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.

201–225 of 52881

  • HighFDA (Devices)·Z-2887-2026·2026-08-12

    HardyDisk AST Cefiderocol 30µg for In Vitro Testing Recalled Due to Incorrect Cartridges

    Hardy Diagnostics is recalling HardyDisk AST Cefiderocol 30µg (Lot 543461) because incorrect cartridges may cause inaccurate susceptibility testing results.

    Product
    HardyDisk AST Cefiderocol 30¿g (FDC30) REF Z9435 HardyDisk AST Cefiderocol 30¿g (FDC30) for in vitro agar diffusion susceptibility testing is indicated when there is the need to determine the susceptibility of Enterobacterales, Pseudomonas aeruginosa, Acinetobacter baumannii
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2898-2026·2026-08-12

    United Orthopedic Recalls U2 Total Knee System Femoral Offset Bushings

    United Orthopedic Corp. is recalling U2 Total Knee System femoral offset bushings due to incorrect engraved numbering that could cause incorrect implant orientation.

    Product
    Brand Name: U2 Total Knee System Product Name: Femoral offset bushing, 2mm and 6mm Model/Catalog Number: 9323-5312 Software Version: N/A Product Description: Manual Orthopedic Surgical Instrument Component: No, N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·26E056000·2026-08-12

    Odyne Recalls Hybrid Systems Due to Traction Battery Fire Risk

    Odyne Systems is recalling certain hybrid systems with specific part numbers because the high-voltage batteries may fail, increasing the risk of a fire.

    Product
    ELECTRICAL SYSTEM:PROPULSION SYSTEM:TRACTION BATTERY recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2859-2026·2026-08-12

    Anti-Torque Instrument in Vector Pedicle Screw System Recalled

    Innovasis, Inc is recalling 5 Anti-Torque instruments (part LS-749) in the Vector Pedicle Screw System due to an undersized condition that may prevent proper engagement during spinal surgery, causing delays.

    Product
    Anti-Torque, Vector, Part: LS-749 part of Vector Pedicle Screw System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2848-2026·2026-08-12

    Quantum Rehab Q6 Edge 2.0 Wheelchair Recall Due to Safety Risks

    The FDA is recalling the Quantum Rehab Q6 Edge 2.0 powered wheelchair because its controller may cause unexpected braking or system crashes that could lead to falls and injuries.

    Product
    Brand Name: Quantum Rehab Product Name: Q6 Edge 2.0 (ilevel) Model/Catalog Number: Q6 Edge 2.0 (ilevel) Software Version: 2.0.11, new version: 2.0.13 Product Description: Wheelchair, Powered (ITI), 890.3860 Component: Controller
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-1198-2026·2026-08-12

    Frozen Flounder Sashimi with Sauce Recalled Due to Undeclared Allergens

    Eunha Fisheries Co., LTD is recalling Frozen Flounder Sashimi with Sauce because it contains undeclared wheat, soy, sesame, Yellow #5, and Blue #1.

    Product
    FLOUNDER SASHIMI WITH SAUCE; Keep Frozen; Net WT: 300g; UPC: 8 809342 366186
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·H-1220-2026·2026-08-12

    Requeson Cheese Recalled for Possible Listeria Contamination

    La Colonia Foods LLC is recalling 19 units of Requeson cheese packed in 18-lb buckets due to possible contamination with Listeria monocytogenes. The product was distributed to MD and VA.

    Product
    Requeson, bulk product from Clover Hill Dairy packed into a plastic 18-lb bucket. Unknown labeling information. Keep refrigerated.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-2866-2026·2026-08-12

    Stryker Strykeflow Suction/Irrigator PS Recalled for Leaking During Use

    Stryker is recalling Strykeflow Suction/Irrigator PS devices due to reports of leaking from the handpiece during use.

