State

Hawaii product recalls

73,100 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 73,100 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

9651–9675 of 75870

HighFDA (Devices)·Z-3216-2024·2024-10-02
ACUSON Redwood Ultrasound Systems Recall for Software Unit Conversion Error
Siemens ACUSON Redwood ultrasound systems may display measurements 10 times smaller than actual if operators change the software from factory defaults to milliliters per second or minute. This could lead to misdiagnosis and poor patient management.
Product
ACUSON Redwood 1.0 and 2.0 Diagnostic Ultrasound Systems, REF: 11503314, with software
Category
Medical Device
Distribution
42 states
HighFDA (Devices)·Z-3296-2024·2024-10-02
Origio Sperm Wash Medium Recalled Due to Low Sodium Pyruvate
CooperSurgical is recalling Origio Sperm Wash Medium due to low sodium pyruvate concentration that could compromise sperm cell development. This affects 980 units distributed worldwide, including throughout the US.
Product
Origio Sperm Wash Medium Pack of Ten 10ml bottles - Intended for washing of spermatozoa Part Number: 84051010A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3251-2024·2024-10-02
Cook Biotech Fistula Plug recalled for expiring before labeled date
Cook Biotech is recalling 3 units of Biodesign Fistula Plug surgical implants because they expire before the printed expiration date. The devices were distributed worldwide.
Product
Biodesign Fistula Plug C-FPB-0.7 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Order Number (GPN): G24668
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3300-2024·2024-10-02
Custodiol HTK Solution Recalled for Potential Particle Contamination
Custodiol HTK Solution is subject to a Class II recall due to the potential for particles in the solution. The affected product consists of 48 cartons distributed in North Carolina.
Product
Custodiol HTK Solution, 500ml bottle. 10 per carton.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3234-2024·2024-10-02
Medical Paracentesis Kit Recalled Over Sterilization Assurance Failure
504 paracentesis kits (Lot 2405102) are being recalled because the manufacturer cannot confirm that sterilization requirements were met during production.
Product
Paracentesis Thoracente, SLPT76H; Medical convenience kit
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3232-2024·2024-10-02
Medical Device Kit Recall: Sterilization Assurance Cannot Be Confirmed
American Contract Systems is recalling 60 Shoulder SESH18I medical convenience kits nationwide due to equipment failure that resulted in out-of-specification humidity readings, preventing sterilization assurance confirmation.
Product
Shoulder, SESH18I; Medical convenience kit
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3212-2024·2024-10-02
Cervical disc replacement recalled for foreign contamination in assembly
Centinel Spine is recalling the Prodisc C SK cervical disc replacement due to blue discoloration on the inlay observed during assembly. This discoloration is a foreign contaminant that was not fully evaluated in manufacturing validations.
Product
prodisc C SK, Total cervical disc replacement, medical device, Model/Catalog Number: PDSM5
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3193-2024·2024-10-02
MRI Diagnostic Device Recalls Due to Loose Screw Assembly Risk
Philips recalls Evolution Upgrade 3.0T MRI devices due to loose screws that may block the tabletop and delay diagnosis. Devices with the affected serial numbers should be taken out of service.
Product
Evolution Upgrade 3.0T - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation. (REF) Numbers: (1) 782117 (2) 782143
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3285-2024·2024-10-02
Esophageal Stent System Recalled Due to Potential Catheter Tip Detachment
Boston Scientific recalls WallFlex and Agile esophageal stent systems (305 units) due to potential delivery catheter tip detachment. Affected products were distributed worldwide.
Product
WALLFLEX PC ESOPH STENT 23/28MM X 125MM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophag
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3282-2024·2024-10-02
Boston Scientific recalls WallFlex and Agile esophageal stents for delivery catheter detachment
Boston Scientific has recalled 308 units of WallFlex and Agile esophageal stent systems due to the potential for delivery catheter tip detachment during stent placement. The affected devices are distributed worldwide.
Product
WALLFLEX PC ESOPH STENT 18/23MM X 123MM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophag
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3235-2024·2024-10-02
IR Procedure Pack Recalled Due to Sterilization Assurance Failure
American Contract Systems recalls IR Procedure Pack (Lot 2405102, expiration 05/10/2024) because it cannot confirm sterilization requirements were met. An inoperable chart recorder caused humidity levels to be out-of-specification.
Product
IR Procedure Pack, CEAT19W; Medical convenience kit
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3233-2024·2024-10-02
Bilateral Tubal Ligation Pack Recalled for Unconfirmed Sterilization
American Contract Systems, Inc. is recalling the Bilateral Tubal Ligation Pack (Lot 2405102) due to inability to confirm proper sterilization following a chart recorder malfunction.
Product
Bilateral Tubal Ligation Pack, FHBT3T; Medical convenience kit
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3278-2024·2024-10-02
FDA Recalls Esophageal Stent Systems Due to Delivery Catheter Tip Detachment Risk
Boston Scientific recalled 364 esophageal stent systems due to potential delivery catheter tip detachment during placement procedures. No injuries have been reported. Affected patients and providers should contact the manufacturer.
