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.

8676–8700 of 22113

  • HighFDA (Devices)·Z-0808-2025·2025-01-15

    Aerin Medical VivAer Stylus Recall: Programming Error Causes Device Misidentification

    Aerin Medical is recalling 479 units of VivAer Stylus (Lot #10235) due to incorrect programming in units from a single lot. When connected to the Aerin Console, affected devices will be incorrectly identified as RhinAer Stylus.

    Product
    Aerin Medical VivAer Stylus, REF CAT1785 (individual stylus), and REF CAT500 (5-pack), sterile.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0186-2025·2025-01-15

    Progesterone Injection Recalled Nationwide for Glass Particulate Matter

    Eugia US LLC is recalling Progesterone Injection due to a market complaint of glass particles found in vials. The affected batch poses a potential risk to patients who receive injections from contaminated vials.

    Product
    PROGESTERONE — PROGESTERONE (PROGESTERONE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0190-2025·2025-01-15

    Duloxetine Drug Recall Due to Manufacturing Impurity Levels

    Rising Pharma recalls Duloxetine DR Capsules 60 mg nationwide due to N-nitroso-duloxetine impurity levels exceeding FDA limits. Affected batches were distributed nationwide; check lot numbers on bottle labels for affected product.

    Product
    Duloxetine DR Capsules USP 60 mg, a) 30 count (NDC 57237-019-30) and b) 1000 count (NDC 57237-019-99) bottles; Distributed by: Rising Pharm Holdings, Inc., East Brunswick, NJ
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0192-2025·2025-01-15

    Metformin ER 500 mg tablets recalled due to foreign tablet contamination

    Granules Pharmaceuticals is recalling Metformin ER 500 mg tablets due to discovery of a Paracetamol tablet in one bottle. Patients taking the affected lot should verify their medication with their pharmacy.

    Product
    METFORMIN ER 500 MG — METFORMIN ER 500 MG (METFORMIN ER 500 MG)
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Food)·F-0381-2025·2025-01-15

    Chow Ciao Breaded Broccoli Nuggets Recalled for Metal Contamination

    Better Brands Inc. recalls Chow Ciao Whole Grain Breaded Broccoli Nuggets due to metal contamination. Lot 24241 from 08/27/2024 affects 168 cases.

    Product
    Chow Ciao Whole Grain Breaded Broccoli Nuggets - 30 lbs.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Drugs)·D-0188-2025·2025-01-15

    Duloxetine Delayed-Release Capsules recalled for manufacturing deviation and impurity

    Rising Pharma is recalling certain batches of Duloxetine Delayed-Release Capsules 30 mg due to a manufacturing deviation that resulted in elevated N-nitroso-duloxetine impurity above FDA's recommended interim limit.

    Product
    Duloxetine Delayed-Release Capsules USP 30 mg, a) 30 count (NDC 57237-018-30) and b) 1000 count (NDC 57237-018-99) bottles, Rx only, Distributed by: Rising Pharm Holdings, Inc., East Brunswick, NJ
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0382-2025·2025-01-15

    Connie's Classic Thin Crust Cheese Pizza Recalled for Plastic Contamination

    Palermo Villa, Inc is recalling Connie's Classic Thin Crust Cheese Pizza due to the presence of plastic in the product. The affected frozen pizzas were distributed in Illinois, Minnesota, and Wisconsin.

    Product
    Connie's Classic Thin Crust Cheese Pizza, Chicago's Finest. Net Wt 20.36 oz. (1lb 4.36 oz) 577g. UPC 0 75706-19104 8. Keep Refrigerated. Distributed by: Palermo Villa, nc. Milwaukee, WI 53208.
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-0809-2025·2025-01-15

    Xhibit Telemetry Receiver may shut down, causing temporary loss of patient monitoring

    Spacelabs Healthcare's Xhibit Telemetry Receiver (Model 96280) may experience a Windows proxy issue causing the system to restart and go offline for 1-1.5 minutes, creating a temporary gap in patient monitoring.

