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.

14626–14650 of 27263

  • HighFDA (Drugs)·D-0016-2024·2023-10-11

    FDA Recalls Injectable Fentanyl-Bupivacaine Mixture for Lack of Sterility Assurance

    Central Admixture Pharmacy Services is recalling fentanyl-bupivacaine injectables due to lack of assurance of sterility. The recalled 250 mL bags were distributed nationwide.

    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 (Devices)·Z-2656-2023·2023-10-11

    GE F2-01 Frame Patient Monitor Communication Interruption Risk

    GE F2-01 Frame physiological patient monitors may experience data communication interruptions with CARESCAPE ONE and CARESCAPE Canvas 1000 monitors if not powered down within 120 days.

    Product
    F2-01 Frame, physiological patient monitor (with arrhythmia detection or alarms)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0019-2024·2023-10-11

    Boston Scientific Guider Softip Guide Catheter Recalled for Incorrect Tip Shape

    Boston Scientific is recalling Guider Softip Guide Catheters (Catalog M003101440) in certain lots due to incorrect tip curve shape that differs from the labeled specification. The recall affects 2,184 units.

    Product
    Guider Softip Guide Catheter 8F PRE-SHAPED 40 100CM, Catalog number M003101440, cardiac guide catheter
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0018-2024·2023-10-11

    Midazolam Injectable Solution Recalled Over Sterility Assurance Concerns

    Central Admixture Pharmacy Services is recalling midazolam injectable solution syringes due to lack of assurance of sterility. Patients should not use the affected lots and consult their healthcare provider.

    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-2662-2023·2023-10-11

    Veran Endobronchial Navigation Devices Recalled for Design Non-Conformance and EMC Issues

    Olympus Corporation recalls Veran endobronchial navigation devices due to manufacturing non-conformances and insufficient electromagnetic compatibility. Approximately 6,318 units distributed worldwide are affected.

    Product
    Veran : Endobronchial Models: INS-5500 View Optical Probe INS-5450 SPiN Xtend¿ 21ga, 1.8 OD, 5/Bx INS-5440 View Peripheral Catheter, 3.8mm OD, 2.5mm WC INS-5411 0.016" Stylet, 1235 mm L, 10/Bx INS-5410 SPiN Flex¿ ANSO¿ Needle, 22ga, 1.8mm OD, 5/Bx
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0020-2024·2023-10-11

    Guider Softip Guide Catheter Recalled for Incorrect Tip Curve Shape

    Boston Scientific is recalling certain lots of Guider Softip cardiac guide catheters because they were distributed with an incorrect tip curve shape that doesn't match the product label. Approximately 3,738 units were affected.

    Product
    Guider Softip Guide Catheter 6F 100CM MULTI PURPOSE, Catalog number M003101460, cardiac guide catheter
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0023-2024·2023-10-11

    FDA Recalls Fentanyl Injectable for Lack of Sterility Assurance

    Central Admixture Pharmacy Services is recalling fentanyl 50 mcg/mL injectable nationwide due to lack of assurance of sterility. The product was distributed in 100 mL bags (lot 17-275322, expires 10/3/2023).

    Product
    fentaNYL, 5,000 mcg/100 mL, (50 mcg/mL), 100 mL Bag, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2003-5
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0009-2024·2023-10-11

    Fentanyl Injectable Solution Recalled for Sterility Assurance Defect

    Central Admixture Pharmacy Services is recalling fentanyl 10 mcg/mL injectable solution due to lack of assurance of sterility. The recall affects 1,767 three-milliliter syringes distributed nationwide.

    Product
    fentaNYL in 0.9% sodium chloride, 10 mcg/1 mL, (10 mcg/mL), 3 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C San Diego, CA 92126, NDC: 71286-2071-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0010-2024·2023-10-11

    Boston Scientific Guider Softip Guide Catheter Recalled for Incorrect Tip Shape

    Boston Scientific is recalling Guider Softip Guide Catheters from certain lots because the tip curve shape does not match the labeled specification. No illnesses or injuries have been reported.

