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.

20476–20500 of 88183

  • HighFDA (Drugs)·D-0317-2023·2023-02-22

    Tobramycin 660mg Injectable Antibiotic Recalled for Lack of Sterility Assurance

    Sentara Infusion Services is recalling Tobramycin 660mg injectable antibiotic used for home infusion therapy due to lack of sterility assurance. Two bags were dispensed to patients nationwide.

    Product
    TOBRAMYCIN 660MG IN NS 66ML, antibiotic, Rx Only, use with homepump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320,
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1132-2023·2023-02-22

    Olympus colonovideoscope recalled for potential microbial contamination from veterinary use

    An Olympus EVIS EXERA III colonovideoscope was used in veterinary endoscopy before being designated as a medical facility loaner, creating potential for microbial contamination.

    Product
    EVIS EXERA III Colonovideoscope-For endoscopy and endoscopic surgery within the lower digestive tract (including the anus, rectum, sigmoid colon, colon, and ileocecal valve) Model/Serial: CF-Q180AL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0307-2023·2023-02-22

    FDA recalls Milrinone injectable medication due to lack of sterility assurance

    Sentara Infusion Services recalls 83 bags of Milrinone injectable medication nationwide due to lack of sterility assurance. Patients should contact their healthcare provider immediately.

    Product
    Milrinone (a) 104MG IN 0.45% NS 130ML,(b) 108MG IN 0.45% NS 135ML, (c) 120MG IN 0.45% NS 150ML, (d) 136MG IN 0.45% NS 170ML, (e) 144MG IN 0.45% NS 180ML, (f) 160MG IN 0.45% NS 200ML, (g) 168MG IN 0.45% NS 210ML, (h) 192MG IN 0.45% NS 240ML, (i) 44MG IN 0.45% NS 55 ML, (j) 52MG…
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0280-2023·2023-02-22

    Cefepime injectable antibiotic bags recalled due to sterility concerns

    Sentara Infusion Services is recalling 71 bags of Cefepime injectable antibiotic due to lack of sterility assurance. Patients who received affected doses should consult their healthcare provider.

    Product
    CEFEPIME, (a) 2GM IN NS 100ML (b)8GM IN NS 400ML (c) 12GM IN NS 600ML, used with a Curlin or Home pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0287-2023·2023-02-22

    Daptomycin Injectable Antibiotic Recalled Due to Sterility Assurance Failure

    Sentara Infusion Services is recalling daptomycin injectable antibiotic bags due to lack of sterility assurance. The 17 affected bags were dispensed nationwide and pose a potential infection risk.

    Product
    DAPTOMYCIN (a) 400MG IN NS 20ML, (b) 550MG IN NS 27.5ML, antibiotic, Rx only, used with a home pump. Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1127-2023·2023-02-22

    Surgical Circumcision Kits Recalled Due to Non-Sterile Outer Wrapping

    MEDLINE INDUSTRIES is recalling CENTURION MEDICAL PRODUCTS Circumcision Tray kits (Lot 22HMH649) because the outer packaging is non-sterile, though the surgical contents inside remain sterile.

    Product
    Surgical convenience kits labeled as: CENTURION MEDICAL PRODUCTS CIRCUMCISION TRAY, Reorder Number CIT3345
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1131-2023·2023-02-22

    HydroPICC Catheters Recalled for Incorrect Expiration Date Labeling

    Access Vascular, Inc is recalling HydroPICC 4Fr Single Lumen catheters (Model 80001001) due to incorrect expiration date labeling. The devices expire earlier than the labeled date.

    Product
    HydroPICC 4Fr Single Lumen, 130cm Guidewire - Basic Kit, Model Number 80001001
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0326-2023·2023-02-22

    FDA Recalls Humatrix Microclysmic Gel for Manufacturing Practice Violations

    Consolidated Chemical, Inc. is recalling 3186 bottles of Humatrix Microclysmic Gel nationwide due to deviations from proper manufacturing practices.

