State

Hawaii product recalls

72,992 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.

Which agencies issued them

These figures cover only the 2,767 recalls whose distribution notice names Hawaii specifically. The 72,992 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

7201–7225 of 75759

HighFDA (Devices)·Z-1464-2025·2025-04-02
Medline Procedure Kits Recalled for Syringe Quality Defects
Medline procedure kits with defective plastic syringes have been recalled due to leaks, breakage, and quality issues that may pose a risk to patient health. The recall involves 422 units distributed in the US and Canada.
Product
Medline procedure kits labeled as: 1) ACOUSTIC NEUROMA PACK-LF, Pack Number DYNJ37741B; 2) ANGIOGRAPHY PACK, Pack Number DYNJ21519W; 3) NEURO ANGIO PACK, Pack Number DYNJ83941; 4) NEURO ANGIO PACK SJF-LF, Pack Number DYNJ55678; 5) NEURO PACK, Pack Number DYNJ04851Q;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1430-2025·2025-04-02
Pressure Monitoring Lines Recalled for Manufacturing Defect in Luer Fittings
Medline Industries is recalling namic medical convenience kits containing Pressure Monitoring Lines with defective female luer fittings manufactured with excess material. The defect could impair device function.
Product
namic convenience kits labeled as: MTS,COLOR,PML,KIT,-,FRENCH HOSPITAL PG; medical convenience kit, REF 600605710
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1439-2025·2025-04-02
Medline Procedure Kits With Defective Plastic Syringes Recalled
Medline is recalling surgical procedure kits with plastic syringes affected by a March 2024 FDA Safety Alert due to leaks, breakage, and quality issues that may pose risks to patients.
Product
Medline procedure kits labeled as: 1) AV FISTULA PACK-LF, Pack Number DYNJ0826753O; 2) BARRINGTON ACCESSORY TTL KNEE, Pack Number DYNJ56717A; 3) CVL INSERTION PACK, Pack Number CVI5065; 4) KT DR VELASCO FISTULA PACK, Pack Number DYNJ46648D; 5) PICC ABSCESS PACK-LF, Pac
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1443-2025·2025-04-02
Medline CV Neonatal Procedure Kits Recalled Due to Syringe Quality Issues
Medline is recalling CV Neonatal Pack procedure kits (Pack Number DYNJ67356) because the plastic syringes may leak or break, potentially harming patients. The recall affects 96 units distributed nationwide and in Canada.
Product
Medline procedure kits labeled as: 1) CV NEONATAL PACK, Pack Number DYNJ67356
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1419-2025·2025-04-02
Baxter TruSystem 7500 Software Issue Impairs Upper Back Adjustment in Emergency Mode
Baxter Healthcare is recalling 93 TruSystem 7500 Hybrid Plus units for a software issue that renders the upper back section inoperable when emergency mode is enabled.
Product
Baxter TruSystem 7500 Hybrid Plus (FC), Product Code 1854087
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1436-2025·2025-04-02
Medline Procedure Kits Recalled Due to Defective Plastic Syringes
Medline is recalling angiography and catheterization procedure kits containing plastic syringes that may leak or break. The recalled kits affect 1939 units distributed nationwide and in Canada.
Product
Medline procedure kits labeled as: 1) ANGIO PACK, Pack Number DYNJ50624A; 2) ANGIO PACK, Pack Number DYNJ30501F; 3) ANGIO PACK-LF, Pack Number DYNJ0954970G; 4) ANGIOGRAPHY 6 FRENCH PACK, Pack Number DYNJ33597J; 5) ANGIOGRAPHY DRAPE PACK, Pack Number DYNJ38120B; 6) AN
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1429-2025·2025-04-02
Medline Arterial Pressure Monitoring Line Kits Recalled for Manufacturing Defect
Medline is recalling certain arterial pressure monitoring line kits due to excess material on female luer fittings. The affected kits were distributed worldwide, including the United States.
Product
namic convenience kits labeled as: KIT,ARTERIAL,60,(152CM),PG; medical convenience kit, REF 70036160
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1418-2025·2025-04-02
Baxter TruSystem 7500 Hybrid: Software Issue Disables Back Adjustment
Baxter is recalling the TruSystem 7500 Hybrid due to a software issue that prevents the upper back section from being adjustable when emergency mode is enabled.
Product
Baxter TruSystem 7500 Hybrid (SC), Product Code 1854086
