The Recall Desk

State

Hawaii product recalls

20,307 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.

10501–10525 of 20307

  • HighFDA (Devices)·Z-0894-2024·2024-02-07

    SCORPIO U-Dome Patella Knee Implant Recalled Due to Material Degradation Risk

    Howmedica Osteonics has recalled certain SCORPIO U-Dome Patella knee implants due to potential material oxidation in units manufactured with raw material over 5 years old. The oxidation may affect the implant's material properties.

    Product
    SCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73-3308
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0831-2024·2024-02-07

    Custom OB/GYN Procedural Kits Recalled for Sterilization Process Failure

    American Contract Systems recalled 144 custom OB/GYN procedural kits after discovering components were sterilized without proper documentation, potentially losing functionality or efficacy. Affected units were distributed nationwide.

    Product
    Custom procedural convenience kits and trays, Obstetrical & Gynecological use, labeled as: a) LavH, kit number BBLV21C; b) LAP HYST 247540, kit number BFHY75U
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0917-2024·2024-02-07

    Knee Replacement Tibial Inserts Recalled Due to Material Oxidation Risk

    Knee replacement tibial inserts from Howmedica may have elevated oxidation if manufactured with raw material over 5 years old, potentially affecting material properties.

    Product
    DURATION A-P LIPPED TIB.INSERT-DURAC Intended for knee replacement Product Number: 6642-1-911
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0817-2024·2024-02-07

    Custom Cardiac Procedural Kits Recalled for Inadequate Sterilization Assessment

    American Contract Systems is recalling 4394 custom cardiac procedural kits due to components added without proper assessment for sterilization exposure, which may result in loss of functionality or drug efficacy.

    Product
    Custom procedural convenience kits and trays, cardiac, labeled as: a) HEART CATHETERIZATION TRAY, kit number JRHC45G; b) TAVR PACK, kit number LLTV10; c) CATH PED LF SJH, kit number SJCA21F; d) CATH HEART ADL LF SJH, kit number SJCH22F; e) INT RAD PORTS-LF - 206060, ki
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0882-2024·2024-02-07

    SCORPIO TS TIB INSERT Knee Replacement Components Recalled for Potential Material Degradation

    Howmedica Osteonics is recalling SCORPIO TS TIB INSERT knee replacement inserts manufactured with aging raw material. The material may develop elevated oxidation that could affect performance.

    Product
    SCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-7524
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0970-2024·2024-02-07

    Vortex Surgical ACTU8 Forceps Recalled Due to Residue on Forceps Tips

    Vortex Surgical has voluntarily recalled 800 ACTU8 FORCEPS units due to residue identified on forceps tips. The recall affects surgical instruments distributed in the US (OH, WA, MN, MI, IA) and Korea.

    Product
    Vortex Surgical ACTU8 FORCEPS, 25 GA, ADAPTIVE, REF VS0740.25
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0927-2024·2024-02-07

    Cryo Module Tank Hose Assemblies Recalled for Material and Design Defects

    AtriCure recalls certain tank hose assemblies for Cryo Module equipment due to manufacturing defects. The units have incorrect inner tube material and missing required perforations on the outer sheathing.

    Product
    Cryo Module Accessories Domestic CMA-OUS, Product Catalog Number A001053
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0907-2024·2024-02-07

    Knee replacement inserts recalled for potential material oxidation

    Howmedica Osteonics Corp. is recalling LEFT LARGE-PCA knee replacement inserts manufactured with raw material over 5 years old due to potential elevated oxidation levels that could affect material properties.

    Product
    LEFT LARGE-PCA MOD.REV.DUR.REV.INSERT Intended for knee replacement Part Number: 6637-0-228
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0904-2024·2024-02-07

    Knee Replacement Component Recalled for Potential Material Degradation

    Howmedica Osteonics Corp. is recalling P7 28MM 10 DEGREE +4MM INSERT knee replacement components (Lot 61311701, 62122001) due to potential oxidation in aged UHMWPE material that could affect material properties.

    Product
    P7 28MM 10 DEGREE +4MM INSERT Intended for knee replacement Part Number: 6302-6-107
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0909-2024·2024-02-07

    Knee replacement implant recall due to material oxidation risk

    Howmedica Osteonics is recalling knee replacement implants manufactured with aged UHMWPE raw material that may have elevated oxidation levels, which could degrade the material's mechanical properties.

    Product
    LEFT X-LARGE-PCA MOD.REV.DUR.REV.INSERT Intended for knee replacement. Product Number: 6637-0-328
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0945-2024·2024-02-07

    Philips Achieva MRI Scanner Recall: Loose Coil Seals May Cause Skin Injury

    Philips is recalling Achieva 1.5T MRI scanners due to a seal adhesive defect on the body coil that may fail during scanning, creating sharp edges that risk skin injury including abrasions and lacerations.

    Product
    Achieva 1.5T. Model (REF) Numbers 781196, 781343, 781296.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0887-2024·2024-02-07

    Knee Replacement Implant Recalled Due to Potential Material Degradation

    Knee replacement components recalled due to potential oxidation in UHMWPE material that could affect durability. Approximately 76 units distributed in the US with additional international distribution.

    Product
    SCORPIO TOTAL KNEE MEDIALIZED DOME PATELLA-SZ #5 -Intended for knee replacement Part Number: 73-0510
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0870-2024·2024-02-07

    Knee implant component recalled due to potential material oxidation

    Howmedica Osteonics is recalling SCORPIO RECESSED PATELLA knee implant components made from UHMWPE material over 5 years old that may develop elevated oxidation.