    Product
    Guider Softip Guide Catheter 7F PRE-SHAPED 40 90CM, Catalog number H965100430, cardiac guide catheter
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0036-2024·2023-10-11

    Meera Mobile Operating Table May Move Unexpectedly During Surgery

    Getinge is recalling the Meera Mobile Operating Table due to unintended movement that could occur during surgery. 224 units nationwide are affected.

    Product
    Meera Mobile Operating Table-to support and position the patient immediately before, during and after surgical interventions as well as for examination and treatment. Model Number: 7200.01F2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0023-2024·2023-10-11

    Guider Softip Guide Catheters recalled for incorrect tip curve shape

    Boston Scientific is recalling certain Guider Softip Guide Catheters due to incorrect tip curve shape that differs from the label. The recall affects 1170 units distributed in Indiana.

    Product
    Guider Softip Guide Catheter 5F PRE-SHAPED 40 100CM, Catalog number M003101620, cardiac guide catheter
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0011-2024·2023-10-11

    Fentanyl Injection Recalled Due to Lack of Sterility Assurance

    Central Admixture Pharmacy Services Inc. is recalling 688 units of fentanyl injection nationwide because it cannot assure the product meets sterility standards.

    Product
    fentaNYL in 0.9% sodium chloride, 500 mcg/50 mL, (10 mcg/mL), 50 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2071-3
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0013-2024·2023-10-11

    Guider Softip Guide Catheter with Incorrect Tip Curve Shape

    Boston Scientific is recalling Guider Softip Guide Catheters due to an incorrect tip curve shape that differs from the labeled specification. The affected units may not perform as intended during cardiac procedures.

    Product
    Guider Softip Guide Catheter 7F 90CM MULTI PURPOSE, Catalog number H965100470, cardiac guide catheter
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0008-2024·2023-10-11

    FDA Recalls Rocuronium Syringes Due to Sterility Assurance Issue

    The FDA is recalling rocuronium 50 mg/5 mL syringes from Central Admixture Pharmacy Services Inc due to lack of assurance of sterility. Approximately 1,389 syringes with affected lot numbers have been distributed nationwide.

    Product
    rocuronium, 50 mg/5 mL, (10 mg/mL), 5 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-6010-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0017-2024·2023-10-11

    Fentanyl and Bupivacaine Injectable Bags Recalled for Sterility Assurance Issues

    Central Admixture Pharmacy Services Inc. is recalling fentanyl-bupivacaine injectable solution due to lack of sterility assurance. The recall affects 190 units (250 mL bags) distributed nationwide.

    Product
    fentaNYL 2 mcg/mL and bupivacaine 0.125% PF in 0.9% sodium chloride / Total Volume = 250 mL, Total fentaNYL 500 mcg/250 mL, bag, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2082-2
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0011-2024·2023-10-11

    Cardiac Guide Catheter Recalled Due to Incorrect Tip Curve Shape

    Boston Scientific recalls certain Guider Softip Guide Catheters with incorrect tip curve shapes that differ from labeled specifications. Approximately 8,475 units were distributed nationwide.

    Product
    Guider Softip Guide Catheter 8F PRE-SHAPED 40 90CM, Catalog number H965100440, cardiac guide catheter
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0071-2024·2023-10-11

    LFS flat screen arm system surgical lamp bracket stopper block defect

    The LFS flat screen arm system with surgical lamp has a broken or missing stopper block that could allow the screen to rotate excessively, potentially causing the spring shaft to break and shear off.

    Product
    LFS Flat screen arm system with surgical lamp for Models Aurora series, Aurora 2 series, Aurora 3 series, Aurora 4 series, Aurora Astro series, Stellar XL, and Stellar series, LFS Flat Screen Arm System Model Numbers LFSST2323, LFSLFSST29TV23, LFSST29TV23, LFSST23TV, LFSST23, LFS
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Food)·F-1700-2023·2023-10-11

    Sweet & Spicy BBQ Sauce Recalled for Undeclared Fish Allergen

    The Fresh Chile Company is recalling Sweet & Spicy BBQ sauce due to an undeclared fish (anchovies) allergen on the label. Consumers with fish allergies may be at risk.