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0293-2025·2025-04-02
Strides Pharma Testosterone Gel Recalled Due to Benzene Contamination
Strides Pharma is recalling Testosterone Gel 1% (195,952 cartons nationwide) due to benzene contamination. Consumers using affected lots should immediately contact their healthcare provider.
Product
TESTOSTERONE — TESTOSTERONE (TESTOSTERONE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1422-2025·2025-04-02
Software Malfunction Disables Back Control on Baxter TruSystem 7500
Baxter TruSystem 7500 medical devices are affected by a software issue that prevents the upper back section from operating when emergency mode is enabled. Approximately 1,709 units have been recalled nationwide.
Product
Baxter TruSystem 7500, Product Code 4091000
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1421-2025·2025-04-02
Baxter TruSystem 7500 Hybrid IMRIS Upper Back Adjustment Software Malfunction
A software issue in the Baxter TruSystem 7500 Hybrid MR IMRIS system prevents the upper back section from being adjusted when emergency mode is enabled. The recall affects 24 units distributed nationwide.
Product
Baxter TruSystem 7500 Hybrid MR IMRIS, Product Code 2067886
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1416-2025·2025-04-02
Baxter TruSystem 7500 Hybrid medical device software defect in emergency mode
Baxter is recalling 2 units of TruSystem 7500 Hybrid (MC) due to a software issue that disables the upper back section adjustment when emergency mode is activated.
Product
Baxter TruSystem 7500 Hybrid (MC), Product Code 1773204
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0303-2025·2025-04-02
Sodium Bicarbonate Injection Recalled Due to Sterility Assurance Issue
Exela Pharma Sciences is recalling Sodium Bicarbonate 8.4% Injection due to lack of sterility assurance. The recall affects approximately 103,950 vials nationwide.
Product
SODIUM BICARBONATE — SODIUM BICARBONATE (SODIUM BICARBONATE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1446-2025·2025-04-02
Medline Delivery and Labor Kits Recalled for Defective Plastic Syringes
Medline is recalling 1,958 delivery and labor procedure kits containing plastic syringes with leaks, breakage, and quality defects that may pose a risk to patient health.
Product
Medline procedure kits labeled as: 1) DELIVERY PACK, Pack Number DYNJ0923016; 2) DELIVERY PACK-LF, Pack Number DYNJ0968863M; 3) L & D PACK-LF, Pack Number DYNJ0373290N; 4) L&D PACK, Pack Number DYNJ51998A; 5) LABOR & DELIVERY PACK-LF, Pack Number DYNJ0348455P; 6) LAB
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1449-2025·2025-04-02
Medline Procedure Kits With Defective Syringes Recalled Nationwide
Medline is recalling 268 procedure kits nationwide due to plastic syringes affected by a March 2024 FDA safety alert. The syringes may leak, break, or have quality issues that could affect patient care.
Product
Medline procedure kits labeled as: 1) CSMC/ABDOMINAL HYST PACK-LF, Pack Number DYNJ0665086F; 2) MAJOR VAGINAL HARPER PACK-LF, Pack Number DYNJ0161768D; 3) ROBOT LAP TOTAL HYST, Pack Number DYNJ907811A; 4) VAG HYSTE PACK-LF, Pack Number DYNJ0773613J; 5) VAG HYSTERECTOMY
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1414-2025·2025-04-02
Baxter TruSystem 7500 U Medical Device Software Malfunction Recall
Baxter is recalling the Stationary column TruSystem 7500 U due to a software issue that prevents the upper back section from being adjustable when emergency mode is enabled.
Product
Baxter Stationary column TruSystem 7500 U, Product Code 1730731
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1467-2025·2025-04-02
Checkpoint Guardian Intraoperative Lead: Potential Electrical Exposure Risk
Adhesive may not fully encapsulate metallic components on Checkpoint Guardian Intraoperative Leads, creating potential for electrical current leakage. This could cause inconsistent muscle responses and incorrect surgical actions.
Product
Brand Name: Checkpoint Guardian Intraoperative Lead Product Name: Checkpoint Guardian Intraoperative Lead, Medium Model/Catalog Number: REF# 9525 (Medium) Product Description: The Checkpoint Guardian Intraoperative Leads are single-patient disposable accessories for providing
