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.

15576–15600 of 27263

  • HighFDA (Devices)·Z-2286-2023·2023-08-09

    Scican STATCLAVE G4 Chamber Autoclave Recall for Sterilization Risk

    Scican has recalled 3 STATCLAVE G4 tabletop autoclaves due to risk of incomplete sterilization if used with incompatible loads. Healthcare facilities should verify only compatible materials are sterilized.

    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 622303
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0992-2023·2023-08-09

    Neonatal TPN Starter Bag Recall Due to Sterility Assurance Concerns

    Central Admixture Pharmacy Services is recalling Neonatal TPN Starter Bags because sterility cannot be assured and decontamination cycle validation data is lacking. The affected lot (36-254911) was distributed nationwide.

    Product
    Neonatal TPN Starter Bag, Amino Acids (trophamine) 2%/Dextrose 10% with CALCIUM, total volume = 250mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0401-1
    Category
    Drug
    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 (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-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 (Food)·F-1333-2023·2023-08-09

    Raisins Recalled for Undeclared Tree Nuts, Peanuts, and Wheat

    Houston Pecan Company is recalling Dark and Gold Raisins in 5 pound bags due to potential undeclared tree nuts, peanuts, and wheat allergens from cross contamination. Products distributed in Texas and online are affected.

    Product
    Dark Raisins packaged in 5 pound bags; Gold Raisins packaged in 5 pound bags
    Category
    Food
    Distribution
    0 states
  • 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 (Devices)·Z-2276-2023·2023-08-09

    OEC 9800 Fluoroscopy Systems Image Intensifier May Detach and Fall

    The image intensifier on GE OEC 9800 fluoroscopy systems can detach and fall if the system experiences a large impact force during movement. This could result in injuries including fractures, bruising, and contusion.

    Product
    OEC 9800 Systems with 9-inch Image Intensifier
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2324-2023·2023-08-09

    Medline Medical Procedural Kits Recalled for Potential Ultrasound Gel Sterility Failure

    Medline Industries recalls 19,907 procedural kits 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. CENTRAL LINE INSERT KIT W/O CA, Model Number: CVI3755; b. CENTRAL LINE KIT, Model Number: DYNDC2582, DYNDC2582A; c. CENTRAL LINE PACK-COMPANION, Model Num
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2314-2023·2023-08-09

    Medline procedural kits with potentially non-sterile ultrasound gel recalled

    Medline Industries is recalling 80 custom procedural kits containing ultrasound gel that may not meet sterility specifications. Kits were distributed worldwide from April 2020 to April 2023.

    Product
    Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. PACK ENDO AAA HYBRID CHRG, Model Number: DYNJ60126B;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1326-2023·2023-08-09

    Papaya Sweetened Recalled for Undeclared Tree Nuts, Peanuts, and Wheat

    Houston Pecan Company recalls Papaya Sweetened in 5-pound bags due to potential undeclared tree nuts, peanuts, and wheat from allergen cross contamination. Affected products were distributed in Texas and through internet sales.

    Product
    Papaya Sweetened packaged in 5 pound bags
    Category
    Food
    Distribution
    0 states
  • 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
  • HighFDA (Food)·F-1346-2023·2023-08-09

    Cassano's Pizza King Dough Recalled for Undeclared Soy Flour

    Cassano's The Pizza King Proprietary Dough is being recalled due to undeclared soy flour. Consumers with soy allergies who consume this product may experience allergic reactions.

    Product
    Cassano's The Pizza King Proprietary Dough: packaged as 6in, 9in, 12in, 14in, and 16in
    Category
    Food
    Distribution
    9 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 (Drugs)·D-0949-2023·2023-08-09

    Succinylcholine Injectable Syringes Recalled for Unvalidated Decontamination Cycles

    Central Admixture Pharmacy Services recalls 26,208 succinylcholine injection syringes nationwide due to lack of validated sterilization procedures. The manufacturer lacks adequate validation data for decontamination cycles.

    Product
    succinylcholine 200 mg/10 mL (20 mg/mL), Syringe, Rx only, this drug was repackaged by CAPS Inc, 2200 South 43rd Avenue Pheonix, AZ, NDC 72196-6011-2.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2296-2023·2023-08-09

    Medline Procedural Kits Recalled for Potential Sterility Specification Failure

    Medline has recalled 63,823 custom procedural kits due to potential sterility specification failure of the ultrasound gel component. The affected kits were distributed worldwide from April 2020 through April 2023.

