State
73,106 recalls have nationwide distribution and so reach Montana. 3,571 additional recalls listed Montana specifically in their distribution scope.
Of the 3,571 recalls naming Montana we have scored against our rubric, 689 (19%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 785 (22%) are Severe.
Which agencies issued them
These figures cover only the 3,571 recalls whose distribution notice names Montana specifically. The 73,106 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.
Abbott GmbH is recalling ARCHITECT Anti-HCV Reagent Kit (7,219 units) due to falsely elevated test results when processed after certain other tests on the same instrument. The product was distributed nationwide.
Medline Industries is recalling 74,339 blood pressure units nationwide (models MDS4001, MDS4001LA, MDS4001PLUS) due to manufacturing non-compliance with specifications.
Exactech has recalled 591 units of Equinoxe Reverse Shoulder humeral liners because the packaging lacks a required oxygen barrier layer (EVOH). The nonconforming packaging may affect material integrity of these surgical implants.
Exactech recalls 66,646 Equinoxe Reverse Shoulder humeral liners due to nonconforming packaging lacking required oxygen barrier protection. The missing EVOH layer means units do not meet established packaging specification.
Medline M1S0179 sterile tape/pen packs may have weak seals that could compromise product sterility. The weakness may not be visible during normal inspection.
Medline Industries is recalling Centurion ear speculum sets due to weak seals that could compromise sterility. The defect may not be detectable by users and could allow contamination if the seal fails.
Terumo is recalling 20,533 cardiovascular procedure kits due to a pressure relief valve that opens at incorrect pressure (200-300 mmHg instead of 400 mmHg). The defect could cause myocardial tissue damage during cardiac surgery.
Covidien is recalling Signia Small Diameter Curved Tip Intelligent Reload surgical stapler reloads due to potential malfunction that could disrupt the staple line during use. The affected reloads may articulate uncontrollably due to unsecured components.
Centurion Sterile Cotton Dental Rolls with weak seals may have compromised sterility. Affected products may allow contamination if the seal fails.
Medline Industries is recalling Centurion Clamp kits due to potential weak seals that could compromise sterility. Affected units were distributed nationwide and internationally.
Covidien recalls 44,777 Auto Suture Blunt Tip Trocars worldwide due to potential seal disengagement when mesh products are used incorrectly with the device.
Exactech is recalling 6,840 units of Equinoxe shoulder implant components because their vacuum packaging lacks the required oxygen barrier layer (EVOH). The defect could potentially allow material degradation during storage.
Life Technologies Corporation is recalling Torrent Suite Dx Software versions 5.14 and earlier due to a cybersecurity vulnerability that could allow unauthorized access to alter instrument settings, configurations, software, or data.
Exactech Equinoxe glenoid shoulder implants were packaged with non-conforming bags lacking an oxygen barrier layer (EVOH), creating potential risk of material degradation. The Class II recall affects 180 units distributed nationwide and internationally.
Abbott is recalling certain myoglobin test kits because of manufacturing defects that could lead to incorrect results and delayed heart attack diagnosis.
Covidien is recalling approximately 124,863 Auto Suture Structural Balloon Trocars worldwide due to potential seal disengagement when used incorrectly with mesh products.
Glenmark Pharmaceuticals is recalling 6,528 bottles of Diltiazem Hydrochloride Extended-Release Capsules nationwide because dissolution testing found the product does not meet specifications. The FDA has classified this as a Class II recall.
Covidien is recalling 93,673 Auto Suture Blunt Tip Trocars due to potential seal disengagement when mesh products are used incorrectly. Improper use could compromise device integrity during laparoscopic procedures.
Medline's Centurion Manual surgical kits may have weak seals that fail to maintain sterility. If seals breach, microorganisms could contaminate the sterile contents, posing infection risk during surgery.
Karl Storz optical scissors (REF 115400S) are being recalled due to inadequate validation evidence for reprocessing procedures. The 27 affected units were distributed nationwide; users should contact the manufacturer for guidance.
MEDLINE INDUSTRIES is recalling Centurion 10mL sterile blood collection tubes due to weak seals that may compromise sterility and allow contamination if they fail.
Covidien Auto Suture Blunt Tip Trocar units may experience seal disengagement when mesh products are used incorrectly with the device. Healthcare facilities should discontinue use of affected units and contact Covidien for guidance.
Exactech is recalling 35 units of Equinoxe shoulder arthroplasty glenoid components because packaging lacks required oxygen barrier protection. The components were packaged in vacuum bags without Ethylene Vinyl Alcohol (EVOH) layers.
Exactech is recalling 805 Equinoxe glenoid implant components due to nonconforming vacuum packaging that lacks required oxygen barrier protection, which could affect sterility.
Abbott is recalling the Alinity i Anti-HCV Reagent Kit (5110 units) due to potential false-positive test results when syphilis testing precedes the HCV test on the same instrument. Customer complaints and internal studies confirmed the interaction that may produce falsely elevated results.