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.

15476–15500 of 27263

  • HighFDA (Drugs)·D-1035-2023·2023-08-09

    Cardioplegia Solution Recalled Due to Insufficient Sterility Assurance

    Central Admixture Pharmacy Services is recalling Cardioplegia Solution due to lacking validation data for decontamination cycles, creating insufficient assurance of sterility in this injectable product.

    Product
    CARDIOPLEGIA SOLUTION, 12 mEq K, Maintenance 4:1 in Ringer's Low Potassium, IV Bag, total volume = 504.8 mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0205-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1007-2023·2023-08-09

    Neonatal TPN Starter Bag Recalled Due to Sterility Assurance Issues

    Central Admixture Pharmacy Services is recalling a neonatal IV nutrition bag due to lack of sterility assurance. The recall affects 156 bags of the product distributed nationwide.

    Product
    Neonatal TPN Starter Bag, Amino Acids (trophamine) 3.5%/Dextrose 10% with CALCIUM, total volume = 250mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043,NDC: 72196-0407-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2252-2023·2023-08-09

    Fusion Lithotripsy Extraction Baskets recalled for mechanical defects

    Wilson-Cook Medical's Fusion Lithotripsy Extraction Baskets are being recalled due to mechanical defects that can prevent the basket from advancing or retracting, or cause the drive wire to break or separate during use.

    Product
    Fusion Lithotripsy Extraction Basket, Model Number FS-LXB-2X4 G48277; 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 (Drugs)·D-0948-2023·2023-08-09

    Vancomycin IV Bags Recalled Nationwide for Lack of Sterility Assurance

    Central Admixture Pharmacy Services is recalling 3,980 IV vancomycin bags nationwide. The decontamination process was not properly validated, raising sterility concerns. No illnesses reported.

    Product
    vancomycin 1 g/250 mL added to 0.9% sodium chloride, 4 mg/mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6064-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2323-2023·2023-08-09

    Medline Procedural Kits with Turkuaz Ultrasound Gel May Not Meet Sterility Requirements

    Medline is recalling 218,163 sterile procedural kits containing Turkuaz Ultrasound Gel that may not meet sterility specifications. Kits distributed April 2020-April 2023 are used in invasive medical procedures.

    Product
    Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ADULT EPIV INSERTION TRAY, Model Number: DYNDA2482; b. ARTERIAL LINE START KIT, Model Number: ART920; c. CENTRAL LINE INSERTION TRAY, Model Number: DT19810;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2285-2023·2023-08-09

    STATCLAVE G4 Medical Sterilizer Recalled for Incomplete Sterilization Risk

    FDA recalls 19 units of the STATCLAVE G4 steam sterilizer (Class II). The device may result in incomplete sterilization when used with incompatible materials.

    Product
    STATCLAVE G4 Chamber Autoclave -Tabletop steam sterilizer intended for use by a health care provider to sterilize medical products by means of pressurized steam. Model: G4 621103
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2298-2023·2023-08-09

    Medical procedural kits recalled due to sterility concerns with ultrasound gel

    Medline recalls 76,870 procedural kits because the ultrasound gel component may not meet sterility standards. Kits were distributed nationwide and internationally from April 2020 through April 2023.

    Product
    Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CRMC MINOR IR PROCEDURE PK-LF, Model Numbers: DYNJ61099B, DYNJ61099C; b. CRMC TUNNEL CATH TRAY-LF, Model Numbers: DYNJ61118C, DYNJ61118F; c. CUSTOM ANGIO TRAY, M
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1360-2023·2023-08-09

    belVita Breakfast Sandwich Recall: Undeclared Peanut Allergen

    Mondelez Global LLC recalls belVita Breakfast Sandwich (Dark Chocolate Creme variety) due to undeclared peanut allergen from cross contamination. The product was distributed to all 50 states.

    Product
    belVita Breakfast Sandwich, Dark Chocolate Creme variety (8 - 14.08 oz packages)
    Category
    Food
    Distribution
    0 states
  • HighFDA (Drugs)·D-1059-2023·2023-08-09

    Fentanyl IV Bags Recalled for Lack of Sterilization Validation

    Central Admixture Pharmacy Services is recalling 19,014 bags of fentanyl IV injection nationwide due to lack of validated sterilization processes, which could affect product sterility.

    Product
    fentaNYL in 0.9% sodium chloride, 1000 mcg/100 mL, (10 mcg/mL), 100 mL bag, Rx only, CAPS, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2071-4
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2328-2023·2023-08-09

    Medline Procedural Kit Ultrasound Gel Sterility Specification Failure

    Medline Industries is recalling procedural kits containing ultrasound gel that may not meet sterility specifications. The affected kits were distributed to healthcare facilities worldwide from 2020 to 2023.

    Product
    Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. DR MOTT DRAPE PACK, Model Number: DYNJ42065B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1000-2023·2023-08-09

    Neonatal TPN Bags Recalled Due to Lack of Sterility Assurance

    Central Admixture Pharmacy Services is recalling 516 Neonatal TPN Starter Bags due to insufficient validation of decontamination processes. The recall affects bags distributed nationwide.

    Product
    Neonatal TPN Starter Bag, Amino Acids (trophamine) 3%/Dextrose 10% with CALCIUM and HEPARIN, IV Bag, total volume = 250mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0420-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1070-2023·2023-08-09

    Fentanyl and Bupivacaine Injectable Recalled for Sterility Concerns

    Central Admixture Pharmacy Services is recalling 1,114 bags of fentanyl and bupivacaine injectable due to lack of validation data for sterilization. The product was distributed nationwide.

