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.

34926–34950 of 50502

  • HighFDA (Food)·F-1937-2016·2016-08-24

    Haitai Matdongsan Peanuts Crunch Snack Recalled for Unlabeled Soy

    H & E Trading Inc is recalling Haitai Matdongsan Peanuts Crunch Snack because it contains soy lecithin that was not listed on the label.

    Product
    Haitai Matdongsan Peanuts Crunch Snack, Net Wt. 11.49 oz. (325gr), Imported and Distributed by: Haitai, Inc, 7227 Telegraph Road, Montebello, CA 90640 - H & E Trading Inc, 514 Eugene Way, Wyckoff, NJ 07481, UPC 8 801019606786
    Category
    Food
    Distribution
    7 states
  • HighNHTSA·16V615000·2016-08-24

    Hyundai Recalls 2016 Sonata Vehicles Due to Driver Air Bag Defect

    Hyundai is recalling specific 2016 Sonata vehicles because the driver-side frontal air bag may not adequately protect the driver's neck in a crash.

    Product
    HYUNDAI — HYUNDAI SONATA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2552-2016·2016-08-24

    Reshape Medical Recalls ReShape Integrated Dual Balloon System Due to Assembly Error

    Reshape Medical Inc. is recalling 56 units of the ReShape Integrated Dual Balloon System because a manufacturing assembly error may cause saline leakage during inflation.

    Product
    ReShape Integrated Dual Balloon System, Gen 1, Catalog No. RSM110, Model No. 01-0013-001 The ReShape Integrated Dual Balloon System is indicated for weight reduction when used in conjunction with diet and exercise, in obese patients with a Body Mass Index (BMI) of 30 40 kg/m2…
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-2555-2016·2016-08-24

    Medtronic Recalls Valleylab Laparoscopic Argon Electrodes Due to Sterile Barrier Risk

    Medtronic is recalling 19,200 Valleylab Laparoscopic Flexible Argon Electrodes because the packaging may be compromised, potentially breaching the sterile barrier.

    Product
    Valleylab Laparoscopic Flexible Laparoscopic Argon Electrodes 3" Item Code: E25303 The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2546-2016·2016-08-24

    Medtronic EnVeo Delivery Catheter System Recalled for Vascular Trauma Risk

    Medtronic is recalling 7,319 EnVeo Delivery Catheter Systems worldwide due to a potential for vascular trauma during use.

    Product
    Medtronic EnVeo R Delivery Catheter System (DCS), Models: ENVEOR-L, ENVEOR-L-C, and ENVEOR-US. Designed to replace the native or surgical bioprosthetic aortic heart valve without open heart surgery and without concomitant surgical removal of the failed valve.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Food)·F-1916-2016·2016-08-24

    Kerry Inc. Recalls Jalapeño Breader Due to E. coli O121 Contamination Risk

    Kerry Inc. is recalling Golden Dipt Jalapeño Breader because it was made with flour potentially contaminated with E. coli O121.

    Product
    Golden Dipt¿ Jalape¿o Breader is in a white 10 pound bag with the UPC number 763089721548 and Item Number: G5620.690.
    Category
    Food
    Distribution
    9 states
  • HighFDA (Devices)·Z-2423-2016·2016-08-24

    Biomet 3i Recalls Dental Implants Due to Potential Unsealed Pouches

    Biomet 3i is recalling 1,648,273 dental implants because pouches may not have been sealed during packing, potentially compromising sterility.

    Product
    LDA Screw SBL 4mm(D) Item: SCRSBL2 Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2558-2016·2016-08-24

    Medtronic Valleylab Laparoscopic Electrode Recall for Sterile Barrier Compromise

    Medtronic is recalling Valleylab Laparoscopic Argon Modified Flat l Electrodes due to a potential sterile barrier breach.

    Product
    Valleylab Laparoscopic Argon Modified Flat l Electrode 28CM Item Code: E258128 The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2574-2016·2016-08-24

    Medtronic Valleylab Laparoscopic Electrode Recall for Sterile Barrier Compromise

    Medtronic is recalling Valleylab Laparoscopic Wire L-Hook Electrodes due to a potential sterile barrier breach. The recall covers 63,320 units distributed worldwide.

    Product
    Valleylab Laparoscopic Wire L-Hook Electrode Retractable Item Code: E2783R28ASP The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1947-2016·2016-08-24

    Codfish Fritter Mix Recalled for Undeclared Allergens

    Productos La Finca, Inc. is recalling Bacalaitos Codfish Fritter Mix in Puerto Rico due to undeclared FD&C Yellow #5, Red #40, and soy.

