State

Colorado product recalls

72,907 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 72,907 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

1076–1100 of 79848

HighFDA (Devices)·Z-2571-2026·2026-07-01
Surgify Halo surgical burrs recalled for potential breakage during spinal surgery
Surgify Medical OY is recalling Surgify Halo 5.4 mm Long surgical burrs due to potential breakage during bi-portal endoscopic spinal surgery. The defect could affect patient safety during the procedure.
Product
Surgify Halo, 5.4 mm, Long, Model/Catalog Number: 54.125.NVG.U1; drills, burrs, trephines & accessories (simple, powered)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2573-2026·2026-07-01
Surgify Halo Surgical Burr May Break During Spinal Surgery
Surgify Halo 5.4 mm surgical burrs may break during bi-portal endoscopic spinal surgery. The recalled burrs have UDI 06429811532335 and were distributed nationwide.
Product
Surgify Halo, 5.4 mm, Long, Model/Catalog Number: 54.140.SHD.U1; drills, burrs, trephines & accessories (simple, powered)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2572-2026·2026-07-01
Surgify Halo Surgical Burr Recalled for Breakage Risk
Surgify Halo 5.4 mm surgical burrs may break during bi-portal endoscopic spinal surgery. The FDA is recalling this device nationwide due to the potential breakage hazard.
Product
Surgify Halo, 5.4 mm, Long, Model/Catalog Number: 54.140.SHD.H1; drills, burrs, trephines & accessories (simple, powered)
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0616-2026·2026-07-01
Sensipar cinacalcet hydrochloride tablets recalled for CGMP deviations
Amgen, Inc. is recalling Sensipar (cinacalcet) 90mg tablets nationwide due to Current Good Manufacturing Practice (CGMP) deviations. The affected lot was distributed across the United States.
Product
SENSIPAR — SENSIPAR (CINACALCET HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2527-2026·2026-07-01
Zimmer Shoulder System Reamer Guide recalled for plastic breakage
Zimmer is recalling the Off-Axis Comprehensive Shoulder System Small Reamer Guide due to plastic guides catching and breaking during reaming procedures.
Product
Off-Axis Comprehensive Shoulder System Small, Augment, Off-Axis, Reamer Guide, Model/Catalog Number: 110040240
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2526-2026·2026-07-01
Multi-Snare Set catheter fails biocompatibility requirements
PFM Medical Inc. is recalling Multi-Snare Set catheters (5 mm and 10 mm sizes) because they failed biocompatibility testing for in-vitro cytotoxicity and could cause localized inflammation and tissue irritation if they contact a patient's blood vessels.
Product
Multi-Snare Set: 5 mm x 125 cm, REF: 147305; 10 mm x 125 cm, REF: 147310
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2588-2026·2026-07-01
Medline 10mL Polycarbonate Colored Syringes Convenience Kits Recalled
Medline Industries is recalling convenience kits containing 10mL polycarbonate colored syringes due to unapproved design changes made outside of FDA clearance requirements.
Product
Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. MAJOR BASIN SET DYNJ85723
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2596-2026·2026-07-01
Medline 10mL Polycarbonate Syringes Recalled for Unapproved Design Changes
Medline Industries is recalling convenience kits containing 10mL polycarbonate colored syringes due to unapproved design changes made outside of FDA clearance. The affected kits were distributed nationwide.
Product
Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. FTMC C-SECTION TRAY-LF DYNJ54603B
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0627-2026·2026-07-01
Povi-One Povidone-Iodine 10% Topical Drug Recall for Sub Potency
Elevate Oral Care is recalling Povi-One 10% Povidone-Iodine Oral Antiseptic nationwide due to sub potency. The affected lots have expiration dates ranging from June 2026 to October 2026.
Product
POVI-ONE — POVI-ONE (POVIDONE-IODINE 10% TOPICAL)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2576-2026·2026-07-01
Octopus Evolution AS Tissue Stabilizer Model TS2500 Tubing Assembly Issue Recall
Medtronic is recalling 288 units of the Octopus Evolution AS Tissue Stabilizer Model TS2500 due to incorrect tubing positioning during manufacturing, where short and long tubes were attached to wrong locations.
Product
Octopus Evolution AS Tissue Stabilizer, Model TS2500
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0611-2026·2026-07-01
Fenofibrate Capsules 200 mg Recalled for CGMP Manufacturing Deviations
Ajanta Pharma USA Inc. is recalling Fenofibrate Capsules, USP 200 mg due to Current Good Manufacturing Practice (CGMP) deviations identified during production. The recall affects 3,648 bottles distributed nationwide.
Product
FENOFIBRATE — FENOFIBRATE (FENOFIBRATE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0613-2026·2026-07-01
Sensipar (Cinacalcet Hydrochloride) Tablets Recalled for CGMP Deviations
Amgen, Inc. is voluntarily recalling 9,565 bottles of Sensipar (cinacalcet) 30mg tablets nationwide due to CGMP manufacturing deviations. The recalled lot was distributed to patients taking the medication for secondary hyperparathyroidism.
Product
SENSIPAR — SENSIPAR (CINACALCET HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2589-2026·2026-07-01
Medline 10mL Polycarbonate Colored Syringes Convenience Kits Recalled
