The Recall Desk

Agency

U.S. Food and Drug Administration

The FDA regulates food, drugs, biologics, medical devices, and tobacco. We aggregate Class I, II, and III enforcement actions across its three recall streams.

Visit the official FDA site →

About FDA recalls

The FDA is the single biggest source of US product recalls by volume. Its enforcement workload splits into three streams — Foods (everything from infant formula to leafy greens to nutritional supplements), Drugs (prescription medicines, over-the-counter products, and active pharmaceutical ingredients), and Medical Devices (everything from implants to home blood-pressure monitors). The Recall Desk ingests all three from the openFDA enforcement endpoint every six hours.

FDA classifies every recall as Class I, II, or III. Class I means there is a reasonable probability that using the product will cause serious health consequences or death — these are the recalls you should treat as urgent. Class II means the product may cause temporary or medically reversible harm. Class III means the product is unlikely to cause adverse health consequences but still violates FDA rules. We map these classifications into our 1–5 severity score using the rubric on the methodology page.

Medical-device recalls are the highest-volume stream by far — software-update letters, calibration corrections, and IFU updates all show up in enforcement reports alongside genuine hazard recalls. We try to surface the severe ones first, but when in doubt, click through to the FDA notice itself for the clinical detail.

15751–15775 of 27263

  • HighFDA (Devices)·Z-2240-2023·2023-08-02

    Mobile X-ray System with Faulty Glue Assembly May Pose Electric Shock Hazard

    Siemens Mobile X-ray systems may have incorrect glue on the tank cover assembly, which could fall off and allow liquid ingress, creating electric shock risk. The recall affects 9 units distributed in the US and internationally.

    Product
    Cios Select VA 21 with FD- A Mobile X-ray system intended for use in Operating room, Traumatology, Endoscopy, Intensive Care Station, Pediatrics, Ambulatory patient care and in Veterinary Medicine. Material #11515088
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2235-2023·2023-08-02

    vRad PACS medical imaging system recalled for intermittent image display failures

    Virtual Radiologic's vRad PACS with Mammography system may intermittently fail to display radiology images, preventing radiologists from viewing diagnostic studies. Eight units across seven U.S. states are affected by this Class II recall.

    Product
    vRad PACS with Mammography
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2233-2023·2023-08-02

    Flexiva Pulse Laser Fiber Recalled Due to Burn Hazard from Incorrect Component

    Boston Scientific is recalling Flexiva Pulse 242 ID Trac laser fibers with incorrect components that may overheat and cause burns if touched during use.

    Product
    Flexiva Pulse 242 ID Trac Single Use Fiber-intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urological anatomy (Single-pack UPN): M006L8406960
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1297-2023·2023-08-02

    Zinc Sulfate Monohydrate ingredient recalled for potential lead contamination

    Jost Chemical Co is recalling Zinc Sulfate Monohydrate, USP, because it may contain elevated levels of lead. This pharmaceutical ingredient was distributed to multiple countries including the United States.

    Product
    Zinc Sulfate Monohydrate, USP, Powder. Net Wt: 55 lb / 25 kg. Jost Chemical 8150 Lackland, St. Louis, MO 63114. Caution: For Manufacturing, Processing, or Repacking.
    Category
    Drug
    Distribution
    4 states
  • HighFDA (Devices)·Z-2244-2023·2023-08-02

    Surgical mesh inflation malfunction in Ventralight ST hernia repair device

    Davol's Ventralight ST surgical mesh may fail to inflate properly during laparoscopic hernia repair, potentially causing inadequate mesh placement and infection.

    Product
    Ventralight ST w EchoPS 4"x6" Ellipse- 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: 5955460G (EU On
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2237-2023·2023-08-02

    Beckman Coulter Recalls DxI Reaction Vessels Due to Inaccurate Test Results

    Beckman Coulter is recalling over 2 million Ringed DxI Reaction Vessels that may produce falsely elevated lab test results due to interior surface defects. The issue was discovered through internal service testing.

    Product
    Ringed DxI Reaction Vessels (RVs)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2238-2023·2023-08-02

    FRED Flow Re-Direction Endoluminal Device recalled for incorrect inner stent length

    The FDA is recalling FRED Flow Re-Direction Endoluminal Devices due to a manufacturing defect that may result in incorrect inner stent length, potentially affecting device performance. 474 units were affected.

    Product
    FRED Flow Re-Direction Endoluminal Device, REF: FRED3507-PMA, FRED3511, FRED3511-PMA, FRED3516-CA, FRED3516-PMA, FRED3524, FRED3524-CA, FRED3524-PMA, FRED3536-CA, FRED3536-PMA, FRED4007-PMA, FRED4012-CA, FRED4012-PMA, FRED4017-PMA, FRED4026, FRED4026-PMA, FRED4038-PMA, FRED4508,
    Category
    Medical Device
    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 (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-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 Metapn
    Category
    Medical Device
    Distribution
    17 states
  • 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
  • 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 (Food)·F-1292-2023·2023-08-02

    Spring Valley Potato Blintzes Recalled for Undeclared Milk

    Spring Valley Potato Blintzes are being recalled because they contain undeclared milk. Consumers with milk allergies face health risks if they consume this product.

