The Recall Desk

State

Hawaii product recalls

72,968 recalls have nationwide distribution and so reach Hawaii. 2,767 additional recalls listed Hawaii specifically in their distribution scope.

What the numbers show

Total
2,767
Critical
333
Severe
567
Most recent
2026-09-16

Of the 2,767 recalls naming Hawaii we have scored against our rubric, 333 (12%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 567 (20%) are Severe.

These figures cover only the 2,767 recalls whose distribution notice names Hawaii specifically. The 72,968 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

4576–4600 of 75735

  • HighFDA (Devices)·Z-0349-2026·2025-11-05

    13mm closed vial spikes recalled because port weld may separate and leak

    ICU Medical is recalling 3,350 ChemoLock 13mm Closed Vial Spikes because the port weld of the drug transfer device may separate or break during use and leak.

    Product
    ICU Medical ChemoLock 13mm Closed Vial Spike REF: CL-82
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0337-2026·2025-11-05

    Oncology transfer kits recalled over port weld separation risk

    ICU Medical is recalling 600 Oncology Transfer Kits with ChemoClave and ChemoLock ports because the port weld of the drug transfer device may separate or break during use and leak.

    Product
    ICU Medical Oncology Transfer Kit w/ChemoClave and ChemoLock Port; Spiros w/Red Cap; ChemoLock Port REF: CL4138
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0319-2026·2025-11-05

    Surgical planning software recalled over image layer misalignment in 2D fusion

    Surgical Theater is recalling 45 units of its SuRgical Planner because a software anomaly may misalign secondary image layers against the primary layer.

    Product
    SuRgical Planner (SRP), software version SRP.7.12.0, imaging processing radiological system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0378-2026·2025-11-05

    Infusion pumps recalled over phantom touches on the touchscreen corner

    Fresenius Kabi is recalling six Ivenix Infusion System large volume pumps over a potential issue causing the device to register phantom touches in the lower-left corner of the touchscreen.

    Product
    Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0103-2026·2025-11-05

    Unit dose prazosin 5 mg cartons recalled over nitrosamine impurity

    Amerisource Health Services is recalling 3,410 unit dose cartons of Prazosin Hydrochloride Capsules 5 mg over N-nitroso Prazosin impurity C above the acceptable intake limit.

    Product
    PRAZOSIN HYDROCHLORIDE — PRAZOSIN HYDROCHLORIDE (PRAZOSIN HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0365-2026·2025-11-05

    Chemotherapy vial adapters recalled because port weld may separate and leak

    ICU Medical is recalling 202,900 ChemosafeLock Vial Adapters because the port weld of the drug transfer device may separate or break during use and leak.

    Product
    ICU Medical ChemosafeLock Vial Adapter REFs: KL-VA001U3 KL-VA002U3 KL-VA131U3 KL-VA201U3 KL-VA202U3 KL-VA321U3
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0321-2026·2025-11-05

    Surgical imaging software recalled over image layer misalignment in 2D fusion

    Surgical Theater is recalling 50 units of its PE SNAP imaging platform because a software anomaly may misalign secondary image layers against the primary layer.

    Product
    Surgical Navigation Advanced Platform Patient Engagement (PE SNAP), software version SNP.3.12.0, imaging processing radiological system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0308-2026·2025-11-05

    Entry system accessories recalled over incomplete seals in sterile pouches

    Alcon Research is recalling 1,632 accessory devices for Unity and Constellation surgical consoles because of incomplete seals in the pouch that provides the sterile barrier.

    Product
    Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation surgical consoles Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' 8065000356 27GA HP ENTRY SYSTEM, 4 MM 1 COUNT 8065000358 25GA HP ENTRY SYSTEM, 6 MM 1 COU
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0367-2026·2025-11-05

    Pyxis Medbank units recalled over fluid ingress causing smoke or fire

    CareFusion is recalling 8,262 BD Pyxis Medbank units because potential fluid ingress of the anesthesia or med station may result in smoke, system downtime and/or fire.

    Product
    Various models of BD Pyxis Medbank: Reference numbers: 1137-00 1145-00 1146-00 1147-00 1148-00 138902-01 138903-01 138905-01 138906-01 138907-01 138908-01 138909-01 138910-01 138911-01 138912-01 138913-01 138914-01 138915-01 138916-01 138917-01 138918-01 13
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0125-2026·2025-11-05

    Testosterone 62.5 mg pellets recalled over potential metal particulate matter

    FarmaKeio Outsourcing is recalling 829 sterile Testosterone 62.5 mg pellets from one lot over the potential presence of metal particulate matter.

    Product
    Testosterone 62.5 MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0383-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0133-2026·2025-11-05

    Testosterone and triamcinolone 50 mg pellets recalled over metal particulate matter

    FarmaKeio Outsourcing is recalling 64,924 sterile Testosterone / Triamcinolone Acetonide 50MG/10MCG pellets over the potential presence of metal particulate matter.

    Product
    Testosterone / Triamcinolone Acetonide 50MG/10MCG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0365-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0414-2026·2025-11-05

    Nasal test kits recalled after a false negative on a positive sample

    Cepheid is recalling 4,132 Xpert SA Nasal Complete kits after post-market half-time stability testing produced a false negative result for a positive sample type.

    Product
    Xpert SA Nasal Complete Catalog Number: GXSACOMP-10 UDI-DI code: 07332940000158 Xpert SA Nasal Complete kit; 10 test kit: A collection of reagents and other associated materials intended to be used for the direct qualitative and/or quantitative detection of nucleic acid from
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0335-2026·2025-11-05

    Bag spikes with Clave additive port recalled over port weld separation

    ICU Medical is recalling 3,000 ChemoLock Bag Spikes with Clave additive port because the port weld of the drug transfer device may separate or break during use and leak.

