State

Colorado product recalls

20,322 recalls have nationwide distribution and so reach Colorado. 0 additional recalls listed Colorado specifically in their distribution scope.

About recalls in Colorado

Most US product recalls have nationwide distribution — the manufacturer ships into every state and the recall sweeps the same way. We include those in this listing because they affect Colorado consumers even though the source notice doesn’t name the state. State-specific recalls are usually for products with regional distribution (a regional dairy, a local store brand) or where the agency was able to narrow the affected shipments to specific destinations.

If you’re checking whether a recall affects your purchase, the recall detail page lists the exact production lot codes, UPCs, and best-by dates. Match those against your package — distribution scope is a starting filter, not the final answer.

12876–12900 of 20322

HighFDA (Devices)·Z-1966-2023·2023-06-21
bellavista 1000 Ventilator Recalled for Software Hang and Use Error Risk
Vyaire Medical is recalling approximately 910 units of the bellavista 1000 Ventilator due to a software issue that can cause the touchscreen to become unresponsive and a potential use error risk if operators do not confirm settings are appropriate for the patient.
Product
bellavista 1000 Ventilator, Catalogue Number 301.100.030; Continuous Use Ventilator
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1693-2023·2023-06-21
p-Chip Wand Reader Recalled for Laser Classification Safety Issue
FDA is recalling 329 p-Chip Wand Reader units due to laser operation potentially exceeding its classified safety level. Affected models are WA-4000, WA-4500, WA-8000, and WA-8500 distributed nationwide.
Product
p-Chip Wand Reader
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1703-2023·2023-06-21
Medicine Dropper Recalled for Potential Glass Particulate Contamination
Apothecary Products, LLC is recalling 1,596 units of Medicine Dropper (Lot 021623) due to potential glass particles on the dropper bulb exterior. Glass particles could contaminate medication or cause injury.
Product
Medicine Dropper, Product Code K508
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1911-2023·2023-06-21
Merit Medical Peritoneal Drainage Catheter Insertion Tray Recalled for Valve Failure
Merit Medical Systems is recalling Aspira Peritoneal Drainage Catheter Insertion Trays because valve assemblies may fail to open, potentially preventing proper fluid drainage in affected lots.
Product
Aspira Peritoneal Drainage Catheter Insertion Tray 15.5F, REF 4992209 Version A, Sterile EO, Rx Only
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1824-2023·2023-06-21
External Fixation System Post Component Recall Due to Thread Stripping
New Standard Device Inc is recalling 222 units of 'n'-Hole Posts used in the Revolution External Fixation System because the threads strip out during tensioning, potentially compromising fracture fixation.
Product
'n'-Hole Post which is a component of the Revolution External Fixation System Catalog Numbers: 100801, 100802, 100803, 100804, 100805
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1919-2023·2023-06-21
Aspira Drainage Catheter Insertion Tray recalled due to valve malfunction
Merit Medical Systems is recalling Aspira Drainage Catheter Insertion Tray 15.5F due to potential valve assembly failure that may prevent fluid drainage. No injuries reported.
Product
Aspira Drainage Catheter Insertion Tray 15.5F, REF: ASP-15, STERILE EO, Rx Only *EU Distribution only
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1914-2023·2023-06-21
Aspira Pleural Drainage Catheter trays recalled for valve failure
Merit Medical Systems recalls Aspira Pleural Drainage Catheter Insertion Trays because valve assemblies may not open, preventing fluid drainage. The recall affects 436 units distributed nationwide and internationally.
Product
Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF 4992508, Version A, Sterile EO, Rx Only
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1825-2023·2023-06-21
Philips Tempus LS-Manual Defibrillator pacing failure due to communication error
A communication failure in the Philips Tempus LS-Manual Defibrillator may prevent pacing delivery. The device displays an error message and potentially becomes ineffective, affecting approximately 1,147 units distributed nationwide.
