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.

33551–33575 of 50502

  • HighFDA (Devices)·Z-0789-2017·2016-12-28

    Smiths Medical Recalls Acuvance 2 Safety Catheters Due to Valve Defects

    Smiths Medical is recalling 26,750 Acuvance 2 Safety Catheters because some devices have missing or incorrectly positioned side port valves.

    Product
    Acuvance¿2 Safety Catheter, Product No. 1720-AI Product Usage: The Acuvance¿ 2 Safety Catheter is a Peripheral Intravenous Catheter (PIVC). PIVCs are designed for single use venipuncture on all patient populations where access to the veins and arteries are required. The…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-0771-2017·2016-12-28

    Wakefern Recalls Macadamia Nut Cookies Due to Metal Contamination Risk

    Wakefern Food Corp. is recalling specific macadamia nut cookies because they may contain metal pieces. The products were distributed in six states.

    Product
    12 pack Gourmet White Choc Chunk Macadamia Cookies Net Wt. 15 oz UPC 289783203994 Gourmet White Chocolate Macadamia Nut Cookies Net Wt. 30 oz. UPC 289770006997
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-0786-2017·2016-12-28

    AbbVie Recalls 20 FR PEG Kits Due to Disconnection Reports

    AbbVie is issuing an urgent field correction for 20 FR PEG Kits due to increased reports of tube disconnections from Y-connectors.

    Product
    AbbVie PEG Kit 20 FR
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0773-2017·2016-12-28

    AngioDynamics Recalls Stiffened Micro-Introducer Kits Due to Component Defect

    AngioDynamics is recalling 80 boxes of Stiffened Micro-Introducer Kits because a component may detach during use.

    Product
    ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 4 F Stiffened Micro-Introducer Kit, 45CM SS/T ECHO B PG, Item Number H787065970465, Catalog No.REF 06597046, 2) 4 F Stiffened Micro-Introducer Kit, 45CM SS/T ECHO S PG, Item Number H787065970485, Catalog…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0800-2017·2016-12-28

    Oscor Medical Sheath Recalled Due to Inner Liner Fragmentation

    Oscor, Inc. is recalling 22 units of the Adelante Breezeway sheath because a fragment of the inner liner detached during insertion.

    Product
    OSCOR ADELANTE BREEZEWAY 10F C55¿ S61CM D66CM Catalog # AB101072 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-0801-2017·2016-12-28

    Oscor Medical Sheath Recalled Due to Inner Liner Fragmentation

    Oscor, Inc. is recalling specific lots of the Adelante Breezeway sheath because a fragment of the inner liner detached during insertion.

    Product
    OSCOR ADELANTE BREEZEWAY 10F C70¿ S61CM D66CM Catalog # AB101073 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-0884-2017·2016-12-28

    Siemens IMMULITE PSA Assay Recalled for High-Dose Hook Effect Failure

    Siemens Healthcare Diagnostics is recalling IMMULITE PSA assays because they do not meet the high-dose hook effect expectations stated in the Instructions for Use.

    Product
    IMMULITE/IMMULITE 1000 Systems Prostate-Specific Antigen (PSA) Assay, REF/Catalog Number LKPTS1, Siemens Material Number (SMN) 10706279 (US); Catalog Number LKPS1, SMN 10380960 and Catalog Number LKPS5, SMN 10380949 (OUS); IVD --- Origin: UK Siemens Healthcare Diagnostics…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0774-2017·2016-12-28

    Wakefern Recalls Gourmet Variety Pack Cookies Due to Metal Pieces

    Wakefern Food Corp. is recalling specific varieties of gourmet cookies because they may contain metal pieces.

    Product
    12PK Gourmet Variety Pack Cookies 15 Oz.. UPC 289786203991 24 pack Variety Cookies Net Wt. 24 oz. UPC 208726004191
    Category
    Food
    Distribution
    6 states
  • HighFDA (Food)·F-0778-2017·2016-12-28

    Wakefern Take&Bake Oatmeal Raisin Cookies Recalled for Metal Pieces

    Wakefern Food Corp. is recalling 24-count Take&Bake Oatmeal Raisin Cookies because they may contain metal pieces. The product was distributed in six states.

    Product
    24CT Take&Bake Oatmeal Rasin Cookies Net Wt. 24oz UPC 20873004194
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-0890-2017·2016-12-28

    Medtronic Recalls Clearify Visualization Systems Due to Sterility Compromise

    Medtronic is recalling 230 Clearify Visualization Systems because the sterile barrier was breached, compromising product sterility. The recall covers worldwide distribution.

    Product
    Best Practices kits containing certain production lots of Clearify Visualization System Item Code: 21-345 Intended to be used prior to and during endoscopic and laparoscopic procedures to prevent fogging of the scope as well as clean the scope lens
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0806-2017·2016-12-28

    Crescent Vending Recalls Hot Sicilian Sandwiches for Undeclared Allergens

    Crescent Vending Co. Inc. is recalling Hot Sicilian sandwiches due to undeclared wheat, soy, and milk allergens.