    Product
    Humatrix Microclysmic Gel, 8 oz per bottle, Care-Tech Laboratories, Inc., Saint Louis, Missouri 63139.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0325-2023·2023-02-22

    FDA recalls Techni-Care Chloroxylenol antiseptic due to manufacturing deviations

    Consolidated Chemical is recalling Techni-Care Chloroxylenol 3% in 4 oz and 8 oz bottles nationwide due to manufacturing practice violations. No illnesses have been reported.

    Product
    Techni-Care Chloroxylenold 3%, [4 fl oz /118 mL or 8 fl oz/236 mL] per bottle, Care-Tech Laboratories, Inc., Saint Louis, Missouri 63139. NDC 4 oz bottle: 46706-222-01; NDC 8 oz: 46706-222-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1056-2023·2023-02-15

    GE Nuclear Medicine Imaging Systems detector fall hazard

    GE Nuclear Medicine 600/800 series imaging systems may have faulty detectors that could fall, causing serious injury. Mitigation measures may not be properly implemented on 34 units distributed worldwide.

    Product
    GE Nuclear Medicine 600/800 series systems, specifically: a) OPTIMA O640 X 3/8 inch NR, b) DISCOVERY O640 X 3/8 inch, c) NM OPTIMA O640 X 3/8 inch, d) O640 NM Gantry 3/8 inch, e) O640 NM GANTRY FINAL ASSY, f) OPTIMA O640 X 3/8 inch; Emission Computed Tomography System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1057-2023·2023-02-15

    GE Nuclear Medicine Systems Recall Due to Potential Detector Fall Hazard

    GE is recalling 86 Nuclear Medicine 600/800 series systems worldwide due to a potential failure in a safety mitigation. If not correctly implemented, the detector can fall and cause life-threatening injury.

    Product
    GE Nuclear Medicine 600/800 series systems, specifically: a) 870 CZT O540+ Gantry 7.25mm, b) D670 CZT Gantry 7.25mm, c) DISCOV NM/CT 870 CZT, d) Discovery NMCT 670 CZT O540+, e) NM/CT 870 CZT CYBER DEFENCE, f) NM/CT 870 CZT O540, g) NM/CT 870 CZT WSO, h) NM/CT 870 CZT…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1058-2023·2023-02-15

    GE Nuclear Medicine 600/800 Systems Recalled for Detector Fall Risk

    GE Medical Systems is recalling 380 GE Nuclear Medicine 600/800 series diagnostic imaging systems worldwide due to potential failure in detector mitigation that could allow the detector to fall, risking life-threatening injury.

    Product
    GE Nuclear Medicine 600/800 series systems, specifically: a) 850, b) 850 / Dismount, c) 850 3/8 inch NM Gantry, d) 860 / Dismount, e) 860 3/8 inch NM Gantry, f) 860 5/8 inch NM Gantry, g) 860 BJ, h) NM 830 3/8 inch BJ, i) NM/CT 850 3/8 inch BJ, j) NM/CT 850 3/8 inch…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1053-2023·2023-02-15

    GE Nuclear Medicine 600/800 Series Systems Detector Fall Risk

    GE Nuclear Medicine 600/800 series systems have a safety mitigation that may not be correctly implemented, allowing the detector to fall and cause life-threatening injury. 557 units are affected worldwide.

    Product
    GE Nuclear Medicine 600/800 series systems, specifically: a) 870, b) 870 DR 3/8 inch NM GANTRY WITH NEW ROTOR - MEA, c) 870 DR / Dismount, d) 870 DR / Dismount / 60HZ, e) 870 DR 3/8 inch WSO, f) 870 DR 3/8 inch NM Gantry, g) 870 DR 3/8 inch, h) 870 DR 3/8 inch CH, i)…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1054-2023·2023-02-15

    GE Nuclear Medicine Systems: Detector Fall Risk Due to Faulty Mitigation

    GE Nuclear Medicine 600/800 series systems (748 units distributed worldwide) may have improperly implemented detector fall mitigations. If the mitigation fails, the detector can fall and cause life-threatening bodily injury.

