The Recall Desk

State

Hawaii product recalls

20,322 recalls have nationwide distribution and so reach Hawaii. 0 additional recalls listed Hawaii specifically in their distribution scope.

About recalls in Hawaii

Most US product recalls have nationwide distribution — the manufacturer ships into every state and the recall sweeps the same way. We include those in this listing because they affect Hawaii consumers even though the source notice doesn’t name the state. State-specific recalls are usually for products with regional distribution (a regional dairy, a local store brand) or where the agency was able to narrow the affected shipments to specific destinations.

If you’re checking whether a recall affects your purchase, the recall detail page lists the exact production lot codes, UPCs, and best-by dates. Match those against your package — distribution scope is a starting filter, not the final answer.

11551–11575 of 20322

  • HighFDA (Devices)·Z-0009-2024·2023-10-11

    Guider Softip Guide Catheter Recalled for Incorrect Tip Curve Shape

    Boston Scientific is recalling certain lots of Guider Softip Guide Catheters because they were manufactured with an incorrect tip curve shape that differs from the labeled specification.

    Product
    Guider Softip Guide Catheter 6F PRE-SHAPED 40 90CM, Catalog number H965100420, cardiac guide catheter
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0024-2024·2023-10-11

    Fentanyl in Dextrose Syringes Recalled for Sterility Assurance Issues

    Central Admixture Pharmacy Services is recalling 962 fentanyl in dextrose syringes distributed nationwide due to lack of assured sterility in the injectable pharmaceutical products.

    Product
    fentaNYL in dextrose 5%, 300 mcg/30 mL, (10 mcg/mL), 30 mL syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2001-2
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0025-2024·2023-10-11

    BD Cathena IV Catheter Safety Shield May Fail to Properly Engage

    Becton Dickinson is recalling BD Cathena IV catheters because the safety shield may fail to properly engage, potentially exposing the contaminated needle.

    Product
    REF: 386862, BD Cathena Safety IV catheter with BD Multiguard Technology, 20 GA 1.00 IN, 1.1 x 25 mm 64 mL/min , Rx Only, Sterile EO
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2660-2023·2023-10-11

    Veran Endobronchial Navigation Devices Recalled for Manufacturing Non-conformance

    Olympus is recalling Veran endobronchial navigation devices (6,484 units) worldwide due to manufacturing non-conformances and insufficient evidence of adequate electromagnetic compatibility. The devices may not function acceptably in environments with electromagnetic interference.

    Product
    Veran Endobronchial: Models: INS-5925 SPiN Access Catheter¿ 180 Degree for use w/ Pentax Scopes INS-5920 SPiN Access Catheter¿ 90 Degree for use w/ Pentax Scopes INS-5915 SPiN Access Catheter¿ 180 for use w/ Olympus Scopes INS-5910 SPiN Access Catheter¿ 90 for u
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0018-2024·2023-10-11

    Guider Softip Guide Catheter Recalled for Incorrect Tip Curve Shape

    Boston Scientific is recalling 1004 units of Guider Softip Guide Catheters because certain lots were distributed with an incorrect tip curve shape that differs from the labeled specifications.

    Product
    Guider Softip Guide Catheter 7F PRE-SHAPED 40 100CM, Catalog number M003101430, cardiac guide catheter
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0002-2024·2023-10-11

    Ketamine syringes recalled for lack of sterility assurance

    CAPS Inc. is recalling 4,775 ketamine syringes nationwide due to lack of confirmed sterility assurance during manufacturing. No illnesses have been reported, but affected healthcare facilities should quarantine and return unused product.

    Product
    ketamine in 0.9% sodium chloride, 50 mg/5mL (10mg/mL), 5 mL syringe, Rx only, CAPS, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-3022-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2655-2023·2023-10-11

    Philips EarlyVue VS30 Monitor Software Flaw Disables Respiration Alarms

    Philips is recalling the EarlyVue VS30 Vital Signs Monitor due to a software issue that prevents the device from alarming when a patient's respiration rate exceeds safe limits, potentially delaying critical clinical intervention.

    Product
    EarlyVue VS30 Vital Signs Monitor, utilizing E01 (Oridion Microstream sidestream etCO2) and R21 (Masimo Rainbow RRa) simultaneously, Product Code 863359
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0032-2024·2023-10-11

    FDA Recalls HYDROmorphone Syringes for Sterility Assurance Issue

    Central Admixture Pharmacy Services has recalled approximately 398 HYDROmorphone in dextrose 5% injectable syringes nationwide due to lack of assurance of sterility. Patients should contact their healthcare provider immediately.

    Product
    HYDROmorphone in dextrose 5%, 0.5 mg/5 mL, (0.1 mg/mL), 5 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 (Drugs)·D-0019-2024·2023-10-11

    Fentanyl Injectable Syringes Recalled Due to Sterility Assurance Issue

    Central Admixture Pharmacy Services is recalling fentanyl 100 mcg/2 mL syringes due to a lack of assurance of sterility. The affected lot was distributed nationwide.

