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.

27101–27125 of 50462

  • HighFDA (Devices)·Z-0361-2019·2018-11-07

    Inpeco FlexLab and Accelerator a3600 Recalled for Missing Safety Labels

    Inpeco S.A. is recalling 679 laboratory automation systems because some modules are missing safety pacemaker labels. The recall addresses a risk of pacemaker malfunction for personnel working near the equipment.

    Product
    FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2) (same product) FlexLab, Accelerator a3600 and Aptio Automation are modular systems designed to automate Pre- Analytical and Post-Analytical processing,
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Drugs)·D-0107-2019·2018-11-07

    Sprayology Recalls Brain Power Homeopathic Oral Spray Due to CGMP Deviations

    Sprayology is recalling Brain Power Homeopathic Oral Spray because it was manufactured under conditions that could result in possible microbial contamination.

    Product
    Brain Power,Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sprayology Gaithersburg. MD 20879. NDC 61096-0033-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighNHTSA·18V773000·2018-11-01

    Subaru Recalls 2018 Legacy and Outback for Fuel Display Software Error

    Subaru is recalling 2018 Legacy and Outback vehicles because a software error may cause the fuel gauge to display incorrect levels, increasing the risk of stalling and a crash.

    Product
    SUBARU — SUBARU OUTBACK, LEGACY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18V772000·2018-11-01

    Subaru and Scion Recall Issued for Engine Valve Spring Fracture Risk

    Subaru and Toyota are recalling specific 2012-2014 Impreza, BRZ, XV Crosstrek, and FR-S models because engine valve springs may fracture, potentially causing an engine stall that increases crash risk.

    Product
    SCION — SCION, SUBARU FR-S, BRZ, XV CROSSTREK, IMPREZA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·19027·2018-11-01

    Black & Decker Recalls Hammer Drills Due to Side Handle Injury Hazard

    Black & Decker is recalling specific hammer drills and drill drivers because the side handles can slip or break, posing an injury risk.

    Product
    Black & Decker, Bostitch and Porter-Cable Hammer Drills and Drill Drivers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·19712·2018-11-01

    Pain Relief Naturally Recalls Lidocaine Products for Child-Resistant Closure Failure

    Pain Relief Naturally is recalling lidocaine creams, sprays, and gels because the packaging failed to meet child-resistant closure requirements, posing a poisoning risk to young children.

    Product
    Numbify, Extra Strength Numbify, Pre-TAT Tattoo, Superior Pain & Itch Relief & Soothing Sore Relief creams, sprays and gels
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0257-2019·2018-10-31

    McCain Recalls Jon-Lin Sauted Green Pepper Strips Due to Listeria and Salmonella

    McCain Foods USA is recalling Jon-Lin Sauted Green Pepper Strips because finished product was released after presumptive positive tests for Listeria monocytogenes and Salmonella without confirmation.

    Product
    Saut¿ed Green Pepper Strips: Sold in 25 lb. containers. Brand Name: Jon-Lin¿
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-0326-2019·2018-10-31

    McCain Foods Recalls Fire-Roasted Red Jalapeno Slices Due to Listeria and Salmonella

    McCain Foods USA is recalling Fire-Roasted Red Jalapeno Slices because finished product was released after presumptive positive tests for Listeria monocytogenes and Salmonella.

    Product
    Fire-Roasted Red Jalapeno Slices; Sold in 2 lb. containers. Brand Name: Jon-Lin¿
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-0214-2019·2018-10-31

    Siemens APTIO Rack Output Module Recall for Missing Warning Label

    Siemens Healthcare Diagnostics is recalling 441 APTIO Rack Output Modules because they may have been shipped without a warning label regarding potential interference with pacemaker functionality.

    Product
    APTIO RACK OUTPUT MODULE
    Category
    Medical Device
    Distribution
    38 states
  • HighFDA (Food)·F-0244-2019·2018-10-31

    McCain Recalls Fire-Roasted Poblano Strips Due to Listeria and Salmonella

    McCain Foods USA is recalling Fire-Roasted Poblano Strips because finished product was released after presumptive positive tests for Listeria monocytogenes and Salmonella without confirmation.

    Product
    Fire-Roasted Poblano Strips; Sold in 20 lb. containers. Brand Name: Jon-Lin¿ NatureSmart¿
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-0325-2019·2018-10-31

    McCain Foods Recalls Fire Roasted Diced Eggplant Due to Listeria and Salmonella

    McCain Foods USA is recalling Fire Roasted 1/2" Diced Eggplant because it was released after presumptive positive tests for Listeria monocytogenes and Salmonella.

