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.

42901–42925 of 50511

  • HighFDA (Devices)·Z-2132-2013·2013-09-11

    DePuy Spine Recalls Confidence Spinal Cement System 5cc Kits

    DePuy Spine is recalling Confidence Spinal Cement System 5cc kits because hydraulic pump leaks can cause loss of pressure during injection.

    Product
    CONFIDENCE SPINAL CEMENT SYSTEM 5CC KIT, Product Code: 2839-05-000 The CONFIDENCE Spinal Cement System is intended for percutaneous delivery of CONFIDENCE Spinal Cement, which is indicated for fixation of pathological fractures of the vertebral body during vertebroplasty or…
    Category
    Medical Device
    Distribution
    33 states
  • HighFDA (Devices)·Z-2157-2013·2013-09-11

    Elekta Recalls DMLC IV-ERGO Beam Shaping Blocks for Radiation Therapy

    Elekta, Inc. is recalling 31 DMLC IV-ERGO beam shaping blocks used in radiation therapy due to potential clinical mistreatment from workflow errors or incorrect settings.

    Product
    DMLC IV-ERGO - Beam shaping block for Radiation Therapy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2142-2013·2013-09-11

    Genzyme Recalls LeGoo Endovascular Occlusion Gel Due to Particulates

    Genzyme Corporation is recalling LeGoo Endovascular Occlusion Gel because the product contains particulates (fibers). The recall affects 5 units distributed worldwide.

    Product
    LeGoo¿ Endovascular Occlusion Gel-0.5 mL LeGoo w/ no Cannula Product Number: PV-50 LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·13V414000·2013-09-10

    Circle D Trailers Recalled for Door Lock Jamming Hazard

    Circle D is recalling 2006-2013 horse and multipurpose trailers because a door lock defect may jam the deadbolt, potentially trapping occupants inside.

    Product
    CIRCLE D — CIRCLE D BHST, GNMPT, GNST
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·13V413000·2013-09-10

    Open Range Travel Trailer Recall for Jamming Deadbolt Locks

    Open Range is recalling 2009-2013 travel trailers because a defect in the deadbolt lock may jam, potentially trapping occupants inside the vehicle.

    Product
    OPEN RANGE — OPEN RANGE TRAVEL TRAILER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·13V411000·2013-09-10

    Team Spirit Trailers Recall 2006-2013 Models Due to Door Lock Jamming Risk

    Team Spirit is recalling 2006-2013 enclosed cargo trailers because a defect in the deadbolt lock could jam, potentially trapping occupants inside the vehicle.

    Product
    TEAM SPIRIT — TEAM SPIRIT TSDPL, TSPL, TSCDTS, TSCFTS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·13278·2013-09-10

    Eco-Novelty Recalls Jumbo Cosmo Beads Toys Due to Ingestion Hazard

    Eco-Novelty is recalling Jumbo Size and Jumbo Multipurpose Cosmo Beads toys because the water-absorbing beads can cause intestinal obstructions if swallowed by children.

    Product
    Water-absorbing polymer beads
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·13E051000·2013-09-09

    Maxzone Recalls DEPO Headlamps for Ford F-150 Trucks

    Maxzone is recalling DEPO-brand replacement headlamps for 2004-2008 Ford F-150 trucks because moisture inside the lens may reduce visibility and increase crash risk.

    Product
    EXTERIOR LIGHTING:HEADLIGHTS recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·13V415000·2013-09-09

    Kingston Recalls Horse Trailers With Potentially Jamming Door Locks

    Kingston is recalling 2006-2013 horse trailers equipped with Fastec door locks that may jam, potentially trapping occupants inside.

    Product
    KINGSTON — KINGSTON BELVEDERE II, BRUNSWICK, BEDFORD, WINDSOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·13V519000·2013-09-09

    Play-Mor Trailers Recall 2006-2013 Models Due to Door Lock Defect

    Play-Mor Trailers is recalling 2006-2013 travel trailers because a door lock defect could jam the deadbolt, trapping occupants inside.

    Product
    PLAY-MOR — PLAY-MOR SPORTSTER, PLAY-MOR, MOTORSPORT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·13277·2013-09-06

    Crosman Recalls Air Pistols Due to Explosion Hazard

    Crosman is recalling specific air pistol models because they can explode at high temperatures, posing a risk of serious injury to users.

    Product
    Air pistols
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·13V404000·2013-09-06

    Homesteader Recalls 2006-2010 Trailers Due to Door Lock Jamming Risk

    Homesteader is recalling 2006-2010 enclosed cargo and horse trailers because a key removal issue may jam the deadbolt, potentially trapping occupants inside.

    Product
    HOMESTEADER — HOMESTEADER HORSE TRAILER, ENCLOSED CARGO TRAILER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·13V405000·2013-09-06

    Suzuki Recalls Grand Vitara and SX4 for Air Bag Sensor Defect

    Suzuki is recalling 2006-2011 Grand Vitara and 2007-2011 SX4 vehicles because the front passenger air bag sensor may fail, causing the air bag to deploy regardless of occupant size.

