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.

11526–11550 of 20322

  • 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 (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-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-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 (Devices)·Z-2658-2023·2023-10-11

    HeartMate Left Ventricular Assist Device Coring Knife Sharpness Defect

    The Apical Coring Knife in HeartMate 3 Left Ventricular Assist System kits may be inadequately sharp, potentially extending surgical implantation time. Thoratec has distributed 2,681 affected units worldwide.

    Product
    Heartmate 3 LVAS Implant Kit, REF: 106524US, 106524INT; Heartmate XVE & HeartMate II Apical Coring Knife, REF: 1050
    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-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-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 (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-0007-2024·2023-10-11

    Phenylephrine Injectable Syringes Recalled for Sterility Assurance

    Central Admixture Pharmacy Services Inc is recalling phenylephrine injectable syringes nationwide due to lack of assurance of sterility. The recall affects 19,510 units distributed across multiple lot numbers.

    Product
    PHENYLephrine in 0.9% sodium chloride, 1,000 mcg/10 mL, (100 mcg/mL), 10 mL syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-6009-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0030-2024·2023-10-11

    Hydromorphone Syringe Recalled Due to Lack of Sterility Assurance

    Central Admixture Pharmacy Services Inc. is recalling hydromorphone syringes due to lack of assurance of sterility. The recall affects 274 syringes distributed nationwide.

    Product
    HYDROmorphone in dextrose 5%, 3 mg/30 mL, (0.1 mg/mL), 30 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2013-2
    Category
    Drug
    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 (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-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 (Devices)·Z-2650-2023·2023-10-11

    IceCure Cryoablation System ProSense Manual Updated for Mechanical Damage Safety

    Icecure Medical Ltd is updating the user manual for IceCure Cryoablation System ProSense surgical devices to add safety guidelines for managing mechanical damage such as bent cryoprobes.

    Product
    IceCure Cryoablation System ProSense -Intended for cryogenic destruction of tissue during surgical procedures by the application of extreme cold temperatures Models: (1)FAS3000000 (100-127 VAC); (2)FAS3000000-2 (100-127 VAC)
    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-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 (Drugs)·D-0029-2024·2023-10-11

    HYDROmorphone Syringes Recalled for Lack of Sterility Assurance

    Central Admixture Pharmacy Services is recalling 4,550 syringes of HYDROmorphone due to lack of assurance of sterility. The product was distributed nationwide.

    Product
    HYDROmorphone in 0.9% sodium chloride, 15 mg/30 mL, (0.5 mg/mL), 30 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2011-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0014-2024·2023-10-11

    Cardiac Guide Catheters Recalled for Incorrect Tip Curve Shape

    Certain lots of Guider Softip Guide Catheters were manufactured with an incorrect tip curve shape that differs from labeled specifications. The recalled devices include 17,436 units distributed in Indiana.

    Product
    Guider Softip Guide Catheter 8F 90CM MULTI PURPOSE, Catalog number H965100480, cardiac guide catheter
    Category
    Medical Device
    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-0069-2024·2023-10-11

    Zimmer Dermatome Blades recalled for producing thin, non-uniform skin grafts

    Zimmer Surgical is recalling dermatome blades that produce thin, non-uniform skin grafts during surgical use. The defect may require additional surgical harvests to adequately cover grafting sites.

    Product
    Zimmer Dermatome Blades- 10-pack boxes of blades. Intended for use with the dermatome handpiece which is a skin grafting instrument that is intended to provide variable graft thickness and width capabilities Part number: 00880000010
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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 (Drugs)·D-0014-2024·2023-10-11

    Fentanyl Injection Bags Recalled Due to Sterility Assurance Concerns

    Central Admixture Pharmacy Services is recalling 403 bags of fentanyl injection due to lack of sterility assurance. The affected lots were distributed nationwide.

    Product
    fentaNYL in 0.9% sodium chloride, 5,000 mcg/250 mL, (20 mcg/mL), 250 mL Bag, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2074-1
    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