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.

44251–44275 of 50511

  • HighFDA (Devices)·Z-0575-2013·2012-12-26

    DePuy Solution Calcar Stems Recalled for Potential Impingement

    DePuy Orthopaedics is recalling Solution Calcar Stems used in hip replacements because engineering analysis found they may not lock properly with certain heads.

    Product
    SOL SYS 8IN CALC 1.5/15.0 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire stem is then placed within a foam sleeve for added protection. The assembly is then placed and sealed in an inner and outer tray…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0842-2013·2012-12-26

    Cook's Delight Lobster Base Recalled for Undeclared Milk Allergen

    Williams West & Witt's Products Company is recalling Cook's Delight Lobster Base because the label failed to identify milk as an ingredient. Consumers with a milk allergy are at risk of serious allergic reactions.

    Product
    #226 Cook's Delight Lobster Base, Net Weight 30 Pounds; 5 Pounds, Packed by Integrative Flavors, Michigan City, Indian
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-0534-2013·2012-12-26

    Arobella Medical 6mm Qurette Recalled for Fracture Risk During Use

    Arobella Medical is recalling 6mm Qurettes used in the AR1000 Wound Therapy System because they can fracture during use and release fragments.

    Product
    Arobella Medical 6mm Qurette used with the Arobella Medical AR1000 Wound Therapy System. Major components of the AR1000 Wound Therapy System include an ultrasonic generator, converter hand piece, done-shaped applicator tip (qurette), and a saline supply reservoir.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0585-2013·2012-12-26

    DePuy Solution Calcar Stem Recalled for Potential Impingement

    DePuy Orthopaedics is recalling Solution Calcar Stems because engineering analysis found they may impinge with certain heads, preventing proper locking.

    Product
    SOL SYS L 9IN CALC 2.25/22.5 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire stem is then placed within a foam sleeve for added protection. The assembly is then placed and sealed in an inner and outer tray…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0533-2013·2012-12-26

    Biomet Recalls Offset Tibial Tray Adaptors Due to Sizing Issue

    Biomet is recalling 200 offset tibial tray adaptors because the locking insert may not engage the tool, potentially delaying surgery and increasing anesthesia time.

    Product
    Biomet Offset Tibial Tray 2.5 mm Adaptor, REF 141490 Sterile, QTY.1 Product Usage: Knee joint replacement prostheses intended for application with or without bone cement. Knee joint replacement components include femoral, tibial, and patellar components, intended for both…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0566-2013·2012-12-26

    Stryker Power-LOAD Ambulance Cot Fastener System Recall for Load Switch Defect

    Stryker is recalling 24 Model 6390 Power-LOAD systems because a load switch slide may not meet specifications, negatively impacting the lifting ability of the arms.

    Product
    The Stryker Model 6390, Power-LOAD, is a power-loading cot fastener system designed to lift, lower, or steer ambulance cots into and out of the ambulance.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0562-2013·2012-12-26

    BioHorizons Recalls Titanium Tack Starter Kits Due to Cleaning Instructions

    BioHorizons is recalling 1,246 units of Titanium Tack Starter Kits because the provided cleaning instructions may not remove residual contaminants after surgical use.

    Product
    Titanium Tack Starter Kit, REF 400-270, Rx Only, non-sterile, BIOHORIZONS, BIRMINGHAM, AL 35244. Dental.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0589-2013·2012-12-26

    DePuy Solution Calcar Stems Recalled Due to Potential Impingement

    DePuy Orthopaedics is recalling Solution Calcar Stems because engineering analysis found they may impinge with certain heads, preventing proper locking.

    Product
    SOL SYS R 9IN CALC 2.25/18 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire stem is then placed within a foam sleeve for added protection. The assembly is then placed and sealed in an inner and outer tray…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0537-2013·2012-12-26

    Zimmer Recalls Coonrad/Morrey Total Elbow Replacement Sets Due to Pin Error

    Zimmer, Inc. is recalling specific lots of Coonrad/Morrey Total Elbow Replacement Sets because they may contain an incorrect small inner pin instead of the required regular pin.