    Product
    SUZUKI — SUZUKI SX4, GRAND VITARA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·13V401000·2013-09-05

    Western Star 4900 Recalled for Seatbelt Anchor Misalignment

    Daimler Trucks North America is recalling 2009-2014 Western Star 4900 trucks because a misaligned B-pillar hole may prevent seatbelts from restraining occupants properly in a crash.

    Product
    WESTERN STAR — WESTERN STAR 4900
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·13V402000·2013-09-05

    ShowHauler Motorhomes Recalled for Door Lock Jamming Risk

    ShowHauler is recalling 2006-2013 motorhomes because the door lock may jam, potentially trapping occupants inside the vehicle.

    Product
    SHOWHAULER — SHOWHAULER MOTORHOME
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2090-2013·2013-09-04

    Zimmer Free Lock Femoral Hip Fixation System Compression Lag Screw Recall

    Zimmer is recalling Free Lock Femoral Hip Fixation System Compression Lag Screws because a packaging failure compromised sterility.

    Product
    Free Lock Femoral Hip Fixation System Compression Lag Screw . Several lengths (55 to 150 mm) and diameters (12.7 and 15. 8 mm). Item codes starting with 00-1181-05, 00-1181-10 and 00-1181-15. ZIMMER Compression Hip Screw, orthopedic implant.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2063-2013·2013-09-04

    Waldemar Link Recalls Trial Stems for Hip Reconstruction Prosthesis

    Waldemar Link is recalling five trial stems for a hip reconstruction prosthesis because they were manufactured using the wrong design.

    Product
    TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/18, Stem size 003, prox. Stem dia. 18 mm, Length 210 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2094-2013·2013-09-04

    Zimmer Recalls Versa-FX II Femoral Fixation System Due to Sterility Failure

    Zimmer, Inc. is recalling Versa-FX II Femoral Fixation System units because a packaging configuration failed a leak test, compromising sterility.

    Product
    VERSA-FX II FEMORAL FIXATION SYSTEM COMPRESSION TUBE/PLATE, standard and short - low profile, different hole/length combinations (4/86, 5/102 and 6/118), different degree angles (130, 135, 140, 145 and 150). Item codes starting with 00-194-130, 00-1194-135, 00-1194-140…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2075-2013·2013-09-04

    Waldemar Link Recalls Trial Stems for Hip Reconstruction Prosthesis

    Waldemar Link is recalling six trial stems for the MP Reconstruction Prosthesis because they were manufactured using the wrong design. The units were distributed only in Tennessee.

    Product
    TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0155/14, Stem size S-1, prox. Stem dia. 14 mm, Length 180 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2072-2013·2013-09-04

    Waldemar Link Recalls Trial Stems for Hip Reconstruction Prosthesis

    Waldemar Link is recalling four trial stems for a hip reconstruction prosthesis because they were manufactured using the wrong design.

    Product
    TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0143/22, Stem size 05, prox. Stem dia. 22.5 mm, Length 250 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2092-2013·2013-09-04

    Zimmer Recalls VERSA-FX Femoral Fixation System Due to Sterility Failure

    Zimmer, Inc. is recalling VERSA-FX Femoral Fixation System compression lag screws because a packaging failure compromised sterility. The recall affects 85,794 units distributed worldwide.

    Product
    VERSA-FX FEMORAL FIXATION SYSTEM COMPRESSION LAG SCREW, several length (55 mm to 155 mm), diameters (12.7 mm and 15.8 mm) and short thread, standard thread and large thread. Item codes starting with 00-1193-005, 00-1193-010 and 00-1193-015. orthopedic implant.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1849-2013·2013-09-04

    Tres Leches cake recalled for undeclared soy oil allergen

    D'Aqui Manufacturing Products Corp. is recalling Tres Leches cakes sold in Puerto Rico due to undeclared soy oil.

    Product
    Tres Leches cake sold under the following brand names: 1) "****Tres Leches***Postres D'Aqui***D'Aqui Manufacturing Products Corp***Peso Neto 3oz***"; 2) "****Tres Leches***Fresh Star***Distribuido por Karelly's Food***PO Box 634 Sabana Seca PR 00952***Peso Neto 3 oz***"
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2116-2013·2013-09-04

    GE Healthcare Recalls Patient Data Modules Due to Signal Noise

    GE Healthcare is recalling CARESCAPE Patient Data Modules because movement of the ECG connector can cause signal noise, potentially reducing the device's ability to detect arrhythmias.

    Product
    SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULE (Marketed As GE Healthcare CARESCAPE Patient Data Module) Product Usage: The Patient Data Module (PDM) is intended to provide uninterrupted acquisition of physiologic parameter data on adult, pediatric and neonatal…
    Category
    Medical Device
    Distribution
    Distributed nationwide