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.

40401–40425 of 50511

  • HighFDA (Devices)·Z-2677-2014·2014-10-01

    Genesys Spine Recalls Circular Lock Screws Due to Material Error

    Genesys Orthopedics Systems is recalling 642 Circular Lock Screws from the TiLock Pedicle Screw System because a portion of the lot was manufactured with stainless steel instead of the specified titanium alloy.

    Product
    Circular Lock Screws, part # G826, lot # 11406. The Lock Screws are part of the Genesys Spine TiLock Pedicle Screw System. The TiLock Pedicle Screw System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2512-2014·2014-10-01

    Blue Star Claw Crab Meat Recalled for Botulism Risk

    Supreme Distributors is recalling Blue Star Claw Crab Meat due to potential Clostridium botulinum toxin formation from temperature abuse.

    Product
    Blue Star Claw Crab Meat, 16 oz; Premium Pasteurized Crab Meat. Product of Thailand. Distributed by Supreme Lobster and Seafood Company, Villa Park, IL 60181
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2694-2014·2014-10-01

    Alcon Recalls Eye-Pak 7407 Tray Support Covers Due to Seal Issues

    Alcon Research, Ltd. is recalling 2,462 Eye-Pak 7407 Tray Support Covers because insufficiently sealed peel pouches may compromise sterility.

    Product
    eye-pak 7407 Tray Support Cover REF 8065740745
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2498-2014·2014-10-01

    Roots Spinach Hummus Recalled for Missing Soy Allergen Labeling

    Roots Organic Gourmet is recalling Spinach Hummus because the label lists Tamari but lacks a 'Contains Soy' statement.

    Product
    Roots, Spinach Hummus, Net Wt. 8 oz (227 g), Gluten-Free Vegan, UPC: 860971000047, 166 W. Haywood St., Asheville, NC 2801, RootsFood.com. This product is packaged in 8 oz. non-flexible plastic tubs.
    Category
    Food
    Distribution
    6 states
  • HighFDA (Food)·F-2500-2014·2014-10-01

    Roots Organic Gourmet Recalls Oil Free Original Hummus for Missing Soy Labeling

    Roots Organic Gourmet is recalling Oil Free Original Hummus because the label lists Tamari but fails to state 'Contains Soy.'

    Product
    Roots, Oil Free Original Hummus, Net Wt. 8 oz (227 g), Gluten-Free Vegan, UPC: 723175787599, 166 W. Haywood St., Asheville, NC 2801, RootsFood.com.This product is packaged in 8 oz. non-flexible plastic tubs.
    Category
    Food
    Distribution
    6 states
  • HighFDA (Food)·F-2495-2014·2014-10-01

    Roots Roasted Red Bell Pepper Hummus Recalled for Missing Soy Labeling

    Roots Organic Gourmet is recalling Roasted Red Bell Pepper Hummus because the label fails to state 'Contains Soy' despite listing Tamari as an ingredient.

    Product
    Roots, Roasted Red Bell Pepper Hummus, Net Wt. 8oz (227 g), and 16oz. (454 g), Gluten-Free Vegan, UPC: 860971000023, and 723175787605, 166 W. Haywood St., Asheville, NC 2801, RootsFood.com. This product is packaged in 8 oz. and 16 oz. non-flexible plastic tubs.
    Category
    Food
    Distribution
    6 states
  • HighNHTSA·14V612000·2014-10-01

    Coach and Equipment Recalls Transit Buses with Cracking Wheelchair Lifts

    Coach and Equipment is recalling 2006-2014 transit buses equipped with certain Ricon wheelchair lifts because the platform side plates may crack, posing an injury risk.

    Product
    COACH AND EQUIPMENT — COACH AND EQUIPMENT CONDOR LT, PHOENIX, ALLEY CAT, PEGASUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2693-2014·2014-10-01

    ArjoHuntleigh Recalls Minstrel Mobile Passive Hoists Due to Bolt Failure

    ArjoHuntleigh is recalling 18 Minstrel mobile passive hoists because a bolt under the scale may unscrew, posing a risk of the spreader bar detaching during use.

    Product
    Minstrel (with scale) Product Usage: is a mobile passive hoist. It is intended for lifting and transporting adult residents on horizontal floors in hospitals, nursing homes or other health care facilitates. The Minstrel device aids in the lifting, transfer and lowering to…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2671-2014·2014-10-01

    Ortho-Clinical Diagnostics Recalls VITROS Anti-HCV Reagent Packs

    Ortho-Clinical Diagnostics is recalling VITROS Anti-HCV Reagent Packs due to signal loss that may cause false negative test results for hepatitis C.

