The Recall Desk

State

Hawaii product recalls

73,584 recalls have nationwide distribution and so reach Hawaii. 2,772 additional recalls listed Hawaii specifically in their distribution scope.

What the numbers show

Total
2,772
Critical
333
Severe
715
Most recent
2026-10-14

Of the 2,772 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 715 (26%) are Severe.

Which agencies issued them

These figures cover only the 2,772 recalls whose distribution notice names Hawaii specifically. The 73,584 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

751–775 of 76356

  • HighFDA (Devices)·Z-3056-2026·2026-09-09

    Medline IV Start Kits Recalled for Potential Sterility Breach

    Medline is recalling 22,736 IV start kits due to packaging defects that may compromise sterility, posing a risk of microbial contamination.

    Product
    Medline Convenience Kits: 1) IV START KIT LAB DRAW-SH, Model Number: CDS860014P; 2) IV START KIT, Model Number: DYKM1000B; 3) KIT, I V START NSK, Model Number: DYKM2187; 4) KIT, I V START NSK, Model Number: DYKM2187A; 5) IV BLOOD CULTURE KIT, Model Number: DYNDH1909A…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3082-2026·2026-09-09

    Boston Scientific Recalls LUX-Dx Insertable Cardiac Monitor Server Software

    Boston Scientific is recalling LUX-Dx Insertable Cardiac Monitor server software due to potential delays in Atrial Fibrillation Burden Alerts, which may delay clinical evaluation.

    Product
    LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System, SERVER SW LAT CLARITY DS EU, Model Number 7246, All Versions (Current 7.7)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3088-2026·2026-09-09

    Medos Velys Robotic-Assist Station Recalled for Software Movement Issue

    Medos International Sarl is recalling 29 Velys Robotic-Assist Stations due to a software issue that may cause unintended robotic arm movement during surgery.

    Product
    Velys Enabling Tech Robotic-Assist Station REF: 451611001
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3058-2026·2026-09-09

    Medline Pre-Op Kits Recalled for Potential Sterility Breach

    Medline is recalling 13,032 pre-operative kits nationwide due to packaging defects that may compromise sterility, posing a risk of microbial contamination.

    Product
    Medline Convenience Kits: 1) PRE-OP KIT, Catalog Number: DYKS1043F; 2) PRE OP KIT, Catalog Number: DYKS1128C; 3) PRE OP KIT, Catalog Number: DYKS1216I; 4) PRE OP KIT, Catalog Number: DYKS1325A; 5) CATARACT PREOP KIT, Catalog Number: DYKS1583; 6) GENERAL PREOP KIT…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3071-2026·2026-09-09

    Medline IV Start Kits Recalled Due to Potential Seal Defects

    Medline is recalling IV start kits containing BD ChloraPrep applicators with potentially open or incomplete seals, which may lead to infection.

    Product
    Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators IV START KIT LAB DRAW-SH CDS860014Q IV START KIT DYKM1000B IV START KIT LAB DRAW-SH CDS860014P ULTRASOUND GUIDED PIV START KI DYNDV2684
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3076-2026·2026-09-09

    Medline Convenience Kits Recalled for Potential Applicator Seal Defects

    Medline is recalling specific lots of Convenience Kits containing BD ChloraPrep Clear applicators due to potential packaging seal defects that could lead to infection.

    Product
    Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators LABOR CDS CDS981762B VAG DELIVERY ADMISSION BAG DYKA1054F
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3049-2026·2026-09-09

    Medline Convenience Kits Recalled for Potential Sterility Breach

    Medline is recalling 4,636 convenience kits nationwide due to packaging wrinkles that may compromise sterility, posing a risk of microbial contamination.

    Product
    Medline Convenience Kits: 1) CDS840396X, Catalog Number: CDS840396X; 2) CDS840396Y, Catalog Number: CDS840396Y; 3) CDS983348AA, Catalog Number: CDS983348AA; 4) CDS983348AB, Catalog Number: CDS983348AB; 5) CDS983672O, Catalog Number: CDS983672O; 6) CDS983672P, Catalog…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0823-2026·2026-09-09

    Allies Group Recalls Subpotent SPF 50 Sunscreen Gel Nationwide

    Allies Group Inc. is recalling 29,014 tubes of THE ONE SPF 50 Invisible Sunscreen Gel because testing showed the product may not provide the labeled SPF 50 protection.