    Product
    Label reads in part as: "Maga***BACALAITOS CODFISH FRITTER MIX***Peso Neto/Net Weight 4.5oz (128gr)***Productos La Finca Inc.***Zona Ind. Machuchal Ave. Quilinchini #61 Sabana Grande, PR 00637"
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2570-2016·2016-08-24

    Medtronic Valleylab Laparoscopic Electrode Recall for Sterile Barrier Compromise

    Medtronic is recalling Valleylab Laparoscopic Curved Spatula Electrodes due to a potential sterile barrier breach. The recall covers lots 209358X through 60870083X distributed worldwide.

    Product
    Valleylab Laparoscopic Curved Spatula Electrode Retractable 28CM Item Code: E2781R28ASP The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2541-2016·2016-08-24

    TYRX Neuro Absorbable Antibacterial Envelope Recalled for Manufacturing Validation Issues

    TYRX Inc. is recalling 194 units of the TRYX Neuro Absorbable Antibacterial Envelope because manufacturing processes were not adequately validated.

    Product
    TRYX Neuro Absorbable Antibacterial Envelope Product Usage: Indicated for stabilization of implanted pacemakers (IPG) and/or implantable cardioverter defibrillators (ICD)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2563-2016·2016-08-24

    Medtronic Valleylab Laparoscopic Electrodes Recalled for Sterile Barrier Compromise

    Medtronic is recalling Valleylab Laparoscopic Curved Spatula Electrodes due to a potential sterile barrier breach. The recall affects 6,381 units distributed worldwide.

    Product
    Valleylab Laparoscopic Curved Spatula Electrode 45CM Item Code: E277145 The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction via a…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2565-2016·2016-08-24

    Medtronic Recalls Valleylab Laparoscopic Electrodes Due to Sterile Barrier Compromise

    Medtronic is recalling Valleylab Laparoscopic Wire J-Hook Electrodes because the packaging may be compromised, potentially breaching the sterile barrier.

    Product
    Valleylab Laparoscopic Wire J-Hook Electrode 36CM Item Code: E277336 The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction via a single…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2551-2016·2016-08-24

    Merge Unity Z3D Software Recalled for Calcium Score Inaccuracy

    Merge Healthcare is recalling Merge Unity Z3D software because it cannot accurately determine calcium scores for scans with slice thicknesses other than 3 mm.

    Product
    Merge Unity Z3D software. Merge Unity PACS (formerly DR Systems PACS) is a medical image and information management system that allows viewing, selection, processing, printing, telecommunications, and media interchange of medical images from a variety of diagnostic imaging…
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-2462-2016·2016-08-24

    Biomet 3i Recalls Drill Stop Dental Implants Due to Unsealed Pouches

    Biomet 3i is recalling Drill Stop Dental implants because pouches may not have been sealed during packing, potentially compromising sterility.

    Product
    Drill Stop Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2503-2016·2016-08-24

    Biomet 3i Recalls Twist Lock Dental Implants Due to Unsealed Pouches

    Biomet 3i is recalling Twist Lock Coping Dental implants because pouches may not have been sealed during packing, potentially compromising sterility.

    Product
    Certain Twist Lock TM Coping Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2564-2016·2016-08-24

    Medtronic Recalls Valleylab Laparoscopic Electrodes Due to Sterile Barrier Risk

    Medtronic is recalling Valleylab Laparoscopic Wire J-Hook Electrodes because the packaging may be compromised, potentially breaching the sterile barrier.

    Product
    Valleylab Laparoscopic Wire J-Hook Electrode 36CM Item Code: E277236 The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction via a…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2529-2016·2016-08-24

    Ab Sciex QTRAP 4500MD Mass Spectrometer Software Recall for Incorrect Results

    Ab Sciex is recalling 28 QTRAP 4500MD mass spectrometers because MultiQuant MD software may display incorrect quantitative results when using the Sum Multiple Ions feature.

    Product
    AB SCIEX QTRAP¿ 4500MD LC/MS/MS System Mass Spectrometer for In-Vitro Diagnostic Use. Instrument Part Number (REF): 5031231 3200MD series and 4500MD series are mass spectrometers intended to identify inorganic or organic compounds (e.g., lead, mercury, and drugs) in human…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2539-2016·2016-08-24

    TYRX Antibacterial Envelope Recalled for Unvalidated Manufacturing Processes

    TYRX Inc. is recalling 3,460 units of TRYX Antibacterial Envelopes because manufacturing processes were not adequately validated.

    Product
    TRYX Antibacterial Envelope Rx Only Product Usage: Indicated for stabilization of implanted pacemakers (IPG) and/or implantable cardioverter defibrillators (ICD)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2566-2016·2016-08-24

    Medtronic Recalls Valleylab Laparoscopic Electrodes Due to Sterile Barrier Risk

    Medtronic is recalling Valleylab Laparoscopic Wire J-Hook Electrodes because the package may be compromised, potentially breaching the sterile barrier.

    Product
    Valleylab Laparoscopic Wire J-Hook Electrode 45CM Item Code: E277345 The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction via a…
    Category
    Medical Device
    Distribution
    Distributed nationwide