    Product
    SPRING VALLEY brand POTATO BLINTZES; NET WT. 13 OZ (369g); KEEP FROZEN; READY TO COOK; INGREDIENTS: WHEAT FLOUR (WHET FLOUR, NIACIN, REDUCED IRON, THIAMIN MONONITRATE, RIBOFLAVEN, ENZYME, FOLIC ACID), WATER, POTATOES, EGG, ONIONS, CANOLA OIL, EGG WHITES, DEXTROSE, CORN STARCH, SA
    Category
    Food
    Distribution
    4 states
  • HighFDA (Drugs)·D-0943-2023·2023-08-02

    Safe Tussin PM Night Time Cough Relief Recalled for Manufacturing Deviation

    Kramer Laboratories is recalling Safe Tussin PM Night Time Cough Relief due to use of non-food-grade lubricant in the mixing vessel during manufacturing. Affected product: lot 8639, expiration 8/2023, distributed nationwide.

    Product
    Safe Tussin PM Night Time Cough Relief (Cough Suppressant/Antihistamine), packaged in 4.0 FL OZ(118mL) bottles, Kramer Laboratories, Inc. Bridgewater, NJ 08807
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0937-2023·2023-08-02

    Oxacillin for Injection Recalled Nationwide for Lack of Sterility Assurance

    Sagent Pharmaceuticals is recalling Oxacillin for Injection due to lack of assurance of sterility. The product was distributed to healthcare facilities nationwide.

    Product
    Oxacillin for Injection, USP, 10 gram per pharmacy Bulk Package bottle, For Intravenous Use, Rx only, packaged as a) NDC 25021-163-99 and b) novaplus NDC 25021-163-68, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195. Made in India.
    Category
    Drug
    Distribution
    Distributed nationwide
  • 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-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
  • 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 on
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1294-2023·2023-08-02

    Trader Joe's Unexpected Broccoli Cheddar Soup recalled for insect contamination

    Winter Gardens Quality Foods is recalling Trader Joe's Unexpected Broccoli Cheddar Soup due to insects found in frozen broccoli florets. The recall affects 10,889 cases distributed to FL, IL, CA, TX, WA, PA, and CT.

    Product
    Trader Joes Unexpected Broccoli Cheddar Soup ( Sharp Cheddar Cheese & Unexpected Cheddar Cheese )Keep Refrigerated, NET WT. 20 OZ (1 LB 4 OZ ) 567g, 12 in a Case
    Category
    Food
    Distribution
    7 states
  • ModerateFDA (Food)·F-1291-2023·2023-08-02

    Sprouts Farmers Market Garbanzo Beans Recalled for Glyphosate Residues

    Sprouts Farmers Market garbanzo beans (16-ounce packages, UPC 6 46670-51757 0) distributed in California are recalled due to glyphosate residues above tolerance levels.

    Product
    GARBANZO BEANS, SPROUTS FARMERS MARKET, Net Wt 16oz (1 LB) 454g units, 12 units / case. UPC 6 46670-51757 0. Distributed by Sprouts Farmers Market, Phoenix, AZ 85054.
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0942-2023·2023-08-02

    Safe Tussin DM Cough Suppressant Recalled for Manufacturing Deviation

    Kramer Laboratories is recalling Safe Tussin DM Cough + Chest Congestion due to a manufacturing deviation involving non-food grade lubricant in the mixing vessel. Affected lots 8753, 8753A, and 8659 were distributed nationwide.

    Product
    Safe Tussin DM Cough + Chest Congestion (Dextromethorphan HBr/ Cough Suppressant Guaifenesin/Expectorant), packaged in 4.0 FL OZ(118mL), 2020 Kramer Laboratories, Inc. Bridgewater, NJ 08807
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2226-2023·2023-08-02

    A901 Communication Manager Software Update Not Available for Intellis System

    The A901 Communication Manager application did not receive a timely update to match the A710 Clinician Programmer software release for Intellis Neurostimulation Systems, creating a version mismatch.

    Product
    A901 Communication Manager Application, used in conjunction with the A710 Clinician Programmer application..
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Food)·F-1296-2023·2023-08-02

    Dietary supplement labeling deficiencies recall - Natural Systems HAIR SKIN NAIL

    Emceta International Inc. recalled Natural Systems HAIR - SKIN NAIL dietary supplement (576 bottles, lot 42049) for labeling deficiencies that fail to comply with FDA regulations.

    Product
    Natural Systems, HAIR - SKIN NAIL, Dietary Supplement 60 Capsules
    Category
    Other
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2246-2023·2023-08-02

    COVID-19 Diagnostic Test Kits Recalled Due to Performance Reliability Issues

    Qiagen has recalled 4155 QIAstat-Dx Respiratory SARS-CoV-2 Panel kits due to decreased performance reliability. Test failures (run abortions) may require samples to be retested, potentially delaying diagnosis.

    Product
    QIAstat-Dx Respiratory SARS-CoV-2 Panel (V1 and V2, CE IVD, not US IVD, not sold in the US.) Qualitative test intended for analyzing nasopharyngeal swab (NPS) samples from patients suspected of respiratory infection REF: 691214
    Category
    Medical Device
    Distribution
    14 states