    Product
    THE ONE SPF 50 INVISIBLE SUNSCREEN GEL, (Avobenzone 3%, Homosalate 7%, Octocrylene 10%, Octisalate 5%), 50ML - 1.7 fl. oz Tube, Made in U.S.A, Distributed by Allies Group Pte Ltd, Singapore 068914. UPC 8 885014 073224
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0824-2026·2026-09-09

    Allies Group Recalls Subpotent SPF 50 Sunscreen Gel Sachets

    Allies Group Inc. is recalling 27,492 sachets of THE ONE SPF 50 Invisible Sunscreen Gel because firm testing indicated the product may not reliably provide the stated SPF 50 protection.

    Product
    THE ONE SPF 50 INVISIBLE SUNSCREEN GEL, (Avobenzone 3%, Homosalate 7%, Octocrylene 10%, Octisalate 5%), 3ml - 0.1 fl. oz, Sachet: Single use only, Made in the U.S.A, Distributed by Allies Group Pte Ltd, Singapore 068914.UPC 8 885014 073293
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3092-2026·2026-09-09

    Fresenius NaturaLyte Liquid Acid Concentrate Recalled for Discoloration

    Fresenius Medical Care is recalling NaturaLyte Liquid Acid Concentrate for Bicarbonate Hemodialysis due to reports of blue-green discoloration in the product.

    Product
    NaturaLyte, Liquid Acid Concentrate for Bicarbonate Hemodialysis: Product Numbers: 08-1251-1, 08-2251-0, 08-2301-3, 08-3251-9, 08-3301-2, 13-2201-5, 13-2251-0, 13-3251-9; Liquid Acid Concentrate for Bicarbonate Hemodialysis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3103-2026·2026-09-09

    Cardinal Health Recalls Urinary Catheter Trays with Potentially Contaminated Wipes

    Cardinal Health is recalling 175 units of Presource Packs containing CliniClean Pericare Wipes due to potential lubricant contamination that may cause localized skin effects.

    Product
    Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) PBCGLVBLI, Catalog Number: KIT, BLO LAVH ; 2) PB15HYFCY, Catalog Number: KIT, UMMC AB HYST II 170032 ; 3) SMA4FTLSCA, Catalog Number: TLH PACK
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3095-2026·2026-09-09

    Cardinal Health Recalls Presource Packs with Potentially Contaminated Wipes

    Cardinal Health 200, LLC is recalling 846 Presource Packs containing CliniClean Pericare Wipes that may be contaminated with a manufacturing lubricant, posing a risk of localized skin irritation.

    Product
    Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT, GYN ROBOTIC GSAM , Catalog Number: PBCCGRSGD; 2) KIT, GYN ROBOT ACCESSORY , Catalog Number: PB35GYBJC; 3) KIT, PRIMARY RESECTION , Catalog Number: PGVMOTBB19…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0816-2026·2026-09-09

    Baxter Recalls Clindamycin Phosphate Injection Due to CGMP Deviations

    Baxter Healthcare is voluntarily recalling Clindamycin Phosphate Injection due to Current Good Manufacturing Practice (CGMP) deviations. The affected product was distributed in the US, Puerto Rico, and Chile.

    Product
    CLINDAMYCIN PHOSPHATE — CLINDAMYCIN PHOSPHATE (CLINDAMYCIN PHOSPHATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3105-2026·2026-09-09

    Cardinal Health Recalls Urinary Catheter Trays with Contaminated Wipes

    Cardinal Health is recalling 44 units of urinary catheter trays containing CliniClean Pericare Wipes that may be contaminated with a manufacturing lubricant.

    Product
    Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT, CHONY ORTHO MAJOR SPINE , Catalog Number: POV2SCCPP; 2) KIT,ORTHOPLASTIC MICROVASCULAR, Catalog Number: PWVMFFABLI
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0822-2026·2026-09-09

    Bionpharma Recalls Doxylamine Succinate Tablets Due to Foreign Material Presence

    Bionpharma Inc. is recalling Doxylamine Succinate and Pyridoxine HCl tablets because foreign tablets or capsules were found in the product.

    Product
    DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE — DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE (DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3104-2026·2026-09-09

    Cardinal Health Recalls Surgical Kits with Potentially Contaminated Wipes

    Cardinal Health is recalling 645 surgical kits containing CliniClean Pericare Wipes that may be contaminated with a manufacturing lubricant.

