The Recall Desk

State

Colorado product recalls

72,940 recalls have nationwide distribution and so reach Colorado. 6,941 additional recalls listed Colorado specifically in their distribution scope.

What the numbers show

Total
6,941
Critical
1,218
Severe
1,507
Most recent
2026-09-09

Of the 6,941 recalls naming Colorado we have scored against our rubric, 1,218 (18%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1,507 (22%) are Severe.

Which agencies issued them

These figures cover only the 6,941 recalls whose distribution notice names Colorado specifically. The 72,940 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

3951–3975 of 79881

  • HighFDA (Devices)·Z-0950-2026·2025-12-24

    Twelve French chest tube trays recalled over misleading securing instructions

    Rocket Medical is recalling 635 Rocket 12Fg Seldinger Catheter Procedure Trays because the instructions and kit labeling contain misleading statements that can lead to improper securing.

    Product
    Brand Name: Rocket Product Name: Rocket 12Fg Seldinger Catheter Procedure Tray Model/Catalog Number: R54544-12-PK Product Description: Chest tube manufactured from PVC, with fenestrations and a barium stripe to the indicated French gauge size. Supplied with a procedure pack to
    Category
    Medical Device
    Distribution
    12 states
  • HighFDA (Devices)·Z-0951-2026·2025-12-24

    Twelve French catheters with safety guard recalled over misleading securing instructions

    Rocket Medical is recalling 240 Rocket 12Fg Seldinger Catheters with Safety Guard because the instructions and kit labeling contain misleading statements that can lead to improper securing.

    Product
    Brand Name: Rocket Product Name: Rocket 12Fg Seldinger Catheter with Safety Guard Model/Catalog Number: R54544-12-SG Software Version: N/A Product Description: Chest tube manufactured from PVC, with fenestrations and a barium stripe to the indicated French gauge size. Supplie
    Category
    Medical Device
    Distribution
    12 states
  • HighFDA (Devices)·Z-0922-2026·2025-12-24

    Sterile Kelly forceps recalled over weak seals that may breach sterility

    Medline is recalling 53 sterile Kelly forceps because weak packaging seals may result in a breach of sterility and an increased risk of infection if the product is used.

    Product
    FORCEP, STD STR, STERILE KELLY, 5.5 IN, Item Number DYNJ04048
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0941-2026·2025-12-24

    Imaging viewer software recalled over inaccurate length measurement values

    DICOM Grid is recalling 924 units of Intelerad InteleShare software because a bug can produce inaccurate length measurement tool values that could lead to misdiagnosis.

    Product
    Intelerad InteleShare software, with ProViewer component
    Category
    Medical Device
    Distribution
    45 states
  • HighFDA (Devices)·Z-0958-2026·2025-12-24

    Insulin pen app recalled over notifications lost after reinstalling the app

    Medtronic MiniMed is recalling 8,251 units of the InPen App for Android because reinstalling the app deletes the notification override permission, so audible and vibratory alerts are not received.

    Product
    InPen App, Model/CFN Number: MMT-8061 (Android Users)
    Category
    Medical Device
    Distribution
    50 states
  • HighFDA (Devices)·Z-0955-2026·2025-12-24

    Twenty French chest tube trays recalled over misleading securing instructions

    Rocket Medical is recalling 246 Rocket 20Fg Seldinger Catheter Procedure Trays because the instructions and kit labeling contain misleading statements that can lead to improper securing.

    Product
    Brand Name: Rocket Product Name: Rocket 20Fg Seldinger Catheter Procedure Tray Model/Catalog Number: R54549-20-PK Software Version: N/A Product Description: Chest tube manufactured from PVC, with fenestrations and a barium stripe to the indicated French gauge size. Supplied w
    Category
    Medical Device
    Distribution
    12 states
  • HighNHTSA·25C011000·2025-12-24

    Evenflo Recalls All4One Child Seats Due to Recline Mechanism Defect

    Evenflo is recalling certain All4One child seats because the recline mechanism may shift out of position, potentially failing to secure a child in a crash.

    Product
    CHILD SEAT:BASE:RECLINE MECHANISM recall
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0953-2026·2025-12-24

    Eighteen French catheters with safety guard recalled over misleading securing instructions

    Rocket Medical is recalling 110 Rocket 18Fg Seldinger Catheters with Safety Guard because the instructions and kit labeling contain misleading statements that can lead to improper securing.

