The Recall Desk

State

Colorado product recalls

73,738 recalls have nationwide distribution and so reach Colorado. 6,951 additional recalls listed Colorado specifically in their distribution scope.

What the numbers show

Total
6,951
Critical
1,215
Severe
1,826
Most recent
2026-10-28

Of the 6,951 recalls naming Colorado we have scored against our rubric, 1,215 (17%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1,826 (26%) are Severe.

These figures cover only the 6,951 recalls whose distribution notice names Colorado specifically. The 73,738 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

4751–4775 of 80689

  • CriticalFDA (Devices)·Z-0885-2026·2025-12-24

    Infusion pump software recalled over anomalies that could cause serious harm

    Fresenius Kabi USA is recalling Ivenix Infusion System LVP software versions 5.10.1 and earlier, which the firm states contain anomalies with the potential to cause serious patient harm or death.

    Product
    Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Software for the controlled administration of fluids to patients.
    Category
    Medical Device
    Distribution
    20 states
  • CriticalFDA (Devices)·Z-0914-2026·2025-12-24

    Carestation 750 anesthesia systems recalled over potential unexpected shutdown

    GE Medical Systems is recalling 888 Carestation 750 series anesthesia systems over potential unexpected shutdown if AC mains power is unplugged or fails. The action is Class I.

    Product
    GE Healthcare Carestation anesthesia system, product number and REF numbers: Carestation 750 A1, REF 1012-9750-000; Carestation 750 A2, REF 1012-9750-002; Carestation 750c A1, REF 1012-9755-000; Products for which affected PMB can be used as a spare part…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0959-2026·2025-12-24

    Leukemia test kits recalled in a second lot family over inaccurate results

    Cepheid is recalling 6,325 Xpert BCR-ABL Ultra kits, catalog GXBCRABL-US-10, because specimens with an elevated white blood cell count above 30,000 cells may cause inaccurate results.

    Product
    Brand Name: Xpert¿ BCR-ABL Ultra Model/Catalog Number: GXBCRABL-US-10
    Category
    Medical Device
    Distribution
    29 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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0952-2026·2025-12-24

    Chest tube procedure trays recalled over misleading instructions for securing the device

    Rocket Medical is recalling 630 Rocket 18Fg 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 18Fg Seldinger Catheter Procedure Tray Model/Catalog Number: R54544-18-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…
    Category
    Medical Device
    Distribution
    12 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…
    Category
    Medical Device
    Distribution
    12 states
  • 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-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…
    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.…
    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-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
  • 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-0921-2026·2025-12-24

    Sterile operating room scissors recalled over weak seals affecting sterility

    Medline is recalling 56 sterile operating room scissors because weak packaging seals may result in a breach of sterility and an increased risk of infection if the product is used.

    Product
    SCISSORS, OR, SHARP/BLUNT, 5.5", STERILE, Item Number DYND04000
    Category
    Medical Device
    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.…
    Category
    Medical Device
    Distribution
    12 states
  • HighFDA (Devices)·Z-0954-2026·2025-12-24

    Sixteen French chest tube trays recalled over misleading securing instructions

    Rocket Medical is recalling 840 Rocket 16Fg 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 16Fg Seldinger Catheter Procedure Tray Model/Catalog Number: R54549-16-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…
    Category
    Medical Device
    Distribution
    12 states
  • HighFDA (Devices)·Z-0960-2026·2025-12-24

    Leukemia test kits recalled over inaccurate results with high white cell counts

    Cepheid is recalling 4,032 Xpert BCR-ABL Ultra test kits because specimens with an elevated white blood cell count above 30,000 cells may cause inaccurate results.

    Product
    Brand Name: Xpert¿ BCR-ABL Ultra Model/Catalog Number: GXBCRABL-10
    Category
    Medical Device
    Distribution
    29 states
  • 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-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 (Devices)·Z-0946-2026·2025-12-24

    Chin implants recalled over specification deviations and missing premarket clearance

    DSAART is recalling 29 AART Chin Implants because the products deviated from established specifications and were distributed without the required FDA premarket approvals or clearances.

    Product
    Brand Name: AART Chin Implant Product Name: Chin Implant Model/Catalog Numbers: 400-0101 Chin Implant style 1 size 1 UDI-DI code: B490400101 400-0103 Chin Implant style 1 size 3 UDI-DI code: B490400103 400-0104 Chin Implant style 1 size 4 UDI-DI code: B490400104…
    Category
    Medical Device
    Distribution
    27 states
  • 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…
    Category
    Medical Device
    Distribution
    27 states
  • 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 (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 (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