Product
Philips Tempus LS-Manual Defibrillator, Part Number: 00-3020
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1968-2023·2023-06-21
Tearaway Introducer Kit Recalled Due to Potential Connector Defect
Galt Medical Corporation is recalling Tearaway Introducer Kits due to potential cracking or dislodging of the luer connection during use, which can render the device unusable and require replacement.
Product
Tearaway Introducer Kit, REF: KIT-010-12, KIT-010-17, KIT-900-16
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1910-2023·2023-06-21
Aspira Peritoneal Drainage Catheter Insertion Tray valve malfunction
Merit Medical's Aspira Peritoneal Drainage Catheter Insertion Tray valve assemblies may fail to open, preventing fluid drainage. 175 units distributed nationwide and internationally are affected.
Product
Aspira Peritoneal Drainage Catheter Insertion Tray 15.5F, REF 4992208 Version A, Sterile EO, Rx Only
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1972-2023·2023-06-21
Driver Instrument May Break During Surgery, Leaving Metal Fragments
The Superion Indirect Decompression System's driver instrument may fracture during implantation if excessive force is applied, potentially leaving metal fragments in the surgical site. Retained fragments contraindicate MRI scans.
Product
Driver Instrument, part of the Superion Indirect Decompression System, REF: 102-9800, used with the Superion Indirect Decompression System IFU, Superion IDS Kit IFU, Surgical Technique Manual
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1917-2023·2023-06-21
Aspira Drainage Catheter Insertion Tray May Have Non-Opening Valve
Merit Medical Systems recalls Aspira Drainage Catheter Insertion Trays due to potential valve assembly malfunction that could prevent fluid drainage.
Product
Aspira Drainage Catheter Insertion Tray 15.5F, REF: ASP-11, STERILE EO, Rx Only *EU Distribution only
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0875-2023·2023-06-21
Tranexamic Acid tablets recalled due to failed specification testing
AVKARE LLC is recalling Tranexamic Acid USP 650mg tablets nationwide due to failed quality control specifications for conductivity. No illnesses have been reported.
Product
TRANEXAMIC ACID — TRANEXAMIC ACID (TRANEXAMIC ACID)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0871-2023·2023-06-21
Tranexamic Acid Tablets Recalled for Failed Manufacturing Specifications
Amring Pharmaceuticals is recalling 48,989 bottles of Lysteda (tranexamic acid) USP 650 mg tablets due to failed manufacturing specifications for impurities and degradation. The affected lots did not meet conductivity specifications during quality testing.
Product
TRANEXAMIC ACID — TRANEXAMIC ACID (TRANEXAMIC ACID)
Category
Drug
Distribution
Distributed nationwide
HighCPSC·23222·2023-06-15
Oceanic SCUBA Buoyancy Compensating Devices Recalled for Drowning Hazard
Huish Outdoors is recalling Oceanic brand SCUBA diving buoyancy compensating devices because the weight pocket handle can break during use, preventing divers from dumping weight in an emergency to surface safely. No injuries have been reported, but 73 broken handles have been documented.
Product
SCUBA Diving Buoyancy Compensating Devices OceanPro, Excursion, Hera
Category
Consumer Product
Distribution
Distributed nationwide
HighCPSC·23223·2023-06-15
Trek Bicycles with Promax Hydraulic Disc Brakes Recalled for Crash Hazard
Trek Bicycle Corp. is recalling about 96,900 bicycles equipped with Promax hydraulic disc brakes because the brake hose can detach from the brake lever, posing a crash hazard. Trek has received 195 reports of this issue with no injuries reported.
Product
Promax hydraulic disc brakes sold on Trek bicycles
Category
Consumer Product
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-1650-2023·2023-06-14
Philips Trilogy and LifeVent ventilator models recalled for flow sensor debris
Environmental debris accumulation may block flow sensors in Philips ventilators, potentially preventing accurate pressure and flow delivery to patients.
Product
Trilogy Evo O2 and LifeVent EVO2, Model Numbers DS2100X11B, IN2100X15B, IN2100X19, FX2100X15B, LA2100X15B, IA2100X15B, FP2100X10, FR2100X14B, ND2100X15B, IT2100X21B, ES2100X15B, DE2100X13B, EU2100X15B, EU2100X19, EE2100X15B, and SP2100X26B
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1651-2023·2023-06-14
