State

Hawaii product recalls

73,096 recalls have nationwide distribution and so reach Hawaii. 2,770 additional recalls listed Hawaii specifically in their distribution scope.

What the numbers show

Total: 2,770
Critical: 333
Severe: 569
Most recent: 2026-09-23

Of the 2,770 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 569 (21%) are Severe.

Which agencies issued them

These figures cover only the 2,770 recalls whose distribution notice names Hawaii specifically. The 73,096 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

9001–9025 of 75866

HighFDA (Devices)·Z-0461-2025·2024-11-20
MEERA CL operating table may stop unexpectedly during surgical procedures
The MEERA CL operating table may experience error code 50037 on its IR-Hand Control, causing the table to stop mid-procedure. No injuries have been reported.
Product
MEERA CL mobile operating table - Designed for the placement and positioning of the patient immediately before, during and after surgical interventions, as well as for examination and treatment Item Number: 710001B2
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0449-2025·2024-11-20
Halyard ENDOVASCULAR surgical kits recalled for loose metal flakes
Halyard ENDOVASCULAR Model VMED008-02 surgical convenience kits are recalled due to potential loose metal flakes in sponge forceps and towel clamps. These flakes could enter a surgical site and cause local or foreign body reactions.
Product
Halyard ENDOVASCULAR - Medical convenience kits Model Number: VMED008-02
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0433-2025·2024-11-20
Surgical forceps and clamps recalled due to detachable metal flakes
AVID Medical is recalling Halyard CPT surgical convenience kits because sponge forceps and towel clamps may shed small metal flakes that could contaminate surgical sites. No illnesses have been reported.
Product
Halyard CPT PEDS ADULT CH PACK - Medical convenience kits Model Number: SHAN431-07
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0416-2025·2024-11-20
Halyard Extremity Pack Surgical Instruments Recalled for Loose Metal Flakes
AVID Medical recalls Halyard Extremity Pack surgical instruments (model MMOK009-03) because small metal flakes may detach from sponge forceps and towel clamps and enter patients' surgical sites. No injuries have been reported.
Product
Halyard EXTREMITY PACK - Medical convenience kits Model Number: MMOK009-03
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0393-2025·2024-11-20
Halyard Anterior Hip Pack surgical kits recalled due to loose metal flakes
AVID Medical is recalling Halyard Anterior Hip Pack surgical kits because sponge forceps and towel clamps may have loose metal flakes that could detach, enter a patient's surgical site undetected, and cause local or foreign body reactions.
Product
Halyard ANTERIOR HIP PACK - Medical convenience kits Model Number: EUOR001-06
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0335-2025·2024-11-20
IV Fluid Container Bags Recalled for Leaking Defect
The Metrix Company is recalling SECURE 100 mL empty EVA containers for IV use due to leaking discovered during filling. Approximately 2,229 cases were distributed to healthcare facilities in the US and Canada.
Product
SECURE 100 mL EMPTY EVA CONTAINER With 2 Ports, REF 66040; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0387-2025·2024-11-20
Halyard Open Heart Surgical Kits Recalled for Loose Metal Flakes in Instruments
AVID Medical is recalling Halyard Open Heart Pack Main surgical kits because sponge forceps and towel clamps may contain loose metal flakes that could detach and enter a patient's surgical site.
Product
Halyard OPEN HEART PACK MAIN - Medical convenience kits Model Number: ESJH003-02
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0352-2025·2024-11-20
Philips Zenition 50 Medical Imaging Device May Experience Electrical Fuse Failure
Philips Zenition 50 imaging systems may experience mains control unit fuse failure during startup or procedures. The defect could cause equipment malfunction.
Product
Philips Zenition 50, Model Number: 718096
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0464-2025·2024-11-20
IMMULITE 2000 PSA assay does not meet high-dose analytical performance claim
Siemens Healthcare is recalling certain IMMULITE 2000 PSA assay diagnostic kits because they do not perform as claimed for high-concentration samples used on IMMULITE 2000 analyzers.
Product
IMMULITE 2000 PSA assay, Catalog Number L2KPTS2(D) (SMN 10706281) and Catalog Number L2KPTS6(D) (SMN 10706282)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0394-2025·2024-11-20
Medical surgical kits recalled due to loose metal flakes
AVID Medical is recalling Halyard TOTAL KNEE surgical kits (Model EUOR002-05) because sponge forceps and towel clamps may shed small metal flakes that could contaminate surgical sites and cause reactions.
Product
Halyard KIT, TOTAL KNEE - Medical convenience kits Model Number: EUOR002-05
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0400-2025·2024-11-20
Surgical procedure kits recalled due to loose metal flakes in instruments
AVID Medical is recalling Halyard BASIC PROCEDURE PACK surgical instrument kits because sponge forceps and towel clamps may contain loose metal flakes that could enter a patient's surgical site and cause local or foreign body reactions.
Product
Halyard BASIC PROCEDURE PACK - Medical convenience kits Model Number: GRAN019-06
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0405-2025·2024-11-20
Halyard GYN TRAY surgical kits recalled for loose metal flakes
AVID Medical is recalling 136 units of Halyard GYN TRAY surgical kits due to small loose metal flakes that could detach from sponge forceps and towel clamps. These metal fragments could enter a patient's surgical site undetected, causing local or foreign body reactions.
