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.

11576–11600 of 20322

  • 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 (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-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-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 (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 (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-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-0008-2024·2023-10-11

    VITROS Proboscis/Piston Assembly Recall for Assay Accuracy Defect

    Ortho-Clinical Diagnostics is recalling 9,860 Proboscis/Piston Assemblies for VITROS diagnostic systems manufactured April-December 2022 due to a manufacturing defect that may cause falsely elevated drug assay results and delayed patient test results.

    Product
    Proboscis/Piston Assembly, Part Number J55375, for VITROS 5,1 FS Chemistry System (Product Code 6801375), VITROS 5,1 Chemistry System (Refurbished) (Product Code 6801890), VITROS 3600 Immunodiagnostic System (Product Code 6802783), VITROS 3600 Immunodiagnostic System (Refurbished
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-0017-2024·2023-10-11

    Cardiac guide catheter recalled for incorrect tip curve shape

    Boston Scientific is recalling 1,728 units of Guider Softip Guide Catheter 6F due to a manufacturing defect producing incorrect tip curve shapes differing from labeled specifications.

    Product
    Guider Softip Guide Catheter 6F PRE-SHAPED 40 100CM, Catalog number M003101420, cardiac guide catheter
    Category
    Medical Device
    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-2665-2023·2023-10-11

    Qiagen therascreen KRAS PCR Kit Handbook Error Could Cause False Negative Results

    Qiagen is recalling therascreen KRAS RGQ PCR Kits due to ambiguous handbook instructions that could lead to false negative results in cancer mutation detection. All kits with expiry dates of March 2023 or later are affected.

    Product
    therascreen ¿KRAS RGQ PCR Kit (24)-IVD qualitative PCR assay used on the Rotor-Gene Q MDx instrument for the detection of seven somatic mutations in the human KRAS oncogene REF 870021 (US IVD)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0012-2024·2023-10-11

    Fentanyl injectable product recalled for lack of sterility assurance

    Central Admixture Pharmacy Services is recalling fentanyl injection product due to lack of sterility assurance. No illnesses have been reported.

    Product
    fentaNYL in 0.9% sodium chloride, 1,000 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-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-0026-2024·2023-10-11

    Injectable Succinylcholine Syringes Recalled for Sterility Assurance Failure

    Central Admixture Pharmacy Services Inc is recalling 3,590 succinylcholine 200 mg/10 mL syringes distributed nationwide due to lack of assurance of sterility. No illnesses have been reported.

    Product
    succinylcholine, 200 mg/10 mL, (20 mg/mL), 10 mL syringe, Rx only, CAPS, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-6011-2
    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-0041-2024·2023-10-11

    Real Intelligence CORI knee surgery software missing planning stage

    Real Intelligence CORI RI.KNEE v2.0 surgical planning software is being recalled due to a missing planning stage in cases with significant knee deformation. Affected units nationwide should not be used without verification.

    Product
    Real Intelligence CORI RI.KNEE v2.0 TKA (Total Knee Arthroplasty) software version 2.0 (2.0.0.5) Product Number: ROB10299
    Category
    Medical Device
    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
  • ModerateFDA (Drugs)·D-0034-2024·2023-10-11

    Dr. Berne's MSM MIST 15% Topical Spray Recalled for Manufacturing Deviations

    Dr. Berne's Whole Health Products has voluntarily recalled Dr. Berne's MSM MIST 15% Solution (30 mL bottles) due to Current Good Manufacturing Practice (CGMP) deviations identified during manufacturing. The recall affects 795 bottles distributed nationwide and internationally.

    Product
    Dr. Berne's MSM MIST 15% Solution, 30 mL/1.014 OZ bottle, Distributed by: Dr. Berne's Whole Health Products, Tesuque, NM, 87574, [email protected].
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0033-2024·2023-10-11

    Dr. Berne's MSM Drops Recalled Due to Manufacturing Practice Deviations

    Dr. Berne's MSM DROPS is being recalled due to manufacturing practice deviations. The recall involves 6,060 bottles distributed nationwide and internationally.

    Product
    Dr. Berne's MSM DROPS 15% Solution, 30 mL/1.014 OZ bottle, Distributed by: Dr. Berne's Whole Health Products, Tesuque, NM, 87574, [email protected], UPC 00854582001036
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0036-2024·2023-10-11

    Drug Recall: Dr. Berne's MSM Drops for Manufacturing Practice Violations

    Dr. Berne's MSM DROPS 5% Solution is being recalled due to Current Good Manufacturing Practice (CGMP) deviations. The voluntary recall affects 3833 bottles distributed nationwide and internationally.

    Product
    Dr. Berne's MSM DROPS 5% Solution, 30 mL/1.014 OZ bottle, Distributed by: Dr. Berne's Whole Health Products, Tesuque, NM, 87574, [email protected], UPC 00854582001111.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0039-2024·2023-10-11

    HydrALAZINE Hydrochloride Tablets recalled due to impurity specifications failure

    Amerisource Health Services LLC is recalling HydrALAZINE Hydrochloride Tablets, 10 mg, nationwide due to impurities exceeding specifications in a repackaged product batch.

    Product
    HydrALAZINE Hydrochloride Tablets, USP, 10 mg, 100 Tablets (10 x 10) per carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Carton NDC#: 68084-447-01; Individual Dose NDC: 68084-447-11
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2648-2023·2023-10-11

    Siemens MAGNETOM headphones may create artifacts during MRI imaging

    Siemens Medical Solutions is recalling over-ear headphones used with MAGNETOM MRI systems. Lubricating grease in the headband may cause visible imaging artifacts during head examinations.

    Product
    (1) Over-ear headphones used with the MAGNETOM Amira MAGNETOM Free.Star MAGNETOM Sempra, MAGNETOM Free.Max, MAGNETOM Mica MAGNETOM Spectra Siemens Model Number:11060845 Used with the following MAGNETOM MRI Systems: MAGENTOM Amira 10836777 & 10838610; MAGENTOM Free.Max 1140
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0038-2024·2023-10-11

    Oxybutynin Extended-Release Tablets Recalled for Failed Dissolution Specifications

    Zydus Pharmaceuticals recalls Oxybutynin Chloride Extended-Release Tablets 10 mg nationwide because the medication failed dissolution specifications. Affected lot numbers: M300652 and M300651.

    Product
    OXYBUTYNIN — OXYBUTYNIN (OXYBUTYNIN)
    Category
    Drug
    Distribution
    Distributed nationwide