State

Hawaii product recalls

20,324 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.

12076–12100 of 20324

HighFDA (Drugs)·D-0977-2023·2023-08-09
Heparin IV bags recalled for lack of validated sterility assurance
Central Admixture Pharmacy Services is recalling 7,509 heparin IV bags nationwide because the company lacks validation data showing the sterilization process works. No illnesses have been reported.
Product
heparin 2500 units/500mL added to 0.9% sodium chloride 5 units/mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-8100-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2312-2023·2023-08-09
Surgical Procedural Kits Recalled for Potential Sterility Specification Failures
Medline Industries is recalling 16,143 custom surgical procedural kits because the sterile ultrasound gel component may not meet sterility specifications. The kits were distributed worldwide from April 2020 to April 2023.
Product
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ABLATION PACK, Model Number: DYNJ40629B; b. AV FISTULA PACK, Model Number: DYNJ81410B; c. BARIATRIC KIT, Model Number: DYNJ901145G; d. BARIATRIC LAP
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2275-2023·2023-08-09
OEC Flexiview 8800 Image Intensifier Risks Detachment During Movement
GE OEC Medical Systems is recalling two OEC Flexiview 8800 fluoroscopic imaging systems due to image intensifiers that may detach and fall during movement, potentially causing fractures, hematoma, contusion, bruise, or pain.
Product
OEC Flexiview 8800 Systems with 9-inch Image Intensifier
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2263-2023·2023-08-09
Olympus Forceps Model INS-0362 Navigation Sensor Malfunction During Procedures
Always-On Tip Tracked Instruments forceps (Model INS-0362) may experience electromagnetic sensor tracking malfunction during endobronchial procedures, impairing navigation functionality and causing procedural delays.
Product
Always-On Tip Tracked Instruments (SPiN Drive instruments) Forceps, 1.8 mm OD, Oval Cup-Intended for use in clinical interventions and for anatomical structures where computed tomography and/or endoscopic brINS-0362onchoscopy are currently used for visualizing Model: INS-0362
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1050-2023·2023-08-09
Fentanyl Injectable Solution Recalled for Unvalidated Sterilization Cycles
Central Admixture Pharmacy Services is recalling 848 bags of fentanyl injection nationwide due to lack of validated sterilization processes that assure product sterility. Multiple lots distributed to healthcare facilities are affected.
Product
fentaNYL, 2500 mcg/50 mL, (50 mcg/mL), 100 mL bag, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2003-4
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2282-2023·2023-08-09
Covidien Cytosponge Cell Collection Device Recall Due to Sponge Detachment Risk
Covidien is recalling certain Cytosponge Cell Collection Devices and Kits because the sponge may detach from the string during removal, potentially causing device fragments, obstruction, and aspiration in patients.
Product
Covidien Cytosponge Cell Collection Device, REF: CYTO-201; and Covidien Cytosponge Cell Collection Kit, REF: CYTO-KIT-USM
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2267-2023·2023-08-09
Olympus SPiN Drive Triple Needle Brush Recalled for Sensor Malfunction
Olympus Corporation recalls the Always-On Tip Tracked Triple Needle Brush due to electromagnetic sensor tracking malfunction that impairs navigation functionality during endobronchial procedures, potentially causing procedural delays.
Product
Always-On Tip Tracked Instruments (SPiN Drive instruments) Triple Needle Brush, 12mm L, 1.8mm OD-Intended for use in clinical interventions and for anatomical structures where computed tomography and/or endoscopic brINS-0362onchoscopy are currently used for visualizing Model:
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2296-2023·2023-08-09
Medline Procedural Kits Recalled for Potential Sterility Specification Failure
Medline has recalled 63,823 custom procedural kits due to potential sterility specification failure of the ultrasound gel component. The affected kits were distributed worldwide from April 2020 through April 2023.
