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.

23801–23825 of 50435

  • HighCPSC·20073·2020-02-13

    Textron Recalls Gas-Powered Off-Road Vehicles Due to Fire Hazard

    Textron Specialized Vehicles is recalling approximately 20,573 gas-powered E-Z-GO, Cushman, and Tracker off-road vehicles because a starter generator wire can contact the exhaust, posing a fire hazard.

    Product
    Gas-powered E-Z-GO, Cushman and Tracker brand off-road vehicles
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0991-2020·2020-02-12

    Cardinal Health Genius 3 Tympanic Thermometer Recalled for Accuracy Drift

    Cardinal Health is recalling Genius 3 tympanic thermometers because readings may drift upward over time, potentially exceeding the stated accuracy range.

    Product
    Genius 3 Tympanic Thermometer- electric thermometer Item Code: 303013
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0963-2020·2020-02-12

    Cook Inc. Recalls Roadrunner Hydrophilic PC Wire Guides Due to Loading Error

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

    Product
    Roadrunner Hydrophilic PC Wire Guide, Guidewire, Global Product Number G18629, G17866
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0933-2020·2020-02-12

    Datascope Recalls Reinforced Introducer Sets Due to Sterility Concerns

    Datascope is recalling specific lots of Reinforced Introducer Sets because breached pouches may have compromised sterility.

    Product
    Reinforced Introducer Sets Maquet 7.5 Fr., Part Number: 068400040305. It is an accessory to be used for percutaneous insertion of MAQUET IntraAortic Balloon Catheters.
    Category
    Medical Device
    Distribution
    36 states
  • HighFDA (Drugs)·D-0828-2020·2020-02-12

    Ascend Recalls Olmesartan Medoxomil Tablets Due to cGMP Deviations

    Ascend Laboratories is recalling 192 bottles of Olmesartan Medoxomil 20 mg tablets because they were released in error with an alternate API source before approval.

    Product
    OLMESARTAN MEDOXOMIL — OLMESARTAN MEDOXOMIL (OLMESARTAN MEDOXOMIL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0936-2020·2020-02-12

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

    B. Braun Medical is recalling 1,050 Y-Type Blood Sets because they may leak at the joint between the blood filters and tubing.

    Product
    Y-Type Blood Set, Catalog Number 490293
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0966-2020·2020-02-12

    Cook Inc. Recalls Angled Tip Ureteral Catheter Sets Due to Loading Error

    Cook Inc. is recalling 13,388 Angled Tip Ureteral Catheter Sets because the wire guide may load incorrectly, causing the stiff tip to enter the patient instead of the flexible tip.

    Product
    Angled Tip Ureteral Catheter Set with Bentson PTFE Wire Guide, Ureteral Catheter, Global Product No. G19108 G14587 G15302 G14326
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0973-2020·2020-02-12

    Cook Inc. Recalls C-Flex Double Pigtail Ureteral Stent Sets

    Cook Inc. is recalling C-Flex Double Pigtail Ureteral Stent Sets because the wire guide may be incorrectly loaded, causing the stiff tip to be introduced into the patient instead of the flexible tip.

    Product
    C-Flex Double Pigtail Ureteral Stent Set, Global Product No. G14364 G14365 G14367
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1067-2020·2020-02-12

    Centurion Medical Products Recalls Sterile Pathology Containers Due to Seal Defects

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

    Product
    Centurion- Pathology Container 1150ST STERILE GRADUATED CONTAINER, 32 OZ. 17070 AI OR CARDIAC STERILE KIT 3703ST STERILE PATHOLOGY CONTAINER 3706ST STERILE CONTAINER 165 OZ.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1088-2020·2020-02-12

    Centurion OR2020 Basin Set Recalled for Incomplete Sterile Seals

    Centurion Medical Products is recalling 188 units of the OR2020 Basin Set because incomplete seals may compromise sterility.

    Product
    Centurion- OR2020 BASIN SET
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1044-2020·2020-02-12

    Centurion Neonatal PICC Trays Recalled for Incomplete Sterile Package Seals

    Centurion Medical Products is recalling 957 Neonatal PICC Trays due to incomplete seals that may compromise sterility. The units were distributed nationwide and to Ghana.

    Product
    Centurion Neonatal PICC Tray: CVI2310 NEONATAL PICC INSERTION TRAY CVI2550 NEONATAL PICC INSERTION TRAY CVI2550 NEONATAL PICC INSERTION TRAY CVI2550 NEONATAL PICC INSERTION TRAY CVI2550 NEONATAL PICC INSERTION TRAY CVI3650 PEDS PICC INSERTION TRAY CVI3730 NEONATAL PICC…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1060-2020·2020-02-12

    Centurion Blood Culture Collection Kit Recalled for Incomplete Seals

    Centurion Medical Products Corporation is recalling blood culture collection kits due to incomplete seals that may compromise sterility.

    Product
    Centurion-BLOOD CULTURE COLLECTION KIT BP115 BLOOD CULTURE COLLECTION KIT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1049-2020·2020-02-12

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

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

    Product
    Centurion- Dressing Change Kits DYNDC1182B PICC INSERTION TRAY DYNDC1251D CENTRAL LINE TRAY DYNDC1251D CENTRAL LINE TRAY DYNDC1586C CENTRAL LINE DRESSING NGE TRAY DYNDC1597A CVC DRESSING CHANGE TRAY DYNDC1796C TRAY, CENTRAL LINE DYNDC1796C TRAY, CENTRAL LINE DYNDC1800…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1072-2020·2020-02-12

    Centurion Vaginal Speculums Recalled Due to Incomplete Sterile Package Seals

    Centurion Medical Products is recalling sterile vaginal speculums because incomplete seals may compromise sterility. The recall covers 1,100 units distributed nationwide and in Ghana.

    Product
    Centurion-Vaginal Speculum VS2000LST STERILE ER VAGINAL SPECULUM W/LIGHT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1010-2020·2020-02-12

    Cardinal Health Recalls Surgical Gowns Due to Unknown Contamination Levels

    Cardinal Health is recalling AAMI 3 Royalsilk Surgical Gowns because they contain unknown levels of bioburden, microbiological flora, and particulate contamination.

    Product
    AAMI 3 ROYALSILK SCRBNURGOWN BNS XL, Gown. Item Code 90380NC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0967-2020·2020-02-12

    Cook Inc. Recalls Percutaneous Entry Sets Due to Wire Guide Loading Error

    Cook Inc. is recalling 13,388 Percutaneous Entry Sets because the wire guide may be incorrectly loaded, causing the stiff tip to be introduced into the patient instead of the flexible tip.

    Product
    Percutaneous Entry Set, Nephrostomy Catheter, Global Product No. G14649
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1026-2020·2020-02-12

    Cardinal Health Recalls Surgical Gowns Due to Unknown Contamination

    Cardinal Health is recalling AAMI 3 Fabric Reinforced Surgical Gowns because they contain unknown levels of bioburden, microbiological flora, and particulate contamination.

    Product
    AAMI 3 FABRIC REINF SURG GOWN 2XL, Item Code 9571
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0964-2020·2020-02-12

    Cook Inc. Recalls Wire Guide Due to Incorrect Loading Risk

    Cook Inc. is recalling 13,388 Wire Guide units because they may be incorrectly loaded, causing the stiff tip to be introduced into patients instead of the flexible tip.

    Product
    Wire Guide, Guidewire, Global Product Number G14326
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1071-2020·2020-02-12

    Centurion Driveline System Kit Recalled for Incomplete Sterile Package Seals

    Centurion Medical Products is recalling 100 units of the Driveline System Kit because incomplete seals may compromise sterility.

    Product
    Centurion- Driveline System Kit TRIDM250 OUTPATIENT DRIVELINE MGMT SYSTEM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0972-2020·2020-02-12

    Cook Inc. Recalls Bander Ureteral Diversion Open-End Stent Sets

    Cook Inc. is recalling Bander Ureteral Diversion Open-End Stent Sets because the wire guide may be incorrectly loaded, causing the stiff tip to be introduced into the patient instead of the flexible tip.

    Product
    Bander Ureteral Diversion Open-End Stent Set, Global Product No. G14822 G14823
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1043-2020·2020-02-12

    Centurion Chest Tube Trays Recalled for Incomplete Package Seals

    Centurion Medical Products is recalling 448 chest tube trays because incomplete seals may compromise sterility.

    Product
    Centurion Chest Tube Trays: Kit Code Product CHT1170 CHEST TUBE TRAY CHT1700 CHEST TUBE INSERTION TRAY CHT1760 CHEST TRAY CHT275 CHEST TUBE INSERTION TRAY CHT440 CHEST TUBE INSERTION TRAY CHT701 CHEST TUBE INSERTION TRAY CHT760 CHEST TUBE…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1018-2020·2020-02-12

    Cardinal Health Recalls AAMI 3 Surgical Gowns Due to Contamination

    Cardinal Health is recalling AAMI 3 Nonreinforced Surgical Gowns because they contain unknown levels of bioburden, microbiological flora, and particulate contamination.

    Product
    AAMI 3 NONREIN SURG GOWN L BNS, Item Code 9515NB
    Category
    Medical Device
    Distribution
    Distributed nationwide