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1423-2025·2025-04-02
Baxter NovumIQ Syringe Infusion Pumps Recalled for Gasket Defect Risk
Baxter Healthcare is recalling 149 NovumIQ syringe infusion pumps with incorrectly installed gaskets that could allow fluid ingress during cleaning or after IV fluid spills.
Product
Baxter NovumIQ Syringe INFUSION SYSTEM , REF 40800BAXUS
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1448-2025·2025-04-02
Medline C-section procedure kits recalled for syringe quality defects
Medline is recalling C-section procedure kits because plastic syringes in the kits may leak or break. The defect was identified in connection with an FDA safety alert and poses a potential risk to patient health.
Product
Medline procedure kits labeled as: 1) C SECTION, Pack Number DYNJ57622; 2) C SECTION PACK, Pack Number DYNJ48483B; 3) C SECTION PACK, Pack Number DYNJ61573; 4) C SECTION PACK, Pack Number DYNJ66801; 5) C SECTION PACK-LF, Pack Number DYNJ0367951P; 6) C SECTION PACK-LF
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1431-2025·2025-04-02
Medline Pressure Monitoring Kits Recalled for Luer Fitting Manufacturing Defect
Medline Industries is recalling 1,669 pressure monitoring line convenience kits distributed worldwide. The female luer fittings contain excess material near the fluid pathway.
Product
namic convenience kits labeled as: 1) MTS,4 VALVE,LFT,HRT,KIT-AHS-A*,NW, REF 60010468; 2) MTS,RIGHT HEART,KIT,W/TRANS,ST. *, REF 60010511; 3) MTS,LT,HT,KIT-BRYAN,LGH,M.C.,EAST, REF 60020323; 4) MTO,RIGHT,KIT-BRONSON,M* HOSP PG, REF 60020676; 5) MTS,LEFT HEART,KIT-C*,ME
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1463-2025·2025-04-02
Medline medical procedure kits recalled for plastic syringe defects
Medline procedure kits with plastic syringes are being recalled due to potential leaks and breakage that may affect patient safety. The recall impacts 1152 units distributed nationwide and in Canada.
Product
Medline procedure kits labeled as: 1) ANGIOGRAPHY SPECIALS
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0292-2025·2025-04-02
Metformin Hydrochloride Extended-Release Tablets Recalled for Foreign Tablet Contamination
A-S Medication Solutions is recalling 411 bottles of Metformin Hydrochloride Extended-Release 500mg tablets (Lot #4260340) distributed nationwide due to the presence of foreign tablets or capsules.
Product
METFORMIN HYDROCHLORIDE — METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1435-2025·2025-04-02
Medline procedure kits with plastic syringes recalled for leaks and breakage
Medline procedure kits containing plastic syringes are recalled for leaks, breakage, and other quality defects identified in an FDA Safety Alert. The recall affects 340 units distributed nationwide in the US and Canada.
Product
Medline procedure kits labeled as: 1) BILATERAL FACET TRAY, Pack Number DYNJRA0869A; 2) PAIN MANAGEMENT TRAY-LF, Pack Number DYNJRA1749
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0295-2025·2025-04-02
Compounded Fentanyl and Bupivacaine Epidural Injections Recalled for Sterility Assurance
QuVa Pharma recalls compounded fentanyl and bupivacaine epidural injections due to lack of sterility assurance. Affected lots distributed nationwide pose potential infection risks.
Product
fentaNYL Citrate PF 200 mcg/100 mL (2 mcg/ml) /0.1% Bupivacaine HCl 100 mg/100 mL (1 mg/mL), 100 ml in NS Yellow CADD FSFF, Injection for Epidural Use (Not intended For IV Use), Compounded, For Institutional or Office Use Only, QuVa Pharma, 1075 West Park One Drive, Suite 100, Su
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1461-2025·2025-04-02
Medline Procedure Kits Recalled for Syringe Leaks and Breakage
Medline Industries is recalling 2,161 medical procedure kits containing plastic syringes with leaks and breakage issues. The affected syringes pose a potential risk to patient health and are distributed in the US and Canada.
Product
Medline procedure kits labeled as: 1) BILLINGS CLINIC SC HEAD & NECK, Pack Number DYNJ33656C; 2) BLEPH/RHINO PACK, Pack Number DYNJ64669A; 3) DB ENT CSTM PACK-LF, Pack Number DYNJ33585C; 4) DENTAL PACK, Pack Number DYNJ54064; 5) EAR PACK, Pack Number DYNJ68678C; 6) EN
Category
Medical Device
Distribution
Distributed nationwide