The Recall Desk

State

Hawaii product recalls

20,305 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.

9701–9725 of 20305

  • HighFDA (Devices)·Z-1469-2024·2024-04-10

    Covidien Auto Suture blunt tip trocar recalled for seal disengagement

    Covidien recalls its Auto Suture blunt tip trocar (OMS-T10BTS) due to potential seal disengagement when mesh products are used incorrectly, affecting approximately 18,048 units worldwide.

    Product
    Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BTS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1439-2024·2024-04-10

    Centurion Curette kits recalled for weak seals potentially compromising sterility

    Medline Industries is recalling Centurion Curette kits because some may have weak seals that could compromise product sterility. The weak seal may not be detectable during inspection.

    Product
    Centurion Curette kits labeled as: a) STERILE BUCK EAR CURETTE "00" (25697), Product Code 66745; b) STERILE "1" EAR CURETTE (505629), Product Code 67050; c) STERILE FOX DERMAL CURETTE, 5MM(32923), Product Code 67430; d) STERILE EXCAVATOR CURETTE (P/S), Product Code I67970
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1428-2024·2024-04-10

    Medline Pediatric Magill Catheter Recalled for Weak Seal Risk

    Medline is recalling its Centurion FCP Magill Catheter (7.5 in. pediatric) because the product may have a weak seal that could compromise sterility. The affected units were distributed in the US, Panama, and Canada.

    Product
    Centurion FCP MAGILL CATH 7.5 IN PED (67575), Product Code 67575
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1462-2024·2024-04-10

    Mobile X-ray System Structural Cable Defect Affects Safety Function

    Agfa DX-D 100 mobile X-ray systems have a structural cable defect in the support column that may prevent the safety mechanism from blocking the arm if the cable fails, potentially resulting in patient injury.

    Product
    Agfa DX-D 100 system-Digital Radiography mobile X-ray System. A mobile X-Ray modality, consisting of X-Ray console, generator, tube, digital detector, and workstation. This modality is used to generate projection X-Ray images of human patients. Models: 5411/ 050, A5411/ 0300
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1447-2024·2024-04-10

    Centurion PICC Line Securement Kit Recalled for Weak Seal

    MEDLINE is recalling the Centurion PICC Line Securement Kit because its seal may be weak, potentially allowing sterility breach. Users may not be able to detect the weakness.

    Product
    Centurion PICC LINE SECUREMENT KIT, Product Code IVS565
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1479-2024·2024-04-10

    ARCHITECT Anti-HCV Reagent Kit Recalled for False Positive Results

    Abbott GmbH is recalling ARCHITECT Anti-HCV Reagent Kit (7,219 units) due to falsely elevated test results when processed after certain other tests on the same instrument. The product was distributed nationwide.

    Product
    ARCHITECT Anti-HCV Reagent Kit, List Numbers: a) 1L79-25, b) 1L79-35
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1435-2024·2024-04-10

    Centurion Surgical Hook Kits Recalled Due to Weak Seal

    Medline Industries is recalling 1,520 Centurion surgical hook kits worldwide due to weak seals that may compromise sterility. The seal defect may not be detectable by users.

    Product
    Centurion hook kits labeled as: a) STERILE SKIN HOOK FINE (EA3975F), Product Code 66660; b) STERILE SMALL 2 PRONG SKIN HOOK (25754), Product Code 67105; c) STERILE NEWS TRACH HOOK(83300), Product Code 67810; d) STERILE LILLIE EAR HOOK DELICATE 7", Product Code I68655
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1472-2024·2024-04-10

    Karl Storz Grasping Forceps Recalled for Inadequate Reprocessing Validation

    FDA recalls 190 units of Karl Storz grasping forceps due to inadequate evidence validating safe reprocessing and sterilization of the instruments.

    Product
    Karl Storz SE & CO. KG, REF 11003MB, Grasping Forceps, Flexible 1 mm, Rx Only
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1401-2024·2024-04-10

    Cardiovascular Procedure Kits Recalled for Pressure Relief Valve Defect

    Terumo is recalling 20,533 cardiovascular procedure kits due to a pressure relief valve that opens at incorrect pressure (200-300 mmHg instead of 400 mmHg). The defect could cause myocardial tissue damage during cardiac surgery.

