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.

12451–12475 of 53081

  • HighFDA (Devices)·Z-2174-2023·2023-07-26

    Medline Ultrasound Probe Cover Kits Recalled for Inadequate Seam Barrier

    Medline is recalling Probe Cover Kits (model DYNJ60126B) with an inadequate barrier at the seams that may compromise sterile protection during ultrasound procedures. The kits were distributed worldwide between December 2017 and May 2023.

    Product
    Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: PACK ENDO AAA HYBRID CHRG, Model Number DYNJ60126B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2170-2023·2023-07-26

    Medline Ultrasound Probe Cover Kits Recalled for Inadequate Seam Barriers

    Medline is recalling probe covers used in ultrasound procedures that may have inadequate seam barriers. No illnesses have been reported.

    Product
    Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) BREAST BIOPSY KIT, Model Number DYNDA1224B; b) U/S CORE BIOPSY KIT, Model Number DYNDH1121C; c) BIOPSY PACK, Model Number DYNDH1124; d) REVAMP BIOPSY TRAY, Model Number DYNDH1147A…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1277-2023·2023-07-26

    Fry Daddy's Jalapeno Party Mix recalled for undeclared walnut allergen

    Fry Daddy's Jalapeno Party Mix is recalled due to undeclared walnut allergen. Affected bags were sold in Michigan with sell-by dates from June 1 to December 31, 2023.

    Product
    Fry Daddy's Jalapeno Party Mix 3.75oz and 12oz bags UPCs 860007991516 and 850047648013. 12 bags per wholesale case
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2162-2023·2023-07-26

    Medline Ultrasound Probe Cover Kits Recalled for Inadequate Seam Barrier

    Medline is recalling ultrasound probe cover kits due to inadequate barrier protection at the seams, which may allow contamination during diagnostic procedures. The recall affects multiple model numbers distributed worldwide from December 2017 through May 2023.

    Product
    Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) CATH PACK, Model Number DYNJ83105; b) TESIO, Model Number DYNJ83251; c) ANGIOGRAPHY PACK-LF, Model Number DYNJ83508; d) OR ANGIOGRAM PACK-LF, Model Number DYNJ83656; e) FERRELL-DUCAN…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1285-2023·2023-07-26

    Fry Daddy's Gluten Free Party Mix recalled for undeclared walnut

    Fry Daddy's Gluten Free Super Ranch Jalapeno Party Mix is being recalled because it contains undeclared walnut. Consumers with walnut allergies should not consume the product.

    Product
    Fry Daddy's Gluten Free Super Ranch Jalapeno Party Mix 10oz bag UPC 860007669590. 12 bags per wholesale case
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2212-2023·2023-07-26

    UFSK Treatment Chair 500 XLE Seat Drive Failure Risk

    The UFSK Treatment chair 500 XLE's electrical seat drive may wear unexpectedly, causing the chair to fail to hold position while the patient is seated in an inclined position. Healthcare facilities should contact the manufacturer regarding affected units.

    Product
    UFSK Treatment chair 500 XLE- Treatment chair for positioning and support of the patient during diagnostic and therapeutic treatments of temporary to short-term duration, especially in ophthalmology Art.no. / REF no.: 15000004 Art.no. / REF no.: 15000006
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2178-2023·2023-07-26

    Medline Ultrasound Probe Covers Recalled for Inadequate Seam Barriers

    Medline is recalling 2,304 probe cover kits because the seams may not provide adequate barrier protection during ultrasound procedures. Affected kits were distributed worldwide from December 2017 to May 2023.

    Product
    Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: CATH LAB BASIN PACK, Model Number DYNJ69864A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1283-2023·2023-07-26

    Gluten-Free Cheddar Party Mix Recalled for Undeclared Walnut

    Fry Daddy's Brand recalls Gluten Free Cheddar Party Mix 10oz bags due to undeclared walnut, a major allergen. The recall affects 1,624 retail units distributed in Michigan.

    Product
    Fry Daddy's Gluten Free Cheddar Party Mix 10oz bag UPC 860007669569. 12 bags per wholesale case
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1282-2023·2023-07-26

    Food Manufacturer Recalls Gluten Free Jalapeno Party Mix Due to Undeclared Walnut

    Fry Daddy's Brand voluntarily recalled its Gluten Free Jalapeno Party Mix (10 oz, UPC 860007669552) distributed in Michigan due to undeclared walnut allergen. Affected product has sell-by dates from June 1 through December 31, 2023.

    Product
    Fry Daddy's Gluten Free Jalapeno Party Mix 10oz bag UPC 860007669552. 12 bags per wholesale case
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2207-2023·2023-07-26

    Medtronic Durepair Dura Matrix Recalled Due to Endotoxin Contamination

    Medtronic is recalling Durepair Dura Regeneration Matrix surgical implants worldwide due to potential endotoxin contamination that may cause inflammation similar to infection.

