The Recall Desk

State

Colorado product recalls

73,092 recalls have nationwide distribution and so reach Colorado. 6,944 additional recalls listed Colorado specifically in their distribution scope.

What the numbers show

Total
6,944
Critical
1,218
Severe
1,509
Most recent
2026-09-23

Of the 6,944 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 1,509 (22%) are Severe.

These figures cover only the 6,944 recalls whose distribution notice names Colorado specifically. The 73,092 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

8751–8775 of 80036

  • HighFDA (Drugs)·D-0159-2025·2025-01-01

    Prescription chlorpromazine tablets recalled due to manufacturing quality defect

    Glenmark Pharmaceuticals is recalling chlorpromazine hydrochloride 10mg tablets nationwide due to manufacturing deviations that allowed excess N-nitroso impurity.

    Product
    CHLORPROMAZINE HYDROCHLORIDE — CHLORPROMAZINE HYDROCHLORIDE (CHLORPROMAZINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0731-2025·2025-01-01

    Abbott Vascular inflation device may leak during cardiovascular procedures

    Abbott Vascular is recalling 20/30 Priority Pack Accessory Kit inflation devices due to potential leaks that could cause air embolism during cardiovascular procedures.

    Product
    20/30 Priority Pack Accessory Kit/.096 RHV, REF: 1000186, or use during vascular procedures in conjunction with interventional and / or diagnostic devices (e.g., balloon dilatation catheters, atherectomy devices, stent delivery systems, intravascular ultrasound devices).
    Category
    Medical Device
    Distribution
    40 states
  • HighFDA (Devices)·Z-0751-2025·2025-01-01

    Daytona Small Stature Locking Caps recalled for manufacturing defects

    SeaSpine Orthopedics is recalling 92 Daytona Small Stature CoCr Locking Caps due to manufacturing defects that prevent proper component mating. The devices were distributed in seven U.S. states.

    Product
    Brand Name: Daytona Small Stature Product Name: CoCr LockingCap 4.5mm, Small Stature, T25, BT Model/Catalog Number: 79-0002 Software Version: N/A Product Description: Locking Cap Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0724-2025·2025-01-01

    Medline Surgical Patties and Strips Recalled for Out-of-Spec Endotoxin Contamination

    Medline is recalling surgical patties and strips in custom surgical kits due to higher-than-expected endotoxin levels in raw materials. These may result in out-of-specification endotoxin levels in finished sterile products.

    Product
    Medline brand, medical procedure convenience kits, labeled as: 1) NEURO CRANIOTOMY CDS #36-RF, SKU CDS780119T; 2) NEURO KIT, SKU CDS981327Q; 3) NEURO POSTERIOR SPINE PACK-LF, SKU DYNJ0311501I; 4) ACOUSTIC NEUROMA PACK-LF, SKU DYNJ37741D; 5) SCRIPPS SW NEURO PACK-LF, SKU D
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0720-2025·2025-01-01

    Medline surgical procedure kits recalled due to endotoxin contamination

    Medline brand surgical procedure convenience kits in specific lots contain higher-than-expected endotoxin levels in surgical patties and strips. The contamination was found in raw materials used to produce sterile components.

    Product
    Medline brand, medical procedure convenience kits, labeled as: 1) SINUS CDS-1, SKU CDS982901F; 2) NASAL PACK, SKU DYNJ17493G; 3) FESS PACK-POB, SKU DYNJ33520A; 4) SINUS PACK, SKU DYNJ44845G; 5) SINUS PACK, SKU DYNJ48330B; 6) ENT PACK, SKU DYNJ50572; 7) ENT PACK, SKU DYNJ53573A; 8
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0161-2025·2025-01-01

    Duloxetine 30mg Capsules Recalled Due to Nitrosamine Impurity

    Breckenridge Pharmaceutical is recalling 163,883 bottles of Duloxetine 30mg capsules nationwide due to N-nitroso-duloxetine impurity above FDA-recommended limits.

    Product
    DULOXETINE — DULOXETINE (DULOXETINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0755-2025·2025-01-01

    Medline Surgical Scissors Recalled for Sterility Seal Defect

    Medline O.R. scissors may have weak seals that compromise sterility, increasing risk of contamination and infection. Approximately 21,440 units from lot 2023052490 have been recalled nationwide.