    Product
    Xhibit Telemetry Receiver, Model 96280, with Service Manual. Intended to provide monitoring system with patient data.
    Category
    Medical Device
    Distribution
    44 states
  • HighFDA (Devices)·Z-0806-2025·2025-01-15

    EnVisio Patient Pad Transition Cushion surgical bed frame detachment risk

    Elucent Medical is recalling the EnVisio Patient Pad Transition Cushion due to a potential safety risk of the surgical bed frame's back section detaching during use. Approximately 283 units are affected across 16 U.S. states.

    Product
    EnVisio Patient Pad Transition Cushion, Model/Catalog Number: ENVISIO-SYS Product Description: The EnVisio Patient Pad Transition Cushion is a component of the EnVisio Navigation System which is a medical device that detects the presence of the SmartClip Soft Tissue Marker(s) an
    Category
    Medical Device
    Distribution
    17 states
  • HighFDA (Devices)·Z-0810-2025·2025-01-15

    Xhibit Telemetry Receiver software versions may cause unsolicited system shutdowns

    Telemetry receivers with affected software versions may unexpectedly shut down for 1-1.5 minutes, temporarily disabling patient monitoring. This could delay clinical response if a patient event occurs during the outage.

    Product
    Xhibit Telemetry Receiver with Software, Model 96280. Intended to provide monitoring system with patient data.
    Category
    Medical Device
    Distribution
    27 states
  • HighFDA (Devices)·Z-0813-2025·2025-01-15

    Medical radiographic system arm drop hazard due to missing safety bolts

    GE Healthcare Optima XR240amx systems with column replacement may have missing bolts in the Column Safety mechanism. If these bolts are missing and the counterpoise cable fails, the X-ray arm could drop.

    Product
    GE Healthcare Optima XR240amx, Mobile Digital Radiographic System, Model Numbers: 1) 5555000-27; 2) 5555000-31; 3) 5555000-33; 4) 5555000-41; 5) 5555000-47; 6) A0700DL; 7) A1700DA; 8) To be provided.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0807-2025·2025-01-15

    Neptune Medical Suction Rovers Recalled Due to Loose Bolts

    Stryker's Neptune 3 and Neptune S Rover surgical suction systems are recalled due to improperly tightened bolts on the vacuum pump filter housing. Loose bolts may cause loss of suction force during medical procedures.

    Product
    100V NEPTUNE 3 ROVER JAPANESE (0703-003-000) 120V NEPTUNE S ROVER (0711-001-000) 230V NEPTUNE 3 ROVER ENGLISH (0703-002-000ENG) 230V NEPTUNE 3 ROVER SPANISH (0703-002-000ES)
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Drugs)·D-0189-2025·2025-01-15

    Duloxetine Delayed-Release Capsules Recalled for Manufacturing Impurity Above Safe Limits

    Rising Pharma is recalling 73,680 bottles of Duloxetine 20 mg capsules nationwide due to N-nitroso-duloxetine impurity above recommended limits from manufacturing deviations. No illnesses have been reported.

    Product
    Duloxetine Delayed-Release Capsules USP 20 mg, 60 count bottles, Rx only, Distributed by: Rising Pharm Holdings, Inc., East Brunswick, NJ NDC 57237-017-60
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0802-2025·2025-01-15

    VACUETTE SAFELINK Blood Collection Holder May Leak Due to Defective Sleeve

    Greiner Bio-One GmbH is recalling VACUETTE SAFELINK blood collection holders because the protective rubber sleeve may bunch up and fail to retract, causing potential blood leakage from the device.

    Product
    VACUETTE SAFELINK, REF: 450210
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0803-2025·2025-01-15

    Beckman Coulter PTH Assay Reagent Packs Recalled for Filling Defects

    Beckman Coulter is recalling Access PTH assay reagent packs from lot 339071 due to under- or over-filling in well 0, which could cause sealing issues, contamination, and inaccurate test results.