    Product
    Cardiovascular Procedure Kits that include High Crack Check Valve PN 205307A Part Number: 6375 16010 62974 65246 66312 66342 66388 66650 66852 70472 74307 74365 74366 74430 74475 74477 74502 74773 74873 75065 75157 75195 75409 75410 75473 75533 75534
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1445-2024·2024-04-10

    Suture Removal and Staple Remover Kits Recalled for Weak Seal

    Medline Industries is recalling suture removal trays and staple remover kits due to weak seals that may compromise product sterility. Approximately 23,290 units were distributed in the US, Panama, and Canada.

    Product
    Centurion manual surgical kits labeled as: a) SUTURE REMOVAL TRAY, Product Code TRI55405; b) SUTURE REMOVAL SET, Product Code 60265 MEDLINE manual surgical kits labeled as: a) SUTURE REMOVAL TRAY, Product Code 60280; b) SUTURE REMOVAL TRAY, Product Code 86125; c) SUT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1402-2024·2024-04-10

    Exactech Equinoxe Glenoid Shoulder Components Recalled for Nonconforming Packaging

    Exactech, Inc. is recalling 2,077 units of Equinoxe Glenoid shoulder components due to nonconforming packaging. The affected units were packaged in vacuum bags lacking the required oxygen barrier layer.

    Product
    Exactech Equinoxe GLENOID,KEELED, CEMENTED, Mates with 38, 41, 44 head, alpha curvature, Sizes: a), Small, Item Number 314-01-02; b) Medium, Item number 314-01-03; c) Large, Item Number 314-01-04, Shoulder Arthroplasty
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1415-2024·2024-04-10

    Exactech Shoulder Implant Components Recalled for Inadequate Oxygen Barrier Packaging

    Exactech Equinoxe shoulder implant components (4,007 units) are recalled because their vacuum-sealed packaging lacks a required oxygen barrier layer, potentially allowing material degradation.

    Product
    Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Right, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-32, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-33, c) 44, 47, 50, 53 head, Large, Item Number 314-13-34, d) 44, 47, 50, 53 head, Ext
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1450-2024·2024-04-10

    Centurion Manual Uterine Dilator Surgical Kits Recalled for Weak Seal

    MEDLINE INDUSTRIES is recalling Centurion Manual uterine dilator surgical kits due to weak seals that may breach sterility. The weak seal could allow contamination and may not be detectable by users.

    Product
    Centurion Manual surgical kits labeled as: a) HEGAR UTERINE DILATOR, 11-12MM, STERILE, Product Code HUD112ST; b) STERILE UTERINE DILATOR 1MM/2MM, Product Code HUD12ST; c) HEGAR UTERINE DILATOR, 5-6MM, STERILE, Product Code HUD56ST; d) HEGAR UTERINE DILATOR, 9-10MM, STERI
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1429-2024·2024-04-10

    Dental Rolls Recalled for Potential Sterility Breach from Weak Seal

    Centurion Sterile Cotton Dental Rolls with weak seals may have compromised sterility. Affected products may allow contamination if the seal fails.

    Product
    Centurion STERILE COTTON DENTAL ROLLS 6/PK, Product Code 9125ST6
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1399-2024·2024-04-10

    BD Phoenix Yeast ID Panel Recalled for Incorrect Substrate Placement

    Becton Dickinson recalls BD Phoenix Yeast ID Panel units (Lot 3312180) due to misplaced esculin substrate that triggers system abortion. No injuries reported.

    Product
    BD Phoenix Yeast ID Panel is a self-inoculating (when used with a BD Phoenix Automated Microbiology System) polystyrene panel (tray) containing control wells and substrate wells with dried biochemical substrates that use traditional qualitative microbiology methods such as fermen
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1422-2024·2024-04-10

    Exactech Equinoxe Reverse Shoulder Humeral Liners Recalled for Nonconforming Packaging

    Exactech, Inc. is recalling 24,303 units of Equinoxe Reverse Shoulder humeral liners due to nonconforming vacuum-bag packaging. The bags lack the required oxygen barrier layer, failing to meet packaging specifications.

    Product
    Exactech Equinoxe REVERSE SHOULDER,42mm Humeral Liner, a) +0mm, Item number 320-42-00, b) +2.5mm, Item Number 320-42-03; Shoulder Arthroplasty
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1412-2024·2024-04-10

    Shoulder Implant Components Recalled for Nonconforming Packaging

    Exactech Inc. is recalling 11,031 shoulder implant components due to nonconforming vacuum bag packaging lacking a required oxygen barrier layer. The missing Ethylene Vinyl Alcohol (EVOH) layer could allow oxygen exposure to the UHMWPE material.