    Product
    COONMAD/MORREY TOTAL ELBOW ELBOW COMPONENT REPLACEMENT SET BUSHINGS & PINS FOR USE W/SIZE REGULAR ELBOW ELBOW COMP REPLACEMENT-REG SET STERILE PROD CLASS: 4100 OPERATION:9000 QTY/PKG:1 Product Usage: The ulnar and humeral components are connected by placing the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0832-2013·2012-12-26

    Clam Base Products Recalled for Undeclared Milk Allergen

    Williams West & Witt's is recalling Clam Base products because the ingredient label failed to identify milk, a major allergen, as a source of butter and cream.

    Product
    #122-A, Piazza Produce Clam Base, Net Weight 16 oz (1 lb) 454G Packed For: Piazza Produce, Indianapolis, IN 46268: #122-A, Primarque Clam Base, Net Wt 16 oz (1 lb) 454 grams Manufactured for Primarque Products Co. Worcester, MA 01610 #122-A, Clam Base, Cook's Delight…
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-0567-2013·2012-12-26

    Medtronic Recalls 140 DBS Extension Kits with Damaged Connector Boots

    Medtronic is recalling 140 Deep Brain Stimulation Extension Kits because the connector boots may be cracked or improperly molded.

    Product
    Medtronic, DBS Extension Kit for Deep Brain Stimulation, Catalog # 7482, 37085, 37086. Rx Only, Manufactured in: Medtronic, Inc. Villalba, Puerto Rico. Medtronic¿ DBSTM Therapy for Parkinson's Disease - Bilateral stimulation of the internal globus pallidus (GPi) or the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0545-2013·2012-12-26

    Zimmer Recalls Persona Tibial Drills to Reduce Perforation Risk

    Zimmer, Inc. is recalling 135 Persona Tibial Drills and associated tools to reduce the risk of tibial perforation and bone fracture.

    Product
    Persona, The Personalized Knee System,Tibial Drill, Cemented, 15.7 mm Diameter, Nonsterile This device is indicated for patients with severe knee pain and disability due to: o Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. o Collagen disorders…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0851-2013·2012-12-26

    Riviana Recalls Yellow Rice Mixes for Undeclared Soy Protein

    Riviana International is recalling specific Shurfine and Hannaford yellow rice mixes because they contain undeclared hydrolyzed soy protein.

    Product
    Yellow rice mixes with the following g brand names: (1) Shurfine brand Yellow Rice with Saffron, NET WT 5 OZ (142g), distributed by TOPCO ASSOCIATES, LLC, 7711 GROSS POINT ROAD, SKOKIE, IL 60077. UPC 011161159834 and (2) Hannaford brand Yellow Rice with real saffron & other…
    Category
    Food
    Distribution
    4 states
  • HighFDA (Devices)·Z-0592-2013·2012-12-26

    DePuy Solution Calcar Stem Recalled for Potential Impingement

    DePuy Orthopaedics is recalling Solution Calcar Stems because an engineering analysis found they may impinge with certain heads, preventing proper locking.

    Product
    SOL SYS R 9IN CALC 2.25/22.5 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire stem is then placed within a foam sleeve for added protection. The assembly is then placed and sealed in an inner and outer tray…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0573-2013·2012-12-26

    DePuy Solution Calcar Stem Recalled for Potential Impingement

    DePuy Orthopaedics is recalling Solution Calcar Stems because an engineering analysis found they may not lock properly with certain femoral heads.

    Product
    SOL SYS 8IN CALCAR SZ12 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire stem is then placed within a foam sleeve for added protection. The assembly is then placed and sealed in an inner and outer tray for…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0583-2013·2012-12-26

    DePuy Orthopaedics Recalls Solution Calcar Stems Due to Impingement Risk

    DePuy Orthopaedics is recalling 1,732 Solution Calcar Stems because engineering analysis found they may not lock properly with certain femoral heads, posing a risk of impingement.

