014-01-15

    Anspach Effort Pneumatic Drill System Recalled Due to Hose Rupture Risk

    The Anspach Effort, Inc. is voluntarily removing Pneumatic Drill Systems because the outer hose can rupture without warning if airflow is blocked.

    Product
    ***REF XMAX***XMax Handpiece***Rx Only***Manufacturer: The Anspach Effort, Inc. Intended for cutting and shaping bone.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0688-2014·2014-01-15

    ICU Medical Recalls NanoClave Needlefree Connectors Due to Potential Leaking

    ICU Medical is recalling specific lots of NanoClave Needlefree Connectors because a small percentage of devices may leak.

    Product
    7" (18 cm) Appx 0.24 ml, Smallbore Ext Set w/NanoClave", Clamp, Luer Lock, Part No. A1000, Item No. K7095-001 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration…
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0665-2014·2014-01-15

    ICU Medical Recalls NanoClave Needleless Connectors Due to Potential Leaking

    ICU Medical is recalling specific lots of NanoClave Needleless Connectors because a small percentage of devices may leak.

    Product
    17 cm (7'') Ext Set w/NanoClave¿, 2 Gang 4-Way NanoClave¿ Stopcock, Rotating Luer, Part No. A1000, Item No. 011-AC103 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the…
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0702-2014·2014-01-15

    ICU Medical Recalls NanoClave Needlefree Connectors Due to Potential Leaking

    ICU Medical is recalling NanoClave Needlefree Connectors because a small percentage of devices may leak.

    Product
    5" Smallbore Ext Set w/MicroClave¿ T-Connector, Clamp, Luer Slip, Item # B3303-T, Lot # 2791243. The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids…
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Food)·F-1384-2014·2014-01-15

    Perrigo Recalls EstroPlus Menopause Supplements Due to Chloramphenicol Contamination

    Perrigo of SC is recalling EstroPlus Maximum Strength Menopause Support dietary supplements due to potential chloramphenicol contamination. The recall affects 68,534 units distributed in seven states.

    Product
    EstroPlus Maximum Strength Menopause Support Dietary Supplement in 28 count and 56 count blister strips under the following labels - CareOne Maximum Strength Multi Symptom Menopause Formula, 28 Caplets/Dietary Supplement; Meijer Maximum Strength Estroplus, Dietary Supplement…
    Category
    Food
    Distribution
    7 states
  • HighFDA (Devices)·Z-0690-2014·2014-01-15

    ICU Medical Recalls NanoClave Needleless Connectors Due to Potential Leaking

    ICU Medical is recalling specific lots of NanoClave Needleless Connectors because a small percentage of the devices may leak.

    Product
    6" (15 cm) Appx 0.56 ml, Smallbore Trifuse Ext Set w/3 NanoClave", 3 Clamps, Luer Lock, Part No. A1000, Item No. K7097-001 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the…
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0652-2014·2014-01-15

    ArthroCare Knot Pusher Recalled Due to Sharp Edge Hazard

    ArthroCare Medical Corporation is recalling 76 units of the SPORTS MEDICINE Knot Pusher because a sharp edge on the tip may damage or cut a suture.

    Product
    Arthrocare SPORTS MEDICINE, Knot Pusher, REF 25-3011, LOT #1049402, CON 1, 2013-10, NON-STERILE, Rx only
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0663-2014·2014-01-15

    ICU Medical Recalls NanoClave Needleless Connectors Due to Potential Leaking

    ICU Medical is recalling specific lots of NanoClave Needleless Connectors because a small percentage of devices may leak.

    Product
    31 cm (12") Smallbore Bifuse Ext Set w/2 NanoClave¿, Orange Ring, 2 Anti Syphon Valves, 0.2 Micron Postive Filter, Clamp, NanoClave¿ TConnector, Rotating Luer, Part No. A1000, Item No. 011-A1097 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device…
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0692-2014·2014-01-15

    ICU Medical Recalls NanoClave Needleless Connectors Due to Potential Leaking

    ICU Medical is recalling specific lots of NanoClave Needleless Connectors because a small percentage of devices may leak.

    Product
    10" (25 cm) Appx 0.41 ml, Smallbore Ext Set w/MicroClave¿ Clear, NanoClave", Clamp, Rotating Luer, Part No. A1000, Item No. K7101-001 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration…
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0641-2014·2014-01-15

    Sandel Weighted Safety Scalpels Recalled for Exposed Blades

    Ansell Sandel Medical Industries is recalling Sandel Weighted Safety Scalpels because the blade may be exposed beyond the safety shield, compromising sterility and causing injury.

