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.

15451–15475 of 27263

  • HighFDA (Drugs)·D-0959-2023·2023-08-09

    EPINEPHrine IV Bags Recalled Due to Sterility Assurance Failure

    Central Admixture Pharmacy Services, Inc. is recalling EPINEPHrine 8mg/250ml IV bags due to lack of sterility assurance and insufficient validation data for decontamination cycles. The recall affects 4,570 units distributed nationwide.

    Product
    EPINEPHrine 8mg/250ml added to dextrose 5%, 32 mcg/mL, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-7019-1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2258-2023·2023-08-09

    Philips CT scanner heat exchanger box may detach and cause injury

    The metal mounting box on the rotating scanner of the Incisive CT system may become detached and contact other components, potentially injuring users or causing system shutdown.

    Product
    Incisive CT-Computed Tomography X-Ray System Model: 728143
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1026-2023·2023-08-09

    IV Transplant Solution Recalled Due to Inadequate Sterilization Validation

    Central Admixture Pharmacy Services is recalling 12 IV bags of Transplant Solution nationwide (Lot 36-252141) because the sterilization decontamination cycles lack proper validation, creating a sterility assurance deficiency.

    Product
    TRANSPLANT SOLUTION, Plasma-Lyte A - 75 ml, MSA/MSG 0.92 Molar -60 ml, dextrose 70% 21.3 ml; IV Bag, Total Volume = 165 mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0014-2
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2279-2023·2023-08-09

    Image intensifier detachment hazard in OEC fluoroscopy imaging systems

    GE OEC field upgrade kits for fluoroscopy systems may have image intensifiers that detach during movement, potentially falling and causing injuries.

    Product
    Field Upgrade Kits: P/N 5451208 RIU, 9 INCH, TOSHIBA; P/N 5485304 SERVICE PART, IMAGE INTENSIFIER, 9 INCH, TOSHIBA; P/N 5761613 SERVICE PART, IMAGE INTENSIFIER, 9 INCH - used with OEC Flexiview 8800, OEC 9800, and OEC 9900 Systems
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1066-2023·2023-08-09

    FDA Recalls PHENYLephrine Syringes Due to Sterility Validation Failure

    FDA is recalling 81,073 PHENYLephrine syringes manufactured by Central Admixture Pharmacy Services. The manufacturer lacks validation data for its sterilization processes, so the syringes may not be sterile.

    Product
    PHENYLephrine in 0.9% sodium chloride, 1000 mcg/10 mL, (100 mcg/mL), 10 mL syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-6009-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2305-2023·2023-08-09

    Medline procedural kits with ultrasound gel may not meet sterility specifications

    Medline Industries recalls 146,157 custom procedural kits distributed April 2020 to April 2023 because the sterile ultrasound gel component may not meet sterility specifications.

    Product
    Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. A V FISTULA, Model Number: DYNJ65711; b. ACCESS CATHETER, Model Number: DYNJ64141A; c. ACCESS PICC PACK, Model Number: DYNJ40682B; d. ADULT EPIV INSERTION T
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1331-2023·2023-08-09

    Apple Rings Recalled for Undeclared Tree Nuts, Peanuts, Wheat

    Houston Pecan Company recalls Apple Rings in 5-pound bags due to potential undeclared allergens from cross-contamination with tree nuts, peanuts, and wheat.

    Product
    Apple Rings Sulfur Dioxide Added packaged in 5 pound bags; Apple Rings, 1/2 pound bag
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-2278-2023·2023-08-09

    Medical X-ray Systems Image Intensifier Detachment Injury Risk

    GE OEC Elite Systems with 9-inch Image Intensifier devices may detach during movement if subjected to impact force, potentially causing injury to personnel and bystanders.

    Product
    OEC Elite Systems with 9-inch Image Intensifier
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2338-2023·2023-08-09

    Medline procedural kits recalled for ultrasound gel sterility concerns

    Medline is recalling 15,323 custom sterile and non-sterile procedural kits worldwide due to potential non-sterility of the Turkuaz ultrasound gel component. Kits were distributed between April 2020 and April 2023.