Product
Halyard GYN TRAY - Medical convenience kits Model Number: LANC014-19
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0443-2025·2024-11-20
Halyard Pacemaker Drape Surgical Instruments Recalled for Loose Metal Flakes
AVID Medical recalls Halyard Pacemaker Drape surgical instruments because metal flakes may detach from sponge forceps and towel clamps. Loose metal fragments could enter surgical sites undetected and cause local or foreign body reactions.
Product
Halyard PACEMAKER DRAPE - Medical convenience kits Model Number: VAST020-06
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0338-2025·2024-11-20
IV Fluid Bags Recalled Due to Leakage During Filling
The Metrix Company is recalling SECURE 50 mL empty IV containers due to leakage found during filling. A limited number of affected bags have been distributed nationwide.
Product
SECURE 50 mL EMPTY EVA CONTAINER With 2 Ports (Bulk Packed) , REF 66043; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0419-2025·2024-11-20
Halyard Lower Extremity Pack surgical kits recalled for loose metal fragments
AVID Medical is recalling Halyard Lower Extremity Pack surgical kits because sponge forceps and towel clamps may shed loose metal flakes that could enter a patient's surgical site undetected, potentially causing local or foreign body reactions.
Product
Halyard LOWER EXTREMITY PACK - Medical convenience kits Model Number: PANJ001-03
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0344-2025·2024-11-20
Imed EVA IV bags recalled for leaking during filling
The Metrix Company is recalling Imed EVA 500 mL IV bags because a limited number have been found to leak during filling. Affected lots were distributed nationwide in the U.S. and Canada.
Product
Imed Products Imed EVA BAG, 500 mL, 2-PORTS, REF IM68050; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0336-2025·2024-11-20
IV Fluid Bags Found to Leak During Filling; Manufacturer Recalls Affected Units
The Metrix Company is recalling 2549 cases of SECURE 100 mL empty IV fluid bags because a limited number were found to leak during filling, which could result in contamination during fluid administration.
Product
SECURE 100 mL EMPTY EVA CONTAINER With 2 Ports (Bulk Packed), REF 66041; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0332-2025·2024-11-20
IV Fluid Containers Recalled for Leakage Risk During Filling
The Metrix Company is recalling CORMIX 150 mL empty IV fluid containers due to leakage found during filling, which could compromise the integrity of intravenous fluids.
Product
CORMIX 150 mL EMPTY EVA CONTAINER With 2 Ports, REF MS64040; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0349-2025·2024-11-20
Surgical hip procedure kit recalled for incomplete product seals
Medline is recalling CARROLLTON HIP FX surgical kits due to incomplete seals on items within the kit. Affected units contain Lot Number 24EBP466 and were distributed in Tennessee.
Product
CARROLLTON HIP FX Convenience kit used for surgical procedures, SKU SYNJ910003A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0392-2025·2024-11-20
Halyard cardiac surgical kit recalled for loose metal flakes risk
AVID Medical is recalling Halyard cardiac surgical kits (Model ESJH017-03) due to sponge forceps and towel clamps that may shed small metal flakes during surgery. These metal flakes could enter the patient's surgical site, potentially causing local or foreign body reactions.
Product
Halyard KIT, CARDIAC ROBOTIC - Medical convenience kits Model Number: ESJH017-03
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0333-2025·2024-11-20
IV Bag Containers Recalled Due to Leaking During Filling
The FDA has recalled CORMIX 250 mL empty IV bags made by The Metrix Company due to leaking during the filling process. Approximately 3,456 cases were distributed across the US and Canada.
Product
CORMIX 250 mL EMPTY EVA CONTAINER With 2 Ports, REF MS64045; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0398-2025·2024-11-20
Halyard FOOT ANKLE PACK surgical instruments recalled due to loose metal flakes
AVID Medical recalls Halyard FOOT ANKLE PACK surgical kits due to loose metal flakes from sponge forceps and towel clamps that could enter surgical sites and cause local reactions.
Product
Halyard FOOT ANKLE PACK - Medical convenience kits Model Number: EUOR005-02
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0386-2025·2024-11-20
ENT surgical kit recalled for potentially detachable metal flakes in forceps
AVID Medical is recalling Halyard ENT T and A Pack surgical kits nationwide due to loose metal flakes in sponge forceps and towel clamps that may contaminate surgical sites.
Product
Halyard ENT T AND A PACK - Medical convenience kits Model Number: EAMC106-02
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0434-2025·2024-11-20
Surgical instrument kits recalled for loose metal flakes
AVID Medical is recalling Halyard CPT EP PACK surgical convenience kits due to loose metal flakes on forceps and towel clamps. Detached metal flakes could enter surgical sites and potentially cause local tissue reactions or foreign body complications.
Product
Halyard CPT EP PACK - Medical convenience kits Model Number: SHAN442-04
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0390-2025·2024-11-20
Halyard Total Knee Surgical Kit Recalled for Loose Metal Flakes
AVID Medical is recalling Halyard total knee surgical kits due to loose metal flakes on sponge forceps and towel clamps that could enter and contaminate the surgical site. The defect poses a risk of local reactions or foreign body complications.
Product
Halyard KIT, TOTAL KNEE - Medical convenience kits Model Number: ESJH012-07
Category
Medical Device
Distribution
Distributed nationwide