    Product
    GE Nuclear Medicine 600/800 series systems, specifically: a) 830, b) 830 / Dismount, c) 830 /, d) 830 / 5842894-20, e) 830 / Dismount / 50HZ, f) 830 / Dismount / 60HZ, g) 830 3/8 inch Detector, h) 830 BJ, i) 830 BJ / 5144407, j) 830 BJ / Dismount, k) 830 ES DEM, l)…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0376-2023·2023-02-15

    Utopia brand Enoki Mushrooms recalled due to Listeria contamination

    Utopia brand Enoki Mushrooms (200g bags, UPC 892891861017) distributed in New York and New Jersey may be contaminated with Listeria monocytogenes. Consumers should not eat these mushrooms and should discard them or return them to the store.

    Product
    Utopia brand Enoki Mushroom; Utopia Foods Inc; 200g; Product of China; Distributed by Utopia Foods Inc.; UPC 892891861017; packaged in blue and clear plastic bag
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Devices)·Z-1055-2023·2023-02-15

    GE Nuclear Medicine BRIVO B615 Imaging System Detector Fall Risk

    GE Nuclear Medicine BRIVO B615 imaging systems may have an ineffective safety mitigation, allowing the detector to fall and cause life-threatening injury. The FDA issued a Class I recall for seven units distributed worldwide.

    Product
    GE Nuclear Medicine 600/800 series systems, specifically: a) BRIVO B615 3/8 inch DHP BJG NR, b) BRIVO 615 3/8 inch, c) BRIVO B615 3/8 inch DHP BJG NR, d) B615 with new rotor, e) BRIVO B615 3/8 inch BJG, f) BRIVO B615 3/8 inch DHP BJG NR, g) B615 with new rotor…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0345-2023·2023-02-15

    Skinny Dipped Dark Chocolate Cashews Recalled for Undeclared Peanut

    Skinny Dipped is recalling Dark Chocolate Salted Caramel Cashews (3.5 oz pouches) due to undeclared peanut. Peanut is present in the product but not listed on the label, posing risk to consumers with peanut allergies.

    Product
    Skinny Dipped Dark Chocolate Salted Caramel Cashews, 3.5 oz, packaged in flexible plastic pouches inside cardboard cases. Ingredients: Cashews, Dark Chocolate (Unsweetened Chocolate Processed with Alkali, Cane Sugar, Cocoa Butter, Milk Fat, Sunflower Lecithin, Vanilla), White…
    Category
    Food
    Distribution
    9 states
  • HighFDA (Devices)·Z-1101-2023·2023-02-15

    RipCord Syndesmosis Button suture may break during orthopedic surgery

    The RipCord Syndesmosis Button's pull suture can break when excessive tension is applied during orthopedic surgery. TriMed Inc. is recalling 76 units due to this structural failure risk.

    Product
    RipCord Syndesmosis Button, REF: STA001K
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1078-2023·2023-02-15

    Medline Sterile Surgical Trays Recalled for Potential Blade Puncture of Packaging

    Medline Industries is recalling sterile procedural trays because blades in the kits may puncture the outer packaging, potentially compromising sterility.

    Product
    Sterile Procedural Trays, labeled as the following: a. ST. ANNE'S MAJOR BASIN SET UP b. SINGLE BASIN SET c. DOUBLE BASIN SET d. LAPAROTOMY BASIN e. ORTHOPEDIC CUSTOM BASIN SET f. OISC BASIN TRAY g. BASIN PACK h. BASIN SET i. SURGI START PACK j. PK, GEN-SET UP…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1097-2023·2023-02-15

    Sterile arthroscopy trays recalled for potential blade puncture risk

    Medline Industries recalls multiple sterile arthroscopy surgical trays because blades in the kits may puncture the outer foil packaging, potentially compromising sterility. Affected products were distributed worldwide.