    Product
    Hot Sicilian- Ham, Pepperoni and Provolone Cheese wrapped in clear film, 5 oz. Undeclared allergens - Wheat, Soy( oil flour), Milk
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-0798-2017·2016-12-28

    Crescent Vending Recalls Ham and Cheese Sandwiches for Undeclared Allergens

    Crescent Vending Co. Inc. is recalling 19 ham and cheese sandwiches distributed in Pennsylvania because they contain undeclared wheat, soy, and milk.

    Product
    Ham and Cheese on Club wrapped in clear film, 5 oz. Undeclared allergens - Wheat, Soy (oil, lecithin), Milk
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-0808-2017·2016-12-28

    Crescent Vending Hot Dog Sandwiches Recalled for Undeclared Allergens

    Crescent Vending Co. Inc. is recalling 18 hot dog sandwiches for failing to declare wheat, soy, and milk allergens.

    Product
    1/4 1b. Hot Dog with Cheese wrapped in clear film, 6 oz. Undeclared allergens - Wheat, Soy(oil, lecithin) Milk
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-0802-2017·2016-12-28

    Crescent Vending Recalls Sandwiches with Undeclared Allergens

    Crescent Vending Co. Inc. is recalling 13 meatball sandwiches for failing to declare wheat, soy, and milk allergens.

    Product
    Meatball on an Italian Roll with Cole Slaw wrapped in clear film, 8 oz. Undeclared allergens - Wheat, Soy (oil, flour), Milk, Egg
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-0795-2017·2016-12-28

    Oscor Medical Sheath Recall Due to Inner Liner Fragmentation

    Oscor, Inc. is recalling 76 units of the Adelante Breezeway sheath because a fragment of the inner liner detached during insertion.

    Product
    OSCOR ADELANTE BREEZEWAY 8F C70¿ S79CM D84CM Catalog # AB081045 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Food)·F-0758-2017·2016-12-28

    Real Fudge Dark Chocolate Fudge Recalled for Undeclared Blue 1 Dye

    Real Fudge is recalling Dark Chocolate Fudge in 8, 16, and 24 oz containers due to undeclared Blue 1 dye. The product was distributed in five states.

    Product
    Dark Chocolate Fudge, brand Real Fudge. Product is sold in clear plastic deli container in 8, 16, and 24 oz.
    Category
    Food
    Distribution
    5 states
  • HighFDA (Food)·F-0809-2017·2016-12-28

    Crescent Vending Recalls Salisbury Steak Sandwiches for Undeclared Allergens

    Crescent Vending Co. Inc. is recalling 8-ounce Salisbury Steak sandwiches with gravy and whipped potatoes because they contain undeclared wheat, soy, and milk.

    Product
    Salisbury Steak with Gravy on Kaiser with whipped potatoes wrapped in clear film, 8 oz. Undeclared allergens - Wheat, Soy (oil, flour), Milk
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-0809-2017·2016-12-28

    Oscor Medical Sheath Recall Due to Inner Liner Fragmentation

    Oscor, Inc. is recalling 20 units of the Adelante Breezeway sheath because a fragment of the inner liner detached during insertion.

    Product
    OSCOR ADELANTE BREEZEWAY 10F STRAIGHT S61CM D66CM Catalog # AB10218 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-0778-2017·2016-12-28

    AngioDynamics Recalls Stiffened Micro-Introducer Kits Due to Detachment Risk

    AngioDynamics is recalling 4F Stiffened Micro-Introducer Kits because the sheath/dilator components may have a rotating luer that detaches from the hub during use.

    Product
    ANGIODYNAMICS 4F Stiffened Micro-Introducer, Item Number H787065971035, Catalog No.REF 06597103 Indicated for percutaneous introduction of guidewire or catheter into the vascular system following a small 21-gauge needle stick
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0790-2017·2016-12-28

    Oscor Medical Sheath Recall Due to Inner Liner Fragmentation

    Oscor, Inc. is recalling 156 units of the Adelante Breezeway sheath because a fragment of the inner liner detached during insertion.

    Product
    OSCOR ADELANTE BREEZEWAY 8F C55¿ S61CM D66CM Catalog # AB081040 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-0807-2017·2016-12-28

    Oscor Medical Sheath Recalled Due to Inner Liner Fragmentation

    Oscor, Inc. is recalling 34 units of the Adelante Breezeway 10F Straight sheath because a fragment of the inner liner detached during insertion.

    Product
    OSCOR ADELANTE BREEZEWAY 10F STRAIGHT S61CM D66CM Catalog # AB101218 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-0793-2017·2016-12-28

    Oscor Medical Sheath Recalled Due to Inner Liner Fragmentation During Insertion

    Oscor, Inc. is recalling 21 units of the Adelante Breezeway 8F sheath because a fragment of the inner liner detached during insertion. The product is distributed worldwide.

    Product
    OSCOR ADELANTE BREEZEWAY 8F C120¿ S61CM D66CM Catalog # AB081043 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.
    Category
    Medical Device
    Distribution
    8 states