Product
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ANGIO, Model Number: DYNJ902507B; b. ANGIO BASIN SET, Model Numbers: DYNJ46043D, DYNJ46043F; c. ANGIO CATH COMBINED PACK, Model Numbers: DYNJ43609K, DYNJ43
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1015-2023·2023-08-09
Cardioplegia Solution IV Bags Recalled for Sterility Assurance Deficiency
Central Admixture Pharmacy Services is recalling Cardioplegia Solution IV bags (Lot 36-257024) due to lack of sterility assurance and insufficient validation of decontamination processes. Healthcare providers should discontinue use immediately.
Product
CARDIOPLEGIA SOLUTION, IV Bag, Total Volume = 1818 mL, CRYSTALLOID INDUCTION, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0216-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2283-2023·2023-08-09
X-ray Imaging System Carriage Bolts May Loosen or Break
Philips Allura Xper FD10 and FD20 X-ray systems may have loose or broken bolts supporting the FlexMove Carriage and cracks in the suspension rail. Affected units distributed worldwide; users should inspect equipment and contact manufacturer.
Product
Allura Xper FD10 and FD20. X-ray Imaging System.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1062-2023·2023-08-09
Fentanyl Injectable Syringes Recalled for Sterility Assurance Concerns
Central Admixture Pharmacy Services is recalling 2,340 fentanyl syringes distributed nationwide due to lack of sterility assurance from unvalidated sanitization procedures.
Product
fentaNYL in 0.9% sodium chloride, 10 mcg/1 mL, (10 mcg/mL), 3 mL syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2071-7
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1020-2023·2023-08-09
Cardioplegia Solution Nationwide Recall Due to Sterility Assurance Failure
Central Admixture Pharmacy Services is recalling a cardioplegia solution nationwide due to lack of sterility assurance and insufficient validation data for sterilization decontamination cycles.
Product
CARDIOPLEGIA SOLUTION, 15 mEq K, Reperfusate 4:1, low potassium/low tromethamine, total volume = 500mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0009-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1037-2023·2023-08-09
Cardioplegia Solution Recalled Due to Sterility Assurance Failure
Central Admixture Pharmacy Services is recalling 356 bags of cardioplegia solution distributed nationwide. The recall is due to lack of assurance of sterility, as validation data for decontamination cycles is lacking.
Product
Cardioplegia Solution, low K, Maintenance 4:1 Plasmalyte, Low Potassium, IV Bag, total volume = 1047 mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0211-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2271-2023·2023-08-09
Chest Stabilization Device Latch May Fail During Cardiac Surgery
The ACCESSRAIL Platform Standard Blade may fail to latch securely, potentially causing loss of heart stabilization or device component release into patients during cardiac surgery.
Product
ACCESSRAIL Platform (Standard Blade) Part Number SB-1000, and (Deep Blades) Part Number C-DB-1000. Component of a chest stabilization system for cardiac and chest surgery.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1064-2023·2023-08-09
Morphine Syringes Recalled Due to Sterility Assurance Failure
Central Admixture Pharmacy Services is recalling 1,699 morphine syringes nationwide due to lack of validated sanitization cycles, which may compromise sterility assurance.
Product
morphine in 0.9% sodium chloride, 1 mg/1 mL, (1 mg/mL), 3 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2040-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1030-2023·2023-08-09
Cardioplegia Solution 122 mEq K Recalled for Sterility Failure
Central Admixture Pharmacy Services is recalling Cardioplegia Solution due to lack of sterility assurance and missing validation data for decontamination. The product was distributed nationwide.
Product
CARDIOPLEGIA SOLUTION 122 mEq K, Modified St. Thomas Formula High Potassium, Total Volume = 1000 mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0209-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1038-2023·2023-08-09
Cardioplegia Solution Recalled Due to Inadequate Sterility Assurance
Central Admixture Pharmacy Services is recalling cardioplegia solution IV bags nationwide due to lack of validated sterilization processes. The recall affects 184 bags from two lots.
Product
CARDIOPLEGIA SOLUTION, low K, Maintenance 4:1 Plasmalyte/Tromethamine, Low Potassium, IV Bag, total volume = 1000 mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0112-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2337-2023·2023-08-09
Medline Procedural Kits Recalled Due to Potential Sterility Specification Failures
Medline Industries is recalling sterile procedural kits containing ultrasound gel that may not meet sterility specifications. The kits were distributed worldwide between April 2020 and April 2023.