    Product
    Brand Name: Rocket Product Name: Rocket 18Fg Seldinger Catheter with Safety Guard Model/Catalog Number: R54544-18-SG Software Version: N/A Product Description: Chest tube manufactured from PVC, with fenestrations and a barium stripe to the indicated French gauge size. Supplie
    Category
    Medical Device
    Distribution
    12 states
  • HighFDA (Devices)·Z-0920-2026·2025-12-24

    Central monitoring workstations recalled over audio failure and screen freezing

    Mindray is recalling 906 BeneVision Distributed Monitoring System units because a specific workstation hardware configuration may experience audio playback failure or screen freezing.

    Product
    Hardware configuration of the BeneVision Central Monitoring System (CMS), marketed as BeneVision Distributed Monitoring System (DMS). Model Number: 115-050935-00 and E115-050935-00. Software Version: Audio Driver version 6.0.9484.1 HP Pro Mini 400 G9 Desktop PC with Realtek HD
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0943-2026·2025-12-24

    Respiratory specimen reagent recalled because fluidification cannot be guaranteed

    Copan Italia is recalling 122,850 units of 1ml DTT liquid reagent because treatment reagent functionality in respiratory specimens fluidification cannot be guaranteed.

    Product
    1ml of DTT in liquid phase, in PET tube with capture cap, in bulk
    Category
    Medical Device
    Distribution
    14 states
  • ModerateFDA (Drugs)·D-0232-2026·2025-12-24

    Benco mepivacaine cartridges recalled over cracked and broken containers

    Novocol Pharmaceutical of Canada is recalling Mepivacaine HCl 3% injection distributed by Benco Dental over a defective container with cracked or broken cartridges.

    Product
    MEPIVACAINE — MEPIVACAINE (MEPIVACAINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0233-2026·2025-12-24

    Carbocaine dental cartridges recalled over cracked and broken containers

    Novocol Pharmaceutical of Canada is recalling 40 cartons of Cook-Waite Carbocaine 3% mepivacaine injection over a defective container with cracked or broken cartridges.

    Product
    CARBOCAINE — CARBOCAINE (MEPIVACAINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0236-2026·2025-12-24

    Cisatracurium 10 mg vials recalled after subpotent stability assay results

    Somerset Therapeutics is recalling 52,340 vials of Cisatracurium Besylate Injection, 10 mg/5 mL, after out of specification assay results during long term stability testing.

    Product
    CISATRACURIUM BESYLATE — CISATRACURIUM BESYLATE (CISATRACURIUM BESYLATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0234-2026·2025-12-24

    Phentolamine mesylate injection recalled over cracked and broken cartridges

    Novocol Pharmaceutical of Canada is recalling 1,636 cartons of OraVerse (Phentolamine Mesylate) Injection over a defective container with cracked or broken cartridges.

    Product
    ORAVERSE — ORAVERSE (PHENTOLAMINE MESYLATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0944-2026·2025-12-24

    Silicone carving implants recalled over specification deviations and missing clearance

    DSAART is recalling 369 AART Silicone Carving Implants because the products deviated from established specifications and were distributed without the required FDA premarket approvals or clearances.

    Product
    Brand Name: AART Silicone Carving Implant Product Name: Silicone Carving Implant Model/Catalog Numbers: 600-601 - Silicone Carving Implant Style 6 Size 1 UDI-DI code: B490600601 600-602 - Silicone Carving Implant Style 6 Size 2 UDI-DI code: B490600602 600-601-9 - Silicone Carvi
    Category
    Medical Device
    Distribution
    27 states
  • ModerateFDA (Devices)·Z-0956-2026·2025-12-24

    Children's mouthguards recalled for distribution without FDA premarket clearance

    Myofunctional Research Company USA is recalling 436 Myosa for Kids devices because the firm mistakenly distributed the product within the US without FDA premarket clearance or approval.

