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.

12401–12425 of 53080

  • HighFDA (Drugs)·D-0944-2023·2023-08-02

    Testosterone Cypionate-Propionate Compounded Injectable Recalled for Sterility Assurance Deficiency

    New Vitalis Pharmacy is recalling its Testosterone Cypionate-Propionate injectable medication due to lack of assurance of sterility. The recall affects 102 vials distributed nationwide.

    Product
    Testosterone Cypionate-Testosterone Propionate 180-20 mg/mL in cottonseed oil, Compounded Rx, For Intramuscular Use Only, a) 1 mL, b) 5 mL Multi-Dose Vial, New Vitalis Pharmacy, 4139 Cadillac Ct, Ste 201, Louisville, KY 40213
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighNHTSA·23V540000·2023-08-02

    2022-2023 Nova Bus LFS Transit Buses Battery Short Circuit Fire Risk

    Nova Bus is recalling certain 2022-2023 LFS transit buses because the high-voltage battery may develop a short circuit due to over-tightened rivnut inserts, creating a fire risk.

    Product
    NOVA BUS — NOVA BUS LFS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2242-2023·2023-08-02

    Hernia repair mesh balloon may not inflate during surgery

    Davol Ventralight ST hernia repair mesh balloons may fail to inflate during surgery, potentially causing inadequate mesh placement, infection, and procedure delays.

    Product
    Ventralight ST 4.5" Circle with Echo PS- A low profile, bioresorbable, coated, permanent mesh, with a pre-attached removable positioning system, designed for the reconstruction of soft tissue deficiencies during laparoscopic ventral hernia repair. Catalog Number: 5955450
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·23V541000·2023-08-02

    Hino Recalls 2022-2023 Trucks for Headlight Installation Defect

    Hino is recalling 468 trucks because improperly installed headlight parts may cause failure or misalignment, increasing crash risk.

    Product
    HINO — HINO NJ7A, NE7A, NJ7B, NV7A
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2227-2023·2023-08-02

    Flexible Laryngeal Mask Airway Packs Lack Required Expiration Date Labels

    Medline Industries is recalling 9,945 DYND3000xxP Series laryngeal mask airway packs because the case and packet labels are missing expiration dates. Without this information, users cannot determine product validity.

    Product
    DYND3000xxP Series - Flexible Laryngeal Mask Airway Packs
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0936-2023·2023-08-02

    Oxacillin for Injection recalled nationwide due to sterility concerns

    Sagent Pharmaceuticals is recalling Oxacillin for Injection USP due to lack of sterility assurance. The recall affects multiple lots distributed nationwide.

    Product
    Oxacillin for Injection, USP, 2 grams per vial, For IV or IM Use, Rx only, labeled as a) NDC 25021-162-24 and b) novaplus NDC 25021-162-68, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195. Made in India.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2239-2023·2023-08-02

    Argon Medical Option Elite Vena Cava Filter Recall Due to Performance Risk

    Argon Medical Devices is recalling 3 Option Elite Retrievable Vena Cava Filters due to a potential performance defect that could result in pulmonary embolism. Affected units were distributed in Texas.

    Product
    Argon Medical Devices, REF 352506070E, Option Elite Retrievable Vena Cava Filter, Suitable of Jugular or Femoral Delivery, STERILEO, RxOnly, CE 2797
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2234-2023·2023-08-02

    Laser fiber medical devices recalled for potential burn injury hazard

    Boston Scientific recalls Flexiva Pulse laser fibers due to manufacturing defects that can cause fiber connector overheating and potential burns if touched. Affects 280 units in US and Canada.

    Product
    Flexiva Pulse ID 242 TracTip single Use Fiber-intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urological anatomy 5-pack UPN: M006L8406961
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2230-2023·2023-08-02

    Laser Fiber Devices May Overheat and Cause Burns During Use

    Boston Scientific is recalling Flexiva Pulse 242 laser fibers due to manufacturing defects that may cause the fiber connector to overheat and cause burn injuries. The recall affects 1,245 units distributed in the US and Canada.

    Product
    Flexiva Pulse 242 TracTip Single-Use Laser Fibers -intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urological anatomy. 5-pack UPN: M006L8405961
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0935-2023·2023-08-02

    Oxacillin Injectable Recalled for Failure to Assure Sterility

    Sagent Pharmaceuticals is recalling Oxacillin for Injection (1 gram vials, Lot OXG301) due to lack of assured sterility. Approximately 65,710 vials distributed nationwide are affected.

    Product
    Oxacillin for Injection, USP, 1 gram per vial, For IV or IM Use, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195. Made in India. NDC 25021-146-10.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2231-2023·2023-08-02

    Flexiva Pulse ID Laser Fiber Recalled for Incorrect Component

    Boston Scientific is recalling Flexiva Pulse ID laser fibers due to an incorrect component that reduces power output and aiming beam brightness. The component can overheat, risking burns to users who touch the fiber connector.