    Product
    Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ANGIOGRAPHY PACK, Model Number: DYNJ65963A; b. ARTHOGRAM TRAY, Model Number: PAIN1524B; c. ARTHROGRAM TRAY, Model Number: PAIN1524A; d. CARPAL TUNNEL K
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2335-2023·2023-08-09

    Custom Sterile Procedural Kits Recalled for Potential Sterility Specification Failure

    Medline is recalling 6,340 custom sterile and non-sterile procedural kits because the ultrasound gel component may not meet sterility specifications, creating contamination risk in surgical applications.

    Product
    Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CUSTOM GYN, Model Number: DYNJ63257C; b. GYN EXP LAPAROTOMY, Model Number: DYNJ906578C; c. INTRAUTERINE TRNSFUSION -LF, Model Number: DYNJ9048708I; d.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2265-2023·2023-08-09

    Olympus SPiN Drive Histology Needle Recalled for Navigation Sensor Malfunction

    Olympus recalls SPiN Drive histology needles due to electromagnetic sensor tracking malfunction that impairs navigation functionality during endobronchial procedures, potentially causing procedural delays.

    Product
    Always-On Tip Tracked Instruments (SPiN Drive instruments) 19ga ANSO Histology Needle, 12mm L, 1.8mm OD-Intended for use in clinical interventions and for anatomical structures where computed tomography and/or endoscopic brINS-0362onchoscopy are currently used for visualizing
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1313-2023·2023-08-09

    Pecan Products Recalled for Undeclared Allergens

    Houston Pecan Company is recalling certain 5-pound bags of pecan products that may contain undeclared tree nuts, peanuts, and wheat due to cross-contamination. Consumers with allergies to these ingredients should not consume these products.

    Product
    Medium Pecan Pieces 5 pound bag; Mammoth Pecan Halves 5 pound bag; Jr. Mammoth Pecan Halves 5 pound bag
    Category
    Food
    Distribution
    0 states
  • HighFDA (Drugs)·D-0970-2023·2023-08-09

    Vancomycin IV Bags Recalled Over Sterility Assurance Concerns Nationwide

    Central Admixture Pharmacy Services is recalling vancomycin 2 g/500 mL IV bags nationwide due to lack of sterility assurance. Validation data for decontamination cycles is not available.

    Product
    vancomycin 2 g/500 mL added to 0.9% Sodium Chloride, 4 mg/mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6078-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1019-2023·2023-08-09

    Cardioplegia Solution Recalled Due to Lacking Decontamination Validation Data

    A cardioplegia solution is being recalled nationwide because the manufacturer lacks validation data for decontamination cycles, raising sterility assurance concerns. Affected lots: 36-254401 and 36-257070.

    Product
    CARDIOPLEGIA SOLUTION, 36 mEq K, Induction 4:1, High Potassium/Low tromethamine, IV Bag, total volume = 500 mL, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0101-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2253-2023·2023-08-09

    Fusion Lithotripsy Extraction Basket Recalled for Mechanical Failure

    Wilson-Cook Medical is recalling Fusion Lithotripsy Extraction Baskets due to mechanical failures that may prevent proper basket advancement or retraction during biliary stone removal procedures.

    Product
    Fusion Lithotripsy Extraction Basket, Model Number FS-LXB-3X6 G48278; Fusion Lithotripsy Extraction Baskets are intended to be used for endoscopic removal of biliary stones and foreign bodies.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2332-2023·2023-08-09

    Medline Recalls Procedural Kits Over Sterility Specification Failure

    Medline Industries is recalling 9,319 procedural kits worldwide because the labeled sterile ultrasound gel component may not meet sterility specifications. The affected kits were distributed between April 2020 and April 2023.

    Product
    Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. FETAL INTERVENTION, Model Number: DYNJ66041A, DYNJ66041B; b. FETAL INTERVENTION PACK, Model Number: DYNJ62319A, DYNJ62319B; c. ULTRASOUND PIV KIT, Model N
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1005-2023·2023-08-09

    Neonatal TPN IV Bags Recalled Over Sterility Assurance Failures

    Central Admixture Pharmacy Services is recalling 304 neonatal TPN IV starter bags nationwide due to lack of sterility assurance and insufficient validation of decontamination processes. No illnesses have been reported.