    Product
    Sterile Procedural Trays, labeled as the following: a. KNEE ARTHROSCOPY CDS-LF b. ARTHROSCOPY CDS c. ARTHROSCOPY LV - EDOC PACK-LF d. ARTHROSCOPY PACK-LF e. ARTHROSCOPY PACK f. ARTHRO PACK-LF g. ARTHROSCOPY PACK-LF h. ARTHROSCOPY PACK-LF i. ARTHROSCOPY KNEE TRAY-LF…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1091-2023·2023-02-15

    Sterile Surgical Trays Recalled for Potential Sterile Packaging Puncture

    Medline Industries recalls sterile surgical procedural trays because blades within the kits could puncture the sterile outer packaging, potentially compromising sterility during surgical use.

    Product
    Sterile Procedural Trays, labeled as the following: a. GYN-URO LAPSCP CDS-LF b. ROBOTIC CDS c. GYN LAPAROSCOPY CDS-LF d. GYN LAPAROSCOPY e. GYN LAPAROSCOPY CDS f. UNIVERSAL ROBOTIC ORLANDO g. GYN ROBOTIC CDS h. GYN LAPAROSCOPY CDS-1 i. CUH GYN LAPAROSCOPY CDS j.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1079-2023·2023-02-15

    Sterile Procedural Trays Recalled for Potential Blade Puncture of Packaging

    Medline Industries is recalling multiple sterile procedural trays because blades within the kits can potentially puncture the outer foil packaging, compromising sterility. The recall affects approximately 215,456 units distributed worldwide.

    Product
    Sterile Procedural Trays, labeled as the following: a. BASIN SET-UP PACK b. LAP CHOLE CDS c. MAJOR CDS d. UROLOGY MINOR CDS e. UROLOGY MAJOR CDS f. SINGLE BASIC CDS g. ORGAN RECOVERY CDS h. GENERAL ABD CDS i. BURN CDS j. MINOR k. MAJOR VASCULAR l. BASIC CORE CDS m. ROBOTIC…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1074-2023·2023-02-15

    Sterile Procedural Trays Recalled Due to Blade Packaging Puncture Hazard

    Medline Industries is recalling multiple sterile procedural trays because blades within the kits can puncture the outer foil packaging. The products were distributed worldwide.

    Product
    Sterile Procedural Trays, labeled as the following: a. LAPAROTOMY CDS-LF b. LAPAROSCOPY CDS-LF c. BASIC LAPAROSCOPY CDS d. LAPAROSCOPY CDS-LF e. GENERAL LAPAROSCOPY PROCEDURE f. LAP CHOLE CDS g. COLO-RECTAL CDS-LF h. MAJOR PROCEDURE-LF i. HYPOSPADIUS CDS j. LAPAROSCOPY-GENERAL…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1071-2023·2023-02-15

    Medline Sterile Procedural Trays Recalled Due to Blade Puncture Risk

    Medline Industries is recalling sterile procedural trays (Rhinoplasty Pack, OSC Otology Pack-LF, and Rhyzotomy) distributed worldwide because sterile blades within the kits may puncture the outer foil layer of sterile packaging, potentially compromising sterility.

    Product
    Sterile Procedural Trays, labeled as the following: a. RHINOPLASTY PACK b. OSC OTOLOGY PACK-LF c. RHYZOTOMY
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1082-2023·2023-02-15

    Sterile Procedural Trays recalled due to potential sterile packaging puncture

    Medline Industries is recalling Sterile Procedural Trays (IM NAIL) because sterile blades may puncture the outer foil layer of sterile packaging, potentially compromising sterility. No illnesses or injuries have been reported.

    Product
    Sterile Procedural Trays, labeled as the following: IM NAIL
    Category
    Medical Device
    Distribution
    Distributed nationwide