    Product
    Flexiva Pulse ID-intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urological anatomy Single-pack UPN: M006L8406910
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2215-2023·2023-08-02

    Respiratory diagnostic panel fails to produce test results

    Qiagen's QIAstat-Dx Respiratory SARS-CoV-2 Panel may fail to produce diagnostic results due to software errors in affected cartridges. Test runs will abort with error codes, leaving no test results available.

    Product
    QIAstat-Dx¿ Respiratory SARS-CoV-2 Panel -IVD intended for the detection and differentiation of nucleic acid from SARS-CoV-2 and the following organism types and subtypes: Adenovirus, Coronavirus 229E, Coronavirus HKU1, Coronavirus NL63, Coronavirus OC43, SARS-CoV-2, Human…
    Category
    Medical Device
    Distribution
    17 states
  • HighFDA (Devices)·Z-2245-2023·2023-08-02

    Respiratory Diagnostic Test Kits Recalled for Decreased Performance Reliability

    Qiagen's QIAstat-Dx Respiratory SARS-CoV-2 Panel diagnostic kits are recalled due to decreased performance reliability. Failed test runs could require sample retesting, potentially delaying diagnosis.

    Product
    QIAstat-Dx Respiratory SARS-CoV-2 Panel -US IVD qualitative test intended for analyzing nasopharyngeal swab (NPS) samples from patients suspected of respiratory infection for the presence of viral or bacterial nucleic acids REF 691223
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-2243-2023·2023-08-02

    Ventral Hernia Mesh Balloon May Fail to Inflate During Surgery

    A surgical mesh implant used in ventral hernia repair may fail to inflate properly during the procedure, potentially causing inadequate placement and infection risk. The manufacturer is recalling 169 units worldwide.

    Product
    Ventralight ST w Echo PS 4.5" Circle A low profile, bioresorbable, coated, permanent mesh, with a pre-attached removable positioning system, designed for the reconstruction of soft tissue deficiencies during laparoscopic ventral hernia repair. Catalog Number: 5955450G (EU…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·23E059000·2023-08-01

    SmartPlug Recalls 30A Shore Power Inlets Due to Fire Risk

    SmartPlug Systems is recalling 30A Shore Power Inlets because D-rings may crack, causing electrical arcing and fire.

    Product
    ELECTRICAL SYSTEM recall
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·23V536000·2023-07-31

    Rosenbauer Fire Trucks Recalled for Winch Remote Water Ingress Risk

    Rosenbauer America is recalling specific fire trucks because water can enter the winch remote, causing corrosion that may allow the winch to operate unintentionally.

    Product
    ROSENBAUER — ROSENBAUER COMMANDER, COMMERCIAL M2-112, COMMERCIAL F-550, AVENGER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V533000·2023-07-31

    Farber Specialty Ford Transit Recall for Fuel Hose Leak Risk

    Farber Specialty Vehicles is recalling one 2021 Ford Transit van because a fuel hose may leak gasoline, increasing the risk of fire.

    Product
    FARBER SPECIALTY — FARBER SPECIALTY FORD TRANSIT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·23249·2023-07-27

    True Fitness Showrunner II Consoles Recalled for Fire Hazard

    True Fitness is recalling about 600 Showrunner II Consoles sold with fitness equipment due to a fire hazard from an exposed wireless charging board. One fire has been reported with no injuries.

    Product
    Showrunner II Consoles, with included wireless phone chargers, sold with fitness equipment
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·23776·2023-07-27

    Sky Wheels Play Component Recalled for Fall Hazard

    Soft Play is recalling about 3,500 Sky Wheels play components because the wheels can detach from the overhead rail, causing a fall hazard and risk of injury to children. The company has received 15 reports of detachment, including three reported injuries involving scalp lacerations.

    Product
    Sky Wheels
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·23V525000·2023-07-27

    2022-2023 Altec Digger Derricks and Aerial Devices recalled for electrical fire risk

    Altec is recalling certain 2022-2023 Digger Derricks and Aerial Devices due to missing circuit breakers on AC power inverters, which could cause electrical fires. Altec will install the circuit breaker free of charge.

    Product
    ALTEC — ALTEC DIGGER DERRICK, AERIAL DEVICE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V520000·2023-07-27

    2022-2023 Lucid Air Rearview Camera Display Failure Recall

    Lucid is recalling 2022-2023 Air vehicles where the rearview camera may fail to display in reverse, violating safety standards. A free over-the-air software update will fix the issue.

    Product
    LUCID — LUCID AIR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V523000·2023-07-27

    Lucid recalls 2022–2023 Air for potential loss of drive power

    Software versions 2.0.64 and older in 2022–2023 Lucid Air vehicles may not respond properly to inverter failures, causing sudden loss of drive power without warning. This increases the risk of crashes.

    Product
    LUCID — LUCID AIR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·23777·2023-07-27

    GAF Energy Timberline Solar Energy Shingles recalled due to fire hazard

    GAF Energy is recalling about 2,100 Timberline Solar Energy Shingles (TLS-1) due to electrical component malfunction that poses a fire hazard. One fire and five thermal incidents resulting in property damage have been reported, with no injuries.

    Product
    Timberline Solar Energy Shingles
    Category
    Consumer Product
    Distribution
    Distributed nationwide