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.

14901–14925 of 53092

  • HighFDA (Devices)·Z-0769-2023·2023-01-04

    Orthopedic Compression Screws Distributed Without FDA Pre-Market Clearance

    Acumed LLC recalled AcuTwist Acutrak Compression Screws (80,805 units) distributed without FDA pre-market clearance. The devices lack FDA evaluation for safety and effectiveness.

    Product
    AcuTwist Acutrak Compression Screws Part Number/Part Description: AI-0010-S 10mm AcuTwist¿ Acutrak Compression Screw AI-0012-S 12mm AcuTwist¿ Acutrak Compression Screw AI-0014-S 14mm AcuTwist¿ Acutrak Compression Screw AI-0016-S 16mm AcuTwist¿ Acutrak Compression Screw…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0770-2023·2023-01-04

    Dual-Trak Clavicle Screws recalled: distributed without FDA pre-market clearance

    Acumed LLC is recalling 7,498 units of Dual-Trak Clavicle Screws distributed worldwide without FDA pre-market clearance. These orthopedic surgical screws were marketed without required regulatory approval.

    Product
    Dual-Trak Clavicle Screws Part Number/Part Description: 40-0136 3.0mm x 80mm Dual-Trak Clavicle Screw 40-0136-S 3.0mm x 80mm Dual-Trak Clavicle Screw 40-0137 3.0mm x 90mm Dual-Trak Clavicle Screw 40-0137-S 3.0mm x 90mm Dual-Trak Clavicle Screw 40-0138 3.0mm x 100mm…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0092-2023·2023-01-04

    Hand Sanitizer Recalled for Excess Chemical Impurities in Manufacturing

    NCH Life Sciences LLC is recalling hand sanitizer products containing excess acetal and acetaldehyde impurities due to manufacturing deviations. The recall affects 2.5 and 55-gallon bottles distributed nationwide in the US and Canada.

    Product
    Alcohol Antiseptic 80% Topical Solution Hand Sanitizer, Non-Sterile Solution, packaged as a a) 2.5 gallon bottle (9,464 ml), NDC 55533-524-02, and b) 55 gallon bottle (208,198 ml), NDC 55533-524-03, Manufactured for: Multi-Mist Products A Division of NCH Corporation 1618…
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0771-2023·2023-01-04

    Remington Medical Automatic Cutting Needle Stylet Longer Than Specified

    Remington Medical is recalling 290 Automatic Cutting Needles with lot number 2224920 because the stylet is longer than specified on the label. Affected units were distributed in NC, WV, CA, PA, AL, and TX.

    Product
    Remington MEDICAL, Automatic Cutting Needle, 18ga (1.3mm) x 20cm, REF NAC-1820M (1)
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Drugs)·D-0091-2023·2023-01-04

    Glycopyrrolate 1 mg Tablets Recalled for Failed Impurity Specifications

    AVKARE LLC is recalling Glycopyrrolate 1 mg tablets distributed nationwide due to failed quality specifications involving unknown impurities. The recall affects 1,237 cartons.

    Product
    GLYCOPYRROLATE — GLYCOPYRROLATE (GLYCOPYRROLATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0211-2023·2023-01-04

    Phil's Power Pancakes recalled due to undeclared wheat allergen

    Phil's Power Pancakes are being recalled because they contain wheat that is not listed on the label. Consumers with wheat allergies who have purchased this product should not consume it.

    Product
    Phil's Power Pancakes 5 oz. individually wrapped units 5 varieties, including (Chocolate Hempseed, Cranberry, Raspberry, Mango, and Date) UPC: 8 3765448372 5
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0772-2023·2023-01-04

    Pilling Wecksorb Cylindrical Sponges recalled due to compromised sterility

    TELEFLEX LLC recalled 1,000 units of Pilling Wecksorb Cylindrical Sponges (Lot 22B0395) because certain lots were not irradiated to eliminate pyronema, potentially compromising sterility. No illnesses have been reported.

    Product
    Pilling Wecksorb Cylindrical Sponges
    Category
    Medical Device
    Distribution
    4 states
  • HighNHTSA·22V957000·2022-12-29

    2022 Indian Chief Bobber Motorcycles Kickstand Failure Increasing Crash Risk

    Indian is recalling 2022 Chief and related motorcycles because the kickstand may not properly retract while riding. A failure to retract increases the risk of a crash.

    Product
    INDIAN — INDIAN CHIEF BOBBER DARK HORSE, SUPER CHIEF, CHIEF, CHIEF DARK HORSE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·23082·2022-12-29

    Inflatable Paddle Boards Recalled for Unexpected Deflation and Drowning Hazard

    Surf 9 is recalling Body Glove Tandem and ULI inflatable paddle boards sold at Costco because glue can separate at the seams, causing unexpected deflation and posing a drowning hazard. Three deflation reports have been received with no injuries yet reported.

    Product
    Body Glove Tandem Inflatable Stand Up Paddle Board, ULI Inventor Inflatable Paddle Board, ULI Zettian Inflatable Supyak and ULI Lila Inflatable Supyak
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·22V956000·2022-12-29

    2023 Volkswagen ID.4 Battery Cable Short-Circuit Fire Risk Recall

    Volkswagen is recalling certain 2023 ID.4 rear-wheel drive vehicles because the 12-volt battery charging cable may wear and cause a short circuit, risking vehicle fire and power loss. Dealers will inspect and repair or replace the cable at no charge.

    Product
    VOLKSWAGEN — VOLKSWAGEN ID.4
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·23719·2022-12-29

    Yamaha Viking Off-Road Side-by-Side Vehicles Parking Brake Failure Recall

    Yamaha is recalling about 500 Viking Off-Road Side-by-Side vehicles because improper installation of parking brake retaining bolts could cause the brake to fail, allowing the parked vehicle to move unintentionally and potentially crash.