    Product
    Access Intact PTH assay, a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of intact parathyroid hormone (parathyrin, PTH) levels in human serum and plasma using the Access Immunoassay Systems, Catalog Number A16972
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0814-2025·2025-01-15

    Anesthesia Vaporizers May Deliver Less Anesthetic Than Dial Setting Due to Manufacturing Defect

    Certain Tec 6 Plus and Tec 800 series anesthesia vaporizers may deliver less anesthetic agent than the dial setting indicates due to a manufacturing issue. Approximately 1,573 units are affected, distributed in the United States and globally.

    Product
    Tec 6 Plus Anesthesia Vaporizer, Reference Numbers 1107-9601-000, 1107-9602-000, 1107-9603-000, 1107-9604-000, 1107-9610-000, 1107-9612-000, 1107-9616-000, 1107-9617-000, 2066835-001, 2069767-001, 2078800-001, 2091008-001, 2091009-001, M1098876, M1145610, M1220023, M1220854, M122
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0811-2025·2025-01-15

    Mobile Radiographic System Arm May Drop Due to Missing Safety Bolts

    GE Healthcare Optima XR200amx mobile radiographic systems may have missing bolts in the Column Safety mechanism, which could allow the X-ray arm to drop if an internal cable fails.

    Product
    GE Healthcare Optima XR200amx, Mobile Digital Radiographic System, Model Numbers: 1) 5555000-3; 2) 5555000-4: 3) A0659MB
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0816-2025·2025-01-15

    Tec 820 SEV Anesthesia Vaporizer Recalled for Inadequate Anesthetic Delivery

    GE Medical Systems is recalling approximately 928 Tec 820 SEV anesthesia vaporizers due to a manufacturing defect that can cause them to deliver less anesthetic agent than the dial setting indicates. The devices are distributed nationwide and globally.

    Product
    Tec 820 SEV Anesthesia Vaporizer, Reference Number 1177-9820-SEV
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0392-2025·2025-01-15

    Wellsley Farm Greek Yogurt recalled for possible plastic contamination

    HP Hood is recalling Wellsley Farm Plain Non-Fat Greek Yogurt (40 oz) because some containers may contain plastic foreign objects. The affected product was distributed in Maryland, Connecticut, and Kentucky.

    Product
    WELLSLEY FARM PLAIN NON-FAT GREEK YOGURT; 40 oz; UPC 888670048085
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-0804-2025·2025-01-15

    Smaxel Fractional CO2 Laser recalled for missing safety label and instructions

    IDS LTD is recalling 23 Smaxel Fractional CO2 Laser systems worldwide due to missing Certification label and inadequate instructions for safe operation.

    Product
    Smaxel Fractional CO2 Laser, a Class IV medical laser system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0812-2025·2025-01-15

    GE Optima XR Mobile Radiographic System Column Safety Mechanism Defect

    GE Healthcare Optima XR mobile X-ray systems with column replacements may have missing bolts in the Column Safety mechanism. If bolts are missing and the internal cable fails, the arm could drop, creating a risk of injury to staff or patients.

    Product
    GE Healthcare Optima XR220amx, Mobile Digital Radiographic System, Model Numbers: 1) 5555000-12; 2) 5555000-5; 3) 5555000-6; 4) A0659PB; 5) to be provided
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0818-2025·2025-01-15

    Tec 850 SEV Anesthesia Vaporizers Recalled for Insufficient Anesthetic Delivery

    GE Medical Systems recalls Tec 850 SEV anesthesia vaporizers due to a manufacturing defect that may cause them to deliver less anesthetic agent than the dial setting indicates. Affected devices distributed nationwide and globally.

    Product
    Tec 850 SEV Anesthesia Vaporizer, Reference Number 1177-9850-SEV
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0817-2025·2025-01-15

    GE Tec Anesthesia Vaporizers Recalled for Insufficient Anesthetic Delivery

    Certain GE Tec anesthesia vaporizers (Tec 6 Plus and Tec 800 series) may deliver less anesthetic agent than the dial indicates due to a manufacturing issue. Users should cease use and contact GE Medical for instructions.

    Product
    Tec 850 ISO Anesthesia Vaporizer, Reference Number 1177-9850-ISO
    Category
    Medical Device
    Distribution
    Distributed nationwide