    Product
    Sweet & Spicy BBQ sauce, Fresh Chile BBQ sweet & Spicy Medium. 19 fluid ounce glass jar 19 fl oz. (510g) , with a metal screw top lid.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-2664-2023·2023-10-11

    Veran Endobronchial Navigation System: Manufacturing and EMC Defects

    Olympus is recalling Veran endobronchial navigation systems due to manufacturing non-conformances and insufficient electromagnetic compatibility evidence. Devices may malfunction or interfere with other medical equipment.

    Product
    Veran : Endobronchial Always on Track Models: INS-0392 AOTT 21ga Needle, 12mm L, 1.8mm OD, 5/BX INS-0382 AOTT 19ga Needle, 12mm L, 1.8 OD, 5/Bx INS-0372 AOTT Serrated Forceps, 1.8mm OD, 5/Bx INS-0362 AOTT Oval Cup Forceps, 1.8mm OD, 5/Bx INS-0352 "Always
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0012-2024·2023-10-11

    Cardiac guide catheters recalled for incorrect tip curve

    Boston Scientific is recalling Guider Softip Guide Catheters because certain lots were distributed with an incorrect tip curve shape that differs from labeled specifications.

    Product
    Guider Softip Guide Catheter 6F 90CM MULTI PURPOSE, Catalog number H965100460, cardiac guide catheter
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2649-2023·2023-10-11

    Medline CirClamp Surgical Clamp Recalled for Incorrect Assembly

    Medline is recalling 106 units of Centurion Sterile CirClamp with 1.45cm bell due to kits containing an incorrect subassembly that results in incorrect bell and base size.

    Product
    Centurion Sterile CirClamp with 1.45cm Bell Reprocessed, Reorder CR3145K, 1 per package, 12 per case.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2659-2023·2023-10-11

    Olympus SPiN Thoracic Navigation System Models Recalled for EMC Non-Conformance

    Olympus is recalling SPiN Thoracic Navigation System and related models due to manufacturing non-conformances and insufficient electromagnetic compatibility (EMC) evidence. The devices may malfunction in certain electrical environments.

    Product
    Veran:SPiN Thoracic Navigation System Models: SYS-4230 SPiN Thoracic Navigation System - 230V 50Hz SYS-4000 SPiN Thoracic Navigation System SYS-3230 ig4 System, 230V, 50Hz / SPiN Thoracic Navigation System 0095 SYS-3000 SPiN Thoracic Navigation System SYS-240
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0040-2024·2023-10-11

    FDA Recalls Subpotent Epinephrine Injectable for Intraocular Surgical Use

    Imprimis NJOF is recalling an epinephrine-lidocaine injectable due to failed potency testing, affecting nationwide distribution. The product was compounded in April 2023 for use during eye surgery.

    Product
    Epinephrine-Lidocaine HCl (0.25mg/mL and 7.5mg/mL) 1mL Single Use Intraocular injection Preservative Free NDC 71384-640-01 Not for resale. Office use only. Lot: 23APR018 Date Compounded: 24APR2023 Expires on: 17APR2024. In case of adverse event contact: www.fda.gov/medwatch or
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0021-2024·2023-10-11

    Guide Catheter Recalled for Incorrect Tip Curve Shape

    Stryker Neurovascular identified that certain Guider Softip XF Guide Catheters were distributed with an incorrect tip curve shape differing from the label. No injuries or illnesses have been reported.

    Product
    Guider Softip Guide Catheter 7F 100CM MULTI PURPOSE, Catalog number M003101470, cardiac guide catheter
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0035-2024·2023-10-11

    Drug eye drops recalled for manufacturing practice deviations nationwide

    Dr. Berne's Organic Castor Oil Eye Drops are being recalled due to manufacturing practice deviations. The voluntary recall affects 1,744 bottles distributed nationally and internationally.

    Product
    Dr. Berne's Organic Castor Oil Eye Drops, Net WT 30 mL/1 fl oz bottle, Distributed by: Dr. Berne's Whole Health Products, Tesuque, NM, 87574, [email protected], Certified Organic by Organic Certifiers.
    Category
    Drug
    Distribution
    Distributed nationwide