    Product
    Yamaha Viking Off-Road Side-by-Side vehicles
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0760-2023·2022-12-28

    Revaclear 400 Dialyzers Recalled for Potential Internal Blood Leaks

    Baxter Healthcare Corporation is recalling 3.6 million Revaclear 400 Dialyzers due to a manufacturing defect where a twisted gasket could cause internal blood leaks during hemodialysis treatment.

    Product
    Revaclear 400 Dialyzer. Product Code: 114746L. Used to treat chronic and acute renal failure by hemodialysis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0755-2023·2022-12-28

    GE Vivid S6 N Ultrasound Battery Fire Risk Recall

    GE Vivid S6 N ultrasound systems may experience battery failure, smoke, or fire if batteries are not replaced every 2 years as recommended. Clinicians should replace batteries per manufacturer Service Manual instructions.

    Product
    Vivid S6 N ultrasound. Not marketed in the US. Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0742-2023·2022-12-28

    HeartWare Model 1100 driveline cover hardening may delay urgent access

    HeartWare Model 1100 driveline covers may harden over time, making it difficult or impossible to access the driveline-to-controller connector. A delay in accessing the connector during an urgent issue could result in prolonged pump stoppage and patient harm.

    Product
    HeartWare Model 1100
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0738-2023·2022-12-28

    Spinal implant insert may fail to disengage from vertebral body device

    NuVasive's X-CORE 2 spinal implants may not disengage properly from the vertebral replacement device, potentially requiring revision surgery. About 2,031 devices worldwide are affected.

    Product
    X-CORE 2 Ti Core, Static. Part of the NuVasive X-Core Expandable VBR System used with spinal fixation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0750-2023·2022-12-28

    HeartWare HVAD Pump Kit driveline cover hardening affects connector access

    Driveline cover hardening in HeartWare HVAD Pump Kits may prevent access to critical connectors, potentially delaying emergency repairs. Affected patients should contact their Medtronic field representative for assessment.

    Product
    HeartWare HVAD Pump Kit, REF MCS1705PU
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0746-2023·2022-12-28

    HeartWare HVAD Pump Kit Driveline Cover Hardening Issue

    HeartWare HVAD Pump Kit driveline covers may harden over time, making it difficult or impossible to access the driveline connector for urgent servicing. Delayed access could result in patient harm from prolonged pump stoppage.

    Product
    HeartWare HVAD Pump Kit, REF 1104
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0751-2023·2022-12-28

    FDA Class II recall: Medical Action cardiac catheter introduction kit

    Medical Action Industries' Port a Cath Kit (cardiac catheter introduction kit) has been subject to an FDA Class II recall affecting 198 cases distributed in Virginia. The specific reason for recall was not provided by the FDA.

    Product
    Medical Action INDUSTRIES INC. Port a Cath Kit REF 58647D, cardiac catheter introduction kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0201-2023·2022-12-28

    Frozen pizza dough recalled for possible foreign object contamination

    It'll Be Pizza frozen pizza dough (20 oz and 24 oz packages) may contain foreign debris from packaging. Consumers should not consume affected products.

    Product
    20 oz Garlic and 24 oz Garlic frozen pizza dough manufactured by It'll Be Pizza
    Category
    Food
    Distribution
    5 states
  • HighFDA (Drugs)·D-0087-2023·2022-12-28

    Glycopyrrolate Tablets Recalled for Failed Impurities and Degradation Specifications

    Glycopyrrolate tablets distributed nationwide are being recalled due to failed impurities and degradation specifications. Patients with affected lots should discontinue use and consult their healthcare provider.

    Product
    GLYCOPYRROLATE — GLYCOPYRROLATE (GLYCOPYRROLATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0196-2023·2022-12-28

    Brava Frozen Pizza Dough Recalled for Possible Foreign Object Contamination

    Brava frozen pizza dough products are being recalled due to possible contamination with debris from packaging. The recall affects 1,678 cases distributed in Maine, Vermont, Massachusetts, Pennsylvania, and New Hampshire.

    Product
    Brava, 20 oz, 22 ct/case and Brava, 24 oz, 18 ct/case frozen pizza dough
    Category
    Food
    Distribution
    5 states
  • HighFDA (Devices)·Z-0745-2023·2022-12-28

    HeartWare HVAD Pump Kit driveline cover may harden, impeding urgent access

    The driveline cover on HeartWare HVAD Pump Kits may harden over time, preventing access to the driveline to controller connector. This could delay urgent intervention for critical device issues.

    Product
    HeartWare HVAD Pump Kit, REF 1103
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0763-2023·2022-12-28

    Revaclear 400 Dialyzers Recalled for Polyurethane Displacement Risk

    Baxter Healthcare is recalling Revaclear 400 dialyzers due to reports of polyurethane displacement, which could result in blood leaks during dialysis treatment. The recall affects over 6 million units distributed worldwide.

    Product
    Revaclear 400 dialyzers. Indicated for treatment of chronic and acute renal failure by hemodialysis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0726-2023·2022-12-28

    Corin BIOLOX DELTA Ceramic Hip Implant Heads Recalled for Incorrect Size Labeling

    Corin Ltd is recalling BIOLOX Delta Ceramic Hip Implant Heads nationwide due to size labeling errors. The 36XL size is labeled as 32XL and vice versa, which could result in implantation of an incorrectly sized component.

    Product
    Corin BIOLOX DELTA MOD HEAD,032mm, EX LONG +7mm, REF 104.3215
    Category
    Medical Device
    Distribution
    Distributed nationwide