    Product
    Durepair Dura Regeneration Matrix: DUREPAIR DURA SUBSTITUTE 2 X 2, 61100; DUREPAIR DURA SUBSTITUTE 3 X 3, 61105; DUREPAIR DURA SUBSTITUTE 1 X 3, 61106; DUREPAIR DURA SUBSTITUTE 4 X 5, 61110; DUREPAIR DURA SUBSTITUTE 1 X 1, 61111; DURA 62100 SUBSTITUTE DUREPAIR 2X2IN NCE…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2194-2023·2023-07-26

    Medline Ultrasound Probe Cover Kits Recalled for Inadequate Barrier Seals

    Medline is recalling 10,080 ultrasound probe cover kits because the seams may not seal properly, potentially compromising barrier protection. The kits were distributed worldwide from December 2017 through May 2023.

    Product
    Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) VANTEX CVC BNDL, 3L 7F 16CM W MICROCLAVE, Model Number ECVC1320; b) CENTRAL VENOUS CATH INSERTION BUNDLE PI, Model Number ECVC1345A; c) TRIPLE LUMEN CVC INSERTION TRAY, Model Number…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2165-2023·2023-07-26

    Medline Ultrasound Probe Cover Kits Recalled for Inadequate Seams

    Medline Industries is recalling probe cover kits used in diagnostic ultrasound procedures due to inadequate barrier protection at the seams. Over 3.7 million units distributed worldwide from December 2017 through May 2023 are affected.

    Product
    Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) EP PACER PACK, Model Number DYNJ67770A; b) EP PROCEDURE PACK, Model Number DYNJ67771; c) EP PACK, Model Number DYNJ68019; d) GWINNETT ENDOVASCULAR WSTE MGT, Model Number DYNJ68198; e)…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2208-2023·2023-07-26

    GEM FLOW COUPLER Monitor LCD Display Fails to Show Correct Active Channel

    Baxter Healthcare is recalling the GEM FLOW COUPLER Monitor due to an LCD display error that may fail to indicate the correct active channel when powered on using battery power. This could lead to incorrect channel selection during use.

    Product
    GEM FLOW COUPLER Monitor, PN 5156-00000-011
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2200-2023·2023-07-26

    Medline Ultrasound Probe Covers Recalled for Inadequate Seam Barrier

    Medline Industries is recalling 70,648 ultrasound probe cover kits used in diagnostic and interventional procedures due to inadequate barriers at the seams.

    Product
    Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) ARTERIAL LINE START KIT , Model Number ART920; b) ULTRASOUND GUIDED PIV KIT , Model Number BSIPIV1005; c) ULTRASOUND GUIDED IV START KIT W/SHIELD , Model Number BSIPIV1006; d) PIV BSI…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2153-2023·2023-07-26

    Simplexa Direct Amplification Disc Kit recalled for potential liquid spillage

    DiaSorin Molecular is recalling the Simplexa Direct Amplification Disc Kit due to potential malfunction that could cause liquid to spill from the device.

    Product
    Simplexa Direct Amplification Disc Kit, Rx Only, IVD The Simplexa Direct Amplification Disc Kit, REF: MOL1455 is 1 box containing 3 Direct Amplification Discs (DADs). Each box contains discs individually pouch-sealed and labeled with REF: MOL1452
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2181-2023·2023-07-26

    Medline Probe Cover Kits Recalled for Inadequate Seam Barriers

    Medline is recalling probe cover kits with ultrasound gel due to inadequate barriers at the seams that may compromise sterility during diagnostic ultrasound procedures.

    Product
    Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) BLOCK SUPPLIES NDL CNTR, Model Number DYNJRA1755; b) VNUS TEST KIT CFP-LF, Model Number DYNJTESTCFP4; c) ULTRASOUND PIV BUNDLE, Model Number IV8635D; d) ULTRASOUND GUIDED PIV KIT, Model…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2161-2023·2023-07-26

    Medline Ultrasound Probe Cover Kits Recalled for Defective Seam Barriers

    Medline Industries recalls probe cover kits used in diagnostic ultrasound procedures because the covers may have inadequate barriers at the seams. Approximately 3.7 million units are affected.

    Product
    Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) ANGIOGRAPHY PACK, Model Number DYNJ55252C; b) CATH LAB PACK, Model Number DYNJ55455A; c) CATH LAB 2, Model Number DYNJ55680A; d) IR ANGIO TRAY, Model Number DYNJ56038A; e) CATH PACK…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1250-2023·2023-07-26

    Botanas Michoacanas Churritos Corn Flour Sticks Recalled for Undisclosed Sesame

    Botanas Michoacanas is recalling Churritos Corn Flour sticks due to undisclosed sesame in the product label. Sesame is present in the ingredient list but not disclosed in the Contains statement.

