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.

23901–23925 of 50435

  • HighFDA (Devices)·Z-1082-2020·2020-02-12

    Centurion Infant Feeding Kit Recalled for Incomplete Sterile Package Seals

    Centurion Medical Products Corporation is recalling Infant Feeding Kits due to incomplete seals on the sterile package, which may compromise sterility.

    Product
    Centurion-Infant Feeding Kit IFK840 INFANT FEEDING KIT (8 FR X 40 IN)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1078-2020·2020-02-12

    Centurion Glass Medicine Cup Recall Due to Incomplete Sterile Seals

    Centurion Medical Products is recalling 600 sterile glass medicine cups because incomplete seals may compromise sterility.

    Product
    Centurion-Medicine Cup GMC205 GLASS MEDICINE CUP 2 OUNCE STERILE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0925-2020·2020-02-12

    Intuitive Surgical Recalls da Vinci Xi Systems Due to Defective Capacitors

    Intuitive Surgical is recalling 123 da Vinci Xi surgical systems worldwide due to potentially defective capacitors that may cause vision loss or system errors.

    Product
    da Vinci Xi Surgical System Surgical System, IS4000, 00886874114216 - Product Usage: used with an endoscope, surgical instruments, and accessories to perform minimally invasive surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0962-2020·2020-02-12

    Cook Inc. Recalls PTFE Wire Guides Due to Loading Error Risk

    Cook Inc. is recalling 3,929 PTFE Wire Guides because they may be incorrectly loaded, causing the stiff tip to be introduced into patients instead of the flexible tip.

    Product
    PTFE Wire Guide, Guidewire, Global Product Number 638813 635413-10
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1057-2020·2020-02-12

    Centurion Medical Suture Trays Recalled for Incomplete Sterile Package Seals

    Centurion Medical Products Corporation is recalling various suture and laceration trays because incomplete seals on the sterile packages may compromise sterility.

    Product
    Centurion-Suture Trays SUT10140 SUTURE TRAY SUT10290 LACERATION TRAY SUT10705 SUTURING TRAY SUT10770 DEBRIDEMENT/SUTURE SET SUT10795 PORT IMPLANT SET SUT11035 SUTURE TRAY SUT11065 LACERATION TRAY SUT1113A SUTURING SET SUT11145 SNAGFREE SUTURE SET W/SURGICAL INST.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1061-2020·2020-02-12

    Centurion Medical Products Recalls Sterile Dressing Change Kits Due to Seal Defects

    Centurion Medical Products is recalling specific sterile dressing change kits because incomplete seals may compromise sterility. The recall covers kits distributed nationwide and in Ghana.

    Product
    Centurion- DRESSING CHANGE KIT BSICVC1005A CVC DRESSING CHANGE KIT NICU BSIPICC1002A PICC DRESSING CHANGE KIT NICU BSIPICC1003A PICC DRESSING CHANGE KIT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0937-2020·2020-02-12

    B. Braun Recalls Y-Type Blood Sets Due to Leakage Risk

    B. Braun Medical is recalling 5,616 Y-Type Blood Sets because of a potential for leakage at the joint between the blood filters and tubing.

    Product
    Y-Type Blood Set, Catalog Number 490314
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0970-2020·2020-02-12

    Cook Inc. Recalls Urethral Dilation Balloon Catheters Due to Wire Guide Defect

    Cook Inc. is recalling 13,388 Urethral Dilation Balloon Catheters because the wire guide may be incorrectly loaded, potentially introducing a stiff tip into the patient.

    Product
    Urethral Dilation Balloon Catheter with Open Tip , Global Product No. G17844
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1075-2020·2020-02-12

    Centurion Suture Tray Recalled Due to Incomplete Sterile Package Seals

    Centurion Medical Products is recalling Suture Trays because incomplete seals on the sterile package may compromise sterility.

