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.

12051–12075 of 20324

HighFDA (Drugs)·D-0958-2023·2023-08-09
Epinephrine IV solution bags recalled due to inadequate sterilization validation
Central Admixture Pharmacy Services is recalling 6,784 bags of Epinephrine IV solution nationwide because validation data for decontamination and sterilization processes is lacking, creating a potential contamination risk.
Product
EPINEPHrine added to dextrose 5%, 4mg/250ml, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-7018-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1036-2023·2023-08-09
Cardioplegia IV Solution Recalled for Sterilization Validation Deficiency
Central Admixture Pharmacy Services is recalling 88 bags of Cardioplegia Solution (Lot 36-255943) due to lack of assurance of sterility and insufficient validation of decontamination cycles. The product is used during cardiac surgery.
Product
CARDIOPLEGIA SOLUTION, 20 mEq K, Maintenance 4:1, Low Potassium, IV Bag, total volume = 810 mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0103-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0978-2023·2023-08-09
Heparin IV Bags Recalled for Lack of Sterility Assurance
Central Admixture Pharmacy Services is recalling 11,824 bags of heparin IV solution nationwide. The recall is due to lack of assurance of sterility and missing validation data for decontamination cycles.
Product
heparin 4000 units/1000mL added to 0.9% sodium chloride, 4 units/mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-7022-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2328-2023·2023-08-09
Medline Procedural Kit Ultrasound Gel Sterility Specification Failure
Medline Industries is recalling procedural kits containing ultrasound gel that may not meet sterility specifications. The affected kits were distributed to healthcare facilities worldwide from 2020 to 2023.
Product
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. DR MOTT DRAPE PACK, Model Number: DYNJ42065B
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0948-2023·2023-08-09
Vancomycin IV Bags Recalled Nationwide for Lack of Sterility Assurance
Central Admixture Pharmacy Services is recalling 3,980 IV vancomycin bags nationwide. The decontamination process was not properly validated, raising sterility concerns. No illnesses reported.
Product
vancomycin 1 g/250 mL added to 0.9% sodium chloride, 4 mg/mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6064-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2299-2023·2023-08-09
Medline Procedural Kits Recalled for Ultrasound Gel Sterility Defect
Medline Industries recalls 104,755 procedural kits due to potential sterility defect in ultrasound gel component. No illnesses or injuries have been reported.
Product
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. MULTI-LUMEN CVC BUNDLE KIT, Model Number: ECVC475; b. MULTI-LUMEN CVC INSERTION BUNDLE, Model Number: ECVC3900; c. MULTIMED 16G 1L 20CM CVC STOCK+BUNDLE US, Mode
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2278-2023·2023-08-09
Medical X-ray Systems Image Intensifier Detachment Injury Risk
GE OEC Elite Systems with 9-inch Image Intensifier devices may detach during movement if subjected to impact force, potentially causing injury to personnel and bystanders.
Product
OEC Elite Systems with 9-inch Image Intensifier
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0986-2023·2023-08-09
FDA Recalls OxyTOCIN IV Bags Over Sterility Assurance Defect
FDA recalls 130,250 bags of oxyTOCIN IV solution from CAPS, Inc., distributed nationwide, due to lack of validated sterilization procedures. No illnesses reported.
Product
oxyTOCIN 30 units added to 0.9% sodium chloride 500 mL, IV Bag, Rx only, This drug was repacked by CAPS, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6044-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2305-2023·2023-08-09
Medline procedural kits with ultrasound gel may not meet sterility specifications
Medline Industries recalls 146,157 custom procedural kits distributed April 2020 to April 2023 because the sterile ultrasound gel component may not meet sterility specifications.
Product
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. A V FISTULA, Model Number: DYNJ65711; b. ACCESS CATHETER, Model Number: DYNJ64141A; c. ACCESS PICC PACK, Model Number: DYNJ40682B; d. ADULT EPIV INSERTION T
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2303-2023·2023-08-09
Medline procedural kits recalled for ultrasound gel sterility defect
Medline recalls 100,549 procedural kits because the sterile ultrasound gel component may not meet sterility specifications. No illnesses or injuries have been reported.
Product
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. VASCULAR PACK, Model Number: DYNJ22350K, DYNJ22350L, DYNJ22676J, DYNJ23445F, DYNJ31902L, DYNJ31902M, DYNJ39432I, DYNJ39432J, DYNJ39432K, DYNJ41625B, DYNJ46246A, DYN
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2262-2023·2023-08-09
Bronchoscopy Instruments Recalled for Electromagnetic Sensor Tracking Malfunction
Olympus Corporation is recalling Always-On Tip Tracked Instruments due to a malfunction in the electromagnetic sensor that impairs navigation functionality during bronchoscopic procedures. The malfunction could result in procedural delays.
Product
Always-On Tip Tracked Instruments (SPiN Drive¿ instruments) Brush, 15mm L, 1.8mm OD Intended for use in clinical interventions and for anatomical structures where computed tomography and/or endoscopic bronchoscopy are currently used for visualizing Model: INS-0352
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2270-2023·2023-08-09
X-Ray Ceiling Tube Support System Recalled Due to Loose Fixing Bolts
Shimadzu ceiling tube supports used with X-ray systems may have loose or missing fixing bolts at the base. The company is providing service to install cables and brackets to prevent the device from falling.