    Product
    Churritos Corn Flour sticks, shelf stable, 6 months shelf life, packed in a rectangular shape clear polypropylene bag with net wt.11 oz (311.845g.), UPC# 6-0972233599-7. Product labeled in part, "***BOTANAS MICHOACANS CHURRITOS CORN FLOUR STICKS***Best By:***Ingredients: Corn…
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-1290-2023·2023-07-26

    Frozen Salmon Spread Recalled for Incomplete Allergen Labeling

    Kenai Red Fish Company is recalling Frozen Wild Alaska Smoked Salmon Spread due to incomplete allergen labeling. The label does not properly declare the presence of salmon and anchovies, major fish allergens that could affect consumers with fish allergies.

    Product
    Frozen Wild Alaska Smoked Salmon Spread packaged in 6 oz. (net weight) rigid plastic tubs. Product packed in 10 units per case. Product is labeled in part, "***KENAI*RED FISH COMPANY***WILD ALASKA SMOKED SALMON SPREAD KEEP FROZEN - STIR & REFRIGERATE AFTER OPENING Ingredients…
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2213-2023·2023-07-26

    MRI Biomet Pin Guide for Knee Surgery Shipped to Wrong Patient

    Materialise N.V. is recalling MRI Biomet Pin Guides for total knee arthroplasty because the wrong patient-specific device was included in a shipment. Using an incompatible guide could affect surgical planning and implant placement.

    Product
    MRI Biomet Pin Guide for Total Knee Arthroplasty (Zimmer Biomet Patient Specific Instruments (PSI)-- patient-matched device designed to fit the patients anatomy to transfer a patient-specific pre-operative plan to the OR. Ref: KNM-ZB02-00-01
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2158-2023·2023-07-26

    Medline Ultrasound Probe Covers Recalled for Inadequate Seam Barriers

    Medline Industries is recalling approximately 23,938 units of sterile ultrasound probe cover kits distributed worldwide from December 2017 to May 2023 due to inadequate barriers at seams that could compromise sterility during diagnostic ultrasound procedures.

    Product
    Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) NERVE BLOCK ACCESSORY PACK, Model Number DYNJRA1220; b) PERI NEURO BLOCK PACK-LF, Model Number DYNJRA1773; c) PERI NEURO BLOCK PACK-LF, Model Number DYNJ51107B; d) PERI NEURO BLOCK…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1274-2023·2023-07-26

    Frozen Fruit Smoothie Blend Recalled Due to Listeria Risk

    Townsend Farms is recalling Private Selection frozen strawberry, mango, and pineapple smoothie blend due to potential Listeria monocytogenes contamination. The product was distributed across 16 states.

    Product
    Private Selection 16oz Strawberry, Mango & Pineapple Blend for Smoothie, frozen product, 10/16oz. bags per case. UPC 0 11110 87853 3. Distributed by The Kroger Co. Cincinnati, OH
    Category
    Food
    Distribution
    16 states
  • HighFDA (Devices)·Z-2182-2023·2023-07-26

    Medline Probe Cover Kits Recalled Due to Inadequate Seam Barrier

    Medline is recalling Probe Cover Kits (Models CVI4325 and DT13351A) distributed worldwide from December 2017 to May 2023. The probe covers may have inadequate barrier protection at the seams, posing a contamination risk during diagnostic ultrasound procedures.

    Product
    Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) UNIVERSAL INSERTION TRAY, Model Number CVI4325; b) PPE BUNDLE KIT, Model Number DT13351A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2191-2023·2023-07-26

    Medline Ultrasound Probe Covers Recalled for Inadequate Sterility Barriers

    Medline is recalling ultrasound probe cover kits used in diagnostic procedures because inadequate barriers at the seams may allow bacterial contamination. The recall affects 19,940 units distributed worldwide.

    Product
    Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) CRANIOTOMY CDS-1, Model Number CDS982889I; b) JOINT INJECTION TRAY, Model Number DYNDH1722; c) LOWER EXTREMITY PACK-LF, Model Number DYNJ0604434X; d) ARTHROSCOPY PACK, Model Number…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2184-2023·2023-07-26

    Medline Ultrasound Probe Covers Recalled for Inadequate Seam Barriers

    Medline Industries is recalling ultrasound probe cover kits used in invasive procedure trays due to inadequate seam barriers that may allow contamination. The recall affects 11,413 units distributed worldwide between December 2017 and May 2023.

    Product
    Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) LACERATION TRAY, Model Number DYNDL1134A; b) ULTRASOUND GUIDED IV/MIDLINE K, Model Number DYNDV2385; c) PEDIATRIC CENTRAL LINE KIT, Model Number DYNJ38885B; d) CENTRAL LINE TRAY…
    Category
    Medical Device
    Distribution
    Distributed nationwide