    Product
    O.R. SCISSORS, S/B, 5.5 STERILE, Medline Item No. DYND04000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0728-2025·2025-01-01

    O&M Halyard Procedure Masks Recalled for Unmet Bioburden Testing Requirements

    O&M HALYARD is recalling O&M Halyard Procedure Masks (Product Code 47117) nationwide because they do not meet bioburden testing requirements printed on the packaging.

    Product
    O&M Halyard Procedure Mask with SO SOFT* Earloops, Yellow-Disposable surgical mask Product Code: 47117
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0740-2025·2025-01-01

    Siemens Blood Analysis Device Recalled Over Patient Name Mix-up Software Defect

    Siemens is recalling the epoc NXS blood analysis system due to a software flaw that can assign incorrect patient names to test results, risking misdiagnosis or mistreatment if the operator doesn't verify the patient name.

    Product
    epoc NXS Host; Siemens Material Number (SMN): 11413583(CN, KR) ; Software Version Number: 4.14.9. Intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial, venous or
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0753-2025·2025-01-01

    Merlin PCS 3650 Pacemaker Programmer Software Anomaly May Cause Loss of Pacing

    A software anomaly in Abbott's Merlin PCS 3650 programmer may prevent proper finalization of leadless pacemakers, causing loss of pacing function. The issue occurs when specific actions combine with brief telemetry loss.

    Product
    The Merlin PCS 3650 programmer Model 3330 The Merlin PCS programmer model 3650 is a portable, dedicated programming system which operates using the Merlin PCS Model 3330 software and is designed to interrogate, program, display data from, and test Abbott Medical implantable
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0730-2025·2025-01-01

    Abbott 20/30 Indeflator devices recalled for potential leak risk

    Abbott Vascular is recalling 20/30 Indeflator devices used in cardiovascular procedures due to potential leaks that could cause air embolism.

    Product
    20/30 INDEFLATOR, REF: 1000184, for use during cardiovascular procedures in conjunction with interventional devices such as balloon dilatation catheters to create and monitor pressure in the balloon.
    Category
    Medical Device
    Distribution
    40 states
  • HighFDA (Devices)·Z-0759-2025·2025-01-01

    Medline ST IUD Removal Hook Recalled Due to Weak Seals and Sterility Risk

    Medline Industries is recalling 21,440 units of the ST IUD Removal Hook due to weak seals that may compromise sterility. The defect is undetectable to users and could increase infection risk.

    Product
    ST IUD REMOVAL HOOK 10" (504090), Medline Item No. I68785
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0737-2025·2025-01-01

    Blood Analysis System Software Malfunction May Assign Incorrect Patient Names

    Siemens epoc NXS Host blood analysis systems contain a software malfunction that may assign incorrect patient names to blood measurements. This could result in clinicians making treatment decisions based on the wrong patient's test results.

    Product
    epoc NXS Host; Siemens Material Number (SMN): 11413506 (CA); Software Version Number: 4.14.9. Intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial, venous or capi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0741-2025·2025-01-01

    Siemens epoc blood analyzer software assigns incorrect patient names

    Siemens epoc NXS blood analysis system has a software defect that can incorrectly assign patient names to blood test results, potentially causing misdiagnosis or mistreatment.

    Product
    epoc NXS Host; Siemens Material Number (SMN): 11413879(IN) ; Software Version Number: 4.14.9. Intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial, venous or capi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0745-2025·2025-01-01

    BD FACSLyric 2L4C Flow Cytometer Power Supply Failure Recall

    BD FACSLyric 2L4C flow cytometers with specific power supplies (part 650781) may fail to power on or stay on. Potential fume inhalation could cause respiratory symptoms in laboratory staff.

    Product
    FACSLyric 2L4C Instrument US, Catalog Number 662875, UDI 00382906628756 BD FACSLyric" flow cytometer is intended for in vitro diagnostic for the following: " Immunophenotyping using up to six fluorescence detection channels and two light scatter channels using a blue (488-nm)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0156-2025·2025-01-01

    Duloxetine Delayed-Release Capsules Recalled Due to N-nitroso Impurity Contamination

    Amerisource Health Services is recalling certain lots of Duloxetine Delayed-Release Capsules due to N-nitroso impurity levels exceeding recommended limits. Consumers with the medication should contact their healthcare provider.