    Product
    fentaNYL 2 mcg/mL and bupivacaine 0.125% PF in 0.9% sodium chloride, Total Volume = 100 mL, Total FentaNYL 200 mcg/100 mL, 100 mL bag, Rx only, CAPS, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2082-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0951-2023·2023-08-09

    FDA recalls dilTIAZem IV bags due to sterility assurance concerns

    Central Admixture Pharmacy Services is recalling 2,260 dilTIAZem IV bags nationwide because validation data for the decontamination process is lacking. Affected lots expire between July and August 2023.

    Product
    dilTIAZem 125mg/125mL (1 mg/mL), added to dextrose 5%, IV Bag, RX only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6054-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1069-2023·2023-08-09

    Injectable Fentanyl-Bupivacaine Mixture Recalled for Sterility Validation Failure

    Central Admixture Pharmacy Services recalls 295 bags of injectable fentanyl-bupivacaine solution nationwide because the sterilization process lacked proper validation documentation.

    Product
    fentaNYL 2 mcg/mL and bupivacaine 0.0625% PF in 0.9% sodium chloride, Total Volume = 250 mL, Total fentaNYL 500 mcg/250 mL, 250 mL bag, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2081-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0976-2023·2023-08-09

    FDA Recalls Oxytocin IV Bags Due to Sterility Assurance Deficiency

    Central Admixture Pharmacy Services is recalling oxytocin IV bags nationwide due to insufficient validation of sterilization decontamination processes. The recall affects 6,037 bags distributed across multiple lots.

    Product
    oxyTOCIN 20 units added to 0.9% sodium chloride 1,000 mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6043-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2260-2023·2023-08-09

    Philips Incisive CT Scanner Mounting Box Poses Injury Risk

    A metal mounting box in the Incisive CT Power scanner may detach and potentially injure operators or cause system failure. Philips is recalling 53 affected units distributed worldwide.

    Product
    Incisive CT Power (China)-Computed Tomography X-Ray System Model: 728148
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1024-2023·2023-08-09

    Cardioplegia solution IV bags recalled for lack of sterility assurance

    Central Admixture Pharmacy Services is recalling 308 bags of cardioplegia solution nationwide due to lack of assurance of sterility and insufficient validation data for decontamination cycles.

    Product
    CARDIOPLEGIA SOLUTION, 48 mEq K, Induction 4:1 in Ringer's, High Potassium, IV Bag, total volume = 522.8 mL, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0206-1
    Category
    Drug
    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 (Drugs)·D-1020-2023·2023-08-09

    Cardioplegia Solution Nationwide Recall Due to Sterility Assurance Failure

    Central Admixture Pharmacy Services is recalling a cardioplegia solution nationwide due to lack of sterility assurance and insufficient validation data for sterilization decontamination cycles.

    Product
    CARDIOPLEGIA SOLUTION, 15 mEq K, Reperfusate 4:1, low potassium/low tromethamine, total volume = 500mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0009-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1050-2023·2023-08-09

    Fentanyl Injectable Solution Recalled for Unvalidated Sterilization Cycles

    Central Admixture Pharmacy Services is recalling 848 bags of fentanyl injection nationwide due to lack of validated sterilization processes that assure product sterility. Multiple lots distributed to healthcare facilities are affected.

    Product
    fentaNYL, 2500 mcg/50 mL, (50 mcg/mL), 100 mL bag, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2003-4
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1075-2023·2023-08-09

    FDA Recalls Midazolam Injectable for Unvalidated Sterilization Process

    Central Admixture Pharmacy Services Inc is recalling 621 syringes of midazolam injection because the manufacturer lacked validation data to confirm the sterilization process was effective.

    Product
    midazolam in dextrose 5%, 50 mg /50 mL, (1 mg/mL), 50 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-4036-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2287-2023·2023-08-09

    ProPlan CMF Mandible Surgical Guides Recall for Wrong Version

    Materialise recalls ProPlan CMF mandible surgical guides because wrong versions were shipped prior to a redesign. Healthcare facilities should verify they have the correct version.

    Product
    ProPlan CMF Patient-Specific Guide, Mandible guides (3A & 3B)-Intended to guide the marking of bone and/or guide surgical instruments in mandibular and maxillofacial surgical procedures. Identification number: SD900.101
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0989-2023·2023-08-09

    FDA Recalls IV Potassium Phosphate Solution Due to Sterility Assurance Issues

    Central Admixture Pharmacy Services is recalling 7,469 bags of potassium phosphate IV solution nationwide because decontamination validation data is lacking, creating a sterility assurance gap.

    Product
    potassium phosphate 15 mmole added to 0.9% sodium Chloride 250 mL, IV Bag, RX Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6060-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2262-2023·2023-08-09

    Bronchoscopy Instruments Recalled for Electromagnetic Sensor Tracking Malfunction

    Olympus Corporation is recalling Always-On Tip Tracked Instruments due to a malfunction in the electromagnetic sensor that impairs navigation functionality during bronchoscopic procedures. The malfunction could result in procedural delays.

    Product
    Always-On Tip Tracked Instruments (SPiN Drive¿ instruments) Brush, 15mm L, 1.8mm OD Intended for use in clinical interventions and for anatomical structures where computed tomography and/or endoscopic bronchoscopy are currently used for visualizing Model: INS-0352
    Category
    Medical Device
    Distribution
    Distributed nationwide