    Product
    Sandel Healthcare Safety Devices Weighted Safety Scalpel 4# Disposable Safety Handle with #20 Blade Manufactured for: Ansell Sandel Medical Solutions LLC 19736 Dearborn St. Chatsworth, CA 91311 USA Emergo Europe Molenstraat 15 2513 BH The Hague The Netherlands Made in China…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0491-2014·2014-01-15

    Carestream DRX-Revolution Mobile X-Ray Systems Recalled for Image Retrieval Failure

    Carestream Health Inc. is recalling 310 mobile X-ray systems because processed images could not be found, leading to patient re-exposure.

    Product
    Carestream DRX-Revolution Mobile X-Ray System -- Made in U.S.A. by Carestream Health Inc. 150 Verona Street, Rochester, NY . 14608 --- The DRX Revolution Mobile system is a mobile diagnostic x-ray system for generation of x-rays for examination of various anatomical regions.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1385-2014·2014-01-15

    Armanino Alfredo Sauce Recalled for Missing Allergen Labeling

    Del Monaco Specialty Foods is recalling Armanino Alfredo Sauce because the cartons are missing the label containing ingredient and allergen information.

    Product
    Armanino Alfredo Sauce; Frozen in 10 oz x 12 pouches per case (sample, not for retail sale) and 3 lb. pouches 4 x 3 lb. pouches per case for food service use UPC - 10 oz. samples: 10041622 002635 UPC 3 lb. pouch: 10041622 019428 Distributed by Armanino Foods, Hayward…
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0653-2014·2014-01-15

    Alere Recalls Oral Fluid Drug Screen Devices Due to Choking Risk

    Alere is recalling specific lots of Oral Fluid Drug Screen Devices because the sponge may dislodge, creating a choking hazard.

    Product
    Product Brand Name(s): Innovacon Oral Fluid Drug Screen Device, OrALert Oral Fluid Drug Screen Device, OrALert Oral Fluid Drug Screen Device with BZO, Reditest On-Site Oral Fluid Drug Screen Device & XALEX One Step Rapid Drug Test. Type of Packaging: 25 individually…
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-0658-2014·2014-01-15

    ICU Medical Recalls NanoClave Needlefree Connectors Due to Potential Leaking

    ICU Medical is recalling specific lots of NanoClave Needlefree Connectors because a small percentage of the devices may leak.

    Product
    NanoClave Connector, Part No. A1000, Item No. 011-A1000, 061-A1000, A1000, K7083-001, Z3769 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a…
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0662-2014·2014-01-15

    ICU Medical Recalls NanoClave Needlefree Connectors Due to Potential Leaking

    ICU Medical is recalling specific lots of NanoClave Needlefree Connectors because a small percentage of the devices may leak.

    Product
    184 cm (72") Smallbore Bifuse Ext Set w/2 NanoClave¿, 2 Anti-Syphon Valves, 0.2 Micron Positive Filter, BCV-Clave¿, NanoClave¿ TConnector, Rotating Luer, Part No. A1000, Item No. 011-A1095 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended…
    Category
    Medical Device
    Distribution
    14 states
  • HighCPSC·14708·2014-01-14

    Arctic Cat Recalls 2014 Snowmobiles Due to Fuel Leak Fire Hazard

    Arctic Cat is recalling about 264 Model Year 2014 500 Sno Pro snowmobiles because fuel can leak from the tank, posing a fire hazard. No injuries have been reported.

    Product
    Arctic Cat snowmobiles
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·14077·2014-01-09

    New Yorker Boiler Recalls Gas-Fired Hot Water Boilers Due to Carbon Monoxide Hazard

    New Yorker Boiler Company is recalling about 191 gas-fired hot water boilers manufactured between May 2012 and February 2013 because a defective air pressure switch can allow excessive carbon monoxide emissions.

    Product
    Gas-fired hot water boilers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·14076·2014-01-09

    U.S. Boiler Recalls Gas-Fired Hot Water Boilers Due to Carbon Monoxide Hazard

    U.S. Boiler is recalling approximately 26,000 gas-fired hot water boilers in the U.S. and 310 in Canada because a faulty air pressure switch may allow excessive carbon monoxide emissions.

    Product
    Gas-fired hot water boilers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0617-2014·2014-01-08

    Stryker Secure II Med/Surg Beds Recalled for Potential Cover Damage

    Stryker is recalling Secure II and S3 Med/Surg beds due to potential damage to the Foot End Cover and Power Coil Cable caused by reduced clearance.

    Product
    Secure II Med/Surg Bed Secure II and the 3002 S3 are the beds typically found in the Med-Surg units of the hospitals. The bed is designed for a 15 year expected service life under normal use conditions, and with appropriate periodic maintenance as described in the maintenance…
    Category
    Medical Device
    Distribution
    Distributed nationwide