    Product
    Neonatal TPN Starter Bag, Amino Acids (trophamine) 3.5%/Dextrose 10% with **low calcium** and HEPARIN, IV Bag, total volume = 250mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0429-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2271-2023·2023-08-09

    Chest Stabilization Device Latch May Fail During Cardiac Surgery

    The ACCESSRAIL Platform Standard Blade may fail to latch securely, potentially causing loss of heart stabilization or device component release into patients during cardiac surgery.

    Product
    ACCESSRAIL Platform (Standard Blade) Part Number SB-1000, and (Deep Blades) Part Number C-DB-1000. Component of a chest stabilization system for cardiac and chest surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2284-2023·2023-08-09

    X-ray therapy system carriage bolts may loosen and suspension rail crack

    Philips Azurion 7 M20 X-ray imaging systems may have loose or broken carriage support bolts and cracks in the suspension rail. The Class II recall affects 648 units distributed worldwide.

    Product
    Azurion 7 M20. X-ray Image guided Therapy System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1061-2023·2023-08-09

    Fentanyl Injectable Solution Recalled for Sterility Validation Failure

    Central Admixture recalls 8,146 bags of fentanyl injection due to lack of sterilization cycle validation. This Class II recall affects patients nationwide who may receive contaminated IV medication.

    Product
    fentaNYL in 0.9% sodium chloride, 2500 mcg/250 mL, (10 mcg/mL), 250 mL bag, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2071-5
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2288-2023·2023-08-09

    TECNIS Symfony Intraocular Lenses Recalled for Unintended Fiducial Marks

    Johnson & Johnson is recalling 42 TECNIS Symfony intraocular lenses that may have been manufactured with unintended toric fiducial marks. The lenses are surgical implants used to restore vision.

    Product
    TECNIS Symfony, Extended Range of Vision IOL, REF: ZXR00, STERILE.EO, Rx Only
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2310-2023·2023-08-09

    Custom Procedural Kits with Ultrasound Gel May Not Meet Sterility Standards

    Medline recalls 4,618 custom sterile procedural kits distributed worldwide from April 2020 through April 2023. The Turkuaz ultrasound gel component may not meet sterility specifications, posing a potential infection risk in surgical procedures.

    Product
    Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. DBD-PACK FETOSCOPY, Model Number: DYNJ906905B; b. FETOSCOPY CDS-LF, Model Number: CDS840215O; c. PACK,FETOSCOPY, Model Number: DYNJ906905A; d. US BR
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2322-2023·2023-08-09

    Custom procedural kits recalled for potential sterility failure in ultrasound gel

    Medline recalled 134,514 custom surgical procedural kits due to potential sterility failure in the Turkuaz Ultrasound Gel component. The affected kits were distributed worldwide from April 1, 2020 through April 28, 2023.

    Product
    Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. 18GX6" FEMORAL ART LINE KIT, Model Number: ART960; b. 20Gx3" RADIAL ART LINE KIT, Model Number: ART970; c. 20GX6" FEMORAL ART LINE KIT, Model Number: ART1165;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1001-2023·2023-08-09

    FDA Recalls Neonatal TPN Starter Bag for Lacking Sterility Assurance

    Central Admixture Pharmacy Services recalls 68 neonatal TPN starter bags nationwide due to lack of validation data for decontamination cycles, posing a contamination risk.

    Product
    Neonatal TPN Starter Bag, Amino Acids (trophamine) 3%/Dextrose 5% with **low calcium** and HEPARIN, IV Bag, total volume = 250mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0427-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0965-2023·2023-08-09

    PHENYLephrine Injectable Syringe Recall Due to Insufficient Sterility Assurance

    Central Admixture Pharmacy Services recalls 499,304 PHENYLephrine syringes nationwide because validation data for sterility decontamination cycles was lacking. No illnesses have been reported.

    Product
    PHENYLephrine 1,000 mcg/10mL, (100mcg/mL) in 0.9% sodium chloride, Syringe, Rx Only, CAPS, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6009-1
    Category
    Drug
    Distribution
    Distributed nationwide