    Product
    Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx only, 90 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-414-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0754-2025·2025-01-01

    Sterile Kelly Hemostat Recalled Due to Weak Seals

    Medline's STERILE STRT KELLY HEMOSTAT (SK8039S) is being recalled due to weak seals that could compromise sterility, increasing the risk of contamination and infection. The recall affects 21,440 units distributed nationwide.

    Product
    STERILE STRT KELLY HEMOSTAT (SK8039S), Medline Item No. 66695
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0316-2025·2025-01-01

    ZOE Daily 30+ Prebiotic Blend Recalled for Possible Foreign Objects

    ZOE brand Daily 30+ Prebiotic blend dietary supplements may contain small metal pieces or stones. Consumers should stop using affected batches and contact the manufacturer.

    Product
    ZOE brand Daily 30+ Prebiotic blend; Dietary Supplement; 500g resealable pouch
    Category
    Food
    Distribution
    26 states
  • HighFDA (Devices)·Z-0766-2025·2025-01-01

    EMPOWR 3D Knee Tibial Insert Package Mix-Up Causes Surgical Delays

    Encore Medical recalls EMPOWR 3D Knee Tibial Insert packages that may contain the wrong size implant (5R 16MM with 3R 14MM and vice versa), potentially delaying surgery. The recall affects 33 units nationwide.

    Product
    EMPOWR 3D Knee Tibial Insert, 5R 16MM, VE, REF: 342-16-705; EMPOWR 3D Knee Tibial Insert, 3R 14MM, VE, REF: 342-14-703
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0717-2025·2025-01-01

    Surgical Patties and Strips Recalled for Endotoxin Contamination

    Medline Industries recalls specific lots of surgical patties and strips in MAJOR NEURO PACK-LF Convenience kits due to higher-than-expected endotoxin levels detected in raw materials, which may have resulted in out-of-specification finished products.

    Product
    MAJOR NEURO PACK-LF Convenience kit, SKU DYNJ0578916X. Convenience kits used for various procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0750-2025·2025-01-01

    BYTE Aligner System Recalled for Virtual-Only Approval Workflow Gaps

    Straight Smile LLC is recalling BYTE Aligner systems due to a virtual-only clinical workflow that may not adequately screen patients with contraindications for aligner use. Approximately 5.3 million devices are affected.

    Product
    BYTE Aligner System REF PRS-0063 BYTE All-Day Aligner System BYTE AT-Night Aligner System A custom-made orthodontic appliance, typically supplied in series intended to be worn in succession and self-changed every few weeks, designed to influence the shape and/or function o
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0769-2025·2025-01-01

    Hip Reconstruction System Component Mislabeled for Size

    Waldemar Link is recalling 3 units of the LINK MP Reconstruction System Neck Segment due to a labeling error indicating the wrong size (XXL instead of standard), though all other specifications on the labels are correct.

    Product
    LINK MP Reconstruction System Neck Segment (with suture holes, standard, uncemented, L= 35 mm, CCD 126¿, Offset= 31 mm, Ti6Al4V, PoroLink, Taper 12/14. Item Number: 99-0984/32 Intended for revision hip arthroplasty in patients whose bone stock is of poor quality or inadeq
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0761-2025·2025-01-01

    EMPOWR 3D Knee Tibial Insert Recalled for Wrong Product in Package

    Encore Medical is recalling 9 units of EMPOWR 3D Knee Tibial Insert (Lot 076T1273A) because packages may contain an acetabular system instead of the intended knee insert, potentially causing surgical delays.

    Product
    EMPOWR 3D Knee Tibial Insert, 6R 10MM, VE, REF: 342-10-706
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0729-2025·2025-01-01

    O&M Halyard Surgical Masks Recalled for Failing Bioburden Testing

    O&M Halyard SOFT TOUCH II Surgical Masks (lot AM4119961) are being recalled for not meeting EN 14683 bioburden testing standards printed on the packaging. No illnesses or injuries have been reported.

    Product
    O&M Halyard SOFT TOUCH II Surgical Mask, Blue-Disposable surgical mask Product Code: 47500
    Category
    Medical Device
    Distribution
    Distributed nationwide