State

Colorado product recalls

72,992 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 72,992 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

7801–7825 of 79933

HighFDA (Devices)·Z-1236-2025·2025-03-05
Video Colonoscope May Cause Thermal Burns to Tissue During Use
The PENTAX Medical Video Colonoscope (Model EC38-i20cL) can develop excessive heat at the tip during procedures, potentially causing thermal burns to patient tissue. Users reported dark images and steam-like smoke from the device.
Product
PENTAX Medical Video Colonoscope- Intended to provide optical visualization of (via a video monitor), and therapeutic access to the lower gastrointestinal tract Model: EC38-i20cL
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1209-2025·2025-03-05
Anatomic Lateral Fibula Plate recalled for locking screw malfunction
Tyber Medical is recalling A.L.P.S. mvX Anatomic Lateral Fibula Plates due to reports of locking screws passing through the locking hole during surgery, causing surgical delays.
Product
A.L.P.S. mvX - ANATOMIC LAT FIB PLATE 4H LT: Anatomic Lateral Fibula Plate, 4-hole, Left Intended for Fixation of fractures of the distal tibia Model/Catalog Number: 770708041
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1243-2025·2025-03-05
GE SIGNA MR380 NMRI System SAR Limit Exceeded During Scan Resumption
GE SIGNA MR380 NMRI systems may allow scans to resume when the 6-minute average SAR (tissue heating rate) exceeds safe limits, potentially causing excessive tissue heating especially in patients with implants or conductive contact.
Product
SIGNA MR380, NMRI system, Non-US Only
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1218-2025·2025-03-05
Orthopedic Fixation Plates Recalled for Screw Locking Failure During Surgery
Tyber Medical is recalling 115 A.L.P.S. mvX orthopedic plates because the locking screw can pass through the locking hole during surgery, causing surgical delays and inadequate fracture fixation.
Product
A.L.P.S. mvX- ANATOMIC LAT FIB PLATE 12H RT- Anatomic Lateral Fibula Plate, 12-Hole, Right. Intended for Fixation of fractures of the distal tibia Model/Catalog Number: 770708122 Product Description:
Category
Medical Device
Distribution
Distributed nationwide
HighNHTSA·25T002000·2025-03-05
Sumitomo Recalls Dunlop GPR-300F Tires Due to Inner Liner Defect
Sumitomo is recalling specific Dunlop GPR-300F tires due to a defect causing inner liner bulging. The defect may lead to sudden air loss and vehicle control issues.
Product
TIRES recall
Category
Vehicle
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1235-2025·2025-03-05
Plato 17 Microcatheter Recall Due to Sterile Barrier Packaging Defect
Scientia Vascular is recalling Plato 17 Microcatheter units due to manufacturing defects in the packaging seal that could compromise sterility during vascular procedures.
Product
Plato 17 Microcatheter REF PL17-160-090 To assist in delivery of therapeutic devices and embolization materials and infusion of diagnostic agents to the neuro and peripheral vasculature during interventional or diagnostic procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1223-2025·2025-03-05
FDA Recalls Medial Tibia Plates for Intra-operative Screw Failure
Tyber Medical is recalling A.L.P.S. mvX Medial Tibia Plates due to reports that the locking screw can pass through the locking hole during surgery, causing surgical delays.
Product
A.L.P.S. mvX-MEDIAL TIBIA PLATE 12H LT-Medial Tibia Plate, 12-Hole, Left Intended forFixation of fractures of the distal tibia Model/Catalog Number: 770715121
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1213-2025·2025-03-05
Orthopedic plate recall: locking screw may pass through hole during surgery
Tyber Medical is recalling 214 units of A.L.P.S. mvX orthopedic plates (nationwide) because the locking screw may pass through the locking hole during surgery. Surgical delays have been reported.
Product
A.L.P.S. mvX- ANATOMIC LAT FIB PLATE 8H LT: Anatomic Lateral Fibula Plate, 8-hole, Left Intended to bridge or otherwise stabilize bone fragments to facilitate healing. Model/Catalog Number: 770708081
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1242-2025·2025-03-05
MRI Systems May Resume Scans When SAR Exceeds Safe Limits
Certain GE Healthcare MRI systems may incorrectly enable scan resumption when radiofrequency energy absorption exceeds FDA-set limits, potentially causing tissue heating. Risk is higher for patients with implants or touching conductive materials.
