State

Hawaii product recalls

72,940 recalls have nationwide distribution and so reach Hawaii. 2,766 additional recalls listed Hawaii specifically in their distribution scope.

What the numbers show

Total: 2,766
Critical: 333
Severe: 567
Most recent: 2026-09-09

Of the 2,766 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.

Which agencies issued them

These figures cover only the 2,766 recalls whose distribution notice names Hawaii specifically. The 72,940 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

4226–4250 of 75706

HighFDA (Devices)·Z-0530-2026·2025-11-26
Neuro and joint kits recalled over smoke pencils that may activate
Medline is recalling 40,151 neurosurgery, back and joint convenience kits containing SafeAir Smoke Evacuation Pencils, after Stryker expanded its recall of the pencils by 47 lots.
Product
MEDLINE convenience kits labeled as: 1) NEURO CRANIOTOMY CDS #36-RF, REF CDS780119V; 2) BASIC BACK CDS, REF CDS780147N; 3) INSTRUMENTED BACK CDS, REF CDS780148R; 4) NEURO-LAMI CDS, REF CDS780208I; 5) TOTAL HIP, REF CDS920027Y; 6) TOTAL KNEE, REF CDS940072Y; 7) TOTA
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0522-2026·2025-11-26
Neuro shunt and laminectomy kits recalled over smoke pencil activation defect
Medline is recalling 1,315 neurosurgery convenience kits containing SafeAir Smoke Evacuation Pencils, after Stryker expanded its recall of the pencils by 47 lots.
Product
MEDLINE convenience kits labeled as: 1) BASIC NEURO PACK, REF CDS780202R; 2) ACDF CDS, REF CDS941061M; 3) NEURO PACK-LF, REF DYNJ0038440C; 4) NEURO VP SHUNT/VAGAL NERVE-RF, REF DYNJ21925S; 5) NEURO-ORTHO EXTRAS, REF DYNJ44882M; 6) LAMINECTOMY, REF DYNJ903870F.
Category
Medical Device
Distribution
Distributed nationwide
HighCPSC·26113·2025-11-26
Macardac baby loungers recalled over fall and entrapment hazards
About 700 Macardac baby loungers are being recalled because the sides are too low to contain an infant, the foot openings are too wide, and the loungers have no stand.
Product
Macardac Baby Loungers
Category
Consumer Product
Distribution
Distributed nationwide
HighCPSC·26107·2025-11-26
Ojaswi fabric dressers recalled over tip over and entrapment hazards
About 285 Ebern Designs Ojaswi 12-Drawer Dressers are being recalled because they are unstable when not anchored to a wall and violate the STURDY Act standard.
Product
Ebern Designs Ojaswi 12-Drawer Dressers
Category
Consumer Product
Distribution
Distributed nationwide
HighCPSC·26109·2025-11-26
KingPavonini bed rails recalled over entrapment and asphyxiation risk
About 81,050 KingPavonini adult portable bed rails are being recalled because users can become entrapped within the rail or between the rail and the mattress.
Product
KingPavonini Adult Portable Bed Rails
Category
Consumer Product
Distribution
Distributed nationwide
HighCPSC·26125·2025-11-26
Hair dryers recalled for lacking an immersion protection device
About 740 MyOnlyStyler Root Booster Hair Dryers are being recalled because they lack an immersion protection device, posing an electrocution risk if dropped in water.
Product
MyOnlyStyler Root Booster Hair Dryers
Category
Consumer Product
Distribution
Distributed nationwide
HighCPSC·26122·2025-11-26
Children's bicycle helmets recalled for failing positional stability and coverage requirements
About 24,300 Outdoor Master children's and youth helmets are being recalled because they do not comply with the mandatory positional stability and coverage requirements.
Product
Outdoor Master Children's and Youth Helmets
Category
Consumer Product
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0509-2026·2025-11-26
ECMO consoles recalled after eleven reports of a blank touchscreen error
Medtronic is recalling 167 MC3 VitalFlow Consoles after eleven reports of an E70 error code that leaves the touchscreen blank for up to two minutes during operation.
Product
MC3 VitalFlow Console, REF 58100; Blood pump of ecmo
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0542-2026·2025-11-26
Cell morphology analyzers recalled over barcodes read from the previous slide
Cellavision is recalling 688 DI-60 automated digital cell morphology analyzers because the barcode reader may read the previous slide's barcode, misattributing diagnostic results.
Product