Product
Over-Head Ceiling Tube Support, CH-200, CH-200M, Used with RadSpeed and RadSpeed PRO, Sonial Vision safire, Versa and G4 units, FluoroSpeed 300 and X1 units
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 (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-2277-2023·2023-08-09
OEC 9900 Systems Image Intensifier Detachment and Fall Risk
GE OEC 9900 fluoroscopy systems' image intensifiers can detach during movement if subjected to large impact force, potentially falling and causing injuries such as fractures or bruising.
Product
OEC 9900 Systems with 9-inch Image Intensifier
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1080-2023·2023-08-09
Morphine Injectable Recalled Due to Unvalidated Sterilization Process
Central Admixture Pharmacy Services recalls 1,235 morphine syringes nationwide due to lack of validation data for sterilization cycles, potentially compromising sterility.
Product
morphine in 0.9% Sodium Chloride, 50 mg/50 mL (1mg/mL), 50 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C San Diego, CA 92126, NDC: 71286-2040-4
Category
Drug
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 (Drugs)·D-1032-2023·2023-08-09
Cardioplegia Solution Recalled Due to Sterility Assurance Concerns
Central Admixture Pharmacy Services is recalling cardioplegia solution due to lack of sterility assurance and missing validation data for manufacturing decontamination cycles.
Product
CARDIOPLEGIA SOLUTION, 108 mEq K, Induction 8:1, High Potassium, IV Bag, total volume = 500 mL, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0102-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2290-2023·2023-08-09
Medline Probe Cover Kits recalled for potential sterility specification failure
Medline is recalling 1,231,480 Probe Cover Kits distributed worldwide due to potential sterility specification failures in the ultrasound gel component.
Product
Medline Probe Cover Kits containing Turkuaz Ultrasound Gel, Labeled as the following: a. COVER, PROBE, W/GEL AND BANDS, 4X48 - Model Number DYNJE5900; b. COVER, PROBE, W/GEL AND BANDS, 6X24 - Model Number DYNJE5910; c. COVER, PROBE, W/GEL AND BANDS, 6X48 - Model Numbe
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2255-2023·2023-08-09
NeuMoDx Diagnostic Cartridges Recalled for Label Misplacement Risk
NeuMoDx Molecular Inc is recalling 20,016 cartridges from three lots due to incorrect label placement during manufacturing. Misplaced labels may interfere with optical performance, increasing risk for false positive test results.
Product
NeuMoDx Cartridge-used for extraction, purification, amplification and detection of nucleic acids on the NeuMoDx 288 and NeuMoDx 96 Molecular Systems (NeuMoDx System(s) Ref: 100100
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0972-2023·2023-08-09
FDA Recalls Oxytocin IV Bags for Sterility Assurance Issues
Central Admixture Pharmacy Services recalls 1,937 bags of oxytocin 10 units in Lactated Ringer's IV bags nationwide due to insufficient sterility assurance and missing validation data for decontamination cycles.
Product
oxyTOCIN 10 units added to Lactated Ringer's 500 mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6036-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0999-2023·2023-08-09
Neonatal TPN Starter Bags Recalled for Sterility Assurance Failure
Central Admixture Pharmacy Services is recalling 84 bags of neonatal TPN starter bags due to lack of sterility assurance and missing validation data for decontamination cycles.
Product
Neonatal TPN Starter Bag, Amino Acids (trophamine) 3%/Dextrose 10% with CALCIUM, total volume = 250mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0405-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1052-2023·2023-08-09
FDA Recalls Hydromorphone Injectable Solution Due to Sterility Validation Failure
The FDA has recalled 3,824 bags of hydromorphone injectable solution due to lack of validated sterilization processes. The affected product may not meet required sterility assurance standards.
Product
HYDROmorphone added to 0.9% sodium chloride, 10 mg/50 mL, (0.2 mg/mL), 100 mL bag, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2010-3
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1058-2023·2023-08-09
HYDROmorphone Injection Recall Due to Sterility Assurance Failure
Central Admixture Pharmacy Services is recalling 2,077 syringes of HYDROmorphone injection (15 mg/30 mL) distributed nationwide due to lack of validation data for sanitization cycles. No adverse events have been reported.
Product
HYDROmorphone in 0.9% sodium chloride, 15 mg/30 mL, (0.5 mg/mL), 30 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2011-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1017-2023·2023-08-09
Cardioplegia Solution Recalled Due to Sterility Assurance Failure
Central Admixture Pharmacy Services is recalling a cardioplegia solution used in cardiac surgery due to lack of sterility assurance and missing decontamination validation data. The affected lot was distributed nationwide.
Product
CARDIOPLEGIA SOLUTION, 30 mEq K, Induction 4:1, High Potassium, IV Bag, total volume = 415 mL, RX only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0106-1
Category
Drug
Distribution
Distributed nationwide