Product
WALLFLEX ESOPHAGEAL FC 23/28MMX10CM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3215-2024·2024-10-02
Siemens ACUSON Juniper ultrasound systems software unit conversion error
Siemens is recalling ACUSON Juniper ultrasound systems that may perform incorrect unit conversions when configured with non-default settings, potentially producing measurements 10 times smaller than actual values and risking patient misdiagnosis.
Product
ACUSON Juniper 1.0, 1.5, 2.0, 2.5 Diagnostic Ultrasound Systems, REF: 11335791, with software. ACUSON Juniper Select 2.0, 2.5 Diagnostic Ultrasound Systems, REF: 11653093, with software.
Category
Medical Device
Distribution
42 states
HighFDA (Devices)·Z-3241-2024·2024-10-02
American Contract Systems Recalls ENT Medical Convenience Kits Due to Sterilization Concerns
American Contract Systems is recalling 66 ENT medical convenience kits because humidity readings were out of specification, preventing confirmation of sterilization.
Product
ENT, COEN27N; Medical convenience kit
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0664-2024·2024-10-02
FDA Recalls Refresh P.M. Eye Ointment Due to Potential Sterility Breach
AbbVie is recalling Refresh P.M. lubricant eye ointment due to potential breaches in tube seals that may compromise product sterility. Approximately 2.4 million tubes were distributed nationwide and internationally.
Product
Refresh P.M., (Mineral Oil 42.5%, White Petrolatum 57.3%) Lubricant Eye Ointment, Net wt, 0.12 oz (3.5g) Tube, Distributed by: Allergen, an AbbVie company, Madison, NJ 07940, UPC code: 300230667043,
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3280-2024·2024-10-02
FDA Recalls WallFlex Esophageal Stent Systems Due to Catheter Tip Detachment Risk
Boston Scientific is recalling WallFlex and Agile esophageal stent systems (516 units) due to potential for delivery catheter tip detachment during stent placement procedures.
Product
WALLFLEX ESOPHAGEAL FC 23/28MMX15CM-Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal f
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3252-2024·2024-10-02
Biodesign Fistula Plug recalled for expiring before printed expiration date
Cook Biotech is recalling 35 units of Biodesign Fistula Plug surgical implants that expire before their printed expiration dates, potentially compromising device function.
Product
Biodesign Fistula Plug C-FPS-0.2 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Order Number (GPN): G54612
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3223-2024·2024-10-02
Karl Storz Hopkins Telescope 6 Endoscope Recalled for Unapproved Reprocessing Instructions
Karl Storz Hopkins Telescope 6 endoscopes (59 units, nationwide) are recalled because their reprocessing instructions lack FDA review and approval for safety and efficacy.
Product
Karl Storz - Endoskope , REF: 27295AA, Hopkins Telescope 6, 18 Fr, Rx only, CE 0123
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3279-2024·2024-10-02
Boston Scientific esophageal stent systems recalled for catheter tip detachment
Boston Scientific is recalling Wallflex and Agile esophageal stent systems due to potential delivery catheter tip detachment during stent placement procedures.
Product
WALLFLEX ESOPHAGEAL FC 23/28MMX12CM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3218-2024·2024-10-02
Karl Storz Hopkins Telescope 6 endoscope with unapproved reprocessing instructions
Karl Storz Hopkins Telescope 6 endoscopes are recalled because their Instructions for Use contain reprocessing procedures that the FDA has not reviewed or approved for safety and efficacy.
Product
Karl Storz - Endoskope , REF: 27092AMA, Hopkins Telescope 6, Rx only, CE 0123
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3239-2024·2024-10-02
Medical Cath Lab Pack Recalled Due to Sterilization Assurance Failure
American Contract Systems is recalling Cath Lab Pack CECL02P medical kits because an inoperable chart recorder caused humidity readings to be out-of-specification, preventing confirmation that sterilization requirements were met.
Product
Cath Lab Pack, CECL02P; Medical convenience kit
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-1833-2024·2024-10-02
Pickled Garlic Product Recalled for Undeclared Fish Allergen
Shiso Katsuo Ninniku pickled garlic products are being recalled due to an undeclared fish allergen. The recall affects 9,482 units distributed across seven states.
Product
Shiso Katsuo Ninniku (Pink Pickled Garlic), Net WT 5.2 OZ (147g). Products of China; Imported By Niitakaya U.S.A. Inc., Motebello, CA 90640 ITEM No. 3700
Category
Food
Distribution
7 states
HighFDA (Devices)·Z-3260-2024·2024-10-02
Biodesign Recto-Vaginal Fistula Plug Recalled for Premature Expiration
Cook Biotech is recalling 8 units of Biodesign Recto-Vaginal Fistula Plug devices because they expire before the date printed on the label. The affected products may lose sterility if used after actual expiration.
Product
Biodesign Recto-Vaginal Fistula Plug RVP-0.7 - For implantation to reinforce soft tissue for repair of recto-vaginal fistulas. Order Number (GPN): G46603
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3257-2024·2024-10-02
Biodesign Fistula Plug implants recalled for premature expiration defect
Cook Biotech is recalling 130 units of Biodesign Fistula Plug C-FPS-0.7-2 surgical implants because the devices expire prior to the expiration date printed on the labeling. Devices were distributed worldwide including the US and 11 other countries.
Product
Biodesign Fistula Plug C-FPS-0.7-2 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Order Number (GPN): G46373
Category
Medical Device
Distribution
Distributed nationwide