    Product
    SOL SYS L 9IN CALC 2.25/19.5 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire stem is then placed within a foam sleeve for added protection. The assembly is then placed and sealed in an inner and outer tray…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0834-2013·2012-12-26

    Primarque Clam Base Recalled for Undeclared Milk Allergen

    Williams West & Witt's Products Company is recalling Primarque Clam Base because the label failed to identify milk as an ingredient, posing a risk to consumers with milk allergies.

    Product
    #223-E Primarque Clam Base, Net Weight 50 pounds (22.68 kg) Packed for Primarque Products, Worcester, MA 01610
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-0559-2013·2012-12-26

    Integra Recalls Mayfield Skull Clamps Due to Performance Issues

    Integra LifeSciences is recalling eight Mayfield Composite Series Skull Clamps (Model A3059) due to product performance issues that could impact functionality.

    Product
    MAYFIELD Composite Series Skull Clamps, Model A3059, 510(k) #K120633. The MAYFIELD Skull Clamps (A3059) are indicated for use in open and percutaneous craniotomies, as well as spinal surgery when rigid skeletal fixation is necessary.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0833-2013·2012-12-26

    Clam Base Products Recalled for Undeclared Milk Allergen

    Williams West & Witt's is recalling Primarque and Cook's Delight Clam Base because the labels failed to identify milk as an ingredient, posing a risk to consumers with milk allergies.

    Product
    #222-C, Primarque Clam Base, Net Weight 5 pounds (2.27kg) & 16 oz ( 1 LB) 454G Packed for Primarque Products, Worcester, MA 01610 #222-C, Cook's Delight Clam Base, Net Weight 5 pounds (2.27kg) & 16 oz ( 1 LB) 454G Packed By Integrative Flavors, Michigan City, Indiana 46360
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-0581-2013·2012-12-26

    DePuy Orthopaedics Recalls Solution Calcar Stems Due to Impingement Risk

    DePuy Orthopaedics is recalling Solution Calcar Stems used in hip replacements because engineering analysis found they may not lock properly with certain heads.

    Product
    SOL SYS L 9IN CALC 2.25/16.5 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire stem is then placed within a foam sleeve for added protection. The assembly is then placed and sealed in an inner and outer tray…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0844-2013·2012-12-26

    Crab Base Products Recalled for Undeclared Milk Allergen

    Williams West & Witt's recalls Primarque and Cook's Delight crab base products because the labels failed to identify milk as an ingredient, posing a risk to consumers with milk allergies.

    Product
    #321N Primarque Crab Base, Net Weight 50 Pounds, Packed For Primarque Products, Worcester, MA 01610 #321 N Cook's Delight,Crab Base, Net Weight 50 Pounds, Packed By Integrative Flavors, Michigan City, Indiana 46360
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-0560-2013·2012-12-26

    GE Healthcare Recalls Advantage Workstation Software Due to Vessel Label Mismatch

    GE Healthcare is recalling specific Advantage Workstation software versions due to a potential vessel label mismatch and a measurement tool refresh issue that may impact patient safety.

    Product
    Advantage Workstation Volume Share 2 (versionAW4.4_04) with Volume Viewer 3 and 3.1 (version7.0 to version7.5 and version 8.1) and only when or more of these applications is installed: " VesselIQ Xpress or AVA Xpress " CardIQ Xpress Pro or Plus " CardEP " CardIQ Fusion PET…
    Category
    Medical Device
    Distribution
    31 states
  • HighFDA (Devices)·Z-0590-2013·2012-12-26

    DePuy Orthopaedics Recalls Solution Calcar Stems Due to Impingement Risk

    DePuy Orthopaedics is recalling Solution Calcar Stems used in hip replacements because engineering analysis found they may not lock properly with certain heads.

    Product
    SOL SYS R 9IN CALC 2.25/19.5 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire stem is then placed within a foam sleeve for added protection. The assembly is then placed and sealed in an inner and outer tray…
    Category
    Medical Device
    Distribution
    Distributed nationwide