    Product
    Centurion-Suture Tray DYNDR1210A SUTURING TRAY
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0593-2020·2020-02-12

    Munk Pack Almond Butter Keto Granola Bar Recalled for Undeclared Milk

    Munk Pack Inc. is recalling Almond Butter Cocoa Chip Keto Granola Bars because they may contain undeclared milk, posing a risk to consumers with milk allergies.

    Product
    Munk Pack Almond Butter Cocoa Chip Keto Granola Bar, 4 pack, 128 g
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1073-2020·2020-02-12

    Centurion Medical Recalls LVAD Kits Due to Incomplete Sterile Seals

    Centurion Medical Products Corporation is recalling various LVAD maintenance kits because incomplete seals on the sterile packages may compromise sterility.

    Product
    Centurion-Drive Kits DM1005 DAILY LVAD MAINTENANCE KIT DM280A LVAD MANAGEMENT SYSTEM 2-7 DM320 PERCUTANEOUS LEAD MANAGEMENT KIT DM380 DAILY LVAD KIT MORRISTOWN MEDICAL DM405A ADVOCATE CHRIST DAILY WET KIT DM405A ADVOCATE CHRIST DAILY WET KIT DM525 LVAD SENSITIVE KIT…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1093-2020·2020-02-12

    Centurion PT225 Pain Management Tray Recalled for Incomplete Seals

    Centurion Medical Products Corporation is recalling 420 PT225 Pain Management Trays due to incomplete seals that may compromise sterility.

    Product
    Centurion- PT225 PAIN MANAGEMENT TRAY
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1032-2020·2020-02-12

    Cardinal Health Recalls Surgical Gowns Due to Unknown Contamination

    Cardinal Health is recalling surgical gowns because they contain unknown levels of bioburden, microbiological flora, and particulate contamination.

    Product
    GOWN SURG LG W/TOWEL ST BACK, Item Code 9515
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1079-2020·2020-02-12

    Centurion Medical Products Recalls Sterile Pitcher Kits Due to Seal Defects

    Centurion Medical Products Corporation is recalling specific sterile pitcher kits because incomplete seals may compromise sterility. The products were distributed nationwide and in Ghana.

    Product
    Centurion-Pitcher Kit GR100150ST GRADUATED PITCHER STERILE 1000 CC Y 2018121090 GR1200ST STERILE 1200CC PITCHER KIT Y 2019031990
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1047-2020·2020-02-12

    Centurion Medical Products Recalls Sterile Dressing Change Trays Due to Seal Defects

    Centurion Medical Products Corporation is recalling various sterile dressing change trays and procedure kits because incomplete seals may compromise sterility.

    Product
    Centurion- Dressing Change Tray DT10290S CENTRAL LINE PREPARATION PACK DT10290S CENTRAL LINE PREPARATION PACK DT10415 PICC INSERTION TRAY DT10495 PICC INSERTION TRAY DT10525 CENTRAL LINE INSERTION DRAPE KIT DT10675 CENTRAL LINE INSERTION PROCEDURE KIT DT10755 DRESS UP KIT…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·20T003000·2020-02-12

    Tornel A/T-09 Tires Recalled for Sidewall Separation Risk

    Tornel is recalling specific A/T-09 tires due to improper manufacturing that may cause sidewall separation, increasing the risk of tire failure and a crash.

    Product
    TIRES:SIDEWALL recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1062-2020·2020-02-12

    Centurion Medical Products Recalls Biopsy Trays Due to Incomplete Seals

    Centurion Medical Products is recalling specific biopsy trays because incomplete sterile package seals may compromise sterility.

    Product
    Centurion-BIOPSY TRAY BT205A MINOR SET UP BIOPSY TRAY BT345A HH PACK BIOPSY
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0999-2020·2020-02-12

    Roche Accu-Chek Aviva Test Strips Recalled for Dosing Issues

    Roche Diabetes Care is recalling Accu-Chek Aviva test strips because they may fail to dose, potentially delaying blood glucose results and treatment decisions.