Product
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CATH LAB PACK, Model Number: DYNJ58351A; b. PV CAROTID PACK, Model Number: DYNJ63341B;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2338-2023·2023-08-09
Medline procedural kits recalled for ultrasound gel sterility concerns
Medline is recalling 15,323 custom sterile and non-sterile procedural kits worldwide due to potential non-sterility of the Turkuaz ultrasound gel component. Kits were distributed between April 2020 and April 2023.
Product
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ANGIOGRAPHY PACK, Model Number: DYNJ65963A; b. ARTHOGRAM TRAY, Model Number: PAIN1524B; c. ARTHROGRAM TRAY, Model Number: PAIN1524A; d. CARPAL TUNNEL K
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2322-2023·2023-08-09
Custom procedural kits recalled for potential sterility failure in ultrasound gel
Medline recalled 134,514 custom surgical procedural kits due to potential sterility failure in the Turkuaz Ultrasound Gel component. The affected kits were distributed worldwide from April 1, 2020 through April 28, 2023.
Product
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. 18GX6" FEMORAL ART LINE KIT, Model Number: ART960; b. 20Gx3" RADIAL ART LINE KIT, Model Number: ART970; c. 20GX6" FEMORAL ART LINE KIT, Model Number: ART1165;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0956-2023·2023-08-09
Cardioplegia Solution del Nido Formula Recalled for Lack of Sterility Assurance
Central Admixture Pharmacy Services is recalling 10,480 bags of Cardioplegia Solution del Nido Formula nationwide due to missing validation data for decontamination cycles, creating potential sterility assurance risks.
Product
Cardioplegia Solution del Nido Formula, IV Bag, Total Volume = 1,052.8 mL, FOR INTRACARDIAC PERFUSION USE ONLY, PLASMA-LYTE A 1000 mL, Mannitol 20% 16.3 mL, Sodium Bicarbonate 8.4% 13 mL, Potassium Chloride 2 mEq/mL 13 mL, Magnesium Sulfate 4.06 mEq/mL 4 mL, Lidocaine 2% 6.5 mL,
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2272-2023·2023-08-09
Cardiac Surgery Device Blade May Fail to Latch Securely During Use
The ACROBAT SUV blade may not latch securely onto its activator drive during use. This could prevent heart stabilization during surgery, cause positioning loss, or release device components into the patient.
Product
ACROBAT SUV Vacuum Off-Pump System, Part Number C-OM-9000S. Component of a chest stabilization system for cardiac and chest surgery.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2259-2023·2023-08-09
Incisive CT Computed Tomography System: Metal Mounting Box May Detach
A metal mounting box in the Incisive CT scanner may become expelled, potentially injuring users or causing the system to shut down. Philips is recalling 20 affected units distributed internationally.
Product
Incisive CT for Brazil SKD-Computed Tomography X-Ray System Model: 728146
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2332-2023·2023-08-09
Medline Recalls Procedural Kits Over Sterility Specification Failure
Medline Industries is recalling 9,319 procedural kits worldwide because the labeled sterile ultrasound gel component may not meet sterility specifications. The affected kits were distributed between April 2020 and April 2023.
Product
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. FETAL INTERVENTION, Model Number: DYNJ66041A, DYNJ66041B; b. FETAL INTERVENTION PACK, Model Number: DYNJ62319A, DYNJ62319B; c. ULTRASOUND PIV KIT, Model N
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2268-2023·2023-08-09
SPiN Drive Needle Navigation Sensor Malfunction Triggers Procedural Delays
Olympus SPiN Drive needles have an electromagnetic sensor tracking malfunction that impairs navigation during endobronchial clinical procedures. Affected devices may generate false coil break warnings and cause procedural delays.
Product
Always-On Tip Tracked Instruments (SPiN Drive instruments) 22ga SPiN Flex Needle, 12mm L, 1.8mm OD-Intended for use in clinical interventions and for anatomical structures where computed tomography and/or endoscopic brINS-0362onchoscopy are currently used for visualizing Mode
Category
Medical Device
Distribution
Distributed nationwide