    Product
    Fire Roasted 1/2" Diced Eggplant;: Sold in 25 lb. containers. Brand Name: Jon-Lin¿
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-0276-2019·2018-10-31

    Medtronic O-arm 1000 2nd Edition Imaging System Software Recall

    Medtronic is recalling O-arm 1000 2nd Edition Imaging Systems due to software anomalies affecting startup, communication, and image acquisition.

    Product
    O-arm 1000 2nd Edition Imaging System, BASE BASE OARM Bl70000027120R SYSTEM 120V RWK, Model Number Bl70000027120R Product Usage: The O-arm Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging and is intended to be used where a physician…
    Category
    Medical Device
    Distribution
    45 states
  • HighFDA (Devices)·Z-0205-2019·2018-10-31

    ESAOTE MyLab Gamma Ultrasound System Recalled for Probe Overheating Risk

    ESAOTE S.P.A. is recalling 10 MyLab Gamma, Model 7410 ultrasound systems because probe power monitoring settings may cause the probe head to overheat during continuous operation.

    Product
    MyLab Gamma, Model 7410
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0246-2019·2018-10-31

    CHS Custom Convenience Kit-PAD recalled for compromised sterility

    Custom Healthcare Systems is recalling 160 units of CHS Custom Convenience Kit-PAD, COTTON SINGLE because incorrect sealing specifications compromised product sterility.

    Product
    CHS Custom Convenience Kit-PAD, COTTON SINGLE Product Number:R1178
    Category
    Medical Device
    Distribution
    9 states
  • HighNHTSA·18V767000·2018-10-31

    Keystone Recalls 2019 Crossroads Cruiser Trailers Due to Gas Leak Risk

    Keystone RV Company is recalling 2019 Crossroads Cruiser recreational trailers because the water heater exhaust may allow carbon monoxide or propane gas to enter the living quarters.

    Product
    CROSSROADS — CROSSROADS CRUISER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0206-2019·2018-10-31

    McCain Recalls Sautéed Diced Onions Due to Listeria and Salmonella Testing Failures

    McCain Foods USA is recalling Sautéed 3/8" Diced Onions because finished product was released after presumptive positive tests for Listeria monocytogenes and Salmonella without confirmation.

    Product
    Saut¿ed 3/8" Diced Onions; Sold in 25 lb. containers. Brand name: Jon-Lin¿, Jon-Lin¿ NatureSmart¿
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-0215-2019·2018-10-31

    McCain Recalls Fire Roasted Red Pepper Strips Due to Listeria and Salmonella

    McCain Foods USA is recalling Fire Roasted Red Pepper Strips because finished product was released after presumptive positive tests for Listeria monocytogenes and Salmonella without confirmation.

    Product
    Fire Roasted Red Pepper Strips: Sold in 20 lb. Brand Name: Jon-Lin¿
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-0210-2019·2018-10-31

    Siemens APTIO Rack Input Module Recall for Missing Pacemaker Warning

    Siemens Healthcare Diagnostics is recalling 441 APTIO Rack Input Modules because they may have been shipped without a warning label regarding potential interference with pacemaker functionality.

    Product
    APTIO RACK INPUT MODULE
    Category
    Medical Device
    Distribution
    38 states
  • HighFDA (Food)·F-0205-2019·2018-10-31

    McCain Foods Recalls Fire-Roasted Diced Red Jalapenos Due to Listeria and Salmonella

    McCain Foods USA is recalling Fire-Roasted 1/4" Diced Red Jalapenos because internal audits found products released after presumptive positive tests for Listeria monocytogenes and Salmonella.

    Product
    Fire-Roasted 1/4" Diced Red Jalapenos; Sold in 25 lb. containers Brand Name: Jon-Lin¿ NatureSmart" Brand name:
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-0272-2019·2018-10-31

    Medtronic Recalls O-arm 1000 2nd Edition Imaging Systems Due to Software Anomalies

    Medtronic is recalling 596 O-arm 1000 2nd Edition Imaging Systems worldwide due to reported software anomalies affecting startup, motion control, and image acquisition.

    Product
    O-arm 1000 2nd Edition Imaging System, OARM ASSY Bl70000027R SYS PRODUCT RWK, Model Number Bl70000027R Product Usage: The O-arm Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging and is intended to be used where a physician benefits from 2D…
    Category
    Medical Device
    Distribution
    45 states