    Product
    Myosa for Kids KS1 REF MyOSAKS1_Sb/Sp/Mb/Mp/Lb/Lc KS2 REF MyOSAKS2_Sb/Sc/Mb/Mc/Mp/Lb/Lc Myosa for Kids is a mouthguard in 3 different sizes (sm, med, lg) that can be used in children ages 3-15 to address breathing and myofunctional disorders. Catalog Numbers:
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0957-2026·2025-12-24

    Bone fixation screws recalled over a labeling error on one lot

    Smith & Nephew is recalling 168 BIOSURE HA Screws, 6mm x 20mm, due to a labeling error on the affected lot.

    Product
    BIOSURE HA SCREW, 6MM x 20 MM. Threaded metallic bone fixation fastener.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0949-2026·2025-12-24

    Calf implants recalled over specification deviations and missing premarket clearance

    DSAART is recalling 35 AART Calf Implants because the products deviated from established specifications and were distributed without the required FDA premarket approvals or clearances.

    Product
    Brand Name: AART Calf Implant Product Name: Calf Implant Model/Catalog Number: 502-103 - Calf Implant style 1 size 3 UDI-DI code: B490502103 502-104 - Calf Implant style 1 size 4 UDI-DI code: B490502104 502-105 - Calf Implant style 1 size 5 UDI-DI code: B490502105
    Category
    Medical Device
    Distribution
    27 states
  • ModerateFDA (Drugs)·D-0231-2026·2025-12-24

    Mepivacaine dental cartridges recalled over cracked and broken containers

    Novocol Pharmaceutical of Canada is recalling 5,520 cartons of Mepivacaine HCl 3% injection over a defective container with cracked or broken cartridges.

    Product
    MEPIVACAINE — MEPIVACAINE (MEPIVACAINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0945-2026·2025-12-24

    Gluteal implants recalled over specification deviations and missing premarket clearance

    DSAART is recalling 118 AART Gluteal Implants because the products deviated from established specifications and were distributed without the required FDA premarket approvals or clearances.

    Product
    Brand Name: AART Gluteal Implant Product Name: Gluteal Implant Model/Catalog Numbers: 501-101 - Gluteal Implant style 1 size 1 UDI-DI code: B490501101 501-103 - Gluteal Implant style 1 size 3 UDI-DI code: B490501103 501-101 UDI-DI code: B490501101 501-103 - Gluteal
    Category
    Medical Device
    Distribution
    27 states
  • ModerateFDA (Drugs)·D-0238-2026·2025-12-24

    Cisatracurium 20 mg multiple-dose vials recalled after subpotent assay results

    Somerset Therapeutics is recalling 71,310 vials of Cisatracurium Besylate Injection, 20 mg/10 mL, after out of specification assay results during long term stability testing.

    Product
    CISATRACURIUM BESYLATE — CISATRACURIUM BESYLATE (CISATRACURIUM BESYLATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0938-2026·2025-12-24

    Clotting time reagent recalled after lots were made with double preservative

    Instrumentation Laboratory is recalling 4,506 units of HemosIL SynthAFax partial thromboplastin time reagent because the recalled lots were manufactured with double the preservative concentration.

    Product
    HemosIL SynthAFax. Partial Thromboplastin Time Tests.
    Category
    Medical Device
    Distribution
    8 states
  • ModerateFDA (Drugs)·D-0240-2026·2025-12-24

    Ciclopirox shampoo recalled after failing impurity specifications at eighteen months

    Sun Pharma/Taro is recalling 17,664 units of Ciclopirox Shampoo 1% after out of specification impurity and degradation results at the 18-month timepoint.

    Product
    Ciclopirox Shampoo, 1%, 120 mL, Rx only, Mfg by: Taro Pharmaceuticals Inc., Ontario, Canada; Dist. by: Taro Pharmaceuticals USA, Inc., NY 10532. NDC 51672-1351-08
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0937-2026·2025-12-24

    Spinal navigation guide recalled for naming an incompatible toolcard system

    SeaSpine Orthopedics is recalling 310 NorthStar OCT Navigation items because the surgical technique guide incorrectly identified Medtronic Infinity toolcards as compatible.

    Product
    Orthofix NorthStar OCT Navigation Surgical Technique Guide, and instruments: Navigation Driver, REF: PC2-400012; Navigation Straight Bone Probe, REF: PC2-400013; Navigation, 3.5mm Drill, REF: PC2-400135; Navigation, 4.0mm Drill, REF: PC2-400140; Navigation, 4.5mm Drill, PC2-4001
    Category
    Medical Device
    Distribution
    24 states