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.

34176–34200 of 50502

  • HighNHTSA·16V786000·2016-10-28

    Starcraft RV Recalls 2017 AR-ONE Trailers for Incorrect Load Labels

    Starcraft RV is recalling 94 model year 2017 AR-ONE trailers because incorrect Federal Placard and Cargo Carrying Capacity labels may lead to overloading and increased crash risk.

    Product
    STARCRAFT RV TT — STARCRAFT RV TT AR-ONE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·16V785000·2016-10-27

    Jayco Recalls 2017 Jay Sport Trailers Due to Incorrect Tire Labels

    Jayco is recalling 2017 Jay Sport camping trailers because tire labels list the wrong tire size and pressure, which could lead to over-inflation and tire failure.

    Product
    JAYCO TRAVEL TRAILER — JAYCO TRAVEL TRAILER JAY SERIES SPORT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0285-2017·2016-10-26

    Windstone Medical Recalls Dr. Fritsch Surgical Kits Due to Sterility Concerns

    Windstone Medical Packaging is recalling 224 Dr. Fritsch surgical kits because the included Medtronic gloves may have splits or holes that compromise sterility.

    Product
    Dr. Fritsch Pack, Kit number AMS2696 convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0147-2017·2016-10-26

    Windstone Medical Recalls Basic Surgery Kits Due to Sterility Compromise

    Windstone Medical Packaging is recalling 6,381 Basic Pack surgery kits because Medtronic gloves inside may have splits or holes that compromise sterility.

    Product
    Basic Pack, Kit part numbers AMS1388(A, AMS1520, AMS1868, AMS1868(A, AMS1868(B, AMS2608, AMS2608(A, AMS2728, AMS2728(A, AMS2758, AMS2758(A, AMS2972, AMS4264, AMS4309, PSS1833, and PSS1848(A. convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0296-2017·2016-10-26

    Ethicon Endo-Surgery Recalls Endoscopic Articulating Linear Cutters

    Ethicon Endo-Surgery Inc is recalling 213 Endoscopic Articulating Linear Cutters because a pinion gear failure could interrupt the firing stroke and expose healthcare professionals to sharps injuries.

    Product
    Endoscopic Articulating Linear Cutter, 38ATW35. VASCULAR/THIN 35MM The ENDOPATH ETS-Flex Endoscopic Articulating Linear Cutter has application in general, gynecologic, urologic, and thoracic surgery for transection, resection, and/or creation of anastomoses
    Category
    Medical Device
    Distribution
    37 states
  • HighFDA (Devices)·Z-0191-2017·2016-10-26

    Windstone Medical Recalls Foot Pack Kits Due to Sterility Concerns

    Windstone Medical Packaging is recalling 85 Foot Pack kits because the included Medtronic gloves may contain splits or holes that compromise sterility.

    Product
    Foot Pack, Kit number AMS3637 convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0190-2017·2016-10-26

    Medtronic Disposable Gloves Recalled for Potential Sterility Compromise

    Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES are being recalled because splits or holes may compromise sterility.

    Product
    Facial Tray, Kit number PSS1558(A convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0272-2017·2016-10-26

    Windstone Medical Packaging Recalls Student Pack-NS Surgical Kits

    Windstone Medical Packaging is recalling Student Pack-NS surgical kits because the Medtronic gloves included may have splits or holes that compromise sterility.

    Product
    Student Pack-NS, Kit number PSS2788 convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0194-2017·2016-10-26

    Windstone Medical Recalls General Surgery Kits Due to Sterility Concerns

    Windstone Medical Packaging is recalling 1,596 General Pack I surgery kits because the included Medtronic gloves may contain splits or holes that compromise sterility.

    Product
    General Pack I, Kit number CMP1811(B convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0228-2017·2016-10-26

    Windstone Medical Recalls Lower Extremity Packs Due to Sterility Concerns

    Windstone Medical Packaging is recalling 582 Lower Extremity Packs because the included Medtronic gloves may contain splits or holes that compromise sterility.

    Product
    Lower Extremity Pack, Kit number AMS1375(A, AMS2540, AMS2540(A, and AMS4669. convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0143-2017·2016-10-26

    Kabobs Mini Vegetable Eggrolls Recalled for E. coli O121 Contamination

    Kabobs Inc is recalling Mini Vegetable Eggrolls because they were made with flour contaminated with E. coli O121.

    Product
    MINI VEGETABLE EGGROLL, 200 CT, Prepared by: Kabobs, 54234 North Lake Dr. Lake City, GA 30260.
    Category
    Food
    Distribution
    27 states
  • HighFDA (Devices)·Z-0189-2017·2016-10-26

    Medtronic Disposable Gloves Recalled for Sterility Compromise in Surgical Kits

    The FDA is recalling Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES found in Windstone Medical Packaging facial plastic kits because the gloves may contain splits or holes that compromise sterility.