Trilogy Evo O2 EV300 respiratory devices recalled for debris accumulation
Philips Respironics recalled 18,855 Trilogy Evo O2 EV300 devices because environmental debris may accumulate on the flow sensor, potentially causing inaccurate delivery of pressure or flow. This could result in patient hypoxemia if not promptly addressed.
Product
Trilogy Evo O2 EV300, Model Numbers DS2200X11B, IN2200X15B, FX2200X15B, CA2200X12B, FR2200X14B, ND2200X15B, ES2200X15B, BL2200X15B, GB2200X15B, EU2200X15B, EE2200X15B, and TR2200X15B
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1649-2023·2023-06-14
Philips Respironics Ventilators Recalled for Flow Sensor Debris Accumulation
Philips Respironics recalled approximately 57,395 ventilators due to environmental debris potentially accumulating on the flow sensor, which may prevent accurate delivery of pressure and volume to patients, risking hypoxemia.
Product
Trilogy Evo, Garbin Evo, and Aeris EVO, Model Numbers DS2110X11B, IN2110X15B, JP2110X16B, AU2110X15B, LA2110X15B, CA2110X12B, BR2110X18B, KR2110X15B, IA2110X15B, FP2110X10, FR2110X14B, ND2110X15B, IT2110X21B, ES2110X15B, DE2110X13B, BL2110X15B, GB2110X15B, EU2110X15B, EE2110X15B,
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1633-2023·2023-06-14
FDA Recalls Walnut Wearable Smart Thermometer Due to Reported Skin Burns
BearCare's Walnut Wearable Smart Thermometer (Model WT20) is being recalled due to reports of skin burns in children ages 0-6. The device was distributed nationwide; 1818 units were affected.
Product
Walnut Wearable Smart Thermometer, intended for continuous chest temperature monitoring of children ages 0-6 years in non-emergency medical situations, Model Number WT20
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1630-2023·2023-06-14
StealthStation Cranial Software Depth Gauge Synchronization Failure Risk
A software anomaly in StealthStation Cranial Software causes depth gauge displays to lose synchronization during cranial biopsy procedures, risking inaccurate surgical guidance and tissue injury.
Product
StealthStation Cranial Software, Models: 9735585, 9735586 (kit), 9735587 (kit), used with StealthStation S7/i7 systems
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1652-2023·2023-06-14
Trilogy Evo Universal Ventilator Class I Recall—22,237 Units Affected
The FDA has issued a Class I recall for the Trilogy Evo Universal Ventilator Model DS2000X11B, affecting 22,237 units distributed nationwide and globally. The device is manufactured by Philips Respironics, Inc.
Product
Trilogy Evo Universal Ventilator, Model Number DS2000X11B
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1689-2023·2023-06-14
TREO Abdominal Stent-Graft Label Does Not Match Actual Device Size
Bolton Medical is recalling the TREO Abdominal Stent-Graft System because the carton label may not match the actual stent-graft size inside. Implanting the wrong size stent-graft could result in surgical complications.
Product
The TREO ABDOMINAL STENT-GRAFT SYSTEM (TREO) consists of four types of implants, specifically a Main Bifurcated Stent-Graft, a Leg Extension Stent-Graft, a Proximal Cuff Stent-Graft and a Straight Iliac Extension Stent-Graft. Each stent-graft is preloaded into its own delivery s
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1676-2023·2023-06-14
Diagnostic Test Recall: 4Kscore Test Software Anomalies May Produce Erroneous Results
BioReference Health is recalling the 4Kscore Test system due to software anomalies in its processing module that may generate erroneous diagnostic results. The recall affects 662 patient test results distributed in New Jersey.
Product
The 4Kscore Test is an in vitro serum or plasma test that combines the results of four immunoassays (Roche Elecsys total PSA (prostate specific antigen), Roche Elecsys free PSA, intact PSA, and human kallikrein 2) into a single numerical score that also incorporates the following
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1683-2023·2023-06-14
QIAstat-Dx Respiratory SARS-CoV-2 Test Kit Recalled for False Result Risk
Qiagen Sciences LLC recalls 347 QIAstat-Dx Respiratory SARS-CoV-2 test kits due to faulty cartridges that could produce false results. Affected kits were distributed nationwide in nine states.
Product
QIAstat-Dx Respiratory SARS-CoV-2 Panel multiplexed nucleic acid real-time PCR test, Reference Number 691223
Category
Medical Device
Distribution
Distributed nationwide