Recalls distributed in Hawaii

Recalls whose official distribution list names Hawaii. A further 6,834 recalls were distributed nationwide and may also affect Hawaii; see the nationwide list.

683 recalls published between October 9, 2024 and September 30, 2026. Most common issues: sterility (99), microbial contamination (73), software (45), injury risk (39). 116 were FDA Class I, the most serious level.

Nationwide recalls →

• nGenuity Patient Monitor with Capnography (ETCO2) CAT 8100E1-ST-US… recall
  FDA September 30, 2026 · Criticare Technologies, Inc. · Class II
• ForeSight Elite Tissue Oximetry Cable recall
  FDA September 30, 2026 · Becton Dickinson & Co. · Class II
• Boston Scientific Corporation StoneSmart Connect Console Contents: (1)… recall
  FDA September 23, 2026 · Boston Scientific Corporation · Class II
• REF:B5ST Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/STABILITY… recall
  FDA September 23, 2026 · Stryker Sustainability Solutions · Class II
• REF:B5LT Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/STABILITY… recall
  FDA September 23, 2026 · Stryker Sustainability Solutions · Class II
• REF:B12LT Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/STABILITY… recall
  FDA September 23, 2026 · Stryker Sustainability Solutions · Class II
• REF:B11LT Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/STABILITY… recall
  FDA September 23, 2026 · Stryker Sustainability Solutions · Class II
• REF:2B5ST Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/OPTIVIEW… recall
  FDA September 23, 2026 · Stryker Sustainability Solutions · Class II
• REF:2B5LT Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/OPTIVIEW… recall
  FDA September 23, 2026 · Stryker Sustainability Solutions · Class II
• HEMOSPRAY ENDOSCOPIC HEMOSTAT Product Name: HEMOSPRAY ENDOSCOPIC HEMOSTAT… recall
  FDA September 23, 2026 · Wilson-Cook Medical Inc. · Class II
• Happiest Baby, Inc recall
  FDA September 23, 2026 · Happiest Baby, Inc · Class II
• Happiest Baby, Inc SNOO Sleep Sack, X-Small Model recall
  FDA September 23, 2026 · Happiest Baby, Inc · Class II
• IV Sets with drip chambers recall
  FDA September 23, 2026 · ICU Medical, Inc. · Class II
• IV Sets with drip chambers recall
  FDA September 23, 2026 · ICU Medical, Inc. · Class II
• IV Sets with drip chambers recall
  FDA September 23, 2026 · ICU Medical, Inc. · Class II
• IV Sets with drip chambers recall
  FDA September 23, 2026 · ICU Medical, Inc. · Class II
• Oncology sets with drip chambers recall
  FDA September 23, 2026 · ICU Medical, Inc. · Class II
• Oncology sets with drip chambers recall
  FDA September 23, 2026 · ICU Medical, Inc. · Class II
• IV Non-Dedicated Gravity Administration Sets with drip chambers recall
  FDA September 23, 2026 · ICU Medical, Inc. · Class II
• Plum administration sets recall
  FDA September 23, 2026 · ICU Medical, Inc. · Class II
• Philips PIC iX Essentials recall
  FDA September 23, 2026 · Philips North America Llc · Class II
• Philips Patient Information Center iX recall
  FDA September 23, 2026 · Philips North America Llc · Class II
• BD Alaris Pump Infusion Sets 10561554* 10885403232565 50885403232563 BD… recall
  FDA September 23, 2026 · Bd Switzerland Sarl · Class I
• DuoGlide Short-Term Straight Dialysis Catheter recall
  FDA September 23, 2026 · Bard Access Systems, Inc. · Class I
• Power-Trialysis Short-Term Straight Dialysis Catheter recall
  FDA September 23, 2026 · Bard Access Systems, Inc. · Class I
• HeartSine SAM 350P 350P US Device, US English - 2 Min CPR UDI-DI codes:… recall
  FDA September 16, 2026 · HeartSine Technologies Ltd · Class II
• Products that contain the Pericare Wipes: (Canada Only) SureStep" Foley… recall
  FDA September 16, 2026 · C.R. Bard Inc · Class II
• Products that contain the Pericare Wipes: SureStep" Foley Tray System… recall
  FDA September 16, 2026 · C.R. Bard Inc · Class II
