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.

23101–23125 of 50433

  • HighFDA (Devices)·Z-2051-2020·2020-05-27

    Cardinal Health Recalls Strep B Carrot Broth Due to Temperature Abuse

    Cardinal Health is recalling Strep B Carrot Broth One-Step tubes because they were stored outside approved temperature ranges, which may lead to patient misdiagnosis.

    Product
    Strep B Carrot Broth One-Step, 16x100mm Tube, 6ml, Item code Z46BX - Product Usage: Intended to detect Group B Streptococcus (GBS) from anovaginal specimen collected from pregnant women. If pregnant woman is positive for GBS colonization, this will indicate a need for treatment…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·20V308000·2020-05-27

    Thor Motor Coach Recalls 2020 Motorhomes Due to Manual Error

    Thor Motor Coach is recalling 566 2020 motorhomes because the owner's manual incorrectly describes the automatic parking function, which could lead to vehicle rollaway.

    Product
    THOR MOTOR COACH — THOR MOTOR COACH, THOR SIESTA, SYNERGY, GEMINI, DELANO
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20V301000·2020-05-26

    Altec Recalls Aerial Devices With Incorrect Tow Hitch Load Ratings

    Altec is recalling 2014-2020 Aerial Devices with Class 3 towing hitches that may have incorrect load ratings or damage from overloading, increasing crash risk.

    Product
    ALTEC — ALTEC AERIAL DEVICE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20V302000·2020-05-26

    2020-2021 Keystone Cougar travel trailer cooktop fire hazard

    Keystone is recalling 2020-2021 Cougar travel trailers because the cooktop may not be properly sealed from the furnace, causing burner flames to invert and increasing fire risk. Dealers will inspect and seal it free of charge.

    Product
    KEYSTONE — KEYSTONE COUGAR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20V298000·2020-05-22

    Mercedes-Benz Recalls 2012 C-Class Vehicles for Incorrect Air Bag Replacement

    Mercedes-Benz is recalling 2012 C-Class vehicles where an incorrect front passenger air bag may have been installed during a prior recall, potentially reducing crash protection.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ AMG C63, C250, C300, C350
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20V297000·2020-05-22

    2020-2021 Forest River Surveyor Travel Trailers Safety Chain Recall

    Forest River is recalling 2020-2021 Surveyor travel trailers because the safety chains are insufficient for the trailer's weight rating and may break if the trailer becomes unhitched, risking complete detachment.

    Product
    FOREST RIVER — FOREST RIVER SURVEYOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20V299000·2020-05-22

    Triple E Recalls 2020 Unity Travel Trailers Due to Latch Defect

    Triple E is recalling 2020 Unity travel trailers because a latch may lock, blocking access to the propane shutoff valve and increasing fire risk.

    Product
    TRIPLE E — TRIPLE E UNITY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20V295000·2020-05-21

    2021 Chevrolet Trailblazer lacks tire size and pressure label information

    General Motors is recalling certain 2021 Chevrolet Trailblazer vehicles with optional sport terrain tires because their certification labels do not show tire size and cold tire pressure information required by federal safety standards.

    Product
    CHEVROLET — CHEVROLET TRAILBLAZER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·20746·2020-05-21

    Viva Doria Recalls Wintergreen Essential Oil Due to Packaging Defect

    Viva Doria is recalling Wintergreen Essential Oil because the packaging is not child-resistant, posing a risk of poisoning if swallowed by young children.

    Product
    Viva Doria Wintergreen Essential Oil
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·20747·2020-05-21

    Herman Miller and Design Within Reach Recall Dressers and Cabinets for Tip-Over Hazards

    Herman Miller and Design Within Reach are recalling Nelson and Lauki dressers and cabinets because they can tip over and entrap children. Consumers should stop using unanchored units and contact the company for a refund.

    Product
    Nelson and Lauki Dressers and Cabinets
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1974-2020·2020-05-20

    Access Scientific Recalls Saline Flush Syringes Due to Packaging Holes

    Access Scientific LLC is recalling 7,395 saline flush syringes used in POWERWAND kits because holes in the packaging compromised sterility.

    Product
    BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 4Fr 8cm Quick Kit. REF/UDI / 94104/10859821006169 - Product Usage: is used to gain access to the vascular system to sample blood and administer fluids intravenously. It may be used for power injection of contrast…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2004-2020·2020-05-20

    Inpeco Abbott Accelerator a3600 Interface Module Recalled for Cross-Contamination Risk

    Inpeco S.A. is recalling 273 Abbott Accelerator a3600 Interface Modules because a timeout error could cause sample cross-contamination.

    Product
    Abbott Accelerator a3600, ARCHITECT cSystem c8000/c16000 Interface Module, Part Numbers: ACP-208-00 - Product Usage: The FlexLab (aka Accelerator a3600) is a modular system designed to automate Pre-Analytical and Post-Analytical processing, sample handling in order to automate…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1929-2020·2020-05-20

    Encore Medical Recalls EMPOWR Acetabular Impactor Balls Due to Fracturing

    Encore Medical is recalling 86 units of EMPOWR Acetabular Impactor Balls because they may fracture during use, potentially leaving debris in the joint space.