    Product
    STRYKER PKG., STRYKEFLOW SUCTION/IRRIGATOR PS, Catalog Number 0250070540
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-1195-2026·2026-08-12

    Big Way Hot Pot Miso Paste Recalled Due to Undeclared Milk

    Big Way Ca Inc is recalling Big Way Hot Pot Miso Paste because it contains undeclared milk from lactose.

    Product
    Big Way Hot Pot "Hot Pot Miso Paste"; 1kg (35.3oz) unit package. Product is packaged in generic bulk packaging.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-2863-2026·2026-08-12

    Stryker Ahto Tube Set Recalled for Handpiece Leaking During Use

    Stryker is recalling 41,052 Ahto Tube Sets worldwide due to reports of handpiece leaking during use.

    Product
    STRYKER AHTO TUBE SET WITH TIP PACKAGING, Catalog Number 0250070620
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2853-2026·2026-08-12

    Quantum Rival Powered Wheelchair Controller Recall for Brake Stop Hazard

    Pride Mobility Products Corp. is recalling 1,102 Quantum Rival powered wheelchair controllers due to a software issue that can cause unexpected brake stops while driving, potentially resulting in falls or injuries.

    Product
    Brand Name: Quantum Rehab Product Name: Quantum Rival Model/Catalog Number: Quantum Rival Software Version: 2.0.11, new version: 2.0.13 Product Description: Wheelchair, Powered (ITI), 890.3860 Component: Controller
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2869-2026·2026-08-12

    Intramedullary Bone Saw Blade Assemblies Recalled Due to Potential Packaging Damage

    Biomet, Inc. is recalling various sizes of Intramedullary Bone Saw Blade Assemblies because an exposed saw blade may have damaged the sterile barrier packaging.

    Product
    Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475630 Product Description: Intramedullary Bone Saw Blade Assembly 14mm
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·H-1221-2026·2026-08-12

    Korean Soybean Paste Recalled for Undeclared Fish Allergen

    JINA F&C is recalling 4,153 units of Wangshin Doenjang soybean paste because the label does not list anchovy (fish) as an ingredient, posing an allergen risk to consumers with fish allergies.

    Product
    Ultimate Mother's Day Wangshin Doenjang Aged 3 Years 9 oz. Korean Traditional Premium Soybean Paste UPC: 8 809897 940169
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-2901-2026·2026-08-12

    COAPTIUM Connect Nerve Repair Device Relabeled Due to Unsubstantiated Shelf Life

    Tissium SA is relabeling COAPTIUM Connect nerve repair devices to reduce the shelf life from 36 to 26 months because the original duration was not supported by real-time data.

    Product
    Brand Name: COAPTIUM Connect Product Name: COAPTIUM Connect Model/Catalog Number: NCOCO1510 Software Version: N/A Product Description: In situ polymerizing peripheral nerve repair device Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2851-2026·2026-08-12

    Quantum 4Front 2HD Powered Wheelchair Recall Due to Potential Safety Issues

    A recall has been issued for the Quantum 4Front 2HD powered wheelchair because its controller software may cause unexpected braking or system failure that could lead to falls or injury.

    Product
    Brand Name: Quantum Rehab Product Name: Quantum 4Front 2HD Model/Catalog Number: Quantum 4Front 2HD Software Version: 2.0.11, new version: 2.0.13 Product Description: Wheelchair, Powered (ITI), 890.3860 Component: Controller
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2902-2026·2026-08-12

    Peripheral Nerve Repair Device Relabeled Due to Unsubstantiated Shelf Life

    Tissium SA is relabeling COAPTIUM CONNECT nerve repair devices because the 36-month shelf life is not supported by real-time data. The revised shelf life is 26 months.

    Product
    Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number: NCOCO1575 Software Version: N/A Product Description: In situ polymerizing peripheral nerve repair device Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2906-2026·2026-08-12

    COAPTIUM CONNECT Peripheral Nerve Repair Device Recall for Shelf Life Labeling

    TISSIUM SA recalls COAPTIUM CONNECT nerve repair devices due to unvalidated 36-month shelf life labeling. Revised 26-month label will be applied. Device breakage beyond validated shelf life may require revision surgery.