• Products that contain the Pericare Wipes: SureStep Intermittent Catheter… recall
  FDA September 16, 2026 · C.R. Bard Inc · Class II
• Products that contain the Pericare Wipes: *Bardex¿ I.C… recall
  FDA September 16, 2026 · C.R. Bard Inc · Class II
• Products that contain the Pericare Wipes: Bard¿ Foley Tray With Lubri-Sil¿… recall
  FDA September 16, 2026 · C.R. Bard Inc · Class II
• Products that contain the Pericare Wipes: Bardex Lubricath Foley Catheter… recall
  FDA September 16, 2026 · C.R. Bard Inc · Class II
• Alfalfa, Net Weight 50 lbs recall
  FDA September 16, 2026 · International Sprout Holdings, Inc · Class I
• Extension Set Product Name: DISCOFIX FOUR WAY STOPCOCK Model recall
  FDA September 9, 2026 · B Braun Medical Inc · Class II
• Baxter Novum IQ Syringe Pump, Loaner, Model Number 40800BAXUSL recall
  FDA September 9, 2026 · Baxter Healthcare Corporation · Class II
• Baxter Novum IQ Syringe Pump, Model Number 40800BAXUS recall
  FDA September 9, 2026 · Baxter Healthcare Corporation · Class II
• HEALON EndoCoat PRO recall
  FDA September 9, 2026 · Johnson & Johnson Surgical Vision, Inc. · Class II
• Byron White FORMULAS A-FNG Herbal Supplement 1.0 fl recall
  FDA September 2, 2026 · Byron White Formulas, Inc. · Class II
• Byron White FORMULAS A-P Herbal Supplement 1.0 fl recall
  FDA September 2, 2026 · Byron White Formulas, Inc. · Class II
• Byron White FORMULAS A-L Complex Herbal Supplement 1.0 fl recall
  FDA September 2, 2026 · Byron White Formulas, Inc. · Class II
• BLACK AND WHITE GLUTINOUS RICE BALLS WITH BLACK SESAME FILLING NET WT… recall
  FDA September 2, 2026 · Khong Guan (Hq) · Class I
• Glutinous Rice Balls with Black Sesame Filling NET WT… recall
  FDA September 2, 2026 · Khong Guan (Hq) · Class I
• Paragonix Technologies Inc recall
  FDA August 26, 2026 · Paragonix Technologies Inc. · Class II
• Arrow-LOK Implant recall
  FDA August 26, 2026 · Arrowhead DE LLC · Class II
• ERBECRYO 2 Cryosurgical Unit Model recall
  FDA August 19, 2026 · Erbe USA Inc · Class II
• FilmArray NGDS Warrior Panel recall
  FDA August 12, 2026 · Biofire Defense · Class II
• M5 Corpus Power Wheelchair recall
  FDA August 5, 2026 · Permobil Inc · Class II
• Permobil M3 Corpus Power Wheelchair with Heavy Duty Shock recall
  FDA August 5, 2026 · Permobil Inc · Class II
• functional formularies NOURISH ORGANIC WHOLE FOODS MEAL REPLACEMENT… recall
  FDA July 22, 2026 · Nutricia North America · Class II
• functional formularies LIQUID HOPE ORGANIC WHOLE FOODS MEAL REPLACEMENT… recall
  FDA July 22, 2026 · Nutricia North America · Class II
• Intracept Access Instruments, Description recall
  FDA July 15, 2026 · Boston Scientific Neuromodulation Corporation · Class II
• GORE¿ TAG¿ Thoracic Branch Endoprosthesis Side Branch Component recall
  FDA July 8, 2026 · W L Gore & Associates, Inc. · Class II
• 4380 ECONOMY SOFT TISSUE BIOPSY TRAY UDI-DI Code: 0110885403108563 4382A… recall
  FDA July 8, 2026 · Bard Access Systems, Inc. · Class II
• CK000880 Provena Midline Catheter 4 Fr Dual-Lumen UDI-DI Code:… recall
  FDA July 8, 2026 · Bard Access Systems, Inc. · Class II
• 1174108 PowerPICC Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741154935… recall
  FDA July 8, 2026 · Bard Access Systems, Inc. · Class II
• 7617408 Groshong NXT ClearVue Catheter 4 Fr Single-Lumen UDI-DI Code:… recall
  FDA July 8, 2026 · Bard Access Systems, Inc. · Class II
• CK000525B PowerPICC Provena SOLO Catheter 4 Fr Dual-Lumen UDI-DI Code:… recall
  FDA July 8, 2026 · Bard Access Systems, Inc. · Class II
• CK000980A PowerMidline Catheter 4 Fr Dual-Lumen UDI-DI Code:… recall
  FDA July 8, 2026 · Bard Access Systems, Inc. · Class II
• CK000727 PowerMidline Catheter 4 Fr Single-Lumen UDI-DI Code:… recall
  FDA July 8, 2026 · Bard Access Systems, Inc. · Class II
• 5855240 Power-Trialysis Slim-Cath Straight Short-Term Dialysis Catheter 12… recall
  FDA July 8, 2026 · Bard Access Systems, Inc. · Class II