    Product
    ICU Medical ChemoLock Bag Spike with Clave Additive Port REF: CL3940
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0311-2026·2025-11-05

    Trocar sealing units recalled over silicone fragments detaching from sealing component

    Aesculap is recalling 26 sealing units for 10/12mm trocars because silicone fragments may detach from the yellow sealing component.

    Product
    Brand Name: AESCULAP Product Name: SEALING UNIT FOR 10/12MM TROCARS Model/Catalog Number: EK086P Software Version: N/A Product Description: SEALING UNIT FOR 10/12MM TROCARS Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0334-2026·2025-11-05

    Oncology kits with vented vial spike recalled over port weld failure

    ICU Medical is recalling 1,100 Oncology Kits containing a ChemoLock Universal Vented Vial Spike because the port weld of the drug transfer device may separate or break and leak.

    Product
    ICU Medical Oncology Kit w/31" (79 cm) 20 Drop Admin Set w/Integrated ChemoLock" Port Drip Chamber, Spiros"; ChemoLock"; ChemoLock" Universal Vented Vial Spike; Bag Hanger REF: CL3929
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0333-2026·2025-11-05

    Chemotherapy administration sets recalled because port weld may separate and leak

    ICU Medical is recalling 7,950 20-drop administration sets with an integrated ChemoLock port because the port weld of the drug transfer device may separate or break during use and leak.

    Product
    ICU Medical 30" (76 cm) Appx 3.6 ml, 20 Drop Admin Set w/Integrated ChemoLock Port Drip Chamber, ChemoLock w/Red Cap, Bag Hanger REF: CL3511
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0350-2026·2025-11-05

    ChemoLock ports recalled because the port weld may separate and leak

    ICU Medical is recalling 133,255 ChemoLock Ports because the port weld of the drug transfer device may separate or break during use and leak.

    Product
    ICU Medical ChemoLock Port REF: CL2100
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0134-2026·2025-11-05

    Testosterone and triamcinolone pellets recalled over potential metal particulate matter

    FarmaKeio Outsourcing is recalling 31,124 sterile Testosterone / Triamcinolone Acetonide 62.5MG/12.5MCG pellets over the potential presence of metal particulate matter.

    Product
    Testosterone / Triamcinolone Acetonide, 62.5MG/12.5MCG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0366-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0343-2026·2025-11-05

    Universal vented vial spikes recalled over port weld separation risk

    ICU Medical is recalling 16,850 ChemoLock Universal Vented Vial Spikes because the port weld of the drug transfer device may separate or break during use and leak.

    Product
    ICU Medical ChemoLock Universal Vented Vial Spike REF: CL-70
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0415-2026·2025-11-05

    Cardiac control material recalled over vial to vial troponin variability

    Microgenics is recalling 4,462 units of Thermo Scientific MAS Omni CARDIO control after customers reported vial-to-vial variability with high sensitivity Troponin I assays.

    Product
    Thermo scientific MAS Omni CARDIO, Liquid Assayed Integrated Cardiac Control, Model/Catalog Number: OCRD-L, OCRD-101, OCRD-202, OCRD-303, OCRD-SP, OCRD-MP, OCRD-UL; Product Description: In Vitro Diagnostic external control
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0344-2026·2025-11-05

    20mm vented vial spikes recalled over port weld separation risk

    ICU Medical is recalling 11,200 ChemoLock Vented Vial Spikes, 20mm, because the port weld of the drug transfer device may separate or break during use and leak.

    Product
    ICU Medical ChemoLock Vented Vial Spike, 20mm REF: CL-70S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0366-2026·2025-11-05

    Parathyroid hormone assay recalled over falsely depressed results at low range

    Siemens Healthcare Diagnostics is recalling 3,318 units of the IMMULITE 2000 Intact PTH assay over the potential for falsely depressed patient results at the low end of the assay range.

    Product
    Assay: IMMULITE 2000 Intact PTH; Test Code: iPT; Siemens Material Number (SMN): (1) 10381441, (2) 10381442; Catalog Number: (1) L2KPP2, (2) L2KPP6;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0316-2026·2025-11-05

    Soft tissue markers recalled over potential contamination with cotton fibers

    Endomagnetics is recalling 1,760 Magseed Pro 7 cm soft tissue markers because of the potential for contamination with cotton fibers.

    Product
    Magseed Pro 7 cm soft tissue marker. Model Number: MS2-17-1-07. Product Description: The Endomag Magseed Pro Magnetic Marker System is a sterile, single use device composed of a marker preloaded in a 17ga Needle Delivery System. The Endomag Magseed Pro Marker is indicated for
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0360-2026·2025-11-05

    Graduated adapter extension sets recalled over port weld separation risk

    ICU Medical is recalling 5,700 7.5-inch extension sets with a ChemoLock port and graduated adapter because the port weld may separate or break during use and leak.

    Product
    ICU Medical 7.5" (19 cm) Appx 1.5 ml, Ext Set w/ChemoLock" Port, Clamp, Graduated Adapter REF: CL3967
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0355-2026·2025-11-05

    Mini bag spike connectors recalled over port weld separation risk

    ICU Medical is recalling 400 ChemoLock connectors with Mini Bag Spike because the port weld of the drug transfer device may separate or break during use and leak.

    Product
    ICU Medical ChemoLock w/Mini Bag Spike ¿ REF: C-17
    Category
    Medical Device
    Distribution
    Distributed nationwide