Medline Industries is recalling convenience kits containing 10mL polycarbonate colored syringes due to unapproved design changes made outside FDA clearance. The affected kits have been distributed nationwide.
Product
Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. KIT NEURO CSTM SAMP0551
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0612-2026·2026-07-01
Corlanor ivabradine tablets recalled for presence of foreign substance
Amgen Inc. is recalling Corlanor (ivabradine) 5 mg tablets nationwide due to the presence of a foreign substance. The recall affects approximately 934,577 bottles distributed in the United States.
Product
CORLANOR — CORLANOR (IVABRADINE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0617-2026·2026-07-01
Duloxetine 30 mg capsules recalled for impurity above FDA limits
Direct Rx is recalling Duloxetine D/R 30 mg capsules (also sold as Cymbalta) distributed nationwide because the drug contains N-nitroso-duloxetine impurity above FDA-recommended interim limits.
Product
DULOXETINE D/R, a) 30 mg (NDC 61919-482-30), 30 Caps; b) 30 mg (NDC 61919-482-60), 60 Caps; CYMBALTA, Packaged and Distributed by Direct Rx.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2595-2026·2026-07-01
Medline 10mL Polycarbonate Colored Syringes in Convenience Kits Recalled
Medline Industries is recalling convenience kits containing 10mL polycarbonate colored syringes because the products contain unapproved design changes that were not cleared by the FDA.
Product
Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. PICC LINEPACK (PCLUI)642-LF DYNJ47717A
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0614-2026·2026-07-01
Sensipar Cinacalcet Tablets Recalled Due to CGMP Deviations
Amgen, Inc. is recalling Sensipar (cinacalcet) 60 mg tablets nationwide due to Current Good Manufacturing Practice (CGMP) deviations. The recall affects 30-count bottles with Lot #1157055 and expiration date 1/31/2028.
Product
SENSIPAR — SENSIPAR (CINACALCET HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2579-2026·2026-07-01
Philips Telemetry Monitor 5500 Device Reset Risk Recall
Philips Telemetry Monitor 5500 (Model 867232) may unexpectedly reset to default "NEW_DEVICE" state, causing loss of device configuration and disconnection from the PIC iX central monitoring system.
Product
Philips Telemetry Monitor 5500 1.4 GHz. Model Number: 867232. Includes the following system descriptions: TELE Monitor 5500, 1.4 Ghz, ECG only, ex; Telemetry Monitor 5500 1.4 GHz FAST EX.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2577-2026·2026-07-01
Octopus 4 Tissue Stabilizer incorrectly assembled tubing positions
Medtronic is recalling 590 units of the Octopus 4 Tissue Stabilizer, Model 29400 due to an assembly error where tubing was attached to the wrong positions during manufacturing.
Product
Octopus 4 Tissue Stabilizer, Model 29400
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0609-2026·2026-07-01
METHYLERGONOVINE MALEATE Tablets 0.2 mg Drug Recall
The Harvard Drug Group LLC is recalling METHYLERGONOVINE MALEATE Tablets 0.2 mg because the drug may be subpotent (contain less active ingredient than intended). The recall affects approximately 790 cartons distributed nationwide.
Product
METHYLERGONOVINE MALEATE — METHYLERGONOVINE MALEATE (METHYLERGONOVINE MALEATE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2584-2026·2026-07-01
Medline 10mL Polycarbonate Colored Syringes Convenience Kits Recalled
Medline Industries is recalling convenience kits containing 10mL polycarbonate colored syringes because the products underwent unapproved design changes outside of FDA clearance.
Product
Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. DR G'S BREAST PACK DYNJ51124B LIPO SUPPLEMENT PACK-LF DYNJ0341174D PLASTIC PACK DYNJ66746 DYNJ85702
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0615-2026·2026-07-01
Corlanor Ivabradine Tablets Recalled for Foreign Substance Contamination
Amgen is recalling specific lots of Corlanor (ivabradine) 7.5mg tablets nationwide due to the presence of a foreign substance. Patients should consult their healthcare provider before stopping this medication.
Product
CORLANOR — CORLANOR (IVABRADINE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2554-2026·2026-07-01
Thuvera Laser Console Software Version 2.2 Recall Notice
IPG Medical Corporation is recalling the Thuvera Laser Console (Software Version 2.2) due to a software anomaly that causes false display of error code 5018. The defect affects 198 units distributed nationwide in Massachusetts.
Product
Thuvera Laser Console. Software Version 2.2. Portable Thulium Fiber Laser.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2581-2026·2026-07-01
Medline Polycarbonate Syringes Recalled for Unapproved Design Changes
Medline Industries is recalling convenience kits containing 10mL polycarbonate colored syringes due to unapproved design changes made outside of FDA-cleared specifications. Affected kits were distributed nationwide.
Product
Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. ANGIOGRAM PACK-LF DYNJ21574J JUDKINS PACK DYNJ51126
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2575-2026·2026-07-01
Octopus Evolution Tissue Stabilizer Model TS2000 tubing assembly error
Medtronic Perfusion Systems is recalling the Octopus Evolution Tissue Stabilizer, Model TS2000, due to an assembly error where tubing was incorrectly positioned during manufacturing.
Product
Octopus Evolution Tissue Stabilizer, Model TS2000
Category
Medical Device
Distribution
Distributed nationwide