    Product
    EMPOWR Acetabular System, Non-Sterile, Model Numbers 803-15-023 803-15-026 803-15-027 803-15-028 803-15-029 803-15-030 Product Usage: The EMPOWR Acetabular Impactor Balls is intended for use in joint replacement in patients suffering from disability due to…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·20125·2020-05-20

    Bunz Kidz Children's Sleepwear Sets Recalled for Burn Hazard

    Stargate Apparel is recalling Bunz Kidz children's sleepwear sets because they fail to meet federal flammability standards, posing a risk of burn injuries.

    Product
    Bunz Kidz Children's Sleepwear Sets
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1950-2020·2020-05-20

    Cardiac Assist Recalls 15 TandemHeart Pumps Due to Assembly Error

    Cardiac Assist, Inc. is recalling 15 TandemHeart pump kits due to an assembly error that may prevent the device from priming.

    Product
    TandemHeart pump is assembled into kits: TandemHeart Kit - TS62/A17, Product: 5710-6217 - Product Usage: provides temporary extracorporeal circulatory system support with the unique ability to locally deliver an anticoagulant through the infusion system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1938-2020·2020-05-20

    Argon Medical Devices Recalls PAC Tray Catheter Introducer Kits

    Argon Medical Devices is recalling 80 PAC Tray/5 Catheter Introducer Trays due to incorrect needle and suture components that may increase the risk of needle sticks.

    Product
    PAC Tray/5 Catheter Introducer Tray 8F, Model 497424, Rx Only, STERILE EO, UDI: 00886333214440 - Product Usage: The introducers are indicated for use in arterial and venous procedures requiring percutaneous introduction of intravascular devices. Curved tip Introducer allows for…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1934-2020·2020-05-20

    CuattroDR System Software Recalled for Potential Image Misattribution

    Cuattro LLC is recalling CuattroDR System Software because images from previous patient studies may appear in later studies, potentially leading to misdiagnosis.

    Product
    CuattroDR System Software, REF: SWR-00069-MD, UDI: B269SWR00069MD0
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-1969-2020·2020-05-20

    BD Alaris PCEA Administration Set Recalled for Potential Leaking

    BD is recalling Alaris PCEA Administration Sets because they may leak at the luer connection, potentially causing inadequate pain control.

    Product
    BD Alaris PCEA Administration Set, Microbore Tubing with Yellow Identification Stripe ASV, Catalog Number 30893-04 (OUS Only) - Product Usage: Microbore Tubing with Yellow Identification Stripe Anti-siphon Valve Use Aseptic Technique Set cannot be used for gravity infusion. 1.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1959-2020·2020-05-20

    Siemens Cios Spin Mobile X-Ray System Recalled for Electrical Shock Risk

    Siemens is recalling 46 Cios Spin mobile X-ray systems because unplugging the main cable during a clinical session can expose users to unsafe electrical voltage.

    Product
    Siemens Cios Spin VA30-mobile X-Ray system, Material # 10308194 - Product Usage: The Cios Alpha and Cios Spin are a mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1965-2020·2020-05-20

    Magstim Horizon PSU Stim Interconnecting Cable Recalled for Potential Failure

    The Magstim Company Limited is recalling 71 Horizon PSU Stim Interconnecting Cables because the high-voltage cable may fail. The device is used for treating Major Depressive Disorder.

    Product
    Horizon PSU Stim Interconnecting Cable - Product Usage: Horizon is indicated for the treatment of Major Depressive Disorder in adult patients who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1955-2020·2020-05-20

    Cardiac Assist Recalls 13 TandemLife Kits Due to Assembly Error

    Cardiac Assist, Inc. is recalling 13 TandemLife Kits because an assembly error may prevent the pump from priming. The kits provide temporary circulatory support.

    Product
    TandemHeart pump is assembled into kits: TandemLife Kit Product: 5740-0000 - Product Usage: provides temporary extracorporeal circulatory system support with the unique ability to locally deliver an anticoagulant through the infusion system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1977-2020·2020-05-20

    Access Scientific Recalls Saline Flush Syringes Due to Packaging Holes

    Access Scientific LLC is recalling 2,055 saline flush syringes because holes in the packaging compromised their sterility.

    Product
    BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 4Fr 10cm Max Barrier Kit. REF/UDI / 94107/10859821006206 - Product Usage: is used to gain access to the vascular system to sample blood and administer fluids intravenously. It may be used for power injection of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·20V285000·2020-05-20

    Navistar Recalls 2019-2020 International CV Vehicles Due to ABS Software Error

    Navistar is recalling 2019-2020 International CV vehicles because a software error may prevent the ABS warning light from illuminating, potentially leaving drivers unaware of system failures.

    Product
    INTERNATIONAL — INTERNATIONAL CV
    Category
    Vehicle
    Distribution
    Distributed nationwide