    Product
    Exactech Equinoxe CAGE GLENOID, CEMENTED, alpha curvature, Mates with: a) 38, 41, 44 head, Small, Item Number 314-13-02, b) 38, 41, 44 head, Medium, Item Number 314-13-03, c) 38, 41, 44 head, Large, Item Number 314-13-04; Shoulder Arthroplasty
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1474-2024·2024-04-10

    Karl Storz Uvula Retractors Recalled for Inadequate Reprocessing Validation

    Karl Storz Endoscopy is recalling 147 units of the REF 723014 Uvula Retractor due to inadequate reprocessing validation. The manufacturer cannot demonstrate that current sterilization methods ensure proper device sterility.

    Product
    Karl Storz SE & CO. KG, REF 723014, Uvula Retractor, For Veterinary Use Only, Rx Only
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1393-2024·2024-04-10

    X-Guide Handpiece Adaptor Sleeve 3 Manufacturing Defect Recall

    X-NAV Technologies is recalling the X-Guide Handpiece Adaptor Sleeve 3 due to a manufacturing defect causing incorrect geometry that prevents proper fit. The recall affects 154 units distributed worldwide.

    Product
    X-Guide Handpiece Adaptor Sleeve 3, Model P010727
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1423-2024·2024-04-10

    Exactech Equinoxe Reverse Shoulder Implant Liners Recalled for Oxygen Barrier Packaging Defect

    Exactech recalls 3,648 reverse shoulder implant liners due to nonconforming packaging. Vacuum bags lack required oxygen barrier (EVOH) protection against material degradation.

    Product
    Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1461-2024·2024-04-10

    Halyard surgical hood mislabeled as surgical cap at dispenser

    O&M Halyard is recalling approximately 75,000 surgical hoods mislabeled as surgical caps at the dispenser level.

    Product
    HALYARD SURGICAL HOOD, Universal Size, Blue, 300 count (3 x 100)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1414-2024·2024-04-10

    Exactech Equinoxe Shoulder Components Recalled for Nonconforming Packaging

    Exactech is recalling 3,436 units of shoulder arthroplasty components due to nonconforming packaging that lacks a required oxygen barrier layer. The products may not be adequately protected against oxidative degradation.

    Product
    Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Left, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-22, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-23, c) 44, 47, 50, 53 head, Large, Item Number 314-13-24, d) 44, 47, 50, 53 head, Extra
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1475-2024·2024-04-10

    3M Tube Securement Devices Recalled for Missing Film Layer and Shape Defects

    3M is recalling 265,435 tube securement devices (REF 1500U and 1501U) due to manufacturing defects including missing or partial top film layers and incorrect device shape from excess material not properly removed.

    Product
    3M Tube Securement Device, Small, 1.7 IN/PO x 2.4 IN/PO, REF 1500U, Sterile; and 3M Tube Securement Device, Large, 2.2 IN/PO x 3.5 IN/PO, REF 1501U, Sterile. Product is packaged 1 device per pouch, 25 pouches per primary carton, and 4 primary cartons per shipper box.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1400-2024·2024-04-10

    Hill-Rom PRO+ Pressure Relief Mattress Service Correction Reassessment

    Baxter Healthcare is reassessing 232 Hill-Rom PRO+ pressure relief mattresses due to identified inconsistencies in service records from a previous correction. These mattresses must be verified to confirm corrections were properly applied.

    Product
    Hill-Rom PRO+ 36" MRS Surface, REF P7924A03, The pro+ mattress is intended for patient support and for the prevention and/or treatment of pressure injuries.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0434-2024·2024-04-10

    Cyclophosphamide Injection Recalled for Package Insert Concentration Labeling Error

    X-Gen Pharmaceuticals recalls Cyclophosphamide for Injection due to a labeling error in the Package Insert. Section 2.3 incorrectly lists the concentration as '20 mg per vial' instead of the correct '20 mg per mL'.

    Product
    Cyclophosphamide for Injection, USP, 1g/vial, Lyophilized, Single Dose Vial, Discard unused solution, Cytotoxic Agent, After Reconstitution: For direct intravenous injection or must be further diluted before intravenous infusion, Rx Only, Manufactured for: XGen Pharmaceuticals DJ
    Category
    Drug
    Distribution
    Distributed nationwide