    Product
    fentaNYL, 100 mcg/2 mL, (50 mcg/mL), 3 mL Syringe, Rx only, Repackaged by CAPS Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2003-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0037-2024·2023-10-11

    API3200MD Mass Spectrometer Recalled for Potential Fire Risk

    AB Sciex is recalling three API3200MD mass spectrometers due to a rare risk of fire and electrode ejection from a solvent leak combined with electrical discharge. The flame could cause injury to users or property damage.

    Product
    API3200MD Mass Spectrometer, Part Number 4466230
    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-0028-2024·2023-10-11

    HYDROmorphone Injectable Syringes Recalled Over Sterility Assurance Issues

    Central Admixture Pharmacy Services is recalling 1,190 units of HYDROmorphone injectable syringes nationwide due to lack of sterility assurance. Patients using affected lots should contact their healthcare provider.

    Product
    HYDROmorphone in 0.9% sodium chloride, 10 mg/50 mL, (0.2 mg/mL), 50 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2010-2
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0025-2024·2023-10-11

    Fentanyl injectable syringes recalled nationwide for sterility assurance failure

    Fentanyl 1,250 mcg/25 mL syringes from Central Admixture Pharmacy Services Inc are being recalled nationwide due to lack of assurance of sterility. The manufacturer could not confirm that affected lots meet required sterility standards.

    Product
    fentaNYL, 1,250 mcg/25 mL, (50 mcg/mL), 30 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2003-7
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2653-2023·2023-10-11

    Apellis Injection Kit Filter Needles Recalled for Structural Defects

    Apellis Pharmaceuticals is recalling 61,943 units of Injection Kit components due to structural variations in the 19-gauge filter needle. No causal relationship has been established between the defect and the rare adverse events observed.

    Product
    Apellis Injection Kit 29g Injection Needle -single use intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin and either an 18-gauge or a 19-gauge 5 micron filter needle. Ref: IVT-KIT-29G
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2654-2023·2023-10-11

    EarlyVue VS30 Vitals Monitor May Fail to Alarm on Respiration Rate Violations

    A software defect in the Philips EarlyVue VS30 Vitals Monitor prevents alarms when respiration rate limits are violated, potentially delaying detection of dangerous breathing changes. Thirteen devices distributed in Massachusetts, Michigan, and Brazil are affected.

    Product
    EarlyVue VS30 Vitals Monitor, utilizing E01 (Oridion Microstream sidestream etCO2) and R21 (Masimo Rainbow RRa) simultaneously, Product Code 863380
    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-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-0013-2024·2023-10-11

    Fentanyl Injectable Solution Recalled Over Sterility Concerns

    Central Admixture Pharmacy Services Inc. is recalling fentanyl injectable solution nationwide due to lack of assurance of sterility. The FDA classified this as a Class II recall.

    Product
    fentaNYL in 0.9% sodium chloride, 2,500 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 (Drugs)·D-0027-2024·2023-10-11

    FDA recalls HYDROmorphone injectable syringes for sterility assurance defect

    The FDA is recalling HYDROmorphone injectable syringes from Central Admixture Pharmacy Services Inc. due to lack of sterility assurance. Approximately 1,190 syringes nationwide are affected.

    Product
    HYDROmorphone in 0.9% sodium chloride, 6 mg/30 mL, (0.2 mg/mL), 30 mL Syringe, Rx only, CAPS, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2010-1
    Category
    Drug
    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 (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 (Devices)·Z-0027-2024·2023-10-11

    Bard Marquee Core Biopsy Kit recalled for needle-cannula diameter mismatch

    Bard Peripheral Vascular is recalling 1,545 Bard Marquee biopsy kits because of a diameter mismatch between the biopsy needle and coaxial cannula. This defect may prevent proper tissue access during procedures and lead to complications including bleeding and pneumotharax.

    Product
    Bard Marquee Disposable Core Biopsy Instrument Kit, REF: MQK2016
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0015-2024·2023-10-11

    Guider Softip XF Guide Catheter Recalled for Incorrect Tip Curve Shape

    Guider Softip XF Guide Catheters were distributed with an incorrect tip curve shape differing from labeled specifications, affecting 1,086 units in Indiana.

    Product
    Guider Softip Guide Catheter 5F PRE-SHAPED 40 90CM, Catalog number M003100620, cardiac guide catheter
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0039-2024·2023-10-11

    Citrine QTRAP Mass Spectrometer Recalled for Flammable Solvent Fire Hazard

    AB Sciex is recalling ten Citrine QTRAP Mass Spectrometer units due to potential flame and electrode ejection from flammable solvent leaks combined with electrical discharge.

    Product
    Citrine QTRAP Mass Spectrometer, Part Number 5063685
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0010-2024·2023-10-11

    FDA Recalls Fentanyl Injectable Syringes Over Sterility Assurance Failure

    Central Admixture Pharmacy Services is recalling 598 fentanyl syringes due to lack of assurance of sterility. The affected lots were distributed nationwide.

    Product
    fentaNYL in 0.9% sodium chloride, 100 mcg/10 mL, (10 mcg/mL), 10 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2071-2
    Category
    Drug
    Distribution
    Distributed nationwide