The Recall Desk

Severity 3 of 5

High recalls

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

What “high” means here

Severity 3 (High) recalls have a known hazard but no confirmed illness, injury, or property damage in the source text. The risk is theoretical-but-real: a pathogen pre-emptively pulled from shelves before anyone got sick, an allergen mislabeling on an uncommon allergen, a precautionary correction on a device that hasn't yet malfunctioned in the field. Most allergen recalls land here, as do most preventive food recalls based on routine sampling. You should still stop using the product, but you don't need to panic.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

13851–13875 of 22165

  • 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-0020-2024·2023-10-11

    Fentanyl Injectable Syringes Recalled Due to Sterility Assurance Issues

    Central Admixture Pharmacy Services recalled 174 fentanyl syringes nationwide due to lack of sterility assurance. The affected injectable medication presents a contamination risk.

    Product
    fentaNYL, 250 mcg/5 mL, (50 mcg/mL), 5 mL Syringe, Rx only, Repackaged by CAPS Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2003-2
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0031-2024·2023-10-11

    FDA Recalls Hydromorphone Syringes Over Sterility Assurance Issue

    Central Admixture Pharmacy Services Inc is recalling 2,664 syringes of HYDROmorphone injectable solution (30 mg/30 mL) distributed nationwide. The recall was initiated due to lack of assurance of sterility.

    Product
    HYDROmorphone in 0.9% Sodium Chloride, 30 mg/30 mL, (1 mg/mL), 30 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2012-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2661-2023·2023-10-11

    Medical Navigation System Recalled for Manufacturing and Electromagnetic Compatibility Defects

    Olympus Veran percutaneous navigation systems are recalled due to manufacturing non-conformances and insufficient electromagnetic compatibility evidence, affecting approximately 9,961 units distributed worldwide.

    Product
    Veran : Percutaneous Models: INS-5620 SPiN Perc Biopsy Needle Guide Kit - 20cm, 5/Bx (includes INS-5028)" INS-5611 SPiN Perc¿ Localization Needle - 2cm, 5/Bx INS-5610 SPiN Perc¿ Localization Needle - 1cm, 5/Bx INS-5600 SPiN Perc¿ Biopsy Needle Guide Kit, 5/Bx
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0006-2024·2023-10-11

    Phenylephrine Syringes Recalled Nationwide for Sterility Assurance Failure

    Central Admixture Pharmacy Services is recalling 3,081 phenylephrine injectable syringes nationwide due to lack of assurance of sterility. Affected lots expire between October 3-18, 2023.

    Product
    PHENYLephrine in 0.9 sodium chloride, 800 mcg/10 mL, (80 mcg/mL), 10 mL Syringe, Rx only, CAPS, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-6008-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1701-2023·2023-10-11

    Sweet and Spicy BBQ Sauce Recalled for Missing Fish Allergen

    The Fresh Chile Company is recalling Sweet and Spicy BBQ sauce because its label failed to declare fish (anchovies) as an allergen. Consumers with fish allergies could face a serious allergic reaction if they unknowingly consume this product.

    Product
    Sweet & Spicy BBQ sauce, Fresh Chile BBQ sweet & Spicy Hot. 16 fluid ounce glass jar 19 fl oz. (510g) , with a metal screw top lid.
    Category
    Food
    Distribution
    0 states
  • 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-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 (Drugs)·D-0015-2024·2023-10-11

    Fentanyl and Bupivacaine Injectable Syringes Recalled for Sterility Defect

    Central Admixture Pharmacy Services Inc. is recalling 895 syringes of fentanyl and bupivacaine injectable solution due to lack of assurance of sterility. The recall affects all doses nationwide.

    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
  • HighNHTSA·23V759000·2023-10-11

    Solar Panels May Detach from Thor Rize and Scope Motorhomes

    Thor Motor Coach is recalling 2021-2024 Rize and Scope motorhomes because the solar panel frame may fracture at the mounting bolts and detach, creating a road hazard.