    Product
    ACCU-CHEK AVIVA ASPAC STRIP 50CT- intended for Blood Glucose Monitoring System Catalog Number: 06453970020
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0634-2020·2020-02-12

    Golden State Foods Recalls Garlic Parmesan Sauce Due to Metal Fragments

    Golden State Foods is recalling Garlic Parmesan Sauce produced for Domino's Pizza due to potential metal fragments in a starch ingredient.

    Product
    Garlic Parmesan Sauce; DP# 4478 FG# 02620 8/16 fl. oz (4.73 ml) pouches; NET WT. 8.05 lbs (3.65 kg) Produced for Domino's Pizza Ann Arbor MI 48105
    Category
    Food
    Distribution
    19 states
  • HighFDA (Devices)·Z-1048-2020·2020-02-12

    Centurion Medical Products Recalls Sterile Surgical Trays Due to Seal Defects

    Centurion Medical Products is recalling various sterile surgical trays and packs because incomplete seals may compromise sterility.

    Product
    Centurion-_General Surgery Trays DYNDA1127A RADIOLOGY CUT DOWN TRAY #1 DYNDA1178 ICIO TRAY DYNDA1183 AUXILARY TOWEL PACK DYNDA1223 CUSTOM PREP CUP KIT DYNDA1223 CUSTOM PREP CUP KIT DYNDA1246A CIRCUMCISION PACK DYNDA1349A CIRCUMCISION TRAY DYNDA1388 STERILE EK DOUBLE PACK…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1051-2020·2020-02-12

    Centurion Circumcision Tray Kits Recalled for Incomplete Sterile Seals

    Centurion Medical Products is recalling specific Circumcision Tray Kits because incomplete seals on the sterile packaging may compromise sterility.

    Product
    Centurion- Circumcision Tray Kits DYNDF1078C CIRCUMCISION TRAY DYNDF1082 CIRCUMCISION TRAY DYNDF1082 CIRCUMCISION TRAY DYNDF1093C UNIVERSAL CIRCUMCISION TRAY W/O CLAMP DYNDF1093C UNIVERSAL CIRCUMCISION TRAY W/O CLAMP DYNDF1109 TRAY,CIRCUMCISION DYNDF1128…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1087-2020·2020-02-12

    Centurion Medical Products Recalls Dressing Trays Due to Incomplete Seals

    Centurion Medical Products Corporation is recalling specific dressing trays and medical packs because incomplete seals may compromise sterility.

    Product
    Centurion- Dressing Tray M101156A DRESSING TRAY M101167A DRESSING TRAY M101168A DRESSING TRAY M101170A MAJOR DRESSING TRAY M101170A MAJOR DRESSING TRAY M101170A MAJOR DRESSING TRAY M101170A MAJOR DRESSING TRAY M101172B MINOR CORE DRESSING TRAY M101172B MINOR CORE…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1056-2020·2020-02-12

    Centurion Medical Products Recalls Sterile Biopsy and Arthrogram Trays

    Centurion Medical Products is recalling specific sterile biopsy and arthrogram trays due to incomplete seals that may compromise sterility.

    Product
    Centurion- SPEC0002B ARTHROGRAM TRAY SPEC0002B ARTHROGRAM TRAY SPEC0004C ARTHROGRAM TRAY SPEC0071B CUSTOM BX TRAY SPEC0076G STEREO BIOPSY PACK-LF SPEC0122 BASIC BIOPSY TRAY SPEC0130B BREAST BIOPSY TRAY SPEC0158A CT BIOPSY TRAY SPEC0248B GENERAL BIOPSY TRAY- LF…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0989-2020·2020-02-12

    Ethicon Recalls VICRYL Sutures Due to Braid Fraying

    Ethicon is recalling specific VICRYL sutures because braid fraying may reduce tensile strength. The recall covers 23,688 units distributed in the US and Puerto Rico.

    Product
    Coated VICRYL (Polyglactin 910) Suture, 18" (45cm) Product Code J497H. The device is a synthetic absorbable sterile surgical suture.
    Category
    Medical Device
    Distribution
    Distributed nationwide