    Product
    Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT, ASLMC CRANIOTOMY , Catalog Number: PNCGCNAUM; 2) KIT, ORP MAJOR SPINE , Catalog Number: PNHDFSVCI; 3) KIT,ORP NEURO TRAUMA , Catalog Number: PNHDOTVCQ…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3100-2026·2026-09-09

    Cardinal Health Recalls Urinary Catheter Trays with Potentially Contaminated Wipes

    Cardinal Health is recalling 61 units of urinary catheter trays containing CliniClean Pericare Wipes that may be contaminated with a manufacturing lubricant.

    Product
    Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT, ENT HARVEST , Catalog Number: PEVMETBJX; 2) KIT, ENT HARVEST , Catalog Number: PEVMETB37
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3096-2026·2026-09-09

    Cardinal Health Recalls Urinary Catheter Trays with Contaminated Wipes

    Cardinal Health is recalling 19 units of urinary catheter trays containing CliniClean Pericare Wipes that may be contaminated with a manufacturing lubricant.

    Product
    Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT, LUNG TX CIRCULATOR , Catalog Number: OVC3507231
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3093-2026·2026-09-09

    Fresenius Citrasate Liquid Acid Concentrate Recalled for Discoloration

    Fresenius Medical Care is recalling Citrasate Liquid Acid Concentrate for Bicarbonate Hemodialysis due to complaints of blue-green discoloration.

    Product
    Citrasate, Liquid Acid Concentrate for Bicarbonate Hemodialysis: Product Numbers: 08-2251-CA, 08-3251-CA, 13-2251-CA; Liquid Acid Concentrate for Bicarbonate Hemodialysis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3097-2026·2026-09-09

    Cardinal Health Recalls Urinary Catheter Trays with Contaminated Wipes

    Cardinal Health is recalling 115 units of urinary catheter trays containing CliniClean Pericare Wipes that may be contaminated with manufacturing lubricant.

    Product
    Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT,ROBOTICS DH , Catalog Number: PGOCRDNHD; 2) KIT, EAS ROBOTIC , Catalog Number: PG36RPEAB; 3) KIT, VIDEO THORACOSCOPY CMC , Catalog Number: PVCGVTACF
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3098-2026·2026-09-09

    Cardinal Health Recalls Urinary Catheter Trays with Potentially Contaminated Wipes

    Cardinal Health is recalling 2,448 urinary catheter trays containing CliniClean Pericare Wipes that may be contaminated with a manufacturing lubricant, posing a risk of localized skin irritation.

    Product
    Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT, GVI OPEN HEART A B , Catalog Number: PCVNCG540; 2) KIT, GVI OPEN HEART A B , Catalog Number: PCVNCG542; 3) KIT, GVI OPEN HEART A B , Catalog Number: PCVNCG55I…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0825-2026·2026-09-09

    Allies Group Recalls Subpotent Sunscreen Gel Due to Inadequate SPF Protection

    Allies Group Inc. is recalling specific lots of THE ONE SPF 50 Invisible Sunscreen Gel because testing showed the product may not provide the labeled SPF 50 protection.

    Product
    THE ONE SPF 50 INVISIBLE SUNSCREEN GEL, (Avobenzone 3%, Homosalate 7%, Octocrylene 10%, Octisalate 5%), 20ml - 0.7 fl. oz. Tube, Made in the U.S.A, Distributed by Allies Group Pte Ltd, Singapore 068914. UPC 8 885014 074733
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0826-2026·2026-09-09

    Allies Group Recalls Subpotent SPF 50 Sunscreen Gel

    Allies Group Inc. is recalling 2,149 tubes of SPF 50 sunscreen gel because testing showed it may not provide the labeled sun protection.

    Product
    THE ONE SPF 50 INVISIBLE SUNSCREEN GEL, (Avobenzone 3%, Homosalate 7%, Octocrylene 10%, Octisalate 5%), 90ml - 3 fl. oz. Tube, Made in the U.S.A, Distributed by Allies Group Pte Ltd, Singapore 068914. UPC 8 885014 075853
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3047-2026·2026-09-09

    Diagnostica Stago Recalls STA Staclot Protein S Reagent Due to QC Drift

    Diagnostica Stago is recalling 5,220 units of STA Staclot Protein S reagent because quality control values drifted within the stated stability period.

    Product
    STA Staclot Protein S, Model/Catalog Number: 00746-Reagent Lot number 273074; qualitative and quantitative factor deficiency test
    Category
    Medical Device
    Distribution
    Distributed nationwide