REF: CC286297 or BS737162 Automated Digital Cell Morphology analyzer DI-60, IVD in conjunction with a Honeywell Vuquest or Jadk FM-5 barcode reader component.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0503-2026·2025-11-26
Oncology software recalled because appended medication orders may mismatch the schedule
Elekta is recalling four systems running MOSAIQ Oncology Information System builds 3.1.3 through 3.2.3.0 because appended wave medication orders may not match the intended schedule.
Product
MOSAIQ Oncology Information System Software Builds 3.1.3, 3.2.1, 3.2.2 & 3.2.3.0 Software Version and UDI Codes: 3.1.3.0 (01)07340201500026(10)3.1.3.0 3.1.3.1 (01)07340201500026(10)3.1.3.1 3.1.3.2 (01)07340201500026(10)3.1.3.2 3.1.3.3 (01)07340201500026(10)3.1.3.3 3.1.3
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0527-2026·2025-11-26
Gynecology surgery kits recalled over smoke pencils that may activate
Medline is recalling 570 gynecology laparotomy, lithotomy and hysterectomy convenience kits containing SafeAir Smoke Evacuation Pencils, after Stryker expanded its recall by 47 lots.
Product
MEDLINE convenience kits labeled as: 1) GYN LAPAROTOMY HARPER PACK-LF, REF DYNJ0160684F; 2) MAJOR LITHOTOMY PACK-LF, REF DYNJ0425778O; 3) MINOR VAGINAL #76-RF, REF DYNJ27434R; 4) ABDOMINAL HYST PACK, REF DYNJ44848M; 5) DA VINCI HYSTERECTOMY, REF DYNJ44863Q; 6) VAGINA
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0512-2026·2025-11-26
Pacemaker packs recalled over smoke pencils that can remain active
Medline is recalling 12 Cath Lab Pacemaker Pack convenience kits containing SafeAir Smoke Evacuation Pencils, after Stryker expanded its recall of the pencils by 47 lots.
Product
MEDLINE convenience kits labeled as: CATH LAB PACEMAKER PACK, REF DYNJ59818A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0540-2026·2025-11-26
Bone void implants recalled over an incorrect product name on packaging
Berkeley Advanced Biomaterials is recalling 62 Tribio Implants 7.5mm x 40mm because the outer packaging carries an incorrect product name.
Product
Tribio Implant 7.5mm x 40mm REF M80 SB008 UDI code: (01) 00816125023653(10) EBL10B13C(17) 270630 Tribio" Implant is indicated for use in bony voids or gaps of the skeletal system (i.e. extremities, pelvis and posterolateral spine). These osseous defects are surgically created
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0507-2026·2025-11-26
Heart pump implant kits recalled over corrosion at the battery connector
Thoratec is recalling 248 HeartMate II LVAS Implant Kits because potential corrosion at the backup battery cable connector may cause a Backup Battery Fault Alarm.
Product
Brand Name: HeartMate Product Name: HeartMate II¿ LVAS Implant Kit Model/Catalog Number: 106015, HeartMate II¿ LVAS Kit, with Pocket Controller, Sealed, US; 106016, HeartMate II¿ LVAS Kit, with Pocket Controller, Sealed, EU Software Version: N/A Product Description: The Heart
Category
Medical Device
Distribution
Distributed nationwide
HighCPSC·26121·2025-11-26
Convertible high chairs recalled for missing the required attached restraint system
About 130 convertible baby high chairs are being recalled because they were sold without the required attached restraint system and a child's head can be trapped between seat and tray.
Product
Baby High Chairs (convertible)
Category
Consumer Product
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0524-2026·2025-11-26
Gynecology and robotic kits recalled over smoke pencils that may self activate
Medline is recalling 2,844 gynecology laparoscopy and robotic convenience kits containing SafeAir Smoke Evacuation Pencils, after Stryker expanded its recall of the pencils by 47 lots.
Product
MEDLINE convenience kits labeled as: 1) GYN LAPAROSCOPY CDS #34-RF, REF CDS920099S; 2) GYN LAPAROSCOPY CDS-LF, REF CDS983764J; 3) ROBOTIC, REF CDS984262N; 4) ROBOTIC, REF CDS984262P; 5) ROBOTIC UROLOGY-RF, REF DYNJ38844N; 6) DA VINCI PROSTATE/COLPOPEXY, REF DYNJ44864
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0506-2026·2025-11-26
Heart pump controllers recalled over corrosion at the backup battery connector
Thoratec is recalling 35,376 HeartMate 3 Controllers because potential corrosion at the backup battery cable connector may cause a Backup Battery Fault Alarm.
Product