    Product
    VITROS Immunodiagnostic Products Anti-HCV Reagent Pack for in vitro qualitative detection of immunoglobulin G antibody to hepatitis C virus (anti-HCV) in human serum and plasma. REF 680 2454, IVD -- Ortho-Clinical Diagnostics High Wycombe UK. Note that one sales unit has 5…
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-2705-2014·2014-10-01

    Vapotherm Precision Flow Disposable Patient Circuit Recalled for Water Leakage

    Vapotherm, Inc. is recalling 865 units of Precision Flow Disposable Patient Circuits because they may allow water to leak into the center gas lumen.

    Product
    Vapotherm Precision Flow,Disposable Patient Circuit PFHDPC-Low. For use with the Heliox Precision Flow system Precision Flow" is intended for use to add warm moisture to breathing gases from an external source for administration to a neonate/infant, pediatric and adult…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2690-2014·2014-10-01

    Justright Surgical Recalls 5mm Staplers Due to Poor Staple Formation

    Justright Surgical is recalling specific lots of JustRight 5mm Staplers because they may deliver poor distal staple formation past the end of the knife cut.

    Product
    Justright Surgical, JustRight 5mm Stapler, REF JR-ST25-2.0, Sterile, EO, Rx Only, JR-ST25-2.0 product is packaged in cases of 6. The JustRight 5mm Stapler is intended for use in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection, and creation of…
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Food)·F-2497-2014·2014-10-01

    Roots Black Bean Hummus Recalled for Missing Soy Allergen Labeling

    Roots Organic Gourmet is recalling Black Bean Hummus because the label lists Tamari but lacks a 'Contains Soy' statement.

    Product
    Roots, Black Bean Hummus, Net Wt. 8oz (227 g), and 16 oz. (454 g), Gluten-Free Vegan, UPC: 860971000030, and 723175787636, 166 W. Haywood St., Asheville, NC 2801, RootsFood.com. This product is packaged in 8 oz. and 16 oz. non-flexible plastic tubs.
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-2709-2014·2014-10-01

    Philips Brilliance CT System Recalled for Finger Squeeze Hazard

    Philips is recalling 364 Brilliance CT systems due to a gap in the tilt stand covers that can squeeze fingers during gantry movement.

    Product
    Brilliance CT System 6/10/16/16P/40 configuration. No packaging, sold as single unit. Computed tomography scanner intended to provide cross sectional images of the human body and visualization of the internal organs.
    Category
    Medical Device
    Distribution
    19 states
  • HighFDA (Food)·F-2501-2014·2014-10-01

    Blue Diamond Nut-Thins Recalled for Gluten Contamination

    Blue Diamond Growers is recalling Artisan Nut-Thins because gluten protein was detected in a product labeled gluten-free.

    Product
    Natural Blue Diamond Almonds Artisan Nut-Thins crafted with brown rice, almonds & Chia Seeds Wheat & Gluten free Net wt. 4.25 oz. Box. (120.5g) Cracker Snacks UPC: 41570 10938 Best Before Dates: AUG 06 15 and AUG 07 15 Manufactured for: Blue Diamond Growers 1802 C St.…
    Category
    Food
    Distribution
    10 states
  • HighFDA (Food)·F-2510-2014·2014-10-01

    Supreme Choice Jumbo Lump Crab Meat Recalled for Botulism Risk

    Supreme Choice Jumbo Lump Crab Meat is being recalled due to potential Clostridium botulinum toxin formation from temperature abuse.

    Product
    Supreme Choice brand Jumbo Lump, 16 oz; Premium Pasteurized Crab Meat. Product of Thailand. Distributed by Supreme Lobster and Seafood Company, Villa Park, IL 60181
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2697-2014·2014-10-01

    Argon UltraStream Hemodialysis Catheter Recall Due to Luer Cracking

    Argon Medical Devices is recalling UltraStream Chronic Hemodialysis Catheters because the red arterial luer may crack during attachment or manipulation.