Product
SIGNA MR355, SIGNA MR360, NMRI system
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1226-2025·2025-03-05
Medial Tibia Plate Recall Due to Locking Screw Malfunction During Surgery
Tyber Medical recalls 109 units of the A.L.P.S. mvX Medial Tibia Plate nationwide due to reports of the locking screw passing through the locking hole during surgery, causing surgical delays.
Product
A.L.P.S. mvX- MEDIAL TIBIA PLATE 16H RT -Medial Tibia Plate, 16-Hole, Right Intended Fixation of fractures of the distal tibia Model/Catalog Number: 770715162
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1240-2025·2025-03-05
MRI System May Resume Scanning Above Safe Thermal Limits
GE Healthcare's Brivo MR355 MRI system can incorrectly resume scans when tissue heating limits are exceeded, potentially causing thermal burns if patients contact conductive materials. The recall affects 22 systems distributed nationwide and internationally.
Product
Brivo MR355, NMRI system
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1224-2025·2025-03-05
A.L.P.S. mvX Medial Tibia Plate Locking Screw Malfunction Recall
Tyber Medical recalls 208 units of A.L.P.S. mvX Medial Tibia Plates due to locking screws that can pass through the locking hole during surgery, causing surgical delays. No patient injuries have been reported.
Product
A.L.P.S. mvX--MEDIAL TIBIA PLATE 12H RT-Medial Tibia Plate, 12-Hole, Right Intended for Fixation of fractures of the distal tibia Model/Catalog Number: 770715122
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1222-2025·2025-03-05
Orthopedic Tibia Plate Locking Screw Malfunction Nationwide Recall
Tyber Medical is recalling 209 A.L.P.S. mvX Medial Tibia plates nationwide due to reports that locking screws can pass through the locking hole during surgery, causing surgical delays.
Product
A.L.P.S. mvX-MEDIAL TIBIA PLATE 10H RT-Medial Tibia Plate, 10-Hole, Right Intended Fixation of fractures of the distal tibia. Model/Catalog Number: 770715102
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1238-2025·2025-03-05
Pentax EPK-i8020c Video Processor Recalled for Thermal Burn Risk
Pentax EPK-i8020c video processors can overheat during endoscopic procedures, creating a risk of thermal burns to patient tissues. The light guide tip becomes hot and may cause injury to mucous membranes.
Product
Pentax Medical Video Processor- Intended to be used with PENTAX Medical endoscopes, monitors and other peripheral devices for endoscopic diagnosis, treatment, and video observation. Model: EPK-i8020c
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0576-2025·2025-03-05
Deiorio Foods Cauliflower Shells Recalled for Plastic Fragment Contamination
Deiorio Foods is recalling 1701 cases of 5912MOD-CAU 11" Gluten Free Friendly Cauliflower Shells due to potential contamination with white plastic fragments. The product may pose a choking hazard.
Product
5912MOD-CAU 11" Gluten Free Friendly Cauliflower Shell; Bulk packaged in a blue poly bag, within a corrugated box. 20 units per case; Product UPC: 074542659125; Master Case GTIN: 00074542659125
Category
Food
Distribution
11 states
HighFDA (Devices)·Z-1214-2025·2025-03-05
Orthopedic Surgical Plates Recalled Due to Intra-Operative Locking Screw Malfunction
Tyber Medical is recalling A.L.P.S. mvX Anatomic Lateral Fibula Plates nationwide due to reports that locking screws may pass through the locking hole during surgery, causing surgical delays.
Product
A.L.P.S. mvX- ANATOMIC LAT FIB PLATE 8H RT: Anatomic Lateral Fibula Plate, 8-hole, Right Indicated for use in Fixation of fractures of the distal tibia Model/Catalog Number: 77070802
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1231-2025·2025-03-05
Infusion Pump Manual Instructs Users to Leave Safety Clamp Open
BD Alaris Pump Module user manual incorrectly instructs users to leave the safety clamp open when reloading infusion sets, potentially causing accidental over-infusion.
Product
BD Alaris Pump Module REF 8100 The BD Alaris System with Guardrails Suite MX is a modular infusion pump and monitoring system for the continuous or intermittent administration of fluids to adult, pediatric, and neonatal patients through clinically accepted routes of administra
Category
Medical Device
Distribution
51 states
HighFDA (Devices)·Z-1220-2025·2025-03-05
Medial tibia plate screw locking defect causes surgical delays
Tyber Medical is recalling A.L.P.S. mvX Medial Tibia Plates because the locking screw may pass through the locking hole during surgery instead of securing properly, causing surgical delays. The recall affects 210 units distributed nationwide.