    Product
    Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number: NCOCO4010 Software Version: N/A Product Description: In situ polymerizing peripheral nerve repair device Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2886-2026·2026-08-12

    United Orthopedic Corp. Recalls Femoral Valgus Offset Adaptors for U2 Total Knee System

    United Orthopedic Corp. is recalling specific femoral valgus offset adaptors used in the U2 Total Knee System due to a manufacturing defect in a component screw.

    Product
    Brand Name: U2 Total Knee System Product Name: Femoral valgus offset adaptor, 2mm, 4mm, 6mm, left and Femoral valgus offset adaptor, 2mm, 4mm, 6mm, right Model/Catalog Number: 9323-5335, 9323-5337, 9323-5339 and 9323-5336, 9323-5338, 9323-5340 Software Version: N/A Product De
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2903-2026·2026-08-12

    Tissium Peripheral Nerve Repair Device Shelf Life Recall

    Tissium SA is recalling the COAPTIUM CONNECT peripheral nerve repair device due to an unsubstantiated 36-month shelf life; devices will be relabeled to a validated 26-month shelf life.

    Product
    Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number: NCOCO2010 Software Version: N/A Product Description: In situ polymerizing peripheral nerve repair device Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2846-2026·2026-08-12

    Quantum Rehab Q6 Edge 2.0 Power Wheelchair Recall

    Pride Mobility is recalling 1,102 Q6 Edge 2.0 power wheelchairs due to a software issue that may cause unexpected braking or control system crashes during use.

    Product
    Brand Name: Quantum rehab Product Name: Q6 Edge 2.0 Model/Catalog Number: Q6 Edge 2.0 Software Version: 2.0.11, new version: 2.0.13 Product Description: Wheelchair, Powered (ITI), 890.3860 Component: Controller
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2834-2026·2026-08-12

    REMISOL Advance Software Version 2.5 Recalled for Incorrect Test Result Reporting

    Beckman Coulter Biomedical GmbH is recalling REMISOL Advance Software Version 2.5 because it may incorrectly report combo assay test outcomes.

    Product
    REMISOL Advance with Software Version 2.5 UDI-DI code: 15099590802073 The Normand Info REMISOL Advance Data Manager collects and manages data and workflow for 128 connections
    Category
    Medical Device
    Distribution
    5 states
  • HighNHTSA·26E055000·2026-08-12

    Mack Recalls Grote Replacement Marker Lights for Visibility Failure

    Mack Trucks is recalling certain Grote replacement marker lights that may fail to illuminate, reducing vehicle visibility and increasing crash risk.

    Product
    GROTE — GROTE CLEARANCE/MARKER LAMP
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2865-2026·2026-08-12

    Stryker Single Spike Tube Set Recalled for Leaking During Use

    Stryker is recalling 11,857 Single Spike Tube Sets due to reports of leaking from the handpiece during use.

    Product
    STRYKER PKG., SINGLE SPIKE TUBE SET, Catalog Number 0250070530
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2907-2026·2026-08-12

    Coaptium Connect Nerve Repair Device Relabeled Due to Unsubstantiated Shelf Life

    Tissium SA is relabeling Coaptium Connect nerve repair devices because the current 36-month shelf life is not supported by real-time data. The shelf life is being reduced to 26 months.

    Product
    Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number: NCOCO5010 Software Version: N/A Product Description: In situ polymerizing peripheral nerve repair device Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2893-2026·2026-08-12

    Philips Fluoroscopy System Recall Over Hard Disk Drive Issue

    Philips is recalling 257 Allura/Centron interventional fluoroscopic X-ray systems due to potential loss of imaging, motorized movement, or data caused by unauthorized hard disk drives.

    Product
    Philips Allura, Cardio Vascular-Allura Centron. Model Number: 722400. Interventional Fluoroscopic X-Ray System.
    Category
    Medical Device
    Distribution
    Distributed nationwide