    Product
    Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ANGIO, Model Number: DYNJ902507B; b. ANGIO BASIN SET, Model Numbers: DYNJ46043D, DYNJ46043F; c. ANGIO CATH COMBINED PACK, Model Numbers: DYNJ43609K, DYNJ43
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2316-2023·2023-08-09

    Medline Procedural Kits Recalled for Potential Sterility Failure in Ultrasound Gel

    Medline is recalling 6,733 custom procedural kits due to potential sterility failure in the Turkuaz ultrasound gel component. The gel may not meet required sterility specifications.

    Product
    Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CVC PACK, Model Number: DYNJ46967F; b. ENDOVENOUS ABLATION PACK, Model Number: DYNJ64059; c. ENDOVENOUS CORE PACK: DYNJ62557; d. TVS4000 ENDOVENOUS
    Category
    Medical Device
    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 (Food)·F-1354-2023·2023-08-09

    San Marco Premium Dough recalled for undeclared soy flour allergen

    Cassanos Inc is recalling San Marco Premium Dough on Parchment due to undeclared soy flour. Consumers with soy allergies who consume this product face allergic reaction risk.

    Product
    San Marco Premium Dough on Parchment: packaged as 8in, 14in
    Category
    Food
    Distribution
    9 states
  • HighFDA (Devices)·Z-2256-2023·2023-08-09

    Siemens Pro.specta Emission CT Systems Sensor Issue Reduces Image Resolution

    Siemens Pro.specta CT imaging systems may produce reduced image quality due to sensors triggering earlier than expected, potentially affecting diagnostic accuracy. Affected units were distributed across the US and internationally.

    Product
    The following Pro.specta Emission Computed Tomography Systems that were manufactured with an SLD Look Ahead Optical Sensor Assembly: (a) Symbia Pro.specta Q3, Model 11364751; (b) Symbia Pro.specta X3, Model 11364752; (c) Symbia Pro.specta X7, Model 11364753.
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Drugs)·D-1067-2023·2023-08-09

    Fentanyl-bupivacaine injection syringes recalled due to sterility assurance issue

    Central Admixture Pharmacy Services is recalling 1,486 syringes of fentanyl-bupivacaine injection nationwide due to lack of validated sanitization processes that may affect product sterility.

    Product
    fentaNYL 1.5 mcg/mL and bupivacaine 0.125% PF in 0.9% sodium chloride, Total Volume = 50 mL, Total fentaNYL 75 mcg/50 mL, 50 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2080-2
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1365-2023·2023-08-09

    Outshine Strawberry Fruit Bars Recalled for Undeclared Milk Allergen

    Dreyer's Grand Ice Cream is recalling Outshine No Sugar Added Strawberry Fruit Bars due to undeclared milk allergen. Consumers with milk allergies in affected states should not consume this product.

    Product
    Outshine No Sugar Added Strawberry Fruit Bars Brand name: Outshine; Unit size:14.7 fl oz carton with 6 bars; Container description: paper cartons; Total package size: 6 bars per case; Storage instructions: frozen
    Category
    Food
    Distribution
    17 states
  • HighFDA (Drugs)·D-1016-2023·2023-08-09

    FDA Recalls Cardioplegia Solution for Lack of Sterility Assurance

    The FDA has recalled Central Admixture Pharmacy Services' Cardioplegia Solution 40 mEq K due to insufficient validation data for sterilization processes. The 80-bag lot may not meet sterility standards required for cardiac use.

    Product
    CARDIOPLEGIA SOLUTION 40 mEq K, Warm Induction 4:1 High Potassium, IV Bag, total volume = 500mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0002-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2297-2023·2023-08-09

    Procedural kits containing Turkuaz ultrasound gel recalled for sterility failure

    Medline Industries recalls approximately 97,677 procedural kits containing Turkuaz Ultrasound Gel due to potential sterility specification failures. The affected kits were distributed worldwide from April 1, 2020 to April 28, 2023.

    Product
    Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. (13) STC IVC FILTER/ANGIOGRAM, Model Number: DYNJ908249A; b. 16CM 3L 7FR CVC INSERTION BUNDLE, Model Numbers: ECVC7410A; c. 16CM 7F 3L CVC MAX BARRIER INSERTION,
    Category
    Medical Device
    Distribution
    Distributed nationwide