Brand Name: HeartMate Product Name: HeartMate 3 Controller (Standalone) Model/Catalog Number: 106531US, HeartMate 3 Controller, US; 106531INT, HeartMate 3 Controller, OUS; 106531LF2, HeartMate 3 Low Flow 2.0 Controller Software Version: N/A Product Description: The HeartMate
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0514-2026·2025-11-26
Central line and flap packs recalled over smoke pencils that may activate
Medline is recalling 142 central line and free flap convenience packs containing SafeAir Smoke Evacuation Pencils, after Stryker expanded its recall of the pencils by 47 lots.
Product
MEDLINE convenience kits labeled as: 1) CENTRAL LINE PACK, REF DYNJ00281P; 2) FREE FLAP PACK, REF DYNJ68213C.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0528-2026·2025-11-26
LEEP procedure packs recalled over smoke pencils that may self activate
Medline is recalling 18 GP-LEEP convenience packs containing SafeAir Smoke Evacuation Pencils, after Stryker expanded its recall of the pencils by 47 lots.
Product
MEDLINE convenience kits labeled as: GP-LEEP PACK-LF, REF PHS396969004F
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0508-2026·2025-11-26
HeartMate II controllers recalled over corrosion at the battery connector
Thoratec is recalling 2,424 HeartMate II Pocket Controllers because potential corrosion at the backup battery cable connector may cause a Backup Battery Fault Alarm.
Product
Brand Name: HeartMate Product Name: HeartMate II¿ Controller (standalone) Model/Catalog Number: 106017, HeartMate II¿ Pocket Controller, US; 106762, HeartMate II¿ Pocket Controller, US; 107801, HeartMate II¿ Pocket Controller Software Version: N/A Product Description: The Hea
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0550-2026·2025-11-26
Plasma separator tubes recalled over unvalidated manufacturing processes
ASP Global is recalling 9,150 SAFE-T-FILL micro capillary blood collection tubes, 300 microlitres with lithium heparin and plasma separator gel, over an inadequate quality system.
Product
SAFE-T-FILL Micro Capillary Blood Collection, 300 ¿L; Prepared with Lithium Heparin and Plasma Separator Gel; Green Model/Catalog Number: 07 7221 Product Description: The SAFE-T-FILL Capillary Blood Collection System is a collection device used to draw capillary blood from t
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0552-2026·2025-11-26
Three hundred microlitre heparin tubes recalled over unvalidated manufacturing processes
ASP Global is recalling 6,050 SAFE-T-FILL micro capillary blood collection tubes, 300 microlitres with lithium heparin, over an inadequate quality system.
Product
SAFE-T-FILL Micro Capillary Blood Collection, 300 ¿L; Prepared with Lithium Heparin; Green Model/Catalog Number: 07 7251 Product Description: The SAFE-T-FILL Capillary Blood Collection System is a collection device used to draw capillary blood from the finger or heelstick.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0566-2026·2025-11-26
Capillary mixing fleas recalled over an inadequate quality system
ASP Global is recalling 50,250 mixing fleas for SAFE-T-FILL blood gas capillaries over an inadequate quality system with unvalidated processes.
Product
Mixing Fleas for SAFE-T-FILL Blood Gas Capillaries, Model 07 9503
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0162-2026·2025-11-26
Antifungal cream recalled over contamination found at the same manufacturing facility
DermaRite Industries is recalling 1,480 packets of DermaFungal antifungal cream because it was made at the same facility where other products and lots were found contaminated.
Product
DermaFungal, Antifungal Cream with 2% Miconazole Nitrate, packaged in a) 5 g (0.18 oz) per packet (NDC 61924-234-05), and b)106 g (3.75 oz.) per tube (NDC 61924-234-04) DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0562-2026·2025-11-26
Sodium heparin blood gas tubes recalled over an inadequate quality system
ASP Global is recalling 160,250 SAFE-T-FILL plastic blood gas capillary tubes, 230 microlitres with sodium heparin, over an inadequate quality system.
Product
SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 230 ¿L; Prepared with Sodium Heparin Model/Catalog Number: 06 0009 Product Description: A clear, plastic capillary blood collection tube
Category
Medical Device
Distribution
Distributed nationwide