    Product
    SCORPIO RECESSED PATELLA- Intended for knee replacement Part Number: 3044-0028
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0836-2024·2024-02-07

    Medical sterilization chemical integrators recalled due to labeling discrepancy

    TERRAGENE S.A. is recalling over 36,000 chemical integrator strips used to verify sterilization in healthcare settings because the instructions distributed with the products don't match the FDA-cleared instructions for use.

    Product
    Terragene Integron IT26-C Terragene Integron IT26-C with extender Benco Dental Chemical Integrator [5726-583] Tuttnauer (WTL198-0082) Terragene Integron (PCD26-C) Terragene Bionova PCD (PCD222-C)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0876-2024·2024-02-07

    Knee Implant Inserts Recalled Due to Potential Material Degradation

    Howmedica Osteonics is recalling SCORPIO TS TIB knee implant inserts (Part Number 72-4-0510) manufactured with UHMWPE material over 5 years old. The material may have elevated oxidation levels that could affect implant performance.

    Product
    SCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-0510
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0875-2024·2024-02-07

    Knee replacement implant recalled for potential material oxidation

    Howmedica Osteonics recalls SCORPIO TS TIB knee replacement inserts (lot TA21X9) manufactured from UHMWPE material over 5 years old due to potential elevated oxidation that could affect material properties. No injuries reported.

    Product
    SCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-0321
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0937-2024·2024-02-07

    EZDilate Fixed Wire Balloon Recalled for Device Failure and Foreign Body Risk

    Olympus recalls approximately 5,031 EZDilate Fixed Wire Balloons due to device bursting, leaking, and foreign body incidents during esophageal dilation procedures. Patients should contact their healthcare provider if they received this device.

    Product
    EZDilate Fixed Wire Balloon 16-17-18. Indicated for endoscopic dilation of strictures of the esophagus in adults and adolescents (>12 years). Model: BD-400P-1880
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0826-2024·2024-02-07

    Custom Procedural Convenience Kits Recalled for Sterilization Validation Failure

    American Contract Systems is recalling 244 custom procedural kits (Baby PICC, Pediatric PICC, and PORT PACK) distributed nationwide. Components subjected to sterilization without proper validation documentation may have reduced functionality or elevated sterilization residuals.

    Product
    Custom procedural convenience kits and trays, general hospital use, labeled as: a) Baby PICC Kit, kit number UIBP90J; b) Baby PICC Kit, kit number UIBP90K; c) PORT PACK (PS 058330), kit number UIPO82AB; d) Pediatric PICC Kit, kit number UIPP76K;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0956-2024·2024-02-07

    Philips MRI coil seal adhesive may fail, creating sharp edges and injury risk

    A Philips MRI coil component's adhesive may fail and create sharp edges that could injure patients during scanning. The defect affects 286 units worldwide.

    Product
    SmartPath to dStream for XR and 3.0T. Model (REF) Numbers 781270, 782113, 782129.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0890-2024·2024-02-07

    Knee replacement implant recalled due to material oxidation risk

    Howmedica Osteonics is recalling a knee replacement patellar component that may have been manufactured with oxidized raw material. Products using UHMWPE over 5 years old can develop elevated oxidation and degraded material properties.

    Product
    SCORPIO TOTAL KNEE CONCENTRIC DOME PATELLA-SZ #11 -Intended for knee replacement Part Number: 73-2110
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0834-2024·2024-02-07

    Endoscopic Surgical Stapler Reload May Fail to Form Complete Staple Line

    An endoscopic surgical stapler reload may fail to properly form staples during use, potentially leaving tissue inadequately sealed. This could lead to bleeding or require additional surgery.

    Product
    ENDOPATH ECHELON 45mm RELOADS WITH GRIPPING SURFACE TECHNOLOGY (GST), ECHELON Endopath Stapler, Endoscopic Linear Cutter Reload (+Gripping Surface technology), 45MM WHITE VASCULAR/THIN, Product No. GST45W
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0884-2024·2024-02-07

    Knee replacement bearing insert recalled due to material degradation risk

    Howmedica Osteonics Corp. is recalling Scorpio-Flex knee bearing inserts made with material over 5 years old that may develop oxidation affecting performance. Affected patients should contact their physician if they experience knee problems.

    Product
    Scorpio-Flex Ttl Kn P-S Tib Brg Insrt Asy- -Intended for knee replacement Part Number: 72-16-0908
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0873-2024·2024-02-07

    Series II Tibial Bear Insert Recalled for Potential Material Degradation

    Howmedica Osteonics Corp. is recalling the Series II Tibial Bear Insert for knee replacement because UHMWPE material over 5 years old may develop elevated oxidation that can affect the component's material properties.

    Product
    SERIES II TIBIAL BEAR INSERT-Intended for knee replacement Part Number: 3052-0515
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0905-2024·2024-02-07

    Knee replacement inserts recalled due to material oxidation risk

    P7 knee replacement inserts may contain UHMWPE material over 5 years old that has developed oxidation, potentially degrading the material's properties. Patients should consult their healthcare provider.

    Product
    P7 32MM 1O DEGREE +4MM INSERT Intended for knee replacement Part Number: 6302-6-307
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0822-2024·2024-02-07

    Custom Surgical Procedure Kits Recalled for Improper Sterilization Assessment

    American Contract Systems is recalling 3,196 custom surgical procedure kits because sterilized components lacked documented suitability assessment. The components may have lost functionality or accumulated excessive sterilization residuals.

    Product
    Custom procedural convenience kits and trays, gastroenterological & urological, labeled as: a) LAP KIDNEY MODULE, kit number AGKD50L; b) ROBOTIC PROSTATE PACK - 264852, kit number ANPR34S; c) LAP CHOLE - 213388, kit number BFLC02AD; d) GENERAL LAPAROSCOPY PACK, kit numbe
    Category
    Medical Device
    Distribution
    Distributed nationwide