Recalls distributed in Colorado

Recalls whose official distribution list names Colorado. A further 6,837 recalls were distributed nationwide and may also affect Colorado; see the nationwide list.

1,370 recalls published between October 9, 2024 and September 30, 2026 (1,365 FDA, 5 CPSC). Most common issues: microbial contamination (156), sterility (130), foreign material (85), listeria (70). 262 were FDA Class I, the most serious level.

Nationwide recalls →

• VOLARA System Product Name: VOLARA, HC, NA A Model recall
  FDA September 30, 2026 · Baxter Healthcare Corporation · Class II
• 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
• SeaSpine Mariner Deformity Product Name: Extended Polyaxial Head… recall
  FDA September 30, 2026 · Seaspine Orthopedics Corporation · 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
• Kinos Axiom Total Ankle System with Axiom PSR, Flat-cut (Cut Guide) recall
  FDA September 23, 2026 · restor3d Inc. · 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
• GM Helix Implant recall
  FDA September 23, 2026 · Straumann USA LLC · 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
• 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
• Extension Set Product Name: DISCOFIX FOUR WAY STOPCOCK Model recall
  FDA September 9, 2026 · B Braun Medical Inc · Class II
• 5008X HD/HDF with Twister Blood Tubing Set Part Number 03-5350-8 recall
  FDA September 9, 2026 · Fresenius Medical Care Renal Therapies Group, LLC · Class II
• 5008X HD/HDF with CLiC Blood Tubing Set Part number 03-5300-3C recall
  FDA September 9, 2026 · Fresenius Medical Care Renal Therapies Group, LLC · Class II
• 5008X HD/HDF Standard Blood Tubing Set Part Number 03-5300-3 recall
  FDA September 9, 2026 · Fresenius Medical Care Renal Therapies Group, LLC · Class II
• 5008X Standard HD Pre-Flush Standard Blood Tubing Set Part Number 03-5110-6 recall
  FDA September 9, 2026 · Fresenius Medical Care Renal Therapies Group, LLC · 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
• STA Staclot Protein S, Model recall
  FDA September 9, 2026 · Diagnostica Stago, Inc. · Class II
• Halyard medical convenience kits labeled as: 1) A-P PACK - 205936… recall
  FDA September 9, 2026 · AVID Medical, Inc. · Class II
• 1) NEURO, (kit) ACNE73-01 recall
  FDA September 9, 2026 · AVID Medical, Inc. · Class II
• Halyard medical convenience kits labeled as: 1) ENT… recall
  FDA September 9, 2026 · AVID Medical, Inc. · Class II
• Broadway Joe's Pain Cream, 3000 gm CBD, (Histamine Dihydrochloride 0.025%)… recall
  FDA September 9, 2026 · Lexia LLC · Class II
• Broadway Joe's Pain Cream, (Histamine Dihydrochloride 0.025%)… recall
  FDA September 9, 2026 · Lexia LLC · 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
• bettergoods brand Pistachio Nut Butter, NET WT 6.7oz (190g) recall
  FDA September 2, 2026 · Botticelli Foods, LLC · Class I
• Outshine Fruit Bars Strawberry, Pineapple, Grape, Tangerine recall
  FDA September 2, 2026 · Dreyer's Grand Ice Cream Inc. · Class II
• Outshine Fruit Bars Black Cherry, 6 Bars, 2.5 ounce, with recall
  FDA September 2, 2026 · Dreyer's Grand Ice Cream Inc. · Class II
• Outshine Fruit Bars Tangerine, 6-Count 2.5 ounce, with recall
  FDA September 2, 2026 · Dreyer's Grand Ice Cream Inc. · Class II
• Outshine Fruit Bars Grape, 6-Count 2.5 ounce, with recall
  FDA September 2, 2026 · Dreyer's Grand Ice Cream Inc. · Class II
• Outshine Fruit Bar Watermelon, 6-Count 2.5 ounce with recall
  FDA September 2, 2026 · Dreyer's Grand Ice Cream Inc. · Class II
• Outshine Fruit Bars Strawberry, 6-Count 2.5 ounce, with recall
  FDA September 2, 2026 · Dreyer's Grand Ice Cream 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