    Product
    Facial Plastic Pack, Kit numbers AMS2533, AMS2533(A, and AMS3327 convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0135-2017·2016-10-26

    Kabobs Wild Mushroom in Phyllo Recalled Due to E. coli O121 Contamination

    Kabobs Inc is recalling Wild Mushroom in Phyllo because it was made with flour contaminated with E. coli O121.

    Product
    WILD MUSHROOM IN PHYLLO, 100 CT and 200 CT, Prepared by: Kabobs, 54234 North Lake Dr. Lake City, GA 30260.
    Category
    Food
    Distribution
    27 states
  • HighFDA (Devices)·Z-0266-2017·2016-10-26

    Medtronic Disposable Gloves Recalled for Potential Sterility Compromise

    Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES are being recalled because they may contain splits or holes that compromise sterility.

    Product
    Robotic Pack, Kit number AMS4389 convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0129-2017·2016-10-26

    Kabobs Vegetable Empanadas Recalled for E. coli O121 Contamination

    Kabobs Inc is recalling Vegetable Empanadas because they were made with flour contaminated with E. coli O121.

    Product
    VEGETABLE EMPANADA, 100 CT, Prepared by: Kabobs, 54234 North Lake Dr. Lake City, GA 30260.
    Category
    Food
    Distribution
    27 states
  • HighFDA (Devices)·Z-0262-2017·2016-10-26

    Windstone Medical Recalls Surgical Kits Due to Potential Sterility Compromise

    Windstone Medical Packaging is recalling 1,164 custom surgical kits because the disposable gloves included may contain splits or holes that compromise sterility.

    Product
    Plastic Kit, Kit number CMP1084(B convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0119-2017·2016-10-26

    Kabobs Recalls Cozy Shrimp Prepared with Contaminated Flour

    Kabobs Inc is recalling Cozy Shrimp prepared with flour contaminated with E. coli O121. The product was distributed across 27 states.

    Product
    COZY SHRIMP, 200 CT, Prepared by: Kabobs, 54234 North Lake Dr. Lake City, GA 30260.
    Category
    Food
    Distribution
    27 states
  • HighFDA (Devices)·Z-0172-2017·2016-10-26

    Medtronic Disposable Gloves Recalled for Potential Sterility Compromise

    Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES are being recalled because splits or holes may compromise sterility. The gloves are part of custom surgical kits used in hospitals.

    Product
    DND Pack, Kit number AMS3846 convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0210-2017·2016-10-26

    Medtronic Disposable Gloves Recalled for Potential Sterility Compromise

    Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES are being recalled because they may contain splits or holes that compromise sterility.

    Product
    Hystero Pack, Kit number PSS3535 convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0130-2017·2016-10-26

    Kabobs Apple Empanada Recalled Due to E. coli O121 Contaminated Flour

    Kabobs Inc is recalling Apple Empanada products because they were manufactured with flour contaminated with E. coli O121.

    Product
    APPLE EMPANADA, 100 CT, Prepared by: Kabobs, 54234 North Lake Dr. Lake City, GA 30260.
    Category
    Food
    Distribution
    27 states
  • HighFDA (Devices)·Z-0166-2017·2016-10-26

    Medtronic Disposable Gloves Recalled for Potential Sterility Compromise

    Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES are being recalled because splits or holes may compromise sterility in custom surgical kits.

    Product
    Custom Pack - with Introducer Kit, Kit number TVS4011NI(K and TVS4011NI(L convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0182-2017·2016-10-26

    Windstone Medical ENT Surgery Kits Recalled for Sterility Compromise

    Windstone Medical Packaging is recalling 1,795 ENT surgery kits because the disposable gloves included may have splits or holes that compromise sterility.

    Product
    ENT Tray, Kit number AMS1195(A convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0139-2017·2016-10-26

    Kabobs Crab Cakes Recalled Due to E. coli O121 Contamination

    Kabobs Inc is recalling crab cakes prepared with flour contaminated with E. coli O121. The product was distributed to multiple states.

    Product
    CRAB CAKES, 1.25 OZ, 112 CT, Prepared by: Kabobs, 54234 North Lake Dr. Lake City, GA 30260.
    Category
    Food
    Distribution
    27 states
  • HighFDA (Devices)·Z-0244-2017·2016-10-26

    Windstone Medical Recalls Surgical Kits Due to Potential Sterility Compromise

    Windstone Medical Packaging is recalling 360 Minor/General/Ortho Packs because Medtronic gloves inside may have splits or holes that compromise sterility.

    Product
    Minor/General/Ortho Pack, Kit number PSS3258, PSS3258(A, and PSS3258(B convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide