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.

21026–21050 of 50413

  • HighFDA (Devices)·Z-1088-2021·2021-02-17

    Cardinal Health Recalls Isolation Gowns Due to Manufacturing Defects

    Cardinal Health is recalling isolation gowns and lab coats due to potential rips, holes, and foreign material that may compromise barrier protection.

    Product
    Gown Isolation W/Ties Xl Blue, SKU 2201PG Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended to provide minimal barrier protection to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0982-2021·2021-02-17

    Aomori Olympus Recalls Electrosurgical Snare Due to Seal Defects

    Aomori Olympus is recalling KD-655L electrosurgical snares because some sterile packages have inadequate seals, posing an infection risk.

    Product
    KD-655L ELECTROSURGICAL SNARE, model no. KD-655L - Product Usage: Used with endoscopes and electrosurgical units to cut tissue using high-frequency current within the upper digestive tract.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0289-2021·2021-02-17

    Publix Parmesan-Crusted Wild Alaskan Salmon Recalled for Undeclared Soy

    Ocean Beauty Seafoods LLC is recalling 845 cases of Publix Parmesan-Crusted Wild Alaskan Salmon Fillets due to undeclared soy. The product was distributed in Florida and Georgia.

    Product
    The RETAIL package is black cardboard box and product is described as: Publix Parmesan-Crusted Wild Alaskan Salmon Fillets, Frozen, net wt. 12 oz. Each retail box has 2 individually vacuum-packaged portions of 5oz salmon with 1oz of glaze of soy sauce for each portion. The…
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1056-2021·2021-02-17

    Aomori Olympus Recalls Aspiration Needles Due to Inadequate Package Seals

    Aomori Olympus is recalling NA-411D-1321 aspiration needles because inspection found some sterile packages have inadequate seals, posing an infection risk.

    Product
    NA-411D-1321 ASPIRATION NEEDLE, model no. NA-411D-1321 - Product Usage: Used with endoscopes to collect cells or tissue specimens in the respiratory organs.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0971-2021·2021-02-17

    Aomori Olympus Recalls Guide Sheath Kits Due to Seal Defects

    Aomori Olympus is recalling K-202 Guide Sheath Kits because some sterile packages have inadequate seals, posing a risk of infection if non-sterile equipment is used.

    Product
    K-202 GUIDE SHEATH Kit 2.0MM, model no. K-202 - Product Usage: Used with endoscopes to collect cells or tissue specimens in the respiratory organs.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0972-2021·2021-02-17

    Aomori Olympus Recalls K-203 Guide Sheath Kits Due to Seal Defects

    Aomori Olympus is recalling K-203 Guide Sheath Kits because some sterile packages have inadequate seals, which could allow non-sterile equipment to be used and lead to patient infection.

    Product
    K-203 GUIDE SHEATH Kit 2.6MM, model no. K-203 - Product Usage: Used with endoscopes to collect cells or tissue specimens in the respiratory organs.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1047-2021·2021-02-17

    Aomori Olympus Recalls NeedleMaster Endoscopic Injection Needles Due to Seal Defects

    Aomori Olympus is recalling NeedleMaster endoscopic injection needles because some sterile packages have inadequate seals, posing a risk of infection.

    Product
    NEEDLEMASTER 6MMx 23G LOWER, model no. NM-610U-0623 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1048-2021·2021-02-17

    Aomori Olympus Recalls Needlemaster Endoscopic Injection Needles Due to Seal Defects

    Aomori Olympus is recalling Needlemaster endoscopic injection needles because some sterile packages have inadequate seals, posing a risk of infection.

    Product
    NEEDLEMASTER 6MMx 25G LOWER, model no. NM-610U-0625 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0970-2021·2021-02-17

    Aomori Olympus Recalls K-201 Guide Sheath Kits Due to Seal Defects

    Aomori Olympus is recalling K-201 Guide Sheath Kits because some sterile packages have inadequate seals, posing an infection risk if used.

    Product
    K-201 GUIDE SHEATH Kit 2.0MM, model no. K-201 - Product Usage: Used with endoscopes to collect cells or tissue specimens in the respiratory organs.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1055-2021·2021-02-17

    Aomori Olympus Recalls Aspiration Needles Due to Seal Defects

    Aomori Olympus is recalling NA-401D-1521 aspiration needles because some sterile packages have inadequate seals, posing a risk of infection.

    Product
    NA-401D-1521 ASPIRATION NEEDLE, model no. NA-401D-1521 - Product Usage: Used with endoscopes to collect cells or tissue specimens in the respiratory organs.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0282-2021·2021-02-17

    Pero Family Farms Recalls Butternut Squash Due to Listeria Risk

    Pero Family Farms is recalling 7,111 cases of cubed butternut squash due to potential Listeria monocytogenes contamination.

    Product
    Butternut Cubed Butternut Tray, Keep Refrigerated, NET WT 13oz (368g)
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-1001-2021·2021-02-17

    Aomori Olympus Recalls ForceMax Endoscopic Injectors Due to Seal Defects

    Aomori Olympus is recalling ForceMax endoscopic injectors because some sterile packages have inadequate seals, posing an infection risk.

