State
72,992 recalls have nationwide distribution and so reach Colorado. 6,941 additional recalls listed Colorado specifically in their distribution scope.
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.
Randox Laboratories is recalling 33 Randox Lipoprotein (a) diagnostic kits nationwide. The assay's claims for use on Roche Cobas c501 analyzers lack required FDA clearance or approval.
Jinan Bodor Cnc Machine Co Ltd is recalling 269 units of Bodor P and C series laser cutting machines distributed nationwide due to non-compliance with FDA standards.
Randox Lipoprotein (a) assay for Roche Cobas c501 analyzers was distributed without required FDA 510(k) or PMA regulatory clearance. The diagnostic test kits lack formal validation for their claimed measurements.
O&M HALYARD is recalling HALYARD Laparotomy Packs due to elevated residues of anti-block/slip additives found in the sterile packaging. These surgical instruments were distributed nationwide.
Olympus has recalled Thunderbeat surgical hand instruments because the probe tips can become damaged or broken, including pad damage and detachment. The recall affects 36,712 units distributed internationally outside the United States.
Trinity Sterile is recalling Dressing Change Kits with ChloraPrep and HaloGUARD due to potential holes in the package that could compromise product sterility. The recall affects 1,980 units distributed across multiple states.
First Aid Beauty is recalling Ultra Repair Cream due to CGMP (Current Good Manufacturing Practice) deviations. Product intended for quarantine was inadvertently distributed nationwide.
Baxter is recalling specific lots of Continu-Flo Solution Sets due to potentially inverted side clamps that render the tubing unusable. Distribution included eight US states.
Adept Medical Ltd is recalling 13,070 Otological Ventilation Tubes because they were distributed without FDA 510(k) clearance. Over 9,000 units were distributed in the US and 3,980 internationally.
Trinity Sterile is recalling Wolf-Pak Dressing Change Kits due to a potential hole in the package that could compromise the sterility of the medical kit. Lot #600022 (3,960 units) distributed nationwide.
Integrity Implants Inc. is recalling Repeater Bone Tamp devices (Model ASY-00132) due to incompatibility between Revision A bone tamps and Revision C bone funnels used in spinal fusion procedures.
Olympus Corporation is recalling Olympus Thunderbeat surgical hand instruments (Model TB-0545FCS) due to probe tips that are being damaged or breaking, which may affect instrument function during medical procedures.
Stryker is recalling 3.0MM Neuro Match Head devices (REF 5820-107-430) where the actual device may not match the product label, potentially causing surgeons to use wrong instruments during neurosurgery.
Adept Medical Ltd is recalling Otological Ventilation Tubes (T-Tube 9mm, Silicone) distributed without FDA 510(k) premarket notification clearance. Approximately 6,280 units were distributed in the US and internationally.
Stryker is recalling the 3.0MM Precision Neuro Match Head due to a packaging discrepancy where the device may not match the product label. Approximately 1,489 units distributed worldwide are affected, including lot numbers 22179047, 22179027, and 22160017.
Olympus is recalling Thunderbeat surgical instruments due to probe tip damage, breaking, and pad detachment.
The VITROS 3600 Immunodiagnostic System may not properly alert users when Signal Reagent Packs expire, risking use of expired products and potentially inaccurate test results. Affected systems worldwide should be checked for this software issue.
Trinity Sterile is recalling Wolf-Pak Premium Dressing Change Kits due to potential holes in packaging that could compromise sterility. The recall affects 5,940 units distributed in Maryland, Pennsylvania, Tennessee, and Texas.
Baxter Healthcare is recalling specific lots of its Solution Set with Duo-Vent Spike due to inverted side clamps that may render the tubing unusable. The affected product was distributed nationwide.
CODMAN CERTAS Plus Programmable Valve (Model 828810) units were distributed with incorrect product descriptions on labels. 132 units affected across multiple U.S. states and international locations.
Medtronic is recalling 745 DLP Pediatric Arterial Cannulae (Models 77008 and 77014) due to incorrect labeling affecting seven manufactured lots distributed nationwide and worldwide.
Adept Medical Ltd is recalling 2,440 otological ventilation tubes due to lack of FDA 510(k) regulatory clearance. The recall affects 1,940 units in the US and 500 units distributed internationally.
Adept Medical Ltd is recalling 2,010 units of T-Tube 6mm Double Silicone otological ventilation tubes distributed without required FDA 510(k) clearance. The recall affects 630 US units and 1,380 international units.
Brands International Corporation is recalling Kissable Diabetics Foot Cream nationwide due to lack of adequate release testing during manufacturing. The FDA has classified this as a Class II recall.
Adept Medical Ltd is recalling 310 units of Otological Ventilation Tubes (Product Code NZ3312-2) distributed in the US and internationally due to lack of FDA 510(k) regulatory clearance. The devices were distributed without required FDA pre-market approval.