    Product
    THOR MOTOR COACH — 2021 THOR MOTOR COACH RIZE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0005-2024·2023-10-11

    Phenylephrine injectable drug recalled due to sterility assurance failure

    Central Admixture Pharmacy Services Inc is recalling 3,384 phenylephrine syringes due to lack of assurance of sterility. The product was distributed nationwide.

    Product
    PHENYLephrine in 0.9 sodium chloride, 400 mcg/10 mL, (40 mcg/mL), 10 mL Syringe, Rx only, CAPS, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-6007-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2652-2023·2023-10-11

    Medical Ultrasound Cart Recall: Tilt Mechanism Failure Can Cause Equipment to Fall

    GE Venue Go ultrasound carts can develop internal tilt mechanism failure, causing the system to detach from the cart and fall. Some 5,986 devices are affected worldwide.

    Product
    Venue Go Standard Carts Ref: (H45181VC and H45103VCW), used with Venue Go R2, R3, R4 systems R2, R3, and R4 systems; pulsed doppler imaging system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0016-2024·2023-10-11

    Guider Softip XF Guide Catheter recalled for incorrect tip curve shape

    Boston Scientific Corporation is recalling 326 units of Guider Softip XF Guide Catheters due to certain lots being distributed with an incorrect tip curve shape that differs from the labeled specifications.

    Product
    Guider Softip Guide Catheter 5F 90CM MULTI PURPOSE, Catalog number M003100630, cardiac guide catheter
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0021-2024·2023-10-11

    FDA Recalls Fentanyl Injectable Syringes Due to Sterility Concerns

    Central Admixture Pharmacy Services is recalling fentanyl 2500 mcg/50 mL injections nationwide due to lack of assured sterility.

    Product
    fentaNYL, 2500 mcg/50 mL, (50 mcg/mL), 50 mL Syringe, Rx only, CAPS, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2003-3
    Category
    Drug
    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 (Food)·F-1699-2023·2023-10-11

    Kratom edible product recalled due to unapproved food additive

    The Crooked Row kratom edible product is recalled because kratom is an unapproved food additive. Consumers who purchased this product should not use it.

    Product
    The Crooked Row - Nkratable 4.5g per bite - 3 bites per pack
    Category
    Food
    Distribution
    1 state
  • 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 (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
  • HighNHTSA·23V761000·2023-10-11

    Prevost Motor Coaches Recalled for Fire Risk in Grid Heater System

    Prevost Car (US) Inc. is recalling 204 certain 2023-2024 H3-45 and X3-45 VIP motor coaches due to loose grid heater cable connections that can cause the relay to overheat, increasing fire risk.

    Product
    PREVOST — 2023 PREVOST H3-45 VIP
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0022-2024·2023-10-11

    Fentanyl Injection Recalled Due to Lack of Sterility Assurance

    Central Admixture Pharmacy Services Inc is recalling 240 units of 100 mL bags of fentanyl 2500 mcg/50 mL due to lack of assurance of sterility. The product was distributed nationwide.

    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 (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-0024-2024·2023-10-11

    Guider Softip Guide Catheter Recalled for Incorrect Tip Curve Shape

    Guider Softip Guide Catheter (cardiac device) is being recalled because certain units have an incorrect tip curve shape that differs from the label. A total of 116 units have been distributed.

    Product
    Guider Softip Guide Catheter 5F 100CM MULTI PURPOSE, Catalog number M003101630, 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
  • 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-0041-2024·2023-10-11

    Drug Recall: Triamcinolone Acetonide Injectable Contains Glass Contamination

    Eugia US LLC is recalling 1,626 vials of Triamcinolone Acetonide Injectable Suspension due to glass contamination. The affected lot (3TC22010, exp. 11/30/2024) was distributed nationwide.

    Product
    TRIAMCINOLONE ACETONIDE — TRIAMCINOLONE ACETONIDE (TRIAMCINOLONE ACETONIDE)
    Category
    Drug
    Distribution
    Distributed nationwide