    Product
    INJECTOR FORCEMAX LOWER 23G 3MM, model no. NM-400U-0323 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0978-2021·2021-02-17

    Aomori Olympus Recalls KD-620UR Electrosurgical Snare Due to Seal Defects

    Aomori Olympus Co., Ltd. is recalling KD-620UR Electrosurgical Snare units because inspection found inadequate package seals, which could compromise sterility and lead to patient infection.

    Product
    KD-620UR ELECTROSURGICAL SNARE, model no. KD-620UR - Product Usage: Used with endoscopes and electrosurgical units to cut tissue using high-frequency current within the upper digestive tract.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1042-2021·2021-02-17

    Aomori Olympus Recalls NeedleMaster Endoscopic Injection Needles Due to Seal Defects

    Aomori Olympus is recalling NeedleMaster endoscopic needles because some sterile packages have inadequate seals, posing a risk of infection if non-sterile equipment is used.

    Product
    NEEDLEMASTER 4MMx 23G LOWER, model no. NM-610U-0423 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0969-2021·2021-02-17

    Aomori Olympus Recalls PR-V614M 2-Lumen Cannulas Due to Seal Defects

    Aomori Olympus is recalling PR-V614M 2-Lumen Cannulas because some sterile packages have inadequate seals, posing a risk of infection if non-sterile equipment is used.

    Product
    PR-V614M 2-LUMEN CANNULA, model no. PR-V614M - Product Usage: Used with endoscopes to inject contrast medium in the biliary or pancreatic duct.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·21080·2021-02-17

    Toro Recalls Power Max Snowthrowers Due to Amputation Hazard

    Toro is recalling about 6,700 Power Max 826 OHAE snowthrowers because the auger may fail to disengage, posing an amputation hazard.

    Product
    Toro Power Max Snowthrowers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1062-2021·2021-02-17

    Aomori Olympus Recalls ViziShot Aspiration Needles Due to Seal Defects

    Aomori Olympus is recalling ViziShot aspiration needles because some sterile packages have inadequate seals, posing a risk of infection if used.

    Product
    NA-201SX-4022-C ASPIRATION NEEDLE ViziShot 22G w/o stylet, model no. NA-201SX-4022-C - Product Usage: Used with ultrasound endoscopes for ultrasound guided fine needle aspiration of submucosal and extramural lesions of the tracheobronchial tree and esophagus.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0999-2021·2021-02-17

    Aomori Olympus Recalls ForceMax Endoscopic Injectors Due to Seal Defects

    Aomori Olympus is recalling ForceMax endoscopic injectors because some sterile packages have inadequate seals, posing an infection risk.

    Product
    INJECTOR FORCEMAX UP 2.8MMCH 23G 6MM, model no. NM-400L-0623 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1069-2021·2021-02-17

    Aomori Olympus Recalls 22G EZSHOT Aspiration Needles Due to Seal Defects

    Aomori Olympus is recalling 22G EZSHOT aspiration needles because some sterile packages have inadequate seals, posing a risk of infection if used.

    Product
    NA-200H-8022 22G EZSHOT ASPIRATION NEEDLE, model no. NA-200H-8022 - Product Usage: Used with ultrasound endoscopes for ultrasound guided fine needle aspiration of submucosal and extramural lesions of the gastrointestinal tract.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·21V079000·2021-02-17

    International LoneStar and LT battery cable defect increases crash risk

    Navistar is recalling certain 2017-2021 International LoneStar and LT vehicles because the battery ground cable may break, causing unintended engine shutdown and increasing the risk of a crash.

    Product
    INTERNATIONAL — INTERNATIONAL LT, LONESTAR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1103-2021·2021-02-17

    DePuy Universal Femoral Sleeves Recalled for Taper Dimension Issues

    DePuy Orthopaedics is recalling 60 Universal Femoral Sleeves because taper dimensions may be out of specification due to a manufacturing issue.

    Product
    Universal Femoral Sleeves - Product Usage: used primarily in revision surgeries with the S-ROM Noiles, LPS, SIGMA, and LCS Knee products.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1053-2021·2021-02-17

    Aomori Olympus Recalls Guide Sheath Kits Due to Seal Defects

    Aomori Olympus is recalling K-204 Guide Sheath Kits because some sterile packages have inadequate seals, posing a risk of infection if used.

    Product
    K-204 GUIDE SHEATH KIT 2.6MM, model no. K-204 - Product Usage: Used with endoscopes to collect cells or tissue specimens in the respiratory organs.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1058-2021·2021-02-17

    Aomori Olympus Recalls Aspiration Needles Due to Inadequate Package Seals

    Aomori Olympus is recalling NA-601D-1519 aspiration needles because some sterile packages have inadequate seals, posing a risk of infection.

    Product
    NA-601D-1519 ASPIRATION NEEDLE, model no. NA-601D-1519 - Product Usage: Used with endoscopes to collect cells or tissue specimens in the respiratory organs.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0985-2021·2021-02-17

    Aomori Olympus Electrosurgical Snare Recalled for Inadequate Package Seals

    Aomori Olympus is recalling SD-210U-15 electrosurgical snares because some sterile packages have inadequate seals, posing a risk of infection if non-sterile equipment is used.

    Product
    SD-210U-15 ELECTROSURGICAL SNARE, SD-210U-15 - Product Usage: Used with endoscopes to electrosurgically resect tissue within the digestive tract.
    Category
    Medical Device
    Distribution
    Distributed nationwide