Product
A.L.P.S. mvX- MEDIAL TIBIA PLATE 6H RT-Medial Tibia Plate, 6-Hole, Right Model/Catalog Number: 770715062 Intended for Fixation of fractures of the distal tibia
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1208-2025·2025-03-05
Medical Imaging Software Bug Affects Diagnostic Calculations on Daylight Saving Time Dates
A software bug in IntelePACS causes incorrect diagnostic value calculations on Daylight Saving Time transition dates, risking incorrect patient diagnoses.
Product
IntelePACS (Image Fusion Module) - InteleViewer
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1210-2025·2025-03-05
Orthopedic fibula plate locking screw failure during surgery
Tyber Medical is recalling A.L.P.S. mvX Anatomic Lateral Fibula Plates due to locking screw passing through the locking hole intra-operatively, causing surgical delays. The recall affects 397 units distributed nationwide.
Product
A.L.P.S. mvX -ANATOMIC LAT FIB PLATE 4H RT: Anatomic Lateral Fibula Plate, 4-hole, Right Model/Catalog Number: 770708042
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1230-2025·2025-03-05
BD Pyxis MedBank medication cabinets recalled for operating room contraindication labeling
CareFusion is recalling BD Pyxis MedBank medication management cabinets due to inadequate labeling. A contraindication statement must be added to warn against use in procedure and operating rooms.
Product
139088-01 BD PYXIS MEDBANK MEDPASS MODULE 169-151 BD PYXIS MEDBANK MINI 1FH-2HH MEDPASS 169-152 BD PYXIS MEDBANK MINI 2HH-1FM MEDPASS 169-150 BD PYXIS MEDBANK MINI 4HH MEDPASS 169-140 BD PYXIS MEDBANK TWR MN 3FH-8HH MEDPASS
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1206-2025·2025-03-05
BD Pyxis Medication Dispensing Devices Labeling Update Addresses Manual Access Risk
FDA is requiring labeling updates for BD Pyxis automated medication dispensing devices to address the risk of delays in medication access due to power loss or device malfunctions. The recall affects approximately 1,521 units distributed nationwide.
Product
BD Pyxis: MedFlex, REF: 1119-00; MedBank Tower REF: 1145-00; MedBank MedPass, REF: 139088-01 and associated BD Pyxis user/software/safety guides and quick reference guides.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1248-2025·2025-03-05
Medical device recall: sterilization validator with incorrect incubation time
TERRAGENE S.A. is recalling 914 ASP BIOTRACE Auto Read 60 sterilization process challenge devices due to incorrect incubation time listed in the product instructions. The IFU lists 20 minutes instead of the correct 60 minutes.
Product
ASP BIOTRACE Auto Read 60 Steam BI Process Challenge Device, REF 73135.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1227-2025·2025-03-05
BD PYXIS MEDBANK systems operating room contraindication labeling update
BD PYXIS MEDBANK medication management systems are subject to a labeling update adding a contraindication against use in procedure and operating rooms. Approximately 6,075 units were distributed nationwide.
Product
138913-01 BD PYXIS MEDBANK MINI CR-2HH-1FH-P 169-114 BD PYXIS MEDBANK MINI CR-2HH-1FH-P 138911-01 BD PYXIS MEDBANK MINI CR-4HH-P 169-115 BD PYXIS MEDBANK MINI CR-4HH-P 139001-01 BD PYXIS MEDBANK MN 200 CR-2HH-1FH-P 139002-01 BD PYXIS MEDBANK MN 200 CR-2HH-1FM-P 139000-01 BD PYXIS
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1229-2025·2025-03-05
BD PYXIS medication cabinets labeling update: operating room contraindication
CareFusion is updating labeling for BD PYXIS medication management cabinets to add a contraindication statement prohibiting use in procedure and operating rooms.
Product
139054-01 BD PYXIS MEDFLEX MN 1000 10HH-1FM 139055-01 BD PYXIS MEDFLEX MN 1000 12HH 139053-01 BD PYXIS MEDFLEX MN 1000 2HH-2FH-3FM 139041-01 BD PYXIS MEDFLEX MN 1000 2HH-2FM 139046-01 BD PYXIS MEDFLEX MN 1000 2HH-5FM 139038-01 BD PYXIS MEDFLEX MN 1000 3FM 139040-01 BD PYXIS MEDFL
Category
Medical Device
Distribution
Distributed nationwide