    Product
    UltraStream Exchange Kit Model Numbers 32001524 (24 cm), 32001528 (28cm), 32001532 (32 cm), and 32001536 (36 cm) and 32002540 (40 cm). The Rex Medical UltraStream Chronic Hemodialysis Catheter is a chronic hemodialysis catheter that can achieve high flow rates at low arterial…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2496-2014·2014-10-01

    Roots Hot Chipotle Hummus Recalled for Missing Soy Allergen Labeling

    Roots Organic Gourmet is recalling Hot Chipotle Hummus because the label lists Tamari but fails to state 'Contains Soy.'

    Product
    Roots, Hot Chipotle Hummus, Net Wt. 8oz (227 g), and 16 oz. (454 g), Gluten-Free Vegan, UPC: 860971000054, and 723175787612, 166 W. Haywood St., Asheville, NC 2801, RootsFood.com. This product is packaged in 8 oz. and 16 oz. non-flexible plastic tubs.
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-2670-2014·2014-10-01

    Centurion Medical Products Recalls Saline Flush Syringes Due to Open Seals

    Centurion Medical Products is recalling 21,388 saline flush syringes used in convenience kits because open seals may compromise package integrity and sterility.

    Product
    0.9% Sodium Chloride Injection, USP BD PosiFlush(TM) SF Saline Flush Syringe 10 mL REF#306553 used in Centurion Convenience Kits. Recalled product is attached to the outside of the Convenience Kits.
    Category
    Medical Device
    Distribution
    20 states
  • HighFDA (Devices)·Z-2704-2014·2014-10-01

    Vapotherm Precision Flow Disposable Patient Circuit Recall for Water Leakage

    Vapotherm, Inc. is recalling 360 units of Precision Flow Disposable Patient Circuits because they allow water to leak into the center gas lumen.

    Product
    Vapotherm Precision Flow,Disposable Patient Circuit PF-E-DPC-Low. PF-DPC-Low packaged with compatible cannulas for evaluation of the Precision Flow system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2701-2014·2014-10-01

    Vapotherm Precision Flow Disposable Patient Circuit Recalled for Water Leakage

    Vapotherm, Inc. is recalling 635 units of Precision Flow Disposable Patient Circuits because they may allow water to leak into the center gas lumen.

    Product
    Vapotherm Precision Flow,Disposable Patient Circuit PFH-DPC-High. For use with the Heliox Precision Flow system Precision Flow" is intended for use to add warm moisture to breathing gases from an external source for administration to a neonate/infant, pediatric and adult…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2676-2014·2014-10-01

    Peters Surgical Recalls CARDIOFLON Evolution Sutures for Surface Splitting

    Peters Surgical is recalling 22,190 units of CARDIOFLON Evolution sutures due to a potential splitting of the surface treatment on thread ends.

    Product
    The synthetic non-absorbable surgical sutures CARDIOFLON Evolution are composed of polyester [poly(ethylene terephtalate)] braids, coated, with or without PLEDGETS of different sizes. CARDIOFLON Evolution sutures are green dyed (D&C green # 6, CI 61565) and white (undyed). Some…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2587-2014·2014-10-01

    Siemens AXIOM Artis and Artis zee Systems Recalled for X-Ray Release Issue

    Siemens is recalling AXIOM Artis and Artis zee angiography systems because a hand switch defect may cause uncontrolled x-ray release.

    Product
    AXIOM Artis or Artis zee system Product Usage: Axiom Artis and Artis zee / zeego are dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2696-2014·2014-10-01

    Argon UltraStream Hemodialysis Catheters Recalled for Luer Cracking Risk

    Argon Medical Devices is recalling UltraStream Chronic Hemodialysis Catheters because cracks may develop on the red arterial luer during use.

    Product
    UltraStream Chronic Hemodialysis Catheter Standard Kit; Model Number 32101524 (24 cm), 32101528 (28cm), 32101532 (32 cm), and 32101536 (36 cm) and 32102540 (40 cm). The Rex Medical UltraStream Chronic Hemodialysis Catheter is a chronic hemodialysis catheter that can achieve high…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2522-2014·2014-10-01

    Southern Home Mozzarella Sticks Recalled for Wheat Allergen Mislabeling

    Great American Appetizers is recalling Southern Home Mozzarella Sticks because the ingredient list includes wheat, but the 'Contains' statement omits it.

    Product
    Product is packaged in a cardboard box and labeled in part, "SOUTHERN HOME Mozzarella Sticks***CONTAINS: WHEY, MILK, EGG, SOY***DISTRIBUTED BY SOUTHERN HOME P.O.BOX 99 MAULDIN, SC 29662***" 